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    [title] => MPO Summit 2017: Dr. Bryce Rutter Talks Surgical Instrument Design 
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    [summary] => Editor Sean Fenske discusses instrument design strategies with Dr. Bryce Rutter of Metaphase Design Group. 

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Bryce G. Rutter, Ph.D., founder and CEO of Metaphase Design Group Inc., shares several design tips from his presentation, “Designing the Perfect Instrument,” at the 2017 MPO Summit. Dr. Rutter suggests enlisting newer surgeons to test an instrument rather than always relying on the key opinion leaders. He also notes that emotional design can be just as critical a factor in surgical instruments as it is with consumer products.

Also mentioned in the video is the article he provided to ODT magazine. That article can be viewed at the ODT website.
 
Couldn't attend in person? Get highlights of all the presentations that took place at the 2017 MPO Summit in our Conference Program Notebook. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-12-05 15:58:00 [updated_at] => 2018-01-18 12:46:16 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["253201","266470","262258","259564","255374","265256","258803","253207","255868","255775","262279","265730","261683","263444","258792","258823","260495","263041","255885"] [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] => 2585 [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] => Videos [short_tag] => videos [class_name] => ServiceRelease [display_view] => viewVideo [list_view] => [slug] => videos [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Videos ) [viewURL] => /contents/view_videos/2017-12-05/mpo-summit-2017-dr-bryce-rutter-talks-surgical-instrument-design/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 253207 [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] => 2491 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-07-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 150353 [primary_image_old] => [slider_image_id] => 150353 [banner_image] => 0 [title] => Perspective (Trends at the Top 2017): Findings of the Top 30 [short_title] => [summary] => [slug] => perspective-trends-at-the-top-2017 [body] => Time breeds perspective if you stare at something long enough. I’ve been staring at the medical device industry since 1999. At that time, the first “trend” I observed was the industry reacting to the threat of Y2K. (I’d venture to guess there’s a younger portion of the readership who may not even be all that familiar with the concept.) Since then, I’ve seen many trends emerge and fade within this always exciting, transformative industry.

Helping to generate the Top 30 company reports (that start in this issue on page 34) with fellow editors, Michael Barbella and Sam Brusco, offers a unique perspective on the medical device industry I hadn’t been privy to in years prior. Taking my first crack at the Top 30 last year, I suffered a bit from being overwhelmed by the sheer size of the project. It was without a doubt the largest, most comprehensive editorial task I had undertaken up until that time (given the time period in which it is accomplished).

This year, I had the benefit of perspective. I had a much better understanding of what I was getting into at the start of the project. I had the prior year’s information having written or read every single report. The perspective gained from being part of the development of the Top 30 two years in a row, without a doubt, provides yet another unique perspective.

Revisiting my Editor’s Letter from this issue’s 2016 counterpart, I reviewed the trends that were called out for that year. And as the saying goes, the more things change, the more they stay the same. I suppose given only a 12-month difference, I shouldn’t expect too dramatic of change, but in that Letter, I noted that the most obvious trend was in mergers and acquisitions. In that respect, the reports this year offer more of the same, although the players have changed. The Top 30 companies spent the year making purchases of other industry firms to introduce new technologies to their product portfolio, enjoy market access and distribution into new regions, and/or increase market share in a particular clinical area. There was yet another mega-merger with St. Jude Medical Inc. being bought by Abbott Laboratories (which also made a play for Alere, then attempted to back out, then tried to back out again, only to finally agree on a lower purchase price). Strategic acquisitions are a part of virtually every company report while some also include divestitures of slower performing units or those that weren’t considered core businesses by the medical device OEM.

Another trend that was revealed in last year’s reports was the shift companies were making to address the change in reimbursement models. With a fee-for-value model continuing to gain traction in healthcare and bundled payments likely growing beyond the orthopedic industry, medical device manufacturers are enhancing services and offerings to ultimately gain access to a greater slice of the reimbursement pie. Different companies are taking their own unique strategies to achieve that goal, but universally, the shifting payment model in healthcare is a factor that all medical device manufacturers should be addressing within their business plan. Fortunately, the end result is very likely to be a greater focus on patient care and truly ensuring the long-term success of the treatment one receives.

The global market view that was also mentioned last year in my Letter is most certainly still a trend—perhaps even more so. Several companies specifically cited new market access as one of the reasons for a particular acquisition. Gaining new customers in a region of the world that a firm is not currently serving is a fantastic strategy for increasing those sales figures for the 2018 MPO Top 30 reports. Further, acquiring a company already doing business in that region provides a much easier path to market rather than attempting to gain share organically as a new name in the area. Existing customers don’t necessarily care who ultimately is behind the familiar name of their product of choice (so long as it maintains the quality and reputation it had to gain their trust and loyalty in the first place; a fact I hope all members of the medtech industry remember).

Another trend highlighted in last year’s Letter was the research and development strategies between medical device OEMs and universities. Similar to last year, not much of this news made it into the reports themselves, but I know in researching several of the company reports I wrote, I found agreements being mentioned with a number of institutions for the purpose of developing new technologies. I am a huge proponent of this type of strategy, as the arrangement is certainly beneficial to both sides of the agreement. I hope to hear even more about these types of pairings between academia and the medical device industry.

