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    [title] => FDA Aims to Prevent Shortages Following Sterilization Shutdowns
    [short_title] => 
    [summary] => The agency will work to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility and the planned shutdown of another.
    [slug] => fda-aims-to-prevent-shortages-following-sterilization-shutdowns
    [body] => A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. We’re working to ensure that safe and effective sterilization of medical devices continues and hospitals, health care providers and patients have access to critical devices.
 
Earlier this year, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The state EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility.
 
As the agency responsible for ensuring the safety and efficacy of all medical devices, the FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices.
 
Certain medical devices need to be sterilized to reduce the risk of those devices causing infections in patients from living microorganisms. Sterilization of medical devices is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing and transmitting infections. It’s critical to our health care system. And ethylene oxide is a commonly used method of medical device sterilization. It’s considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care. Devices sterilized with ethylene oxide range from wound dressings to more specialized devices, like stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials. However, the FDA recognizes the environmental considerations that are currently impacting manufacturers’ ability to use this process.
 
To that end, and in light of the recent state EPA order, the FDA has been working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility in order to mitigate potential product supply issues. We’re taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care. At the same time, we’re undertaking new efforts to encourage innovative and improved sterilization options.
 
Steps to Prevent Potential Shortages
First, the FDA is actively working to prevent potential medical device shortages that may arise from the closing of the Willowbrook facility. Upon learning that the facility was ordered to stop sterilizing hundreds of various types of medical devices, we immediately reached out to the medical device manufacturers that relied on Sterigenics’ services to better understand which devices were affected by the facility ceasing operations and to assess the potential impact to patients. We are working directly with manufacturers, as needed, to help them transition to another sterilization site or sterilization method.
 
According to the FDA’s Establishment Registration & Device Listing database, Sterigenics listed a total of 594 types of devices that undergo an ethylene oxide sterilization process at the Willowbrook facility and therefore could be affected by the closure. These include products such as sutures, clamps, knives, stents, and needles. At this time, the FDA isn’t aware of any device shortages attributable to the Willowbrook facility closure. We’re closely monitoring the situation and will continue to provide updates. There’s a risk that for some sterile packaged products that are already in distribution, existing supply may be diminished—or even depleted—as health care facilities use their inventory before alternative arrangements can be made accommodate the sterilization of new products coming off manufacturing lines. This could lead to temporary or “spot” shortages of some products until sterilization can be restored. 
 
In addition, the FDA is aware that Viant, another contract sterilizer, recently made public that their Grand Rapids ethylene oxide sterilization facility is scheduled to close later this year after receiving attention from the Michigan Department of Environmental Quality for air quality issues. According to the FDA’s Establishment Registration & Device Listing database, Viant listed a total of 46 types of devices that undergo an ethylene oxide process at the Grand Rapids facility which, in the future, could be affected by the closure of the facility. These include devices such as catheters and surgical mesh. 
 
Because of the shutdown of the Sterigenics Willowbrook facility and the planned closing of the Viant Grand Rapids facility, the FDA is urging medical device manufacturers that use these facilities to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain to end users (such as health care facilities), and ultimately on patient care. We’re also encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. We’ve already communicated the steps manufacturers need to take to make changes to their contract sterilizers and maintain availability of their devices. We’re committed to working closely with manufacturers to expedite our review of any site change submissions to ensure they can efficiently switch to other contract sterilizer facilities while still ensuring safe and effective sterilization of their devices.
 
Second, while every effort is being taken to prevent a potential shortage, we’re monitoring the situation closely and stand ready to act quickly with strategies intended to limit the impact of device supply interruptions on patients. These include looking at making devices available from other sources if needed. 
 
Early awareness of a potential shortage enables us to be proactive and develop a plan to mitigate its effects on patient care. We’re taking steps to proactively identify potential shortages. Among other steps, we’ve established a device shortages mailbox so that any user, patient or organization within the supply chain that’s aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us.
 
Third, as we continue to monitor any shortages associated with facility closings, we’re also working with stakeholders—including sterilization experts, medical device manufacturers, and other government agencies—to identify innovative ways to sterilize medical devices that don’t raise the same concerns as those identified at the Willowbrook facility. About half of all sterilized medical devices undergo sterilization using ethylene oxide. In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.
 
We’ve already started exploring ways we can continue to ensure sterilization processes are safe and effective and evolving with the current science. This includes considering validation of methods that would support using lower levels of currently-used agents like ethylene oxide gas, thereby reducing environmental exposure risks, while still ensuring effective device sterilization. There may also be ways to employ—and eventually validate—new sterilization agents or processes that don’t come with the same environmental risks but still enable the safe and effective sterilization of devices.
 
To advance these efforts, we plan to discuss this issue with the infection control community at the May 2019 Healthcare Infection Control Practices Advisory Committee (HICPAC). We will also host a public advisory committee meeting that will be announced later this year dedicated to discussing how best to encourage innovation in medical device sterilization. In addition, later in 2019, we will announce a public innovation challenge to encourage the development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices. 
 
Finally, we recognize that new challenges may arise from the current situation. To help ensure transparency and communication about the use of ethylene oxide in medical device sterilization, today we launched a new FDA web page to act as a resource on this sterilization method as well as any future actions we take regarding shortages or other activities associated with this issue. We’ll update this site as new information becomes available. We’ll continue to act to help ensure patient access to safe and effective medical devices. And we’ll work directly with manufacturers, contract sterilizers, government agencies, and other public health stakeholders to evaluate potential impacts and take additional steps as needed to avert device shortages. We’re seeking to not only limit the immediate impact of these facility closures but also to identify new and improved methods for medical device sterilization. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-03-27 15:37:00 [updated_at] => 2019-03-27 15:42:03 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["306934","301785","310992","310355","309564","309243","309187","308446","308217","308074","308066","307999","306728","304414","306727","304505","307644","307528","306032","299797","310106","307639"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2019-03-27/fda-aims-to-prevent-shortages-following-sterilization-shutdowns/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 299797 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2490 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2018-10-01 [author_name] => {"name":"Florence Joffroy-Black and Dave Sheppard","title":"MedWorld Advisors"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176257 [primary_image_old] => [slider_image_id] => 176257 [banner_image] => 0 [title] => Supply Chain 2020—How Are You Trending? [short_title] => [summary] => [slug] => supply-chain-2020-how-are-you-trending [body] => Since the dawn of the 21st century, prognosticators have been looking ahead to the year 2020 and predicting what life might be like for various industries, markets, and professions. As that target year quickly approaches (14 months out), it’s worth taking a look at key supply chain initiatives and how they are currently trending. 

Key 2020 topics have been extensively discussed, examined with vigor and intensity, and shared with supply chain professionals. Some of the more interesting predictions for the sector include:
Let’s examine these topics on an individual basis.

Supply Chain Professionals
As the 20th century faded into the new millennium, it was clear the occupation of the supply chain executive had forever changed from a tactical purchasing role to that of a strategic professional. That observation has never been more true than it is now, in 2018. The supply chain executive role has been elevated in most organizations, with strategic purchasing decisions in many cases significantly impacting corporate profitability. These decisions can help facilitate market entry or create obstacles in various geographies and/or industries. As a result, there has been an increase in educational programs (both inside and outside the academic setting) dedicated to supply chain management and the success of supply chain professionals.

Global Supply Chains
In the medtech industry, the idea of global supply chains sprouted from the need for lower-cost products due to increasing pricing pressure during the past 20 years. It began with the production of less expensive components such as circuit boards, widgets, and other items in lower-cost (oftentimes developing) countries. Today, however, the practice has evolved into a much broader spectrum.

Ability to Segment Regionally and Globally
The “spaghetti string” of the early global supply chains became problematic. What an organization saved in component cost was often counteracted by increases in logistical (i.e., shipping) expenses. Therefore, the benefits of the initial creation of global supply chains has allowed for continuous improvement through segmentation of the supply chain on a regional basis. Additionally, many companies have realized the importance of manufacturing closer to the customer. In Europe, this idea of “local-for-local manufacturing” has created an increase in Eastern European production to serve the European Union markets. Across the Atlantic, Puerto Rico, Costa Rica, and Mexico have driven cost efficiencies in the Americas through free trade zones, while China has reaped the biggest benefits of this trend in the Asian market. Considered merely a lower-cost component manufacturing country at the turn of the century, China is now a fully capable “finished device” manufacturer for the emerging markets. Companies are finally realizing the competitive advantage that comes with designing and manufacturing their products locally, for local sale.

External Supply Chain Transparency
The need for additional supply chain transparency in the medical technology industry has been driven by regulatory factors and social media/cultural pressures. The regulatory environment used to be far less complicated than it is today. Around the turn of the century, a company only needed to manage its own manufacturing processes from the time it received a supplier’s product (assuming it performed an incoming inspection, etc.). But that is no longer an acceptable practice. The U.S. Food and Drug Administration now requires device manufacturers to manage their supply chains the same way they manage their own internal processes. Consequently, medical manufacturers now require their supply chains to conform to requirements such as ISO 13485; standards like ISO 9001 are no longer enough for most OEMs.

Thanks to social media, large medical technology companies (J&J, Medtronic plc, Stryker Corp., Baxter, Boston Scientific, etc.) are now more visible (and exposed) to the public than ever before. This creates an opportunity for the consumer to expect—and in some cases, demand—that these major companies engage in social responsibility in their supply chain practices. While initially a “pain” for some of these companies, most organizations have now embraced this issue as an opportunity to differentiate themselves and create an additional value proposition for their end customers.

Sustainability
Although it used to be an aspirational topic for many companies, most organizations have constructively engaged in sustainability in recent years. In doing so, they have moved from sustainability as an aspiration to a core value. Thus, sustainability goals are now set—and even measured. An MPO Supply Chain column in October 2017 (“Sustainable Procurement—What is Your Target?”) identifies key medtech OEMs that are heavily investing (and measuring) their sustainability results. These companies include industry giants like Cardinal Health, Edwards Lifesciences, Varian Medical Systems, and 3M.

Cloud Impact on Supply Chain
There are numerous white papers and articles addressing the positive impact of the Cloud on supply chain management and performance. Many of these documents (largely, white papers and articles) are written (or supported) by Cloud vendors that benefit from such references. These documents, however, are “directionally correct.” The Cloud is a positive influence on supply chain management performance in key areas like global access and the removal of regional boundaries;  the capacity for worldwide scalability; the integration of multiple IT platforms (i.e., due to M&A many organizations do not have a unified IT platform throughout their various regions and/or business units); and the ability to increase analytical tools on a transparent basis for key executives throughout the organization.

AI as a Key Factor
Outside the medical technology industry, it’s clear that companies like Walmart, Target, and Amazon are utilizing artificial intelligence as predictive analytics for demand forecasting and warehouse management. Within the industry, companies like Deloitte and Optum are marketing solutions for OEMs to improve their performance. As this is a recent trend, we look forward to more future documentation of the results of these efforts. This is likely to be a trend far beyond 2020.

Robotics in the Supply Chain
Moving to a low-cost country used to give supply chain executives enough confidence to justify the decision based on the labor savings alone. However, these markets are now experiencing wage inflation and have assumed increased cost pressures (excluding the potential tariff issues, which is a separate topic to address). With this escalating employee cost metric and the need for improved productivity on a global basis, robotics is increasingly being utilized in both developed and emerging markets. As robotics becomes more commonplace, the technology will likely increase the potential value of manufacturing jobs worldwide.

