Medtech's 2021 Full Service Outsourcing Roundtable

By Sean Fenske, Editor-in-Chief | 05.03.21

Outsourcing service providers share lessons learned and how they were able to tackle the COVID-19 challenges to fulfill the needs of their OEM customers.

The pandemic has been a taxing event: on businesses, industries, and the general population. It’s a rare event that has taken its toll on everyone across the board. While the experience has unveiled vulnerabilities and shortcomings of systems and practices in place, such as those realized within the supply chain and with component sourcing, it also revealed areas of strength, including the partnership between medical device OEMs and their outsourcing partners.

While demand for certain medical devices skyrocketed, the stress put on the companies supplying those critical items similarly increased. Companies were being asked to ramp up production rapidly under extreme circumstances that significantly hampered their ability to do so.

Fortunately for medical device manufacturers who had already established close collaborative partnerships with outsourcing partners, the strain they felt was somewhat alleviated as a result of the aid provided by their industry companions. The true value of the outsourcing arrangement was on full display as these companies worked tirelessly, arm-in-arm, to meet the needs of a desperate healthcare community.

This year’s roundtable of full-service outsourcing organizations not only highlights the trends and topics of concern to both OEMs and their suppliers, but also features success stories of the pandemic. The collection of representatives from 10 firms share their victories and discuss practices established during the pandemic that could become best practices for the future. Their tales mirror many experiences other companies had during the pandemic as the medical device manufacturing industry heard the call from the medical community and answered loudly.

Among this year’s roundtable participants:

From Flex Health Solutions, Ana Abina, VP, global HR; Riccardo Butta, SVP, business development & account management; Mark Finn, Sr. director of business development; Patty Kamysz, Sr. marketing manager; Patrick Kostraba, VP global account management; and Erik Larsen, VP of supply chain management. Headquartered in Singapore, Flex’s Health Solutions division offers contract manufacturing services for electronic medical device products for a number of healthcare segments.

Jennifer Bolt, SVP, Global Operations and ESG at Integer, a Plano, Texas-headquartered contract development and manufacturing partner focused on the medical device space.

Mike Kaiser, VP of Business Operations for Donatelle Plastics Inc., a New Brighton, Minn.-based medical device contract manufacturer of components and complete products.

Greg Paulsen, director of Application Engineering at Xometry, a Gaithersburg, Md.-based supplier network firm that leverages manufacturing services from more than 5,000 supplier companies.

Jason Sauey, president of Flambeau Inc., which includes a Phoenix, Ariz.-based Medical Markets group that focuses on full-service contract manufacturing from design through to assembly.

Alton Shader, CEO of Viant, a design and manufacturing services provider to the medical device industry, with headquarters in Foxborough, Mass.

Greg Stotts, VP and GM of Teleflex Medical OEM, a vertically-integrated, full-service contract manufacturer of suture and interventional technologies, which has its headquarters in Plymouth, Minn.

Gary Switzer, SVP of Medical Systems at Sanmina, a San Jose, Calif.-based end-to-end design, manufacturing, and logistics solutions provider for industries including medtech.

Anja White, CRO of Cretex Medical, a manufacturing and engineering services partner, based in Elk River, Minn.

Marshall White, president and CEO of TEAM Technologies, an end-to-end manufacturing and supply chain solutions partner in the medical and dental device markets, headquartered in Morristown, Tenn.

Sean Fenske: Overall, how has your company responded to the pandemic to ensure critical components still got to OEMs?

Jennifer Bolt: Our top priority throughout the year was—and continues to be—protecting the health and safety of our associates. Integer’s Pandemic Team, including more than 90 professionals across the company, continues to monitor local and global guidance to ensure we have the necessary policies, processes, tools, and rigor in place to keep our manufacturing facilities safe and open for business, so we can continue to deliver the critical devices and components our customers’ patients count on to improve, sustain, and save lives.