It is my hope that this issue provides you with some perspective on the industry, the changes that are occurring, and where we’re headed. Enjoy!

Check out this year's Top 30 Global Medical Device Companies Report here! [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-07-26 10:45:06 [updated_at] => 2017-07-28 09:57:16 [last_updated_author] => 199474 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["253294","253235","253229","249894","249638","249619","245225","244642","244358","243238","239719"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 253201 [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] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-07-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 150342 [primary_image_old] => [slider_image_id] => 150342 [banner_image] => 0 [title] => An Outsourcing Focus in San Diego [short_title] => [summary] => The MPO Summit travels to southern California for sun, surf, networking, and industry insights. [slug] => an-outsourcing-focus-in-san-diego [body] => Harkening back to the brand’s roots, the 2017 MPO Summit celebrates the medical device OEM and outsourcing service provider relationship, while also addressing a number of critical issues the industry faces. On the first day, the agenda focuses on a variety of pain points for many companies active in the medical device outsourcing community. Presenters will offer their expertise on several topics with outsourcing as the central theme, discussing global sourcing, supply chain, regulatory and quality management, as well as the make versus buy decision.

Before those issues are addressed, however, the first day will kick off with a bird’s-eye view of the medtech industry. This dual presenter session will offer a comprehensive review of trends the industry is experiencing, the impact of consolidation from both the supply chain and OEM points of view, the outlook for outsourcing, and what to expect in 2018 and beyond. Attendees can get involved in the discussion by asking questions on related topics that are important to them.

Chris Oleksy, founder and CEO of Oleksy Enterprises and Next Life Medical and CEO of Emergent Respiratory, brings to the Summit the expertise he shares in his regular contributed MPO supply chain column. In his session, Oleksy will address a potentially serious issue that involves the potential collapse of the supply, value, and care chains affecting the medical device industry—similar to the collapse the housing market experienced in 2008. Attendees will find out what’s behind this critical crisis, how they can help prepare their companies, and learn how to navigate the situation should it come to pass.

In the Make versus Buy panel, two supplier representatives and two medical device OEMs will discuss this significant question, which every major company must address somewhere along the product development path. Some of the issues a company might address when making this decision include the advantages and disadvantages of both routes, and the kind of support to expect from a supplier. These matters, and various other questions and topics associated with this topic will be the central focus of this panel. Audience members are encouraged to get involved in the discussion as well by sharing their own experiences with this process.

Following an extended networking opportunity (coupled with a buffet lunch) will be MPO Editorial Advisory Board member Bill Ellerkamp, operating partner with Inverness Graham Investments. He will examine the topic of global sourcing for the worldwide marketplace. In today’s healthcare space, serving one region is typically not enough. Better healthcare technologies are being demanded worldwide; if a company cannot address product demand and deliver its device to a certain area of the globe, a competitor will happily do so. Serving this worldwide market efficiently often means installing manufacturing centers within those regions. While that can help with costs, it can also bring new challenges associated with sourcing in those new regions. Ellerkamp will attempt to address many questions OEMs often have when attempting to serve a new region.

Companies may have already realized the cost savings that can be enjoyed via outsourcing, but they’re still concerned with their supply partners. OEMs often struggle with ways to ensure their outsourcing vendor(s) maintain regulatory and quality compliance standards, as  one mistake by a third-party vendor can be devastating to a major company. Thus, Brian Weller RAC, partner with the Business Value Group Intl., will share techniques and best practices to help OEMs make the most of outsourcing arrangements while collaborating with their supply partners to ensure compliance and quality is upheld to the highest standards.

The event’s second day focus broadens beyond the outsourcing relationship to include commercialization, product development, and skills development and training. MedWorld Advisors’ COO and principal, Dave Sheppard, gets the day started with a session that should resonate particularly well with those in attendance from smaller and startup companies, or those who have a great idea for a new medical technology, but haven’t quite flushed out the business plan. Addressing areas such as commercialization, international markets, licensing, and private labeling, this session will provide insights on what a new business owner may not have considered. Unfortunately, a great new product idea isn’t enough; there’s much more that needs to be discussed. Sheppard’s session will identify and explore these building blocks in depth.

Developing the product idea, however, is quite important as well. Throw all the rest out the window if the best idea doesn’t take all factors into consideration and, ultimately, the company provides a product to the industry that it doesn’t want to use. Dr. Bryce G. Rutter, founder and CEO of the Metaphase Design Group, will explore the world of design in a session that will illustrate the critical factors necessary to ensure the right product is being made the right way. Although the focus will be on surgical instruments, there will undoubtedly be design takeaways for any professional involved in any stage of the product development process.

Closing out the Summit will be another panel discussion. This session will focus on the concerns involved with aging manufacturing professionals and the lack of young talent to replace them. Aware of the issue, many companies and organizations are attempting to provide solutions before this becomes a true problem for the industry and a real skills shortage takes hold. Topics of discussion for the panel include the problem itself and how participants are addressing it in their own sectors of the industry. Whether through apprenticeship, education, or training, real-world solutions will be shared and discussed. The audience is invited to pose questions to the panel regarding this growing problem or even share their own unique experiences related to the issue.