Blockchain Technology
Trendy, trendy, trendy—just referencing “blockchain” is instantly topical and edgy. However, blockchain is yet to be proven as a viable efficient technology (outside of bitcoin and initial coin offerings). It certainly has potential to have a tremendous impact across industries and market segments. It will be interesting to witness some of the actual utilizations and impacts of blockchain technology in supply chain management and specifically in medtech supply chain efficiency.

Conclusion
Overall, the prognosticators have been fairly accurate with their predictions. Some of these trends have occurred quickly while others are taking time to develop. Clearly, there will be additional key “trendy” items to discuss as the year 2020 looms larger on the horizon. In the meantime, be flexible and stay abreast of the trends affecting the supply chain. The future will be here in no time. v


Florence Joffroy-Black, CM&AA, is a long-time marketing and M&A expert with significant experience in the medical technology industry, including working for multi-national corporations based in the United States, Germany, and Israel. She can be reached at florencejblack@medworldadvisors.com

Dave Sheppard is a former Fortune 500 MedTech executive and is now a principal at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-16 13:52:33 [updated_at] => 2018-10-16 13:52:33 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279724","283689","289756","289798","299952","290022","289765","289745","279662","299790","289770","289744","285583"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304414 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Vicki Anastasi, VP and Global Head, Medical Device and Diagnostics Research, ICON","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179692 [primary_image_old] => [slider_image_id] => 179692 [banner_image] => 0 [title] => How Value-Based Healthcare Affects Medical Device Development [short_title] => [summary] => Manufacturers need to employ new methods and tools to maximize the effectiveness of their efforts in bringing new devices to market. [slug] => how-value-based-healthcare-affects-medical-device-development [body] => Value-based healthcare (VBHC) models are poised to transform everything from how patient care is delivered to how treatments are priced. An analysis by United Healthcare estimated that at the end of 2018, more than $65 billion will be tied to value-based contracts. Furthermore, as the movement gains momentum, the adoption of value-based care is projected to account for about 59 percent of healthcare payments by 2020, according to Aetna 2018 Health Care Trends Report.

Unlike traditional models where care is considered to be the treatment a patient receives at the time he or she sees a healthcare provider, VBHC models consider care to be a long-term affair that stretches from the first doctor visit to months, or even years after the treatment was first delivered. This encourages providers to consider the long-term outcomes and costs of a treatment or medical device.

VBHC follows the idea that payments for services are linked to the clinical and cost outcomes for treating a defined patient need, condition, or episode of care—as opposed to the volume of the provided services. Policymakers believe that holding healthcare providers accountable incentivizes improvements that will ultimately produce better individual patient and population health outcomes at a lower overall cost.

To achieve success in a VBHC market, device manufacturers will need to work with providers to control costs, while demonstrating value in terms of improved patient outcomes through new types of evidence. Manufacturers will need to share product performance data to providers that offer a complete solution to the procedures in which their devices are used. What’s more, they need to integrate themselves further in the healthcare delivery system.

For device manufacturers, the challenges that come with the shift to VBHC are a marked departure from how the relationship between device manufacturers, payers, and providers has been conducted in previous years.

Value Can Mean Many Things
Aligning the many definitions of value that each stakeholder holds is the biggest challenge in the transition to value-based healthcare. Patients and physicians might put the highest value on individual clinical efficacy and convenience. On the other hand, payers and governments may not consider these as important as cost and population health impact.

An example that illustrates the misaligned definitions of value is the 90-day episode-of-care bundled payment for joint replacement surgery. A provider group that is getting a flat-rate bundled payment might be reluctant to spend more on a costlier joint replacement implant, when there is a cheaper alternative readily available, even if the expensive implant can potentially reduce the patient’s healthcare costs over the subsequent 20 years. Therefore, the short-term financial incentive on the part of the provider is not aligned with the patients’ long-term best interests, in addition to the long-term treatment cost implications for the healthcare system.

The key to success is to ensure the many definitions of value align across stakeholders, especially with payers, who have the most sway in decisions. It is important to determine what benefits accrue to whom and over what time frame, and then to focus on those benefits when establishing a target market or during price negotiations.

A fundamental shift needs to occur when considering value. For instance, factoring value into clinical trial design should occur earlier in the product lifecycle and in balance with other aspects of a patient's care. A stakeholder value mapping process can help identify what various stakeholders value and over what time frame that value is returned. Manufacturers can use this map to assess the market potential of devices in development and guide evidence generation and actions that foster alignment of incentives for all stakeholders, so that they all can realize the value they expect.

Putting a Price on Value
To ensure devices achieve success in the marketplace, manufacturers need to work with providers to control costs. Provider groups may attempt to circumvent the high price of a more expensive, but better performing, product by negotiating a lower price point from the manufacturers. Also, providers may turn to insurers to make a deal that pays the provider more for using a specific device because its higher upfront cost can be offset by lower treatment costs over future years.

In other cases, patients may be asked to pay the extra cost of a non-standard device or diagnostic, since payers reason patients would pay for a device that provides an improved outcome over the standard option.

Regardless of what cost-reducing method is chosen, payers will continue to hold providers accountable for delivering better patient outcomes at a lower overall price. This could cause device manufacturers to consistently and aggressively lower the price of their products to remain a viable and attractive option for providers.

However, lowered pricing places cost pressures on device manufacturers, who could see lower margins on their devices as a result of operating in a VBHC system. While achieving profitability may become more challenging, manufacturers have the opportunity to increase sustainability and improve patient outcomes by changing how they approach device development. For example, carefully assessing, planning, and coordinating with a range of potential stakeholders will be required to generate higher margins.

As detailed earlier, to counteract the potential decline in margins, device manufacturers need to incorporate steps to address value earlier in the product lifecycle. Traditionally, clinicians write study protocols that maximize clinical data collection, and an economist’s valuation of the device occurs late in the development process. This leaves the economist little time to gather and analyze data, which can significantly impair a new device or diagnostic’s survival in an already tough market.

Proving New Is More Than Better
In the past, to clear lower risk devices under the FDA 510(k) or CE mark process, it was necessary to demonstrate that the new device was equivalent to a previously approved device, but no clinical outcomes evidence was required for Class I and Class II devices. Currently, under VBHC, buyers and regulators are requiring more evidence of clinical effectiveness and cost impact of new treatments to ensure they are getting their money’s worth.

As a result, device manufacturers will need to provide evidence that a product not only works, but also generates offsetting savings or patient benefits that make it worth the extra cost if it is a premium price over similar products.

In addition, from the provider’s perspective, claiming a device is equivalent to an older device means its worth is no more than the older device. So, for truly innovative devices, manufacturers must consider the worth of investing in a pre-market approval program that gathers detailed clinical evidence and cost impact information, at the same time, to provide the innovative device an edge once it is available on the market. Therefore, clinical and economic data are essential to developing a value-based case for higher payment.

mHealth Helps to Gather Evidence
Showing the long-term benefits of novel devices requires new types of metrics and data gathering methods. For example, data from mobile health technologies (mHealth)—which includes mobile sensors for detecting clinical signs and patient activity; mobile apps for running diagnostic quizzes and reporting symptoms; and telemedicine applications that run on smartphones, tablets, and other electronic devices—can be transmitted wirelessly, enabling continuous monitoring of patient progress or therapy adherence.

Using mHealth and other innovative technologies can generate the evidence needed for manufacturers to demonstrate value in several ways. The litany of mobile sensors can generate continuous streams of data on vital signs such as blood pressure, blood sugar, and heart rate. mHealth can also identify changes in patient outcomes of which they themselves may not be aware, such as increased activity due to relief of chronic pain.

Perhaps the most important information that mHealth technologies bring to light are data for real-time patient activity, which show how a therapy impacts patient outcomes, especially those that are difficult to document through periodic clinical visits, such as the ability to walk to the grocery store or care for themselves or others.

Moreover, diagnostic and telemedicine apps can keep patients in communication with clinics, creating scenarios where healthcare providers can discharge patients earlier after surgery, since they’ll be monitored in a home setting and still be in close contact with the provider in the event there are complications.

Conclusion
Moving forward, the implementation of VBHC models means manufacturers will need to demonstrate clinical efficacy and cost impact of new devices—especially earlier in the development process—to ensure products benefit patients, while outweighing any extra costs. mHealth technologies have the potential to document the value of treatments more effectively and efficiently, helping manufacturers to increase treatment value, while presenting a persuasive case to payers. Despite the challenges, the rewards of value-based care can be high for manufacturers, as they can help patients to have more timely access to innovative medical technologies.

Partnering with a CRO that has a proven track record in clinical evidence generation, economic modeling, and commercialization expertise can help throughout the stakeholder value mapping process and ensuring a new device can have a good market impact.


Vicki Anastasi is vice president and global head, Medical Device and Diagnostics Research at ICON plc. She provides leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over 25 years of experience in the medical device industry, with over 15 years specifically focused on global medical device strategic consulting. Prior to joining the company in 2007, Anastasi held senior management roles for medical device companies focused in orthopedics, cardiovascular, general hospital, and general surgical devices. In diagnostics, she held senior positions at companies involved in the development of infectious disease and genetic-based products. She is actively involved in medical device industry groups, including Advamed, MDIC, and MassMedic, where she regularly speaks and participates in medical device focused panels and discussions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-17 14:28:00 [updated_at] => 2018-12-18 07:50:18 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["288057","304069","297162","290316","296990","257743","252658","249412","301046","296463","302323","302604","291642","301768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304505 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Editorial Advisory Board","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179758 [primary_image_old] => [slider_image_id] => 179758 [banner_image] => 0 [title] => Sounding Board: 2018 Reflections and Looking Ahead [short_title] => [summary] => MPO’s board members speak on 2018’s most significant headlines and offer insights on what’s on the horizon for the industry. [slug] => sounding-board-2018-reflections-and-looking-ahead [body] => Prior to Michael Barbella, managing editor, writing his 2018 Year in Review feature, the team reached out to the magazine’s Editorial Advisory Board to ask two questions:
 
1. What news headline, event, or technology was the most significant in 2018 and why?
2. What’s one expectation you have for 2019 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on?)

 
As always, we received great feedback from a number of board members who shared their thoughts on the questions. Unfortunately, only a handful of quotes were able to be featured in Barbella’s article, so all of the responses are provided here.
 
Note: These responses were provided throughout the second half of October 2018, so that should be taken into account given events that have occurred since that time period which may alter how a given response is viewed.
 
Sara E. Dyson, Esq., Assistant Vice President of Risk Management, Medmarc Insurance Group
2018 Reflections—The ongoing opioid litigation will forever change the life sciences industry. As companies grapple with the fallout of this litigation, pharmaceutical manufacturers will have to make significant changes to both their practices and the products they create, and device manufacturers will rethink drug delivery systems as well as other technologies—alternatives to pharmaceuticals—that help patients manage pain.
 
Looking Ahead—In 2018, FDA came under simultaneous attack by two different constituent groups, each critical of the time it takes FDA to bring new products to market. However, one side claims FDA takes too long to bring new products to market, and the other side argues FDA doesn’t take enough time to assess product safety. Pressure from the one side has already resulted in policy changes designed to put products in the hands of patients faster, such as the “right to try” laws that give terminally ill patients the right to try new drugs while they are still in clinical trials. Meanwhile, the other side is advocating changes that will make the 510(k) process more rigorous, among other things. I think 2019 will continue to see FDA “squeezed” by pressure from both sides, though it is unclear who will win this “tug-of-war” over the long term. Much will depend on the political climate as well as the public’s perception of high-profile examples of device failures alleged to result from a “rushed” process.
 