We partnered closely with customers to better forecast demand and adjust production accordingly, and with suppliers to help them keep their doors open and deliver on their commitments so we could deliver for our customers.

Mike Kaiser: Donatelle was able to respond quickly at the start of the pandemic to have most of our non-manufacturing and support personnel work from home. Appropriate social distancing practices and mandatory mask wearing were also quickly implemented on the manufacturing floor. We also increased inventory levels for personal protective equipment in an effort to stay ahead of pending supply shortages. This allowed us to maintain a stable workforce and continuity of manufacturing without any manufacturing shutdowns. We also focused on securing critical purchased components to ensure continuity of supply.

Erik Larsen: Because of Flex’s global scale across regions and industries, including a broad-reaching and complex supply chain, we were able to respond to the repercussions of COVID-19 swiftly. In early 2020, Flex assembled a cross-functional global task force that met daily, with visibility to evolving supply chain events through our Flex Pulse platform, which provides real-time data and conditions, even down to an individual part level. This task force quickly executed internal changes and worked with supplier partners to manage weak spots in their own supply chains.

Localized disruptions required real-time analysis and mitigation. Over the pandemic’s changing trajectory, we carefully, strictly, and strategically managed the closing and re-opening of various sites worldwide. Operations pivoted to ramp up production of priority medical devices. Collaborating with suppliers and customers, Flex was able to analyze demand and balance the need for supply against the risk of creating an artificially constrained market.

These actions enabled us to produce critical-care equipment in record time and quantities: four times as many patient monitors, five times as many infusion pumps, 10 times the diagnostic testing kits, and three times the ICU beds.

Further, we began manufacturing ventilators for the first time. As entities worldwide were called upon to accelerate production of these life-saving devices, we resolved to join in. Flex launched seven ventilator production lines for four different customers across the globe, moving from contract signing to delivering final product units in less than 90 days, something that normally takes at least a year.

To accomplish this, Flex had to dramatically redeploy its workforce, tapping into personnel beyond its medical solutions practice who had needed expertise. That meant shifting hundreds of remote workers and determining the best way to optimize staff deployments. Flex turned to its global supply chain specialists to support the ventilator programs and recruited our talent to manage and drive these critical projects.

Greg Paulsen: Xometry’s platform uses a distributed manufacturing model, which was invaluable during the pandemic response. Because of geographic distribution and the high redundancy of capable suppliers, Xometry could produce custom parts with little disruption. Our projects included many critical components for medical OEMs as well as startups founded during the pandemic response.

Xometry was able to expand its network to include more medical manufacturers, such as those with FDA or ISO 13485 certifications, and increase its capacity while ensuring these businesses had a new revenue stream.

Jason Sauey: Flambeau has gone to great lengths to continue supply throughout the pandemic. We kept our operations at all six U.S. locations running, as well as our plants in Mexico and the U.K. We worked to increase hiring, raised wage scales, and ran overtime in arguably the most challenging labor market in our country’s history to continue to supply product with spiked demand in many cases.

Alton Shader: Our first priority was to take care of our people and ensure our associates were safe. Focusing on them and on the safety protocols we put in place for the team is what helped us to serve our customers. Our people are by far our most important asset, and without a critical mass in each of our plants, we would not have been able to deliver on one of our core values: Being customer oriented.

Across our enterprise, we understood potential constraints versus customer needs, and focused our efforts on ensuring critical inventory was available to meet customer demand. Throughout the pandemic, we were able to limit disruption in our manufacturing facilities and supply chain. Ultimately, we worked very closely with both our suppliers and customers, and maintained consistent service while ensuring the safety and well-being of our team members.