On behalf of the MPO Summit team, I hope to see you there! 


Get further details on the speakers, panelists, and other conference sessions, as well as the networking opportunities and sponsors for the 2017 MPO Summit at www.mposummit.com. [views] => 0 [published] => 1 [status] => 3 [priority] => 3 [publish_date] => 2017-07-26 15:18:48 [updated_at] => 2017-07-26 15:18:48 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["251850","246131","245210","244642","243464","243455","243238","240998","240724","240252","238375","238372"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255374 [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] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 194075 [primary_image_old] => 127332 [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Off-Label Use [short_title] => [summary] => Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use. [slug] => mike-on-medtech-off-label-use [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other podcasts. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-08-25 08:30:00 [updated_at] => 2019-08-13 15:27:51 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => {"video_url":{"video_url":"Video URL","value":"http://players.brightcove.net/73033050001/default_default/index.html?videoId=5551504278001"},"image_url":{"image_url":"Image URL","value":"http://rodpub.com/email/mpo/images/1400x1400.jpg"},"video_id":{"video_id":"Video ID","value":"5551504278001"}} [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["320011","319679","319180","318935","318889","318858","318706","317769","317622","316570","316351","316297","315502","315274","315263","311437","311395","310103","309296"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255868 [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] => 2491 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-09-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 152327 [primary_image_old] => [slider_image_id] => 152327 [banner_image] => 0 [title] => The Way Ahead for Outsourcing R&D [short_title] => [summary] => [slug] => the-way-ahead-for-outsourcing-rd [body] => The overwhelming consensus of the medtech community is that innovation is the lifeblood of the industry. Without it, company revenues stagnate, healthcare quality and efficiency plateaus, and new challenges go unmet. It is vital for medical device companies to continue to improve upon current technologies, whether by the slower-paced incremental innovation commonly seen with legacy products or by leaps and bounds such as the inventions often developed by smaller startup firms.

Other regions of the world recognize this need and have established a type of community to support it, typically made up of industry, academia, and government. All three contribute to the effort. Look to Ireland and Singapore for exciting working examples of these types of symbiotic relationships. Unfortunately, here in the U.S., the government thinks it wise to assess a 2.3 percent excise tax on medical device sales to help pay for healthcare (back next year if something isn’t done in the next few months). But I digress.

At the same time, we’re experiencing a skills gap between those who are leaving medtech (as well as the manufacturing industries that support it) through retirement (i.e., the graying of the industry) and those coming in to fill their positions. Those going through the exit door are outnumbering those coming in and it’s an issue that desperately needs to be addressed. (Side note, at this year’s MPO Summit in San Diego, we’ll be discussing that topic in a panel session with five participants who are each involved in some way with addressing this very issue. See www.mposummit.com for details.)

There may be a potential solution to both challenges that’s already in place to a lesser degree. While researching the MPO Top 30 company reports published in the last issue, when reviewing R&D expenditures, every company stated that part of these costs included money provided to academic institutions. In some cases, these are for grants or donations for research. In other cases, it could be in support of an innovation competition (such as the one managing editor Michael Barbella writes about in this issue; click here to view that article). There are also the situations where this money is going toward an effort to establish a more formal partnership between the medical device OEM and a university. It is from these examples, I believe, that both the industry and academia stand to gain significant value.

In 2015, Philips announced that it was establishing a $25 million alliance with MIT and moving its R&D headquarters to Cambridge. The agreement was specifically made to have the school support the company’s core areas in healthcare and lighting technologies. Philips solicited research proposals and met with representatives from the labs on campus. The partnership provides the company with a new source of potential medical device innovations while MIT enjoys an avenue for projects to move out of the realm of simply being fodder for a published paper. Further, MIT expects to gain insights into how their developments are utilized in real-world environments.

“One of the things I’m really looking forward to, since they [Philips] are actually making stuff that gets used in hospitals around the world, is that they will develop some of these ideas,” said Peter Szolovits, a professor of computer science and engineering and of health science and technology at MIT. “That, in turn, would allow MIT students and faculty to do follow-up studies on ‘how well these things work in the real world.’”

[Learn more about this arrangement here.]

More recently, Wake Forest Innovations, the commercial arm of the Wake Forest Baptist Medical Center, teamed with Ethicon, a division of Johnson & Johnson, on comparing the OEM’s Echelon Flex 35 Powered Vascular Stapler to a manual stapler to determine potential differences in tissue tension. Both entities viewed the arrangement as a trial to determine if a more robust R&D partnership could be established between them.

“We can maintain specialists in very narrow areas of expertise, like gene-based therapies, biomedical engineering, and others,” explained Heather Ramsay, associate director of alliance management for the Center for Industry Research Collaboration at Wake Forest Innovations. “Companies can’t support that kind of specialization in-house, so they want to work with people in academia who have specific knowledge and skills.”