J. Mark King, President and CEO, Tegra Medical
2018 Reflections—The news items with the most impact in 2018 have been those discussing the evolution of healthcare. Market forces are precipitating a higher focus on value that is tied to patient outcomes [e.g., treating patients appropriately and reducing the need for return visits (often the ER), reducing unnecessary diagnostic tests, and finding alternatives to avoidable surgeries]. Medtech companies offer the technology to help streamline and improve the quality of care and can play a huge role in the transformation.
 
Looking Ahead—I always say that people are what is most important, so keep an eye on them! Your people can make the biggest impact. Medtech companies that place a high value on their employees and treat them well are making a critical investment. The institutional knowledge and expertise of long-term employees is a strong competitive advantage; customers appreciate working with someone they have long learned to trust.
 
Patrick Lynch, Supply Chain Director, Tear Film Innovations
2018 Reflections—The U.S.-led trade war implications have upended medical device cost models not only for contract manufacturing but also component sourcing as a whole, with China markets taking the biggest hit.
 
Sizable landed cost increases of 5-15 percent have forced renegotiations, and in some cases, subsequent sourcing efforts to move production to new suppliers as a means of offsetting the tariffs, which have created a backlog of sourcing projects, including:
   
Our experience has shown these past several months that incumbent suppliers, sensitive to the customer’s cost impact have provided some relief, allowing a portion of cost increases to be recovered, however, best results have been achieved by initiating new RFQs.
 
Looking Ahead—Repositioning of the major contract manufacturers to shuffle equipment and resources to alternate sites and countries to retain their customer base, in light of the tariff action.
 
Steve Maylish, Co-Founder and CCO, Fusion Biotec
2018 Reflections—One of the biggest changes our healthcare system is undergoing is the move to consumerization. It started slowly, but in 2018, the investment in Oscar Health has now gone over $1 billion dollars. In addition, there are a large number of startups crowding into this space; Bright Health, Devoted Health, and Clover Health, just to name a few. This year, Devoted Health raised $300 million in a series B round and Clover Health has raised $425 million over the last few years. These “payvidors” offer patient-centric care designed to support and monitor patients by using data science to cut costs and promote preventative care. Some are working with prescription services. Others are using genomic data, machine learning, and artificial intelligence to promote health. Some offer in-home primary care programs and house calls.
 
Looking Ahead—The large interest in digital healthcare is driven by this move to consumerization. Although many of these startups are targeting the Medicare Advantage segment, they will eventually migrate to the larger insurance industry. This is the typical path of disruptive innovation. The days of jumping from primary care doctors to specialists to hospitals to imaging facilities may be numbered. Because patient experience is uncoordinated, reactive, and filled with administrative bureaucracy, 2019 should see continued interest, investment, and growth in the “payvidor” space.
 
Susan Mucha, President, Powell-Mucha Consulting Inc.
2018 Reflections—I think the China tariffs are the most significant event in 2018. The unintended consequences of placing a tariff on electronic components is incentivizing migration of U.S. manufacturing to Mexico and other parts of the world. If the tariff situation is short-lived or it is adjusted to impact only finished goods, it will be good for U.S. manufacturing if it helps open Chinese markets to a larger amount of U.S. goods and reduce unfair trade practices. However, if it continues as is currently written through 2019, I think it will impact U.S. manufacturing growth negatively.
 
Looking Ahead—I think the most significant event of 2019 will relate to what Congress does regarding healthcare. The Affordable Care Act (ACA) changed the healthcare landscape dramatically. Legislative action has eliminated the penalties associated with not buying insurance and insurance costs have skyrocketed for both individuals and employers. If the situation continues unchecked, healthcare providers will be dealing with larger populations of uninsured and/or underinsured patients, and most likely a drop in elective procedures. That could slow medical capital equipment purchases and put more cost pressure on all medical devices.
 
Tony Mulone, President, Winstable Group LLC
2018 Reflections—Trade negotiations with China and its impact on "re-shoring or on-shoring." As a way to avoid tariffs, companies may use China as a component supplier and move finished goods assembly out to other countries. This could help U.S.- and Mexico-based CMs gain back lost OEM medical device business.
 
Looking Ahead—I’ll be watching the China trade negotiations and its impact on tariffs and IP protection.
 
Jeff Nelson, President, Nelson Laboratories
2018 Reflections—The medical device industry is experiencing increasing compliance requirements. FDA is regulating mobile medical apps and stressing human factors engineering; while the EU has implemented a new set of Medical Device Regulations (MDRs) that will require manufactures’ close attention. Also, regulators continue to look at new ways to evaluate the biocompatibility and biological risk of materials in medical devices—driving the need for more in vitro and chemical characterization solutions.
 
Looking Ahead—As healthcare becomes more personalized, 3D printing (additive manufacturing) will continue to take a larger role in medical device manufacturing. The goal of 3D printing is to manufacture medical devices that are uniquely customized to each patient, are safer, and reduce costs and decrease time to market. However, this could create a new set of challenges and opportunities for evaluating biocompatibility, testing for particulates, validating cleaning, sterilizing, packaging, and distributing devices.
 
Chris Oleksy, CEO and Founder, Oleksy Enterprises and Next Life Medical
2018 Reflections—To me, the top news event of 2018 was the announcement that players like Walmart and CVS were partnering and/or acquiring organizations like Humana and Aetna, which could ultimately control “where” an individual spends their healthcare dollars or even “what type” of healthcare an individual will be “allowed” to have within their offerings. Additionally, the new venture between Amazon, Berkshire Hathaway, and JP Morgan could create some very interesting value chains for these organizations and their employees. Bottom line, the “eat or be eaten—survival of the fittest” mantra I have been writing about the past two years is no longer speculation, but reality!
 
Looking Ahead—Regardless of which party controls Congress, one key expectation I have for 2019 is the return of an old term to Washington—gridlock—creating an environment in which it will be very difficult to make further needed improvements to Obamacare. The divisive bickering in Washington makes it practically impossible to accomplish much. But, there could be one silver lining; the Senate will finally finish the work started by the House and repeal the medical device tax at the beginning of 2019, before the new Congress is installed.
 
Paul Orlando, Vice President of External Operations, Olympus Surgical Technologies America
2018 Reflections—By far, President Trump’s action and strategies regarding fair trade and tariffs was most significant. This will impact companies to reconsider where/how to outsource. Second would be the continuation of suppliers being acquired and consolidated via private equity plays. These mergers and acquisitions make financial performance a higher priority than patient health, product performance, and quality.
 
Dr. Bryce G. Rutter, Founder and CEO, Metaphase Design Group
2018 Reflections—One of the most active spaces for R&D in 2018 was in robotic surgery, with giants including Medtronic, Stryker, and J&J jumping into a market space that, for so many years, has been dominated by Intuitive Surgical. It will be interesting to see how each of these companies try to differentiate themselves by specializing in specific surgical techniques and/or marrying adjacent technologies with their robotic systems.
 
No one can ignore the intersection between surgical, test, and monitoring devices and the Internet of Things. And, while not new, the acceleration is geometric. The potency of this juncture is undeniable, however, it's clear that because it is easy to create an app to support a device, far too many are not asking the fundamental question of whether or not it truly adds value to the end user or is just one more thing to learn, adding more noise to the user experience.
 
Looking Ahead—Without a doubt, the FDA's requirement for conducting thorough user needs research and usability testing throughout the design development process will drive down use errors and improve clinical efficacy by making products, instructions for use, and secondary packaging more intuitive and easier-to-use.
 
Dave Sheppard, COO and Principal, MedWorld Advisors
2018 Reflections—2018 has been an interesting year as there has not been any one defining event or technology. However, there are several key issues that had possible impacts on the future of the medtech industry. In summary, 2018 was a C.O.M.A. (China, Obamacare, M&A, and AI) year for medtech.
   
Looking Ahead—2019 has the potential to be a R.A.D. (Robotics, Acquisitions, and Digital Health) year for the following reasons.
   
Tom Vassallo, Executive Vice President, Global Business Development, Freudenberg Medical
2018 Reflections—My top choice would be the future application of robotics in the delivery of surgical procedures. This is relevant to the progress of joint ventures between premier medical device companies and tech giants. It is also significant to the anticipation of shared knowledge, technologies, and resources in joint ventures/partnerships.
 
Looking Ahead—I’ll be primarily watching three things.
 
  1. Wearables and the interface with apps and devices
  2. The myriad of possible combinations of insurance companies, clinics, and the supply chain (CVS)
  3. The Googles and Microsofts of Silicon Valley and Nashville’s entrepreneurs anticipated (disruptive) entrance into healthcare.
 
One additional item of interest will be most important for component manufacturers and custom/special medical device providers—3D printing of components and implantable devices. Rapid progress is being made regarding the types of materials available including frameworks (scaffolds) for growing new tissues utilizing the 3D printing process.
 

Interested in getting further insights on these questions? Jump over to ODT and see what the Editorial Advisory Board members there had to say. Click here to go to the ODT feature. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-18 15:06:00 [updated_at] => 2018-12-18 15:11:25 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304105","304021","303430","301013","301011","298924","291771","302307","299785","235504","299799","296454","302302","289748","299798","289747"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306032 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Brianna Sporbert, VP of Engineering, Boyd Technologies","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181049 [primary_image_old] => [slider_image_id] => 181051 [banner_image] => 0 [title] => Strategies for Maximizing Your Supply Chain [short_title] => [summary] => How to grow faster with less risk by leveraging manufacturing partners. [slug] => strategies-for-maximizing-your-supply-chain [body] => In today’s evolving regulatory environment, supply chain transparency is a game-changing differentiator. Collaborating with manufacturing partners who have excellent supplier relationships and a deep understanding of materials can revolutionize the product development process. Even after a robust supply chain has been established, there are still hurdles in commercializing a medical device. Often, in an attempt to conserve resources, cutting corners in the design process leads to product failure. One way to mitigate this risk is to establish a comprehensive validation plan that does not compromise quality and reaps long-term cost savings.
 
Considerations for Raw Materials
Raw Materials Challenges
When it comes to medical devices, OEMs must be able to manufacture them with complete consistency of quality. Raw materials are often the biggest challenge to this consistency. Because of the risks that are associated with raw materials, governments and international regulating bodies are increasing regulations on the medical device industry.
 
The complexity of supply chains is another piece that adds risk into this evolving landscape. Traceability and the control of raw materials through the entire supply chain are becoming ever-more critical. Globalization and the consolidation of the supply chain need to be handled by medical device manufacturers and their trusted partners. This requires OEMs to develop trusting relationships with supply chain partners. It also necessitates them to demand more traceability for every raw material as it makes its way through the supply chain.
 
Regulations require medical device manufacturers to assess and mitigate risk throughout their entire processes, especially of raw materials. The recent trend to new regulations is that they are reaching further up into the supply chain more so than they ever have in the past. It is essential for device manufacturers to have the support and cooperation of the raw materials suppliers. The better your partnership is with your contract manufacturer, the more of a cohesive network this can become.
 
An approved supplier list can be an excellent tool for keeping track of supplier monitoring and the critical aspects of purchasing control, provided it is actively maintained. FDA requires the level of supplier assessment to be proportionate to the level of risk associated with the medical device. If you have a higher risk supplier who may be supplying a key component to your device, or providing a critical service such as sterilization, then your qualification process will be much more involved. To effectively deploy and implement these requirements, OEMs must both support and cooperate with their raw material suppliers.
 
Updates to Regulations
One of the most comprehensive ways the FDA has enhanced regulatory success is through consistency with international commercial standards. The International Organization for Standardization (ISO) standard specific to medical devices is ISO 13485. This management system was first published in 2003 and was updated in 2016.
 