Greg Stotts: A few years prior to the pandemic, Teleflex Medical OEM launched our state-of-the-art EPIC Medtec Centers (engineering, prototyping, innovation, and collaboration). Our Mansfield, Mass., center focuses on suture and performance fiber device development, while the Maple Grove, Minn., and Limerick, Ireland, centers are dedicated to catheter and access device innovation. These facilities bring together expert engineering talent and extensive, integrated capabilities to enable our customers to develop market-ready devices, reduce technical risk, and speed up the time to market. Most device development can be accomplished in just a few days instead of the weeks, months, or years required by traditional methods. When we introduced the EPIC Medtec Centers, visits were in-person collaborative meetings only. After the pandemic hit, we quickly adapted our process using online collaboration tools—including video conferencing and a secure way to work remotely with our expert teams, with no travel required. It continues to be a total collaborative process from concept to production. As geographies begin to reopen, we are offering both options, providing our customers with choices in how to engage.

Gary Switzer: Many existing programs and procedures at Sanmina greatly aided our ability to respond and adapt when the pandemic first arrived. Whatever the crisis might be, we have established a planned set of actions based on risk assessment and recovery as part of our business continuity plan. Having a strong and rigorous quality management system also made it easier to close gaps created during the pandemic.

At the beginning of the pandemic, we developed an IT tool that can quickly calculate the impact of possible regional shutdowns. The status of key suppliers was monitored hourly and changing requirements were regularly communicated to customers. A freight contingency plan was also implemented to mitigate the impact in the reduction in freight capacity, when passenger flights were first cancelled at the beginning of the crisis.

Two aspects of supply chain management also helped us maintain component supply for essential production during the pandemic. Having multiple sources for components allowed us to rapidly change to an alternative supplier when needed. Strong partnerships and open communication lines with our suppliers and freight providers enabled us to have clear visibility into component availability and to reserve freight capacity accordingly. By working closely with our customers and suppliers, we were able to address significant increases in business and manufacture medical products that had a positive impact on the medical community in a time of great need.

Anja White: We began monitoring our supply chain exposure very early and reacted quickly to implement safety precautions within our facilities to ensure we could maintain a healthy workforce and fulfill our obligations as an essential business. Our private family ownership and long-term focus allowed us to enter the pandemic with a strong balance sheet and no concerns about the financial viability and resiliency of Cretex, even in our worst-case scenarios.

While we were impacted by COVID like nearly all businesses, I am so proud of how our team responded. We were able to keep potential at-work COVID transmissions to less than a handful of cases out of over 2,000 employees. Our key metrics in quality and delivery performance improved in 2020 as we worked closely with our customers to ensure their needs were met. We also had our highest capital investment year in history. While we are still vigilant, we are pleased to be back to full strength and above pre-COVID levels of sales and operating performance.

Marshall White: Thankfully, we had a Pandemic Response Policy prepared prior to the crisis starting, which allowed us to respond and act quickly. The first thing we did was institute the strict policies from our plan regarding workplace safety—from temperature screening to additional washing of hands to wearing additional/appropriate PPE and spacing out our employees to meet social distancing requirements. Protecting our employees is a priority because it allowed us to continue to manufacture products and deliver our services to those who needed them. Our mission is to “Help Those Who Help Others” and we needed to be able to manufacture our products to do so.

Fenske: Were there lessons learned (i.e., best practices) that you will be able to carry forward post-pandemic?

Kaiser: Many of our systems were already setup as paperless, which allowed for an easier transition to a remote work environment. These included most of our manufacturing, quality, process monitoring, planning/purchasing, and other business systems. Internal and external communication moved to virtual meetings and included the need to expand our video conferencing capabilities, which we were quickly able to accomplish. Those systems have now become the norm in our day-to-day interactions.

Larsen: A best practice that Flex will carry forward is implementing velocity of purpose. We were deliberate in how our technical resources were leveraged throughout our COVID-19 programs for customers. We provided key technical resources to the critical programs at the required moments in the programs’ lifecycles. This strategy eliminated redundancies and oversaturation that dependent activities sometimes cause. The ability to rapidly deploy and re-deploy technical resources allowed our programs to accelerate throughout the product lifecycle without compromising quality, regulatory, or performance requirements.