[Learn more about this arrangement here.]

Indeed, greater, more established relationships between academic organizations and medical device OEMs offer great benefits to both sides. Further, once the students graduate, those who are already intimately familiar with the company’s technologies instantly become perfect candidates to fill in the skills gap, able to hit the ground running on the project they’ve already been working on for years during their time in college.

It’s a rare example of a true win-win scenario. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-01 08:00:00 [updated_at] => 2017-09-05 07:44:32 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["255515","254654","254122","254113","254017","253226","253207","252632","252357","252273","251271","251019","250724","249619","249459","249384","247751","244651","244642","244415","244340","241975","241078"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255885 [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] => 2017-09-01 [author_name] => {"name":"Dawn A. Lissy","title":"Empirical"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 152351 [primary_image_old] => [slider_image_id] => 152351 [banner_image] => 0 [title] => So We’re All on the Same Page: You Need a Test Plan [short_title] => [summary] => [slug] => so-were-all-on-the-same-page-you-need-a-test-plan [body] => I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on my computer, tablet, smartphone, spiral paper planner, and a series of Post-it notes that wing up around my office like neon butterflies.

It would never occur to me to not have a test plan. But I frequently find myself explaining the benefits of a plan to clients and dispelling a series of misunderstandings about how a test plan can make the development cycle easier and less expensive. I’ve even had clients who have never heard of such a thing and wonder why anyone would ever craft one.
I have special list just for them.

“Less expensive” typically catches everyone’s attention when explaining the benefits of devising a test plan. It varies from client to client, but some have saved as much as 30 percent of overall testing time and financial costs, depending on the type and scope of project. A testing plan solid enough to be the foundation of a successful project yet fluid enough to allow for course corrections eases the path to market—particularly for Class III devices.

“Easier” is a subjective measurement, however; there’s not necessarily a bottom line or hard number attached to it. But based on what I’ve noticed over the course of my career, it’s better to form a test plan at the beginning of the development cycle. If you wait until mid-cycle, a challenge that could’ve been foreseen might sideline the project and measures must then be put in place to deal with it.

The Why
Clients have argued a test plan could limit their options and they don’t want to feel pigeon-holed or wedded to a single path. But after considering the options and plotting the course, identify where and when that plan may need reassessment. The plan will not be carved in stone. Hopefully it won’t manifest in fluorescent paper slips all over the office, but rather a happy medium that allows forward momentum and won’t trap you in a corner.

Plan Before You Plan
A failure modes and effects analysis (FMEA) is a risk analysis and starting point. This is a must for Class III devices as well as Class II devices containing a feature with the potential to cause harm, such as an intervertebral body fusion device (IBFD) with a new locking mechanism for expansion purposes. The FMEA will determine any additional testing to consider in order to prove the overall safety and efficacy of the device—benchtop testing, animal testing, or other evaluations needed in the overall test plan. For Class III devices, you’ll also want to consider feasibility testing. Again, this may apply for Class IIs with breakthrough technology applications.

Now the actual plan is ready to be developed. Feel free to dust off my article “Driving a Successful Medical Device Product Development Cycle” in the July/August 2015 edition of MPO for more details on putting that plan together, but it should include minimum required tests from relevant regulatory agencies, in addition to feasibility or other evaluations identified during the risk analysis.

More Than Guidance Documents
Some clients have argued that they don’t need a plan because there are regulatory documents that spell out required tests. While established guidelines and regulatory direction are great fodder for a plan, they’re not an actual process guide for a device. The U.S. Food and Drug Administration’s guidance documents serve as the foundation and minimum requirements, but they’re not a device-specific path to market.

It’s easy to over- or under-test if those documents aren’t read correctly. Some devices such as vertebral body replacements or cervical or lumbar IBFDs can be tested to up to six different methods per the American Society for Testing and Materials (ASTM) standards. But not every device needs all six tests depending on its indication and location. Only two of six tests have to be performed on a monolithic lumbar device. Knowing the regulatory requirements for the specific kind of device helps to put the best plan in place to use time, money, and testing wisely. With Class III devices, there may not be a standard to test a device to, thereby requiring a test plan to propose to the regulatory agency.

I’ve actually had face-palm moments when a client informs me they performed all six tests when they only needed four. They covered their bases mid-process because they didn’t have a plan, which cost them time and money they didn’t need to spend.

Let’s also consider who you’re working with. The regulatory community is full of planners. Anyone who reports to a governmental agency—regardless of what country it’s in—has a series of boxes to check. It will be easier on everyone if a document to share with reviewers at any point in the cycle is available.

Putting It in Writing
When developing a test plan, you’re making a map—creating a document that will enable the entire team to literally be on the same page. This is where you’re doing homework and will see potential liabilities as well as possible shortcuts. Once this critical baseline is obtained, a realistic timeline and the bookends of possibilities can be developed. Best-case to worse-case scenarios and where/when those issues can pop up will be known.

With this outline of major deadlines and turning points, you’ll be able to allocate resources and refine schedules to smooth the journey.