ISO 13485: 2016 is now harmonized with FDA 21 CFR Part 820 and has explicit requirements for monitoring and re-evaluating suppliers. This has been a shift in focus from the 13485: 2003 version with the key concept focused on mitigating risk, specifically with the end user in mind. This makes the Quality Management System of suppliers critical. The new standard puts more emphasis on risk management before product realization. It also requires an increased focus on supplier selection criteria, including assessment of risks and regulatory requirements.
 
Both this voluntary standard and the FDA’s enforced regulation have explicit requirements for monitoring and re-evaluating suppliers. With the revision of the ISO standard, there has been a renewed emphasis on risk. The topic of risk was covered so little by the first publication of the standard that a formal definition of the term was not given. The newly published standard, however, defines risk and expands it to encompass more than just product realization. It states that a risk-based approach needs to be applied to:
   
It should be noted that the FDA is not alone in implementing more enforceable regulations. The EU has also decided to enhance regulatory oversight with Medical Device Regulation (EU) 2017/745 and In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. While previous EU oversight was mainly accomplished through directives, these new regulations are changing Europe’s medical device industry dramatically and will continue to do so while they are being phased in by 2020 (EU MDR) and 2022 (EU IVDR). In short, governments around the world are beginning to recognize the importance of increasing and harmonizing the regulations surrounding medical device manufacturing. At the center of these regulation enhancements is the priority of effectively evaluating risk and responding appropriately to it.
 
Regulatory Considerations
Moving forward, OEMs must remain aware of the evolving regulations surrounding the raw materials they use and the suppliers who provide the materials. Risk assessment of these factors of medical device manufacturing will only continue to be prioritized by regulatory bodies in the industry and around the world.
 
Manufacturers will find that the best way to minimize risk surrounding the quality of raw materials and suppliers is to control the parameters of the manufacturing process as a whole. Working with a supplier who is willing to submit a Certificate of Analysis or Certificate of Conformance that is directly related to a specification that is in place helps to reduce that variability. 
 
Supply Chain Transparency
The most effective method for navigating the challenges that come with supply chains is to increase transparency. When manufacturers have a bird’s-eye view of their vendors, their materials, and the logistics they can much more effectively follow and enforce the regulations that surround the manufacturing process. The following points are important factors to keep in mind to create better transparency:
 
Supplier Selection Best Practices
There is no substitute for consistently following the medical device manufacturing industry’s best practices for supplier approval. The industry leaders, as well as outside researchers and thought leaders, have created methods for identifying and utilizing the right suppliers. Five key best practices can and should be implemented:
 
  1. Evaluation Plan: Manufacturers need to develop a plan for evaluating and ranking their potential suppliers. This will require them to create a persona for their ideal supplier. It can consist of preferences, but it must include the need for full compliance with industry regulations and methods for ensuring transparency in the sourcing and movement of raw materials. One important note to keep in mind is that it will cost more money to reactively fix a problem in your supply chain than to proactively address it, even if it’s a more expensive option at the moment.
  2. Utilize Medical Device Industry Suppliers: The best option for any manufacturer is to work with suppliers that have experience in the medical device industry. This type of experience will indicate that they understand the regulatory environment and already have systems in place to assist manufacturers in their compliance.
  3. Measure and Monitor: After a supplier is identified, establish a process following qualification for measuring and monitoring supplier performance. Make it an ongoing process rather than a one-time event.
  4. Regular Audits: Performing regular audits in collaboration with measuring supplier performance continues to strengthen the supply chain. Manufacturers should regularly utilize an audit to verify whether the processes and systems that they have put in place in their supply chain are working.
  5. Supplier Engagement: Creating open lines of communication can transform the way supply chains operate. However, this engagement will provide much more valuable outcomes if manufacturers purposefully engage with suppliers who participate in a meaningful validation program. When suppliers are already involved in these programs, it means they are actively identifying issues before they turn into problems. In other words, they are reducing risk in the supply chain. These are the type of suppliers that manufacturers should be working with—those that value transparency.
 
When these practices are implemented simultaneously, device manufacturers will see that they can identify suppliers that will help them to create a robust, transparent supply chain; a supply chain that can help to manage risk when new medical devices are being introduced to the market.
 
Design For Manufacturability
While there are processes, systems, and tools that can provide increased transparency in the supply chain, these options will only take an OEM so far in managing risk and complying with regulations under enhanced scrutiny. The glue that will hold all of these transparency techniques together, and, work to strengthen them, is strong relationships.
 
OEMs must prioritize building long-lasting and trusting relationships with the contract manufacturers and raw material manufacturers. There are two substantial benefits to developing relationships across the supply chain. The first is that as the various partners build trust with each other, they can have increased ease in communication, as well as a higher likelihood that the partnership will continue over the long-term. Making suppliers a part of the quality assessment means it is much more likely that you will receive acceptable parts. This can be facilitated by involving them in the design process up front. Whenever you design a new product, an opportunity exists to collaborate with a raw materials manufacturer and being transparent with your suppliers upfront can lead to a more optimized design for manufacture.
 
The second benefit is that each partner in the supply chain, from the OEM to the contract manufacturer to the raw material manufacturer, has a unique set of knowledge and expertise regarding the use of materials. These differing perspectives and broader proficiencies, when combined, can considerably strengthen the supply chain, allowing for better risk management. It also allows the OEM to avoid over-engineering the medical device that they are designing. Because there is more in-depth knowledge about every component of the device, it works to reduce the complexity. This means that there is even more standardization with every device, alongside the uniformity to the supply chain as a whole.
 
When these benefits of strong supplier relationships are combined, it leads to better product design, as well as a design that is more manufacturable. The OEM can rely on a higher quality of raw materials from their suppliers. This higher quality comes from the fact that suppliers can provide a more accurate characterization of each raw material, which reduces variability. This then leads to a greater consistency when assembling the final product.
 
Additionally, because the OEM can have more confidence in quality assurance, they are able to build up their manufacturing processes to be both more robust and more controlled. This also extends to the analytics behind the manufacturing, enabling the OEM to get a more accurate picture of the lifespan of each product, from design to market introduction to order fulfillment.
 
Finally, a stronger relationship that contributes to more trust and better communication will lead to easier change. As new devices are designed, old devices are updated, manufacturing methods change, technology advances, and regulations evolve, OEMs and their supply chains are forced to change. Traditionally, change was not easy. It disrupted the current processes. When there is greater transparency in the supply chain and change notifications can be quickly provided, the organizations involved can adapt with less effort. The roadmap for bringing a device from concept to market becomes much more manageable for all involved.
 
Documentation
In any industry, documentation can be a bottleneck. In medical device manufacturing, collecting the right documents and information from suppliers is one of the most significant contributors to raw material qualification delays. As regulations tighten, these delays will only create more delays to ill-prepared manufacturers and suppliers.
 
To prevent these bottlenecks and provide a strong example of the necessary transparency, OEMs should clearly and expediently communicate what documentation they need from each supplier. This includes any documentation that supports raw material qualification and the information required for ongoing material management. However, device manufacturers should never assume that partners have agreed to provide these documents. They need to get verification—a commitment in writing, and possibly a plan from the provider that discloses what processes they are putting in place to guarantee they fulfill the documentation obligation. To provide a show of good faith, OEMs can request that they share quality agreement templates in the early phases of the partnership.
 
These quality agreement templates can only be created after the manufacturer and their suppliers discuss the nature of the quality agreement. This discussion must happen early on in the qualification process. If it occurs later, the manufacturer could fail to agree on the specifics around raw material quality. This means that the partnership cannot happen and both the manufacturer and the supplier have wasted time in discussions.
 
OEMs can save additional time, as well as facilitate the qualification process, by working with a supplier who already has documentation packages prepared and readily available.
 
Risk Mitigation Throughout the Development Process
The actual design process is formalized with the application of design controls. Feedback paths are required between each phase of the process and previous phases, representing the iterative nature of product development. Design controls also serve as a series of checks and balances and aid to identify and analyze risk throughout the design process, leading to a well-made product.
 
The Design Process
The most effective way to mitigate risk in the design process is to break the design process down, identify the various possible risks and develop methods for addressing each risk. This is done in an iterative fashion, evaluating both component parts as well as the device as a whole.
   
Design Controls
Design controls serve as checks and balances to the product development process and are codified in FDA 21 CFR Part 820.30. FDA uses a risk-based approach with the application and requirement for design controls. Design Controls also ensure that the device meets requirements and inputs, applicable standards, and performance criteria. At its core, the FDA’s design controls are comprehensive documentation from the design process. The regulator wants manufacturers to provide a thorough record of every phase in the design process. Therefore, design controls play an integral role throughout the medical device development process—with every step forward, design control documentation is present.
 
The strength that design controls bring to the medical device development process is that they offer checks and balances. Through this documentation, device manufacturers get a chance to identify, measure, analyze, evaluate, and mitigate potential risks that may be associated with the product. In the end, it is the design controls that allow medical devices to be as safe as possible.
 
Risk Management
Design controls and risk management in the product development process are closely related. Just as with design controls, risk management identifies, measures, analyzes, evaluates, and mitigates potential risk. Risk management starts with the design input requirements. As the design evolves, new risks may become evident. The risk management process is integrated into the design process to systematically identify and, when necessary, reduce these risks. This way, unacceptable risks can be identified and managed much earlier in the design process when changes are easier and less costly to make. The main difference is that the design controls and risk management look at device development from different perspectives. While design controls are proof of safety, risk management is used to develop the right tools to maintain device safety.
 
It is important for manufacturers to realize that their risk perspective is not necessarily the same as the risk perspectives of the contract manufacturers and suppliers. OEMs are concerned with the performance of the product. Contract manufacturers and suppliers, on the other hand, are concerned with the process. So, while the OEM’s primary concern is whether the product adversely affects the end user, the contract manufacturer and supplier’s concern is whether the product and components meet the acceptance criteria.
 
In an example for our case study, a specification called for rounded corners on a heat laminated bag. Rounded corners vs. non-radiused corners were of little consequence to the OEM both aesthetically or functionally, however, manufacturing rounded edges requires a different cutting method from non-radiused corners and carries a different level of risk. This isn’t something that was considered by the OEM in their initial design. This speaks to designing for manufacturability—a lot of the input from a contract manufacturer is the impact on design, the level of risk of failure when it is scaled up to production volumes, and how often that failure is going to be present.
 
In order to be effective at risk management, manufacturers also need to quantify the risk. There are four processes for quantifying risk:
 
Failure Modes And Effects Analysis (FMEA)
This failure analysis method identifies potential failure modes by assessing the functionalities, designs, and processes of subsystems and components of the device. Throughout the design process informal FMEAs can be done as brainstorm exercise; however, no formal FMEA is completed until the design is settled. Up until this point, it is important to think through where risk is introduced and propose changes in the design to mitigate that risk before the design output phase, and a formal FMEA is completed.
 
Risk Priority Number (RPN)
The RPN quantifies the severity of failure happening, how probable it is to occur, and the likelihood that the failure or issue would go undetected until end-user awareness. There is an RPN for every identified failure mode and the overall sample size. Values that go into it are the frequency, severity, and the detection rate. The FMEA identifies the current controls and the recommended actions to mitigate risk. If an RPN value is above a certain threshold, the validation team needs to make changes to the process in an attempt to lower the RPN. Then there is a reevaluation of the RPN number to ensure a reduction of the specific failure mode to an acceptable level.
 
Edge Of Failure (EOF)
Defined as the point in the design space where individual lots or batches will fail lot acceptance criteria. Edge of failure analysis is an essential start to the design space analysis. It helps to assess and define process risks and usually happens in the early stage of design.
 