Paulsen: One of the challenges with the massive disruptions to OEM supply chains was the technical data required to make the part was often not directly accessible. For new suppliers to get started on a project, this was a gap that needed closure. I feel this should drive many OEMs to build a virtual inventory, where manufacturing data can be quickly shared with alternate suppliers to mitigate disruptions. I also see increased usage of resilient services like Xometry that significantly reduce the complexity of finding and sourcing custom manufactured goods.

Sauey: We have learned a number of lessons—the first is know your team can be better than you think. Let them be better. Lay out the expectations and let them run with it. The second is to try to get ahead of uncertainty by talking openly with customers about their demand needs and getting a forecast from them they will commit to. Establishment of supply agreements have also increased in profile and value. Unfortunately, many customers have had to learn some tough lessons too as conditions of abundancy may have been taken for granted. Third, we learned there is great risk in relying on a far-flung supply chain. The lead times and associated inventory and delivery implications are not worth the risks and costs of running out of supply in a time of critical need. There is value in having reliable quality domestic supply. Fourth, don’t count on the government to save you or to provide a reliable supply of anything in a time of need for your business.

Shader: We’ve learned three key lessons. First, maintain open, transparent communication channels with our customers. In a time of unprecedented uncertainty, we learned that customers needed to hear from us more, and we needed to be even more proactive in our communications when we learned new information or when situations changed. Second, ensure redundancy in our supply base. And third, update our business continuity plans to more fully address the risks of a future pandemic or similar high-impact challenge.

Stotts: We put temperature monitoring and other protocols in place to ensure employee health and safety, while also ensuring our supply chain continues to deliver products to our customers who are providing expert care to patients around the world.

Switzer: The pandemic has facilitated faster digital transformation of many business practices. Leveraging our cloud-based IT infrastructure enabled thousands of Sanmina employees to successfully communicate and collaborate in a virtualized working environment over the past year. Many business activities that were previously considered dependent on business travel and face-to-face meetings are now performed virtually. Instead of traveling to the facility, customers and regulatory bodies can now participate in interactive virtual plant tours, remote audits, and online document reviews, saving significant time and cost.

A. White: Before the pandemic, we assumed certain interactions had to be in-person; today, we are much more open to considering alternatives. For example, we became more flexible in our hiring process by conducting interviews virtually. This allowed us to quickly schedule interviews with several stakeholders at different facilities, rather than coordinating multiple schedules for an in-person meeting. Additionally, the openness of applying a virtual format to training has dramatically increased the amount of learning opportunities we can provide to a broader employee base.

M. White: I think there are a few lessons for manufacturers in general—both OEM and contract—with the greatest being, “Be prepared.” This preparation certainly should include policies for a potential crisis such as this, but it also includes things like making sure you have a robust and redundant supply chain that can handle some level of fluctuation. And through all of it, ensure you are communicating, even overcommunicating, with everyone—customers, suppliers, and especially your teammates.

Fenske: How did your communication with customers/OEMs change during the pandemic and did you find ways to improve communication that you will continue to use going forward?

Bolt: The pandemic certainly compelled us to evolve our approach in staying connected to our customers. We quickly pivoted to an entirely virtual approach, extending to video conferences, webinars, and other online options to meet our customers’ respective needs. In addition, we focused on ensuring our customers were regularly updated on Integer’s response and approach to the pandemic, as well as our continued ability to safely meet their dynamic needs.

To a large extent, the frequency and speed we’ve communicated has actually improved during this time. As we adapted along with our customers, we witnessed greater productivity and efficiency during meetings. Moving forward, we’ll continue to leverage virtual communications and webinars along with in-person meetings to stay closely connected with our customers.