Everyone will have the deadlines, everyone will get the same information, and the whole team will work off the same document. Given the number and variety of people that must work together to get a medical device to market—regulatory, manufacturing, production development, surgeons, etc.—this is essential. If everyone understands what the steps are and that those steps can’t be skipped, precious time will not be wasted. It’s ultimately about setting and managing stakeholder expectations.

Bringing the Future to the Present
Alan Lakein, author of “How to Get Control of Your Time and Your Life,” sums it up nicely: “Planning is bringing the future into the present so you can do something about it now.”
Consider the future of the device, the team, and your goals. Then bring all of that into the present with a test plan that will move the endeavor forward to meet those goals. 


Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-01 09:02:00 [updated_at] => 2017-09-07 09:27:00 [last_updated_author] => 195666 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["253215","249633","246152","243474","241072"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 253207 [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] => 2491 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-07-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 150353 [primary_image_old] => [slider_image_id] => 150353 [banner_image] => 0 [title] => Perspective (Trends at the Top 2017): Findings of the Top 30 [short_title] => [summary] => [slug] => perspective-trends-at-the-top-2017 [body] => Time breeds perspective if you stare at something long enough. I’ve been staring at the medical device industry since 1999. At that time, the first “trend” I observed was the industry reacting to the threat of Y2K. (I’d venture to guess there’s a younger portion of the readership who may not even be all that familiar with the concept.) Since then, I’ve seen many trends emerge and fade within this always exciting, transformative industry.

Helping to generate the Top 30 company reports (that start in this issue on page 34) with fellow editors, Michael Barbella and Sam Brusco, offers a unique perspective on the medical device industry I hadn’t been privy to in years prior. Taking my first crack at the Top 30 last year, I suffered a bit from being overwhelmed by the sheer size of the project. It was without a doubt the largest, most comprehensive editorial task I had undertaken up until that time (given the time period in which it is accomplished).

This year, I had the benefit of perspective. I had a much better understanding of what I was getting into at the start of the project. I had the prior year’s information having written or read every single report. The perspective gained from being part of the development of the Top 30 two years in a row, without a doubt, provides yet another unique perspective.

Revisiting my Editor’s Letter from this issue’s 2016 counterpart, I reviewed the trends that were called out for that year. And as the saying goes, the more things change, the more they stay the same. I suppose given only a 12-month difference, I shouldn’t expect too dramatic of change, but in that Letter, I noted that the most obvious trend was in mergers and acquisitions. In that respect, the reports this year offer more of the same, although the players have changed. The Top 30 companies spent the year making purchases of other industry firms to introduce new technologies to their product portfolio, enjoy market access and distribution into new regions, and/or increase market share in a particular clinical area. There was yet another mega-merger with St. Jude Medical Inc. being bought by Abbott Laboratories (which also made a play for Alere, then attempted to back out, then tried to back out again, only to finally agree on a lower purchase price). Strategic acquisitions are a part of virtually every company report while some also include divestitures of slower performing units or those that weren’t considered core businesses by the medical device OEM.

Another trend that was revealed in last year’s reports was the shift companies were making to address the change in reimbursement models. With a fee-for-value model continuing to gain traction in healthcare and bundled payments likely growing beyond the orthopedic industry, medical device manufacturers are enhancing services and offerings to ultimately gain access to a greater slice of the reimbursement pie. Different companies are taking their own unique strategies to achieve that goal, but universally, the shifting payment model in healthcare is a factor that all medical device manufacturers should be addressing within their business plan. Fortunately, the end result is very likely to be a greater focus on patient care and truly ensuring the long-term success of the treatment one receives.

The global market view that was also mentioned last year in my Letter is most certainly still a trend—perhaps even more so. Several companies specifically cited new market access as one of the reasons for a particular acquisition. Gaining new customers in a region of the world that a firm is not currently serving is a fantastic strategy for increasing those sales figures for the 2018 MPO Top 30 reports. Further, acquiring a company already doing business in that region provides a much easier path to market rather than attempting to gain share organically as a new name in the area. Existing customers don’t necessarily care who ultimately is behind the familiar name of their product of choice (so long as it maintains the quality and reputation it had to gain their trust and loyalty in the first place; a fact I hope all members of the medtech industry remember).

Another trend highlighted in last year’s Letter was the research and development strategies between medical device OEMs and universities. Similar to last year, not much of this news made it into the reports themselves, but I know in researching several of the company reports I wrote, I found agreements being mentioned with a number of institutions for the purpose of developing new technologies. I am a huge proponent of this type of strategy, as the arrangement is certainly beneficial to both sides of the agreement. I hope to hear even more about these types of pairings between academia and the medical device industry.

It is my hope that this issue provides you with some perspective on the industry, the changes that are occurring, and where we’re headed. Enjoy!