Design Of Experiments (DOE)
A systematic method to determine the relationship between factors affecting a process and the output of that process. Designed Experiments are also powerful tools to achieve manufacturing cost savings by minimizing process variation and reducing rework, scrap, and the need for heightened inspection. In other words, it is used to find cause-and-effect relationships. Factorial experiments are versatile because many factors can be modified and studied at once. This information is needed to manage process inputs to optimize the output.
 
Conclusion
The increasing regulations surrounding the manufacturing of medical devices have the potential to create bottlenecks, slowing down the entire process from concept to production. Today, it is common for OEMs to have complex global supply chains and outsource design, product development, and manufacturing. At the end of the day, it is the device manufacturer who is ultimately responsible for product quality. However, these new regulations do not have to impede OEMs; building strong relationships with suppliers aids in creating a robust, transparent supply chain that helps to manage risk when bringing a new medical device to market. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-18 08:14:00 [updated_at] => 2019-01-18 08:45:04 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305643","305426","304505","304021","303430","301013","301011","298924","291771","302307","305612","305313","305056","304107","303306","302016","300334","300250","299761"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306934 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Viant","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181951 [primary_image_old] => [slider_image_id] => 181951 [banner_image] => 0 [title] => Venclose, Viant Partner To Deliver Vein Treatment Solutions [short_title] => [summary] => Venclose leverages Viant’s manufacturing bandwidth to increase catheter production capabilities by 400 percent. [slug] => venclose-viant-partner-to-deliver-vein-treatment-solutions [body] => Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease, and Massachusetts-based Viant, an ISO-certified medical device contract manufacturer, have announced a partnership for the manufacture of Venclose’s next-generation VENCLOSE RF ablation catheter.
 
Venclose’s system will be transferred to Viant’s manufacturing facility in Costa Rica. This transfer, which will take place by Q3 2019, allows the company to meet its growing demand as well as continue to scale with future market expansions.
 
“With the innovative VENCLOSE System’s first year of commercialization far surpassing our expectations, we realized the need to have a manufacturing partner with the ability to keep pace with our future growth and production scale. Based on an initial annual production capacity of over 250,000 catheters and the future ability to triple that volume, Viant ensures that our company can meet the accelerating demands of our growing customer base,” said Jerry Gibson, Venclose chairman and CEO. “Our confidence in choosing Viant is supported by its decades of industry leadership including demonstrated expertise in manufacturing the highest quality minimally invasive, thermal ablation catheter products.”
 
“We take pride in being able to help our customers bring their technologies to life,” stated Viant CEO Brian King. “Our ability to scale up as well as our robust supply chain and focus on operational excellence offers companies like Venclose the consistent level of quality and performance that they need to be successful.” With Viant’s global footprint extending to Asia and the EU, it is well-positioned to support Venclose’s future marketing directions.
 
The VENCLOSE System is the next-generation endovenous RF ablation system designed to close the damaged vein and restore healthy blood flow in patients with venous reflux disease, a progressive medical condition which is often associated with varicose veins. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-31 08:17:00 [updated_at] => 2019-01-31 08:20:43 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305027","305156","289290","302314","304505","293408","301035","302830","303845","303812","303811","292549","294220","291333","298716","296393","302385","302205","293847","296195"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 299797 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2490 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2018-10-01 [author_name] => {"name":"Florence Joffroy-Black and Dave Sheppard","title":"MedWorld Advisors"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176257 [primary_image_old] => [slider_image_id] => 176257 [banner_image] => 0 [title] => Supply Chain 2020—How Are You Trending? [short_title] => [summary] => [slug] => supply-chain-2020-how-are-you-trending [body] => Since the dawn of the 21st century, prognosticators have been looking ahead to the year 2020 and predicting what life might be like for various industries, markets, and professions. As that target year quickly approaches (14 months out), it’s worth taking a look at key supply chain initiatives and how they are currently trending. 

Key 2020 topics have been extensively discussed, examined with vigor and intensity, and shared with supply chain professionals. Some of the more interesting predictions for the sector include:
Let’s examine these topics on an individual basis.

Supply Chain Professionals
As the 20th century faded into the new millennium, it was clear the occupation of the supply chain executive had forever changed from a tactical purchasing role to that of a strategic professional. That observation has never been more true than it is now, in 2018. The supply chain executive role has been elevated in most organizations, with strategic purchasing decisions in many cases significantly impacting corporate profitability. These decisions can help facilitate market entry or create obstacles in various geographies and/or industries. As a result, there has been an increase in educational programs (both inside and outside the academic setting) dedicated to supply chain management and the success of supply chain professionals.

Global Supply Chains
In the medtech industry, the idea of global supply chains sprouted from the need for lower-cost products due to increasing pricing pressure during the past 20 years. It began with the production of less expensive components such as circuit boards, widgets, and other items in lower-cost (oftentimes developing) countries. Today, however, the practice has evolved into a much broader spectrum.

Ability to Segment Regionally and Globally
The “spaghetti string” of the early global supply chains became problematic. What an organization saved in component cost was often counteracted by increases in logistical (i.e., shipping) expenses. Therefore, the benefits of the initial creation of global supply chains has allowed for continuous improvement through segmentation of the supply chain on a regional basis. Additionally, many companies have realized the importance of manufacturing closer to the customer. In Europe, this idea of “local-for-local manufacturing” has created an increase in Eastern European production to serve the European Union markets. Across the Atlantic, Puerto Rico, Costa Rica, and Mexico have driven cost efficiencies in the Americas through free trade zones, while China has reaped the biggest benefits of this trend in the Asian market. Considered merely a lower-cost component manufacturing country at the turn of the century, China is now a fully capable “finished device” manufacturer for the emerging markets. Companies are finally realizing the competitive advantage that comes with designing and manufacturing their products locally, for local sale.

External Supply Chain Transparency
The need for additional supply chain transparency in the medical technology industry has been driven by regulatory factors and social media/cultural pressures. The regulatory environment used to be far less complicated than it is today. Around the turn of the century, a company only needed to manage its own manufacturing processes from the time it received a supplier’s product (assuming it performed an incoming inspection, etc.). But that is no longer an acceptable practice. The U.S. Food and Drug Administration now requires device manufacturers to manage their supply chains the same way they manage their own internal processes. Consequently, medical manufacturers now require their supply chains to conform to requirements such as ISO 13485; standards like ISO 9001 are no longer enough for most OEMs.

Thanks to social media, large medical technology companies (J&J, Medtronic plc, Stryker Corp., Baxter, Boston Scientific, etc.) are now more visible (and exposed) to the public than ever before. This creates an opportunity for the consumer to expect—and in some cases, demand—that these major companies engage in social responsibility in their supply chain practices. While initially a “pain” for some of these companies, most organizations have now embraced this issue as an opportunity to differentiate themselves and create an additional value proposition for their end customers.

Sustainability
Although it used to be an aspirational topic for many companies, most organizations have constructively engaged in sustainability in recent years. In doing so, they have moved from sustainability as an aspiration to a core value. Thus, sustainability goals are now set—and even measured. An MPO Supply Chain column in October 2017 (“Sustainable Procurement—What is Your Target?”) identifies key medtech OEMs that are heavily investing (and measuring) their sustainability results. These companies include industry giants like Cardinal Health, Edwards Lifesciences, Varian Medical Systems, and 3M.

Cloud Impact on Supply Chain
There are numerous white papers and articles addressing the positive impact of the Cloud on supply chain management and performance. Many of these documents (largely, white papers and articles) are written (or supported) by Cloud vendors that benefit from such references. These documents, however, are “directionally correct.” The Cloud is a positive influence on supply chain management performance in key areas like global access and the removal of regional boundaries;  the capacity for worldwide scalability; the integration of multiple IT platforms (i.e., due to M&A many organizations do not have a unified IT platform throughout their various regions and/or business units); and the ability to increase analytical tools on a transparent basis for key executives throughout the organization.

AI as a Key Factor
Outside the medical technology industry, it’s clear that companies like Walmart, Target, and Amazon are utilizing artificial intelligence as predictive analytics for demand forecasting and warehouse management. Within the industry, companies like Deloitte and Optum are marketing solutions for OEMs to improve their performance. As this is a recent trend, we look forward to more future documentation of the results of these efforts. This is likely to be a trend far beyond 2020.

Robotics in the Supply Chain
Moving to a low-cost country used to give supply chain executives enough confidence to justify the decision based on the labor savings alone. However, these markets are now experiencing wage inflation and have assumed increased cost pressures (excluding the potential tariff issues, which is a separate topic to address). With this escalating employee cost metric and the need for improved productivity on a global basis, robotics is increasingly being utilized in both developed and emerging markets. As robotics becomes more commonplace, the technology will likely increase the potential value of manufacturing jobs worldwide.

Blockchain Technology
Trendy, trendy, trendy—just referencing “blockchain” is instantly topical and edgy. However, blockchain is yet to be proven as a viable efficient technology (outside of bitcoin and initial coin offerings). It certainly has potential to have a tremendous impact across industries and market segments. It will be interesting to witness some of the actual utilizations and impacts of blockchain technology in supply chain management and specifically in medtech supply chain efficiency.

Conclusion
Overall, the prognosticators have been fairly accurate with their predictions. Some of these trends have occurred quickly while others are taking time to develop. Clearly, there will be additional key “trendy” items to discuss as the year 2020 looms larger on the horizon. In the meantime, be flexible and stay abreast of the trends affecting the supply chain. The future will be here in no time. v


Florence Joffroy-Black, CM&AA, is a long-time marketing and M&A expert with significant experience in the medical technology industry, including working for multi-national corporations based in the United States, Germany, and Israel. She can be reached at florencejblack@medworldadvisors.com

Dave Sheppard is a former Fortune 500 MedTech executive and is now a principal at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-16 13:52:33 [updated_at] => 2018-10-16 13:52:33 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279724","283689","289756","289798","299952","290022","289765","289745","279662","299790","289770","289744","285583"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304414 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Vicki Anastasi, VP and Global Head, Medical Device and Diagnostics Research, ICON","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179692 [primary_image_old] => [slider_image_id] => 179692 [banner_image] => 0 [title] => How Value-Based Healthcare Affects Medical Device Development [short_title] => [summary] => Manufacturers need to employ new methods and tools to maximize the effectiveness of their efforts in bringing new devices to market. [slug] => how-value-based-healthcare-affects-medical-device-development [body] => Value-based healthcare (VBHC) models are poised to transform everything from how patient care is delivered to how treatments are priced. An analysis by United Healthcare estimated that at the end of 2018, more than $65 billion will be tied to value-based contracts. Furthermore, as the movement gains momentum, the adoption of value-based care is projected to account for about 59 percent of healthcare payments by 2020, according to Aetna 2018 Health Care Trends Report.

Unlike traditional models where care is considered to be the treatment a patient receives at the time he or she sees a healthcare provider, VBHC models consider care to be a long-term affair that stretches from the first doctor visit to months, or even years after the treatment was first delivered. This encourages providers to consider the long-term outcomes and costs of a treatment or medical device.

VBHC follows the idea that payments for services are linked to the clinical and cost outcomes for treating a defined patient need, condition, or episode of care—as opposed to the volume of the provided services. Policymakers believe that holding healthcare providers accountable incentivizes improvements that will ultimately produce better individual patient and population health outcomes at a lower overall cost.

To achieve success in a VBHC market, device manufacturers will need to work with providers to control costs, while demonstrating value in terms of improved patient outcomes through new types of evidence. Manufacturers will need to share product performance data to providers that offer a complete solution to the procedures in which their devices are used. What’s more, they need to integrate themselves further in the healthcare delivery system.

For device manufacturers, the challenges that come with the shift to VBHC are a marked departure from how the relationship between device manufacturers, payers, and providers has been conducted in previous years.