Kaiser: All of our customer communication moved to virtual meetings, including the use of various video conferencing systems. Zoom and Microsoft Teams were the predominant platforms. The transition allowed us to maintain the frequency of customer communication, and everyone was able to adapt quickly. It’s difficult to replace the effectiveness of in-person meetings with our local customers when you need to look at parts or processes and make real-time decisions.

Patrick Kostraba: We pivoted to virtual meetings through Zoom, MS Teams, and WebEx to engage with customers for business development, regular communications, and to discuss issues. This has been challenging for complicated discussions or interactive problem-solving sessions that are better addressed through face-to-face meetings. Virtual meetings do work well for introductions, general overviews, or quarterly business reviews. We foresee the latter types of meetings continuing after the pandemic, as it has eliminated travel time and gives people more flexibility to hold meetings across multiple time zones.

Paulsen: We were ready and willing to make parts, PPE, and other supplies critical to the pandemic response but faced OEMs that needed those parts yesterday. By understanding those needs, we could proactively communicate and build a forecast for risk mitigation with buyers and suppliers.

Sauey: Our communication was continually updated as circumstances evolved and changed. We have had to be more active and interactive in our contact with our customers and use multiple forms of communication as relying solely on a passive form isn’t effective when immediate response and adjustments are required for effective service.

Shader: The guidance to our teams was to communicate early and often, and that bad news travels even faster than good news. The most important thing was to be in constant communication.

Our COO, Sean Crowley, and I held a highly attended weekly call with more than 100 customers to keep them abreast of the supply situation and how COVID-19 was impacting our operations, including down to the facility level. We held these calls weekly for four months and then bi-weekly for the next few months as the situation became more stable. We received very positive feedback from our customers, as we were really transparent throughout these conversations and in the Q&A sessions.

The virtual communication also increased the number of touchpoints and frequency of communications with customers at all levels, and this will definitely continue going forward. We’ve placed a premium on communicating and we’ve raised our own internal expectations for how often and how transparently our teams communicate with our customers. We see this as a way to build trust and stay connected with our customers’ challenges. Customers know our leadership team is available for them; they can pick up the phone at any time.

Stotts: As communication methods changed as a result of the pandemic, everyone began to interact in some form of virtual manner—using traditional tools such as email and telephone—but the proliferation of video chat became the standard. I see this as a great tool for increasing productivity for everyone. Personal interaction cannot be replaced, but when speed is critical, this is an excellent communication aide.

A. White: Overall, our relationships with our customers became stronger. Personal relationships evolved on a deeper level as people worked from their respective homes and general concerns over each other’s health and well-being entered dialogs more frequently. We also strengthened our relationships by putting emphasis on delivering customer information and presentations more effectively.

M. White: As a global company that focuses on innovation, we already had processes in place that enabled us to adapt easily to virtual customer meetings. We’ve maintained consistent, high-quality connections with each customer. Moving forward, we will continue utilizing virtual meetings, but also look forward to collaborating face-to-face and building even stronger relationships. The one thing that did change during the pandemic is we increased the frequency and kept a regular cadence of communication, even if there wasn’t anything new to share, to ensure there were no surprises.

Fenske: Have you had OEM customers take part in virtual tours, audits, inspections, or another such activity that would have normally taken place in person?

Mark Finn: The pandemic created significant challenges in building new client relationships. During the early stages of a partnership, on-site visits and in-person meetings with facility leaders were the best ways to verify supplier capabilities and experience. Now, all such activities are conducted via Flex’s Virtual Customer Experience Center—a unique platform that allows customers to visit each site virtually through video tours combined with live commentary, content, and discussion.

We quickly learned that for customers to fully experience custom material workflows and quality management systems (QMS) controls, video alone would not suffice. So, we created an adjoining quality systems presentation tracing custom material workflows that accompanied each video to illustrate QMS and shop-floor process controls throughout the entire production line, which enabled an “audit-like” experience. Combining the two mediums allowed viewers to experience the advanced manufacturing and quality systems controls deployed at each Flex site as if they were right there on the production floor. In one instance, a multinational provider of a major FDA Class II device was interested in two of our facilities that are oceans apart. We utilized our virtual experience center to create confidence and ultimately become selected as a major supplier in their program launch.