Check out this year's Top 30 Global Medical Device Companies Report here! [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-07-26 10:45:06 [updated_at] => 2017-07-28 09:57:16 [last_updated_author] => 199474 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["253294","253235","253229","249894","249638","249619","245225","244642","244358","243238","239719"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 253201 [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] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-07-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 150342 [primary_image_old] => [slider_image_id] => 150342 [banner_image] => 0 [title] => An Outsourcing Focus in San Diego [short_title] => [summary] => The MPO Summit travels to southern California for sun, surf, networking, and industry insights. [slug] => an-outsourcing-focus-in-san-diego [body] => Harkening back to the brand’s roots, the 2017 MPO Summit celebrates the medical device OEM and outsourcing service provider relationship, while also addressing a number of critical issues the industry faces. On the first day, the agenda focuses on a variety of pain points for many companies active in the medical device outsourcing community. Presenters will offer their expertise on several topics with outsourcing as the central theme, discussing global sourcing, supply chain, regulatory and quality management, as well as the make versus buy decision.

Before those issues are addressed, however, the first day will kick off with a bird’s-eye view of the medtech industry. This dual presenter session will offer a comprehensive review of trends the industry is experiencing, the impact of consolidation from both the supply chain and OEM points of view, the outlook for outsourcing, and what to expect in 2018 and beyond. Attendees can get involved in the discussion by asking questions on related topics that are important to them.

Chris Oleksy, founder and CEO of Oleksy Enterprises and Next Life Medical and CEO of Emergent Respiratory, brings to the Summit the expertise he shares in his regular contributed MPO supply chain column. In his session, Oleksy will address a potentially serious issue that involves the potential collapse of the supply, value, and care chains affecting the medical device industry—similar to the collapse the housing market experienced in 2008. Attendees will find out what’s behind this critical crisis, how they can help prepare their companies, and learn how to navigate the situation should it come to pass.

In the Make versus Buy panel, two supplier representatives and two medical device OEMs will discuss this significant question, which every major company must address somewhere along the product development path. Some of the issues a company might address when making this decision include the advantages and disadvantages of both routes, and the kind of support to expect from a supplier. These matters, and various other questions and topics associated with this topic will be the central focus of this panel. Audience members are encouraged to get involved in the discussion as well by sharing their own experiences with this process.

Following an extended networking opportunity (coupled with a buffet lunch) will be MPO Editorial Advisory Board member Bill Ellerkamp, operating partner with Inverness Graham Investments. He will examine the topic of global sourcing for the worldwide marketplace. In today’s healthcare space, serving one region is typically not enough. Better healthcare technologies are being demanded worldwide; if a company cannot address product demand and deliver its device to a certain area of the globe, a competitor will happily do so. Serving this worldwide market efficiently often means installing manufacturing centers within those regions. While that can help with costs, it can also bring new challenges associated with sourcing in those new regions. Ellerkamp will attempt to address many questions OEMs often have when attempting to serve a new region.

Companies may have already realized the cost savings that can be enjoyed via outsourcing, but they’re still concerned with their supply partners. OEMs often struggle with ways to ensure their outsourcing vendor(s) maintain regulatory and quality compliance standards, as  one mistake by a third-party vendor can be devastating to a major company. Thus, Brian Weller RAC, partner with the Business Value Group Intl., will share techniques and best practices to help OEMs make the most of outsourcing arrangements while collaborating with their supply partners to ensure compliance and quality is upheld to the highest standards.

The event’s second day focus broadens beyond the outsourcing relationship to include commercialization, product development, and skills development and training. MedWorld Advisors’ COO and principal, Dave Sheppard, gets the day started with a session that should resonate particularly well with those in attendance from smaller and startup companies, or those who have a great idea for a new medical technology, but haven’t quite flushed out the business plan. Addressing areas such as commercialization, international markets, licensing, and private labeling, this session will provide insights on what a new business owner may not have considered. Unfortunately, a great new product idea isn’t enough; there’s much more that needs to be discussed. Sheppard’s session will identify and explore these building blocks in depth.

Developing the product idea, however, is quite important as well. Throw all the rest out the window if the best idea doesn’t take all factors into consideration and, ultimately, the company provides a product to the industry that it doesn’t want to use. Dr. Bryce G. Rutter, founder and CEO of the Metaphase Design Group, will explore the world of design in a session that will illustrate the critical factors necessary to ensure the right product is being made the right way. Although the focus will be on surgical instruments, there will undoubtedly be design takeaways for any professional involved in any stage of the product development process.

Closing out the Summit will be another panel discussion. This session will focus on the concerns involved with aging manufacturing professionals and the lack of young talent to replace them. Aware of the issue, many companies and organizations are attempting to provide solutions before this becomes a true problem for the industry and a real skills shortage takes hold. Topics of discussion for the panel include the problem itself and how participants are addressing it in their own sectors of the industry. Whether through apprenticeship, education, or training, real-world solutions will be shared and discussed. The audience is invited to pose questions to the panel regarding this growing problem or even share their own unique experiences related to the issue.

On behalf of the MPO Summit team, I hope to see you there! 