Value Can Mean Many Things
Aligning the many definitions of value that each stakeholder holds is the biggest challenge in the transition to value-based healthcare. Patients and physicians might put the highest value on individual clinical efficacy and convenience. On the other hand, payers and governments may not consider these as important as cost and population health impact.

An example that illustrates the misaligned definitions of value is the 90-day episode-of-care bundled payment for joint replacement surgery. A provider group that is getting a flat-rate bundled payment might be reluctant to spend more on a costlier joint replacement implant, when there is a cheaper alternative readily available, even if the expensive implant can potentially reduce the patient’s healthcare costs over the subsequent 20 years. Therefore, the short-term financial incentive on the part of the provider is not aligned with the patients’ long-term best interests, in addition to the long-term treatment cost implications for the healthcare system.

The key to success is to ensure the many definitions of value align across stakeholders, especially with payers, who have the most sway in decisions. It is important to determine what benefits accrue to whom and over what time frame, and then to focus on those benefits when establishing a target market or during price negotiations.

A fundamental shift needs to occur when considering value. For instance, factoring value into clinical trial design should occur earlier in the product lifecycle and in balance with other aspects of a patient's care. A stakeholder value mapping process can help identify what various stakeholders value and over what time frame that value is returned. Manufacturers can use this map to assess the market potential of devices in development and guide evidence generation and actions that foster alignment of incentives for all stakeholders, so that they all can realize the value they expect.

Putting a Price on Value
To ensure devices achieve success in the marketplace, manufacturers need to work with providers to control costs. Provider groups may attempt to circumvent the high price of a more expensive, but better performing, product by negotiating a lower price point from the manufacturers. Also, providers may turn to insurers to make a deal that pays the provider more for using a specific device because its higher upfront cost can be offset by lower treatment costs over future years.

In other cases, patients may be asked to pay the extra cost of a non-standard device or diagnostic, since payers reason patients would pay for a device that provides an improved outcome over the standard option.

Regardless of what cost-reducing method is chosen, payers will continue to hold providers accountable for delivering better patient outcomes at a lower overall price. This could cause device manufacturers to consistently and aggressively lower the price of their products to remain a viable and attractive option for providers.

However, lowered pricing places cost pressures on device manufacturers, who could see lower margins on their devices as a result of operating in a VBHC system. While achieving profitability may become more challenging, manufacturers have the opportunity to increase sustainability and improve patient outcomes by changing how they approach device development. For example, carefully assessing, planning, and coordinating with a range of potential stakeholders will be required to generate higher margins.

As detailed earlier, to counteract the potential decline in margins, device manufacturers need to incorporate steps to address value earlier in the product lifecycle. Traditionally, clinicians write study protocols that maximize clinical data collection, and an economist’s valuation of the device occurs late in the development process. This leaves the economist little time to gather and analyze data, which can significantly impair a new device or diagnostic’s survival in an already tough market.

Proving New Is More Than Better
In the past, to clear lower risk devices under the FDA 510(k) or CE mark process, it was necessary to demonstrate that the new device was equivalent to a previously approved device, but no clinical outcomes evidence was required for Class I and Class II devices. Currently, under VBHC, buyers and regulators are requiring more evidence of clinical effectiveness and cost impact of new treatments to ensure they are getting their money’s worth.

As a result, device manufacturers will need to provide evidence that a product not only works, but also generates offsetting savings or patient benefits that make it worth the extra cost if it is a premium price over similar products.

In addition, from the provider’s perspective, claiming a device is equivalent to an older device means its worth is no more than the older device. So, for truly innovative devices, manufacturers must consider the worth of investing in a pre-market approval program that gathers detailed clinical evidence and cost impact information, at the same time, to provide the innovative device an edge once it is available on the market. Therefore, clinical and economic data are essential to developing a value-based case for higher payment.

mHealth Helps to Gather Evidence
Showing the long-term benefits of novel devices requires new types of metrics and data gathering methods. For example, data from mobile health technologies (mHealth)—which includes mobile sensors for detecting clinical signs and patient activity; mobile apps for running diagnostic quizzes and reporting symptoms; and telemedicine applications that run on smartphones, tablets, and other electronic devices—can be transmitted wirelessly, enabling continuous monitoring of patient progress or therapy adherence.

Using mHealth and other innovative technologies can generate the evidence needed for manufacturers to demonstrate value in several ways. The litany of mobile sensors can generate continuous streams of data on vital signs such as blood pressure, blood sugar, and heart rate. mHealth can also identify changes in patient outcomes of which they themselves may not be aware, such as increased activity due to relief of chronic pain.

Perhaps the most important information that mHealth technologies bring to light are data for real-time patient activity, which show how a therapy impacts patient outcomes, especially those that are difficult to document through periodic clinical visits, such as the ability to walk to the grocery store or care for themselves or others.

Moreover, diagnostic and telemedicine apps can keep patients in communication with clinics, creating scenarios where healthcare providers can discharge patients earlier after surgery, since they’ll be monitored in a home setting and still be in close contact with the provider in the event there are complications.

Conclusion
Moving forward, the implementation of VBHC models means manufacturers will need to demonstrate clinical efficacy and cost impact of new devices—especially earlier in the development process—to ensure products benefit patients, while outweighing any extra costs. mHealth technologies have the potential to document the value of treatments more effectively and efficiently, helping manufacturers to increase treatment value, while presenting a persuasive case to payers. Despite the challenges, the rewards of value-based care can be high for manufacturers, as they can help patients to have more timely access to innovative medical technologies.

Partnering with a CRO that has a proven track record in clinical evidence generation, economic modeling, and commercialization expertise can help throughout the stakeholder value mapping process and ensuring a new device can have a good market impact.


Vicki Anastasi is vice president and global head, Medical Device and Diagnostics Research at ICON plc. She provides leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over 25 years of experience in the medical device industry, with over 15 years specifically focused on global medical device strategic consulting. Prior to joining the company in 2007, Anastasi held senior management roles for medical device companies focused in orthopedics, cardiovascular, general hospital, and general surgical devices. In diagnostics, she held senior positions at companies involved in the development of infectious disease and genetic-based products. She is actively involved in medical device industry groups, including Advamed, MDIC, and MassMedic, where she regularly speaks and participates in medical device focused panels and discussions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-17 14:28:00 [updated_at] => 2018-12-18 07:50:18 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["288057","304069","297162","290316","296990","257743","252658","249412","301046","296463","302323","302604","291642","301768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304505 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Editorial Advisory Board","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179758 [primary_image_old] => [slider_image_id] => 179758 [banner_image] => 0 [title] => Sounding Board: 2018 Reflections and Looking Ahead [short_title] => [summary] => MPO’s board members speak on 2018’s most significant headlines and offer insights on what’s on the horizon for the industry. [slug] => sounding-board-2018-reflections-and-looking-ahead [body] => Prior to Michael Barbella, managing editor, writing his 2018 Year in Review feature, the team reached out to the magazine’s Editorial Advisory Board to ask two questions:
 
1. What news headline, event, or technology was the most significant in 2018 and why?
2. What’s one expectation you have for 2019 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on?)

 
As always, we received great feedback from a number of board members who shared their thoughts on the questions. Unfortunately, only a handful of quotes were able to be featured in Barbella’s article, so all of the responses are provided here.
 
Note: These responses were provided throughout the second half of October 2018, so that should be taken into account given events that have occurred since that time period which may alter how a given response is viewed.
 
Sara E. Dyson, Esq., Assistant Vice President of Risk Management, Medmarc Insurance Group
2018 Reflections—The ongoing opioid litigation will forever change the life sciences industry. As companies grapple with the fallout of this litigation, pharmaceutical manufacturers will have to make significant changes to both their practices and the products they create, and device manufacturers will rethink drug delivery systems as well as other technologies—alternatives to pharmaceuticals—that help patients manage pain.
 
Looking Ahead—In 2018, FDA came under simultaneous attack by two different constituent groups, each critical of the time it takes FDA to bring new products to market. However, one side claims FDA takes too long to bring new products to market, and the other side argues FDA doesn’t take enough time to assess product safety. Pressure from the one side has already resulted in policy changes designed to put products in the hands of patients faster, such as the “right to try” laws that give terminally ill patients the right to try new drugs while they are still in clinical trials. Meanwhile, the other side is advocating changes that will make the 510(k) process more rigorous, among other things. I think 2019 will continue to see FDA “squeezed” by pressure from both sides, though it is unclear who will win this “tug-of-war” over the long term. Much will depend on the political climate as well as the public’s perception of high-profile examples of device failures alleged to result from a “rushed” process.
 
J. Mark King, President and CEO, Tegra Medical
2018 Reflections—The news items with the most impact in 2018 have been those discussing the evolution of healthcare. Market forces are precipitating a higher focus on value that is tied to patient outcomes [e.g., treating patients appropriately and reducing the need for return visits (often the ER), reducing unnecessary diagnostic tests, and finding alternatives to avoidable surgeries]. Medtech companies offer the technology to help streamline and improve the quality of care and can play a huge role in the transformation.
 
Looking Ahead—I always say that people are what is most important, so keep an eye on them! Your people can make the biggest impact. Medtech companies that place a high value on their employees and treat them well are making a critical investment. The institutional knowledge and expertise of long-term employees is a strong competitive advantage; customers appreciate working with someone they have long learned to trust.
 
Patrick Lynch, Supply Chain Director, Tear Film Innovations
2018 Reflections—The U.S.-led trade war implications have upended medical device cost models not only for contract manufacturing but also component sourcing as a whole, with China markets taking the biggest hit.
 
Sizable landed cost increases of 5-15 percent have forced renegotiations, and in some cases, subsequent sourcing efforts to move production to new suppliers as a means of offsetting the tariffs, which have created a backlog of sourcing projects, including:
   
Our experience has shown these past several months that incumbent suppliers, sensitive to the customer’s cost impact have provided some relief, allowing a portion of cost increases to be recovered, however, best results have been achieved by initiating new RFQs.
 
Looking Ahead—Repositioning of the major contract manufacturers to shuffle equipment and resources to alternate sites and countries to retain their customer base, in light of the tariff action.
 
Steve Maylish, Co-Founder and CCO, Fusion Biotec
2018 Reflections—One of the biggest changes our healthcare system is undergoing is the move to consumerization. It started slowly, but in 2018, the investment in Oscar Health has now gone over $1 billion dollars. In addition, there are a large number of startups crowding into this space; Bright Health, Devoted Health, and Clover Health, just to name a few. This year, Devoted Health raised $300 million in a series B round and Clover Health has raised $425 million over the last few years. These “payvidors” offer patient-centric care designed to support and monitor patients by using data science to cut costs and promote preventative care. Some are working with prescription services. Others are using genomic data, machine learning, and artificial intelligence to promote health. Some offer in-home primary care programs and house calls.
 
Looking Ahead—The large interest in digital healthcare is driven by this move to consumerization. Although many of these startups are targeting the Medicare Advantage segment, they will eventually migrate to the larger insurance industry. This is the typical path of disruptive innovation. The days of jumping from primary care doctors to specialists to hospitals to imaging facilities may be numbered. Because patient experience is uncoordinated, reactive, and filled with administrative bureaucracy, 2019 should see continued interest, investment, and growth in the “payvidor” space.
 
Susan Mucha, President, Powell-Mucha Consulting Inc.
2018 Reflections—I think the China tariffs are the most significant event in 2018. The unintended consequences of placing a tariff on electronic components is incentivizing migration of U.S. manufacturing to Mexico and other parts of the world. If the tariff situation is short-lived or it is adjusted to impact only finished goods, it will be good for U.S. manufacturing if it helps open Chinese markets to a larger amount of U.S. goods and reduce unfair trade practices. However, if it continues as is currently written through 2019, I think it will impact U.S. manufacturing growth negatively.
 