Kaiser: Pre-pandemic, all customer/OEM audits and ISO re-certifications were competed in person. A large number of these were performed virtually over the past year, with minimal prep work needed. Having the electronic systems already available, including CAPA, MRB, SPC, ECO, and manufacturing lot traceability, we realized very good success. Prior to the pandemic, we were able to access all the required information in a conference room setting. Having robust systems already in place allowed for a seamless transition to virtual audits.

With no travel allowed, we recognized the need to offer a virtual presentation of our manufacturing capabilities and facility. With the help of a professional videography company, we produced a video that is the best alternative to showing our capabilities through an in-person tour. The video is now available on our website.

Paulsen: Virtual audits, source inspections, and manufacturing traceability have been on the rise to mitigate in-person interactions. Xometry implemented a program called “VQC,” or Virtual Quality Check. This included photos, certs, and documentation to be uploaded to Xometry’s secure work portal by our suppliers. All this documentation is time stamped and auditable to meet our QMS requirements. VQC supplemented our in-house quality facilities, reducing handling and shipments while achieving our overall quality goals.

Sauey: We have conducted a number of virtual tours and audits during the pandemic, primarily out of necessity due to customers’ own restrictions on travel. While those experiences weren’t optimal, we were able to satisfy the customers’ needs to support their requirements. So long as customers are willing and desirous for the use of this means for these purposes, we can refine and improve upon the experience.

Shader: We’ve used virtual activities extensively. This has been most beneficial for new customers and new divisions of companies with whom we already work. As we’ve worked to communicate with our customers more frequently, we’ve found we were better able to directly involve more subject matter experts (SMEs) and leadership and it has brought great benefit. A key challenge is keeping up the momentum after video calls. People are very busy and they can, at times, move on to the next topic without strong follow-up or engagement.

We’ve also learned that preparing a complete, useful virtual tour can take as much (or more) time than preparing for an in-person tour if you want it to be truly impactful. But the advantage is that once you build virtual tools, they’re readily accessible and are quick and easy to share and enable you to reach a broader audience.

Switzer: When travel was initially prohibited, we had to develop a way for customers and auditors to tour our facilities in real time, as essential manufacturing for vital medical and communications products had to continue. Sanmina’s IT, marketing, quality, and operations teams collaborated on a virtual tour program that has been quite successful at locations around the world. The team established consistent wi-fi access on factory floors, implemented noise cancelling technology to mitigate background noise from machines, and added stabilizing equipment to ensure a steady video image at various locations on the production line. A number of dry runs were conducted with local production teams at each plant to rehearse each customer tour and resolve any potential issues before a live interactive session took place.

Feedback from customers who participated in the virtual tours has been overwhelmingly positive. We discovered that you can do an even better job of showcasing a specific area, manufacturing tool, or methodology used in a particular operation when you can zoom in on different areas that you might not have been able to as easily show to a large group in person. At any point, a customer could stop us and ask questions. Sanmina also participated in remote audits and remote document reviews that were performed very efficiently through online platforms and video conferencing. Customers have enjoyed these highly productive sessions, as well as the time and cost savings of participating remotely.

A. White: Over the past year, we have enhanced our technology to virtually perform many activities previously done in-person such as facility tours, first article inspections (FAIs), and customer and supplier audits. We configured our conference rooms to better support virtual meetings and audits, and utilized innovative technologies like augmented reality goggles.

M. White: We’ve had customer and third-party audits performed remotely over the past year and they were challenging in the beginning due to spotty wi-fi service in some areas of our facilities. But we’ve learned to work through the connection issues.