Get further details on the speakers, panelists, and other conference sessions, as well as the networking opportunities and sponsors for the 2017 MPO Summit at www.mposummit.com. [views] => 0 [published] => 1 [status] => 3 [priority] => 3 [publish_date] => 2017-07-26 15:18:48 [updated_at] => 2017-07-26 15:18:48 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["251850","246131","245210","244642","243464","243455","243238","240998","240724","240252","238375","238372"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255374 [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] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 194075 [primary_image_old] => 127332 [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Off-Label Use [short_title] => [summary] => Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use. [slug] => mike-on-medtech-off-label-use [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other podcasts. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-08-25 08:30:00 [updated_at] => 2019-08-13 15:27:51 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => {"video_url":{"video_url":"Video URL","value":"http://players.brightcove.net/73033050001/default_default/index.html?videoId=5551504278001"},"image_url":{"image_url":"Image URL","value":"http://rodpub.com/email/mpo/images/1400x1400.jpg"},"video_id":{"video_id":"Video ID","value":"5551504278001"}} [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["320011","319679","319180","318935","318889","318858","318706","317769","317622","316570","316351","316297","315502","315274","315263","311437","311395","310103","309296"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255868 [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] => 2491 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-09-01 [author_name] => {"name":"Sean Fenske","title":"Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 152327 [primary_image_old] => [slider_image_id] => 152327 [banner_image] => 0 [title] => The Way Ahead for Outsourcing R&D [short_title] => [summary] => [slug] => the-way-ahead-for-outsourcing-rd [body] => The overwhelming consensus of the medtech community is that innovation is the lifeblood of the industry. Without it, company revenues stagnate, healthcare quality and efficiency plateaus, and new challenges go unmet. It is vital for medical device companies to continue to improve upon current technologies, whether by the slower-paced incremental innovation commonly seen with legacy products or by leaps and bounds such as the inventions often developed by smaller startup firms.

Other regions of the world recognize this need and have established a type of community to support it, typically made up of industry, academia, and government. All three contribute to the effort. Look to Ireland and Singapore for exciting working examples of these types of symbiotic relationships. Unfortunately, here in the U.S., the government thinks it wise to assess a 2.3 percent excise tax on medical device sales to help pay for healthcare (back next year if something isn’t done in the next few months). But I digress.

At the same time, we’re experiencing a skills gap between those who are leaving medtech (as well as the manufacturing industries that support it) through retirement (i.e., the graying of the industry) and those coming in to fill their positions. Those going through the exit door are outnumbering those coming in and it’s an issue that desperately needs to be addressed. (Side note, at this year’s MPO Summit in San Diego, we’ll be discussing that topic in a panel session with five participants who are each involved in some way with addressing this very issue. See www.mposummit.com for details.)

There may be a potential solution to both challenges that’s already in place to a lesser degree. While researching the MPO Top 30 company reports published in the last issue, when reviewing R&D expenditures, every company stated that part of these costs included money provided to academic institutions. In some cases, these are for grants or donations for research. In other cases, it could be in support of an innovation competition (such as the one managing editor Michael Barbella writes about in this issue; click here to view that article). There are also the situations where this money is going toward an effort to establish a more formal partnership between the medical device OEM and a university. It is from these examples, I believe, that both the industry and academia stand to gain significant value.

In 2015, Philips announced that it was establishing a $25 million alliance with MIT and moving its R&D headquarters to Cambridge. The agreement was specifically made to have the school support the company’s core areas in healthcare and lighting technologies. Philips solicited research proposals and met with representatives from the labs on campus. The partnership provides the company with a new source of potential medical device innovations while MIT enjoys an avenue for projects to move out of the realm of simply being fodder for a published paper. Further, MIT expects to gain insights into how their developments are utilized in real-world environments.

“One of the things I’m really looking forward to, since they [Philips] are actually making stuff that gets used in hospitals around the world, is that they will develop some of these ideas,” said Peter Szolovits, a professor of computer science and engineering and of health science and technology at MIT. “That, in turn, would allow MIT students and faculty to do follow-up studies on ‘how well these things work in the real world.’”

[Learn more about this arrangement here.]

More recently, Wake Forest Innovations, the commercial arm of the Wake Forest Baptist Medical Center, teamed with Ethicon, a division of Johnson & Johnson, on comparing the OEM’s Echelon Flex 35 Powered Vascular Stapler to a manual stapler to determine potential differences in tissue tension. Both entities viewed the arrangement as a trial to determine if a more robust R&D partnership could be established between them.

“We can maintain specialists in very narrow areas of expertise, like gene-based therapies, biomedical engineering, and others,” explained Heather Ramsay, associate director of alliance management for the Center for Industry Research Collaboration at Wake Forest Innovations. “Companies can’t support that kind of specialization in-house, so they want to work with people in academia who have specific knowledge and skills.”

[Learn more about this arrangement here.]

Indeed, greater, more established relationships between academic organizations and medical device OEMs offer great benefits to both sides. Further, once the students graduate, those who are already intimately familiar with the company’s technologies instantly become perfect candidates to fill in the skills gap, able to hit the ground running on the project they’ve already been working on for years during their time in college.