Looking Ahead—I think the most significant event of 2019 will relate to what Congress does regarding healthcare. The Affordable Care Act (ACA) changed the healthcare landscape dramatically. Legislative action has eliminated the penalties associated with not buying insurance and insurance costs have skyrocketed for both individuals and employers. If the situation continues unchecked, healthcare providers will be dealing with larger populations of uninsured and/or underinsured patients, and most likely a drop in elective procedures. That could slow medical capital equipment purchases and put more cost pressure on all medical devices.
 
Tony Mulone, President, Winstable Group LLC
2018 Reflections—Trade negotiations with China and its impact on "re-shoring or on-shoring." As a way to avoid tariffs, companies may use China as a component supplier and move finished goods assembly out to other countries. This could help U.S.- and Mexico-based CMs gain back lost OEM medical device business.
 
Looking Ahead—I’ll be watching the China trade negotiations and its impact on tariffs and IP protection.
 
Jeff Nelson, President, Nelson Laboratories
2018 Reflections—The medical device industry is experiencing increasing compliance requirements. FDA is regulating mobile medical apps and stressing human factors engineering; while the EU has implemented a new set of Medical Device Regulations (MDRs) that will require manufactures’ close attention. Also, regulators continue to look at new ways to evaluate the biocompatibility and biological risk of materials in medical devices—driving the need for more in vitro and chemical characterization solutions.
 
Looking Ahead—As healthcare becomes more personalized, 3D printing (additive manufacturing) will continue to take a larger role in medical device manufacturing. The goal of 3D printing is to manufacture medical devices that are uniquely customized to each patient, are safer, and reduce costs and decrease time to market. However, this could create a new set of challenges and opportunities for evaluating biocompatibility, testing for particulates, validating cleaning, sterilizing, packaging, and distributing devices.
 
Chris Oleksy, CEO and Founder, Oleksy Enterprises and Next Life Medical
2018 Reflections—To me, the top news event of 2018 was the announcement that players like Walmart and CVS were partnering and/or acquiring organizations like Humana and Aetna, which could ultimately control “where” an individual spends their healthcare dollars or even “what type” of healthcare an individual will be “allowed” to have within their offerings. Additionally, the new venture between Amazon, Berkshire Hathaway, and JP Morgan could create some very interesting value chains for these organizations and their employees. Bottom line, the “eat or be eaten—survival of the fittest” mantra I have been writing about the past two years is no longer speculation, but reality!
 
Looking Ahead—Regardless of which party controls Congress, one key expectation I have for 2019 is the return of an old term to Washington—gridlock—creating an environment in which it will be very difficult to make further needed improvements to Obamacare. The divisive bickering in Washington makes it practically impossible to accomplish much. But, there could be one silver lining; the Senate will finally finish the work started by the House and repeal the medical device tax at the beginning of 2019, before the new Congress is installed.
 
Paul Orlando, Vice President of External Operations, Olympus Surgical Technologies America
2018 Reflections—By far, President Trump’s action and strategies regarding fair trade and tariffs was most significant. This will impact companies to reconsider where/how to outsource. Second would be the continuation of suppliers being acquired and consolidated via private equity plays. These mergers and acquisitions make financial performance a higher priority than patient health, product performance, and quality.
 
Dr. Bryce G. Rutter, Founder and CEO, Metaphase Design Group
2018 Reflections—One of the most active spaces for R&D in 2018 was in robotic surgery, with giants including Medtronic, Stryker, and J&J jumping into a market space that, for so many years, has been dominated by Intuitive Surgical. It will be interesting to see how each of these companies try to differentiate themselves by specializing in specific surgical techniques and/or marrying adjacent technologies with their robotic systems.
 
No one can ignore the intersection between surgical, test, and monitoring devices and the Internet of Things. And, while not new, the acceleration is geometric. The potency of this juncture is undeniable, however, it's clear that because it is easy to create an app to support a device, far too many are not asking the fundamental question of whether or not it truly adds value to the end user or is just one more thing to learn, adding more noise to the user experience.
 
Looking Ahead—Without a doubt, the FDA's requirement for conducting thorough user needs research and usability testing throughout the design development process will drive down use errors and improve clinical efficacy by making products, instructions for use, and secondary packaging more intuitive and easier-to-use.
 
Dave Sheppard, COO and Principal, MedWorld Advisors
2018 Reflections—2018 has been an interesting year as there has not been any one defining event or technology. However, there are several key issues that had possible impacts on the future of the medtech industry. In summary, 2018 was a C.O.M.A. (China, Obamacare, M&A, and AI) year for medtech.
   
Looking Ahead—2019 has the potential to be a R.A.D. (Robotics, Acquisitions, and Digital Health) year for the following reasons.
   
Tom Vassallo, Executive Vice President, Global Business Development, Freudenberg Medical
2018 Reflections—My top choice would be the future application of robotics in the delivery of surgical procedures. This is relevant to the progress of joint ventures between premier medical device companies and tech giants. It is also significant to the anticipation of shared knowledge, technologies, and resources in joint ventures/partnerships.
 
Looking Ahead—I’ll be primarily watching three things.
 
  1. Wearables and the interface with apps and devices
  2. The myriad of possible combinations of insurance companies, clinics, and the supply chain (CVS)
  3. The Googles and Microsofts of Silicon Valley and Nashville’s entrepreneurs anticipated (disruptive) entrance into healthcare.
 
One additional item of interest will be most important for component manufacturers and custom/special medical device providers—3D printing of components and implantable devices. Rapid progress is being made regarding the types of materials available including frameworks (scaffolds) for growing new tissues utilizing the 3D printing process.
 

Interested in getting further insights on these questions? Jump over to ODT and see what the Editorial Advisory Board members there had to say. Click here to go to the ODT feature. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-18 15:06:00 [updated_at] => 2018-12-18 15:11:25 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304105","304021","303430","301013","301011","298924","291771","302307","299785","235504","299799","296454","302302","289748","299798","289747"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306032 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Brianna Sporbert, VP of Engineering, Boyd Technologies","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181049 [primary_image_old] => [slider_image_id] => 181051 [banner_image] => 0 [title] => Strategies for Maximizing Your Supply Chain [short_title] => [summary] => How to grow faster with less risk by leveraging manufacturing partners. [slug] => strategies-for-maximizing-your-supply-chain [body] => In today’s evolving regulatory environment, supply chain transparency is a game-changing differentiator. Collaborating with manufacturing partners who have excellent supplier relationships and a deep understanding of materials can revolutionize the product development process. Even after a robust supply chain has been established, there are still hurdles in commercializing a medical device. Often, in an attempt to conserve resources, cutting corners in the design process leads to product failure. One way to mitigate this risk is to establish a comprehensive validation plan that does not compromise quality and reaps long-term cost savings.
 
Considerations for Raw Materials
Raw Materials Challenges
When it comes to medical devices, OEMs must be able to manufacture them with complete consistency of quality. Raw materials are often the biggest challenge to this consistency. Because of the risks that are associated with raw materials, governments and international regulating bodies are increasing regulations on the medical device industry.
 
The complexity of supply chains is another piece that adds risk into this evolving landscape. Traceability and the control of raw materials through the entire supply chain are becoming ever-more critical. Globalization and the consolidation of the supply chain need to be handled by medical device manufacturers and their trusted partners. This requires OEMs to develop trusting relationships with supply chain partners. It also necessitates them to demand more traceability for every raw material as it makes its way through the supply chain.
 
Regulations require medical device manufacturers to assess and mitigate risk throughout their entire processes, especially of raw materials. The recent trend to new regulations is that they are reaching further up into the supply chain more so than they ever have in the past. It is essential for device manufacturers to have the support and cooperation of the raw materials suppliers. The better your partnership is with your contract manufacturer, the more of a cohesive network this can become.
 
An approved supplier list can be an excellent tool for keeping track of supplier monitoring and the critical aspects of purchasing control, provided it is actively maintained. FDA requires the level of supplier assessment to be proportionate to the level of risk associated with the medical device. If you have a higher risk supplier who may be supplying a key component to your device, or providing a critical service such as sterilization, then your qualification process will be much more involved. To effectively deploy and implement these requirements, OEMs must both support and cooperate with their raw material suppliers.
 
Updates to Regulations
One of the most comprehensive ways the FDA has enhanced regulatory success is through consistency with international commercial standards. The International Organization for Standardization (ISO) standard specific to medical devices is ISO 13485. This management system was first published in 2003 and was updated in 2016.
 
ISO 13485: 2016 is now harmonized with FDA 21 CFR Part 820 and has explicit requirements for monitoring and re-evaluating suppliers. This has been a shift in focus from the 13485: 2003 version with the key concept focused on mitigating risk, specifically with the end user in mind. This makes the Quality Management System of suppliers critical. The new standard puts more emphasis on risk management before product realization. It also requires an increased focus on supplier selection criteria, including assessment of risks and regulatory requirements.
 
Both this voluntary standard and the FDA’s enforced regulation have explicit requirements for monitoring and re-evaluating suppliers. With the revision of the ISO standard, there has been a renewed emphasis on risk. The topic of risk was covered so little by the first publication of the standard that a formal definition of the term was not given. The newly published standard, however, defines risk and expands it to encompass more than just product realization. It states that a risk-based approach needs to be applied to:
   
It should be noted that the FDA is not alone in implementing more enforceable regulations. The EU has also decided to enhance regulatory oversight with Medical Device Regulation (EU) 2017/745 and In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. While previous EU oversight was mainly accomplished through directives, these new regulations are changing Europe’s medical device industry dramatically and will continue to do so while they are being phased in by 2020 (EU MDR) and 2022 (EU IVDR). In short, governments around the world are beginning to recognize the importance of increasing and harmonizing the regulations surrounding medical device manufacturing. At the center of these regulation enhancements is the priority of effectively evaluating risk and responding appropriately to it.
 
Regulatory Considerations
Moving forward, OEMs must remain aware of the evolving regulations surrounding the raw materials they use and the suppliers who provide the materials. Risk assessment of these factors of medical device manufacturing will only continue to be prioritized by regulatory bodies in the industry and around the world.
 
Manufacturers will find that the best way to minimize risk surrounding the quality of raw materials and suppliers is to control the parameters of the manufacturing process as a whole. Working with a supplier who is willing to submit a Certificate of Analysis or Certificate of Conformance that is directly related to a specification that is in place helps to reduce that variability. 
 
Supply Chain Transparency
The most effective method for navigating the challenges that come with supply chains is to increase transparency. When manufacturers have a bird’s-eye view of their vendors, their materials, and the logistics they can much more effectively follow and enforce the regulations that surround the manufacturing process. The following points are important factors to keep in mind to create better transparency:
 
Supplier Selection Best Practices
There is no substitute for consistently following the medical device manufacturing industry’s best practices for supplier approval. The industry leaders, as well as outside researchers and thought leaders, have created methods for identifying and utilizing the right suppliers. Five key best practices can and should be implemented:
 
  1. Evaluation Plan: Manufacturers need to develop a plan for evaluating and ranking their potential suppliers. This will require them to create a persona for their ideal supplier. It can consist of preferences, but it must include the need for full compliance with industry regulations and methods for ensuring transparency in the sourcing and movement of raw materials. One important note to keep in mind is that it will cost more money to reactively fix a problem in your supply chain than to proactively address it, even if it’s a more expensive option at the moment.
  2. Utilize Medical Device Industry Suppliers: The best option for any manufacturer is to work with suppliers that have experience in the medical device industry. This type of experience will indicate that they understand the regulatory environment and already have systems in place to assist manufacturers in their compliance.
  3. Measure and Monitor: After a supplier is identified, establish a process following qualification for measuring and monitoring supplier performance. Make it an ongoing process rather than a one-time event.
  4. Regular Audits: Performing regular audits in collaboration with measuring supplier performance continues to strengthen the supply chain. Manufacturers should regularly utilize an audit to verify whether the processes and systems that they have put in place in their supply chain are working.
  5. Supplier Engagement: Creating open lines of communication can transform the way supply chains operate. However, this engagement will provide much more valuable outcomes if manufacturers purposefully engage with suppliers who participate in a meaningful validation program. When suppliers are already involved in these programs, it means they are actively identifying issues before they turn into problems. In other words, they are reducing risk in the supply chain. These are the type of suppliers that manufacturers should be working with—those that value transparency.
 