Virtual audits are slower and less personal, and we had to spend more time explaining whereas auditors normally could get a first-hand view. In some cases, remote audits are fantastic; in others, they are challenging. We had one auditor in particular that dragged the audit out for days, whereas if they had come onsite, I think it would have been much quicker. I would attribute these challenges to the auditor’s preparedness for a virtual environment.

We’ve invested in a better camera system and we are trying out a video software, but the difficulty with videos is ensuring that if we are being audited by customer A, the video doesn’t include anything for customer B or C.

Fenske: What has been the impact to your company without participating in/attending live (i.e., in-person) tradeshows?

Kaiser: Historically, Donatelle has participated in a variety of conferences and tradeshows—both large and small. It’s difficult to replace the impromptu face-to-face interactions and touchpoints with new prospects and existing customers that take place during tradeshows. We experienced great success using increased web-based activities over the past year. They generated new program leads that would potentially be uncovered during tradeshows. We look forward to the time when there is no hesitance in exhibiting and attending tradeshows, hopefully in the near future.

Patty Kamysz: While we miss interacting with customers and other industry professionals during live conferences and exhibits, we have replaced these experiences with virtual interactions when offered by the conference organizers. Our subject matter experts have adapted well to recording on-demand versions that are just as compelling. For instance, Sr. Director Design, Process, and Technology Marco De Angeli recorded himself from his home lab for a virtual conference on drug delivery partnerships. His animated discussion of new sensor technologies in autoinjectors to improve remote patient monitoring appeared to be as well attended as if it were on site at a convention center.

Paulsen: Trade shows are a great resource to generate new business leads as well as network with industry colleagues. The exhibitors are just as attractive as the attendees for our teams as we serve both buyers and sellers on our marketplace. With everything going virtual, we have had to adapt. We have seen some platforms that work well for networking and direct communication; these usually involve small tables and video interfacing. Other virtual fair events have been much better for lead generation by allowing attendees to click through a booth’s features. We approach different virtual shows with other goals and expectations based on the venue.

Sauey: We have found a way to get on with transacting and developing business without tradeshows. I think the value of tradeshows going forward will face greater scrutiny and some will be discontinued. Those that do continue will likely see exhibitors and attendees scale back on levels of participation depending on the nature of the industry and products involved. Obviously, the use of virtual demonstrations will likely continue and augment any in-person events.

M. White: There is no adequate substitute for the networking you can get when attending tradeshows live, however, we’ve managed to maintain a presence at virtual trade shows for the OEM sector and our medical- and dental-branded products were more productive than we anticipated. Virtual events are a nice option to stay connected with customers, but our TEAM is really looking forward to meeting face-to-face with customers in 2021.

Fenske: Some have speculated there may be some reshoring of medical device manufacturing in the coming years (i.e., back to the U.S.). What are your thoughts on this?

Kaiser: There have been a number of unforeseen disruptions in supply chains due to offshore supply of components and assemblies. Risk mitigation and potential dual sourcing for critical components will most likely be a priority moving forward.

Kostraba: Some customers are saying they need to build in the U.S. to meet government policy or are moving back for supply chain resiliency and continuity. This has made NPI launch capabilities and cleanroom manufacturing space a premium in the U.S.

Paulsen: I do think it will be a little of both. There are high-quality established manufacturing facilities closely tied to OEMs for medical devices globally. It is challenging to uproot these relationships, especially if the quality is not an issue. The challenge is supply chain disruption, and that’s where the distribution of suppliers helps. Alternate suppliers and mixed supply chains can mitigate impacts by providing supplies from dispersed locations. Additionally, many items in the bill of materials for that device may be measured by how secure they are to the source, often showing a requirement for alternatives or holding different stock sizes.

Sauey: I would expect some reshoring of supply to occur. As I alluded to previously, the risks of relying solely on a far-flung import supply chain in blind pursuit of the lowest purchase price carries risks that often outweigh the purchase price benefit. We look forward to further supporting customers and prospects who now better understand and realize the benefit of a high quality and reliable domestic source of supply.