It’s a rare example of a true win-win scenario. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-01 08:00:00 [updated_at] => 2017-09-05 07:44:32 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["255515","254654","254122","254113","254017","253226","253207","252632","252357","252273","251271","251019","250724","249619","249459","249384","247751","244651","244642","244415","244340","241975","241078"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 255885 [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] => 2017-09-01 [author_name] => {"name":"Dawn A. Lissy","title":"Empirical"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 152351 [primary_image_old] => [slider_image_id] => 152351 [banner_image] => 0 [title] => So We’re All on the Same Page: You Need a Test Plan [short_title] => [summary] => [slug] => so-were-all-on-the-same-page-you-need-a-test-plan [body] => I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on my computer, tablet, smartphone, spiral paper planner, and a series of Post-it notes that wing up around my office like neon butterflies.

It would never occur to me to not have a test plan. But I frequently find myself explaining the benefits of a plan to clients and dispelling a series of misunderstandings about how a test plan can make the development cycle easier and less expensive. I’ve even had clients who have never heard of such a thing and wonder why anyone would ever craft one.
I have special list just for them.

“Less expensive” typically catches everyone’s attention when explaining the benefits of devising a test plan. It varies from client to client, but some have saved as much as 30 percent of overall testing time and financial costs, depending on the type and scope of project. A testing plan solid enough to be the foundation of a successful project yet fluid enough to allow for course corrections eases the path to market—particularly for Class III devices.

“Easier” is a subjective measurement, however; there’s not necessarily a bottom line or hard number attached to it. But based on what I’ve noticed over the course of my career, it’s better to form a test plan at the beginning of the development cycle. If you wait until mid-cycle, a challenge that could’ve been foreseen might sideline the project and measures must then be put in place to deal with it.

The Why
Clients have argued a test plan could limit their options and they don’t want to feel pigeon-holed or wedded to a single path. But after considering the options and plotting the course, identify where and when that plan may need reassessment. The plan will not be carved in stone. Hopefully it won’t manifest in fluorescent paper slips all over the office, but rather a happy medium that allows forward momentum and won’t trap you in a corner.

Plan Before You Plan
A failure modes and effects analysis (FMEA) is a risk analysis and starting point. This is a must for Class III devices as well as Class II devices containing a feature with the potential to cause harm, such as an intervertebral body fusion device (IBFD) with a new locking mechanism for expansion purposes. The FMEA will determine any additional testing to consider in order to prove the overall safety and efficacy of the device—benchtop testing, animal testing, or other evaluations needed in the overall test plan. For Class III devices, you’ll also want to consider feasibility testing. Again, this may apply for Class IIs with breakthrough technology applications.

Now the actual plan is ready to be developed. Feel free to dust off my article “Driving a Successful Medical Device Product Development Cycle” in the July/August 2015 edition of MPO for more details on putting that plan together, but it should include minimum required tests from relevant regulatory agencies, in addition to feasibility or other evaluations identified during the risk analysis.

More Than Guidance Documents
Some clients have argued that they don’t need a plan because there are regulatory documents that spell out required tests. While established guidelines and regulatory direction are great fodder for a plan, they’re not an actual process guide for a device. The U.S. Food and Drug Administration’s guidance documents serve as the foundation and minimum requirements, but they’re not a device-specific path to market.

It’s easy to over- or under-test if those documents aren’t read correctly. Some devices such as vertebral body replacements or cervical or lumbar IBFDs can be tested to up to six different methods per the American Society for Testing and Materials (ASTM) standards. But not every device needs all six tests depending on its indication and location. Only two of six tests have to be performed on a monolithic lumbar device. Knowing the regulatory requirements for the specific kind of device helps to put the best plan in place to use time, money, and testing wisely. With Class III devices, there may not be a standard to test a device to, thereby requiring a test plan to propose to the regulatory agency.

I’ve actually had face-palm moments when a client informs me they performed all six tests when they only needed four. They covered their bases mid-process because they didn’t have a plan, which cost them time and money they didn’t need to spend.

Let’s also consider who you’re working with. The regulatory community is full of planners. Anyone who reports to a governmental agency—regardless of what country it’s in—has a series of boxes to check. It will be easier on everyone if a document to share with reviewers at any point in the cycle is available.

Putting It in Writing
When developing a test plan, you’re making a map—creating a document that will enable the entire team to literally be on the same page. This is where you’re doing homework and will see potential liabilities as well as possible shortcuts. Once this critical baseline is obtained, a realistic timeline and the bookends of possibilities can be developed. Best-case to worse-case scenarios and where/when those issues can pop up will be known.

With this outline of major deadlines and turning points, you’ll be able to allocate resources and refine schedules to smooth the journey.

Everyone will have the deadlines, everyone will get the same information, and the whole team will work off the same document. Given the number and variety of people that must work together to get a medical device to market—regulatory, manufacturing, production development, surgeons, etc.—this is essential. If everyone understands what the steps are and that those steps can’t be skipped, precious time will not be wasted. It’s ultimately about setting and managing stakeholder expectations.

Bringing the Future to the Present
Alan Lakein, author of “How to Get Control of Your Time and Your Life,” sums it up nicely: “Planning is bringing the future into the present so you can do something about it now.”
Consider the future of the device, the team, and your goals. Then bring all of that into the present with a test plan that will move the endeavor forward to meet those goals. 


Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio. 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