When these practices are implemented simultaneously, device manufacturers will see that they can identify suppliers that will help them to create a robust, transparent supply chain; a supply chain that can help to manage risk when new medical devices are being introduced to the market.
 
Design For Manufacturability
While there are processes, systems, and tools that can provide increased transparency in the supply chain, these options will only take an OEM so far in managing risk and complying with regulations under enhanced scrutiny. The glue that will hold all of these transparency techniques together, and, work to strengthen them, is strong relationships.
 
OEMs must prioritize building long-lasting and trusting relationships with the contract manufacturers and raw material manufacturers. There are two substantial benefits to developing relationships across the supply chain. The first is that as the various partners build trust with each other, they can have increased ease in communication, as well as a higher likelihood that the partnership will continue over the long-term. Making suppliers a part of the quality assessment means it is much more likely that you will receive acceptable parts. This can be facilitated by involving them in the design process up front. Whenever you design a new product, an opportunity exists to collaborate with a raw materials manufacturer and being transparent with your suppliers upfront can lead to a more optimized design for manufacture.
 
The second benefit is that each partner in the supply chain, from the OEM to the contract manufacturer to the raw material manufacturer, has a unique set of knowledge and expertise regarding the use of materials. These differing perspectives and broader proficiencies, when combined, can considerably strengthen the supply chain, allowing for better risk management. It also allows the OEM to avoid over-engineering the medical device that they are designing. Because there is more in-depth knowledge about every component of the device, it works to reduce the complexity. This means that there is even more standardization with every device, alongside the uniformity to the supply chain as a whole.
 
When these benefits of strong supplier relationships are combined, it leads to better product design, as well as a design that is more manufacturable. The OEM can rely on a higher quality of raw materials from their suppliers. This higher quality comes from the fact that suppliers can provide a more accurate characterization of each raw material, which reduces variability. This then leads to a greater consistency when assembling the final product.
 
Additionally, because the OEM can have more confidence in quality assurance, they are able to build up their manufacturing processes to be both more robust and more controlled. This also extends to the analytics behind the manufacturing, enabling the OEM to get a more accurate picture of the lifespan of each product, from design to market introduction to order fulfillment.
 
Finally, a stronger relationship that contributes to more trust and better communication will lead to easier change. As new devices are designed, old devices are updated, manufacturing methods change, technology advances, and regulations evolve, OEMs and their supply chains are forced to change. Traditionally, change was not easy. It disrupted the current processes. When there is greater transparency in the supply chain and change notifications can be quickly provided, the organizations involved can adapt with less effort. The roadmap for bringing a device from concept to market becomes much more manageable for all involved.
 
Documentation
In any industry, documentation can be a bottleneck. In medical device manufacturing, collecting the right documents and information from suppliers is one of the most significant contributors to raw material qualification delays. As regulations tighten, these delays will only create more delays to ill-prepared manufacturers and suppliers.
 
To prevent these bottlenecks and provide a strong example of the necessary transparency, OEMs should clearly and expediently communicate what documentation they need from each supplier. This includes any documentation that supports raw material qualification and the information required for ongoing material management. However, device manufacturers should never assume that partners have agreed to provide these documents. They need to get verification—a commitment in writing, and possibly a plan from the provider that discloses what processes they are putting in place to guarantee they fulfill the documentation obligation. To provide a show of good faith, OEMs can request that they share quality agreement templates in the early phases of the partnership.
 
These quality agreement templates can only be created after the manufacturer and their suppliers discuss the nature of the quality agreement. This discussion must happen early on in the qualification process. If it occurs later, the manufacturer could fail to agree on the specifics around raw material quality. This means that the partnership cannot happen and both the manufacturer and the supplier have wasted time in discussions.
 
OEMs can save additional time, as well as facilitate the qualification process, by working with a supplier who already has documentation packages prepared and readily available.
 
Risk Mitigation Throughout the Development Process
The actual design process is formalized with the application of design controls. Feedback paths are required between each phase of the process and previous phases, representing the iterative nature of product development. Design controls also serve as a series of checks and balances and aid to identify and analyze risk throughout the design process, leading to a well-made product.
 
The Design Process
The most effective way to mitigate risk in the design process is to break the design process down, identify the various possible risks and develop methods for addressing each risk. This is done in an iterative fashion, evaluating both component parts as well as the device as a whole.
   
Design Controls
Design controls serve as checks and balances to the product development process and are codified in FDA 21 CFR Part 820.30. FDA uses a risk-based approach with the application and requirement for design controls. Design Controls also ensure that the device meets requirements and inputs, applicable standards, and performance criteria. At its core, the FDA’s design controls are comprehensive documentation from the design process. The regulator wants manufacturers to provide a thorough record of every phase in the design process. Therefore, design controls play an integral role throughout the medical device development process—with every step forward, design control documentation is present.
 
The strength that design controls bring to the medical device development process is that they offer checks and balances. Through this documentation, device manufacturers get a chance to identify, measure, analyze, evaluate, and mitigate potential risks that may be associated with the product. In the end, it is the design controls that allow medical devices to be as safe as possible.
 
Risk Management
Design controls and risk management in the product development process are closely related. Just as with design controls, risk management identifies, measures, analyzes, evaluates, and mitigates potential risk. Risk management starts with the design input requirements. As the design evolves, new risks may become evident. The risk management process is integrated into the design process to systematically identify and, when necessary, reduce these risks. This way, unacceptable risks can be identified and managed much earlier in the design process when changes are easier and less costly to make. The main difference is that the design controls and risk management look at device development from different perspectives. While design controls are proof of safety, risk management is used to develop the right tools to maintain device safety.
 
It is important for manufacturers to realize that their risk perspective is not necessarily the same as the risk perspectives of the contract manufacturers and suppliers. OEMs are concerned with the performance of the product. Contract manufacturers and suppliers, on the other hand, are concerned with the process. So, while the OEM’s primary concern is whether the product adversely affects the end user, the contract manufacturer and supplier’s concern is whether the product and components meet the acceptance criteria.
 
In an example for our case study, a specification called for rounded corners on a heat laminated bag. Rounded corners vs. non-radiused corners were of little consequence to the OEM both aesthetically or functionally, however, manufacturing rounded edges requires a different cutting method from non-radiused corners and carries a different level of risk. This isn’t something that was considered by the OEM in their initial design. This speaks to designing for manufacturability—a lot of the input from a contract manufacturer is the impact on design, the level of risk of failure when it is scaled up to production volumes, and how often that failure is going to be present.
 
In order to be effective at risk management, manufacturers also need to quantify the risk. There are four processes for quantifying risk:
 
Failure Modes And Effects Analysis (FMEA)
This failure analysis method identifies potential failure modes by assessing the functionalities, designs, and processes of subsystems and components of the device. Throughout the design process informal FMEAs can be done as brainstorm exercise; however, no formal FMEA is completed until the design is settled. Up until this point, it is important to think through where risk is introduced and propose changes in the design to mitigate that risk before the design output phase, and a formal FMEA is completed.
 
Risk Priority Number (RPN)
The RPN quantifies the severity of failure happening, how probable it is to occur, and the likelihood that the failure or issue would go undetected until end-user awareness. There is an RPN for every identified failure mode and the overall sample size. Values that go into it are the frequency, severity, and the detection rate. The FMEA identifies the current controls and the recommended actions to mitigate risk. If an RPN value is above a certain threshold, the validation team needs to make changes to the process in an attempt to lower the RPN. Then there is a reevaluation of the RPN number to ensure a reduction of the specific failure mode to an acceptable level.
 
Edge Of Failure (EOF)
Defined as the point in the design space where individual lots or batches will fail lot acceptance criteria. Edge of failure analysis is an essential start to the design space analysis. It helps to assess and define process risks and usually happens in the early stage of design.
 
Design Of Experiments (DOE)
A systematic method to determine the relationship between factors affecting a process and the output of that process. Designed Experiments are also powerful tools to achieve manufacturing cost savings by minimizing process variation and reducing rework, scrap, and the need for heightened inspection. In other words, it is used to find cause-and-effect relationships. Factorial experiments are versatile because many factors can be modified and studied at once. This information is needed to manage process inputs to optimize the output.
 
Conclusion
The increasing regulations surrounding the manufacturing of medical devices have the potential to create bottlenecks, slowing down the entire process from concept to production. Today, it is common for OEMs to have complex global supply chains and outsource design, product development, and manufacturing. At the end of the day, it is the device manufacturer who is ultimately responsible for product quality. However, these new regulations do not have to impede OEMs; building strong relationships with suppliers aids in creating a robust, transparent supply chain that helps to manage risk when bringing a new medical device to market. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-18 08:14:00 [updated_at] => 2019-01-18 08:45:04 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305643","305426","304505","304021","303430","301013","301011","298924","291771","302307","305612","305313","305056","304107","303306","302016","300334","300250","299761"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306934 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Viant","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181951 [primary_image_old] => [slider_image_id] => 181951 [banner_image] => 0 [title] => Venclose, Viant Partner To Deliver Vein Treatment Solutions [short_title] => [summary] => Venclose leverages Viant’s manufacturing bandwidth to increase catheter production capabilities by 400 percent. [slug] => venclose-viant-partner-to-deliver-vein-treatment-solutions [body] => Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease, and Massachusetts-based Viant, an ISO-certified medical device contract manufacturer, have announced a partnership for the manufacture of Venclose’s next-generation VENCLOSE RF ablation catheter.
 
Venclose’s system will be transferred to Viant’s manufacturing facility in Costa Rica. This transfer, which will take place by Q3 2019, allows the company to meet its growing demand as well as continue to scale with future market expansions.
 
“With the innovative VENCLOSE System’s first year of commercialization far surpassing our expectations, we realized the need to have a manufacturing partner with the ability to keep pace with our future growth and production scale. Based on an initial annual production capacity of over 250,000 catheters and the future ability to triple that volume, Viant ensures that our company can meet the accelerating demands of our growing customer base,” said Jerry Gibson, Venclose chairman and CEO. “Our confidence in choosing Viant is supported by its decades of industry leadership including demonstrated expertise in manufacturing the highest quality minimally invasive, thermal ablation catheter products.”
 
“We take pride in being able to help our customers bring their technologies to life,” stated Viant CEO Brian King. “Our ability to scale up as well as our robust supply chain and focus on operational excellence offers companies like Venclose the consistent level of quality and performance that they need to be successful.” With Viant’s global footprint extending to Asia and the EU, it is well-positioned to support Venclose’s future marketing directions.
 
The VENCLOSE System is the next-generation endovenous RF ablation system designed to close the damaged vein and restore healthy blood flow in patients with venous reflux disease, a progressive medical condition which is often associated with varicose veins. 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