Shader: That’s a great question, and I don’t have a strong opinion on which way the wind is blowing on that. But we know that global conditions are in a constant state of change and our customers’ strategies can change quite frequently as well. This is one of the reasons we feel so great about our network. As a global company with 24 sites over multiple continents, our customers know they can trust us to have a solution as their needs and strategies change.

Switzer: For existing medical products, there are significant costs to re-validate the supply chain and production line if manufacturing is moved from one location to another. For future products, we are seeing medical device OEMs evaluate past strategies as they look to make decisions about where to produce new products. They are examining the most competitive footprint that would make sense, based on overall total cost of ownership and return on investment. This analysis factors in where all of the various components and materials for products are sourced from, the local staffing and technology resources that are available to support production, and locations where the finished product will be sold. Without country-specific trade expertise and an accurate picture of the entire supply chain, it’s impossible to correctly compare true total landed costs for alternative manufacturing locations.

M. White: The trend seems to be moving toward reshoring or near-shoring, which offer several benefits. First, it allows for faster turnaround times and is less dependent upon transportation challenges we saw during the pandemic. Second, it allows for tighter quality control over processes and the finished product or part. So, it is a win-win for the industry. We are seeing a number of customers take a position where they are reshoring at least a portion of their supply chain to give themselves redundancy for the future.

Fenske: With shortages becoming an issue for certain types of products during the pandemic, have OEMs approached you about offering warehousing or logistics services?

Larsen: With manufacturing and supply chain locations in all major regions of the world, as well as strategic partnerships with global logistics service providers, Flex has traditionally offered customers the service of warehousing and logistics for their programs. As critical shortages continue, more customers are leveraging this capability from Flex. As demand grows, we are implementing enhanced risk mitigation and security of supply measures that will ensure the continued availability of supply for our customers. Whether the focus is on raw material for manufacturing, finished goods distribution and fulfillment, or a combination of both, we believe we are well positioned to continue to meet the needs of our customers during these challenging times.

Paulsen: Stock, holding, and shipping have increased as a need during the pandemic. Many products were prioritized for near immediate distribution, so the most considerable requirement was strong supply chain management.

Sauey: We have had requests from some OEMs for warehousing and logistics services, and we are willing to support in this fashion for the right pricing and terms to go along with those services. We have also found OEM customers more willing to carry greater levels of inventory and also increase their minimum order quanitities. They have run up against the risks of operating with too tight a supply chain. Lean practices, taken to an extreme, can become counterproductive, and we have seen many customers butt up against the adverse effects of such practices.

Shader: Yes, our customers have approached us to provide a number of additional services, including holding additional inventory and providing greater visibility to our supply chain. We’re happy to work with customers to provide these services. Since our end goal is to be a trusted partner, we’re always open to creative new ways to earn their trust.

Fenske: Given the fallout from the pandemic, are international manufacturing locations as attractive as they were before the pandemic?

Bolt: Yes. The medical device market is global. As a result, Integer has supported and will continue to support the global development and manufacturing needs of our customers. Our international manufacturing and development footprint enables us to be more responsive to our customers’ needs, recruit a culturally diverse and talented workforce, and identify and adopt global best practices. All of these factors contribute to us being our customers’ partner of choice.

Kostraba: Flex routinely works with companies when they are deciding where to locate their manufacturing operations. Companies evaluate these decisions based on capital infrastructure, availability of unskilled and specialized/skilled labor, and proximity to a robust supplier ecosystem or specific natural resources. Policy and de-risking of geographical footprints also influences these decisions.

Paulsen: Price is always a critical point in deciding manufacturing suppliers and locations. I feel that overall the attractiveness of international suppliers has not changed. Still, the strategy and need for alternative supply chain solutions, like Xometry’s distributed manufacturing platform, have become part of a long-term plan for OEMs. Companies need to plan for events like the pandemic that could impact access to overseas production as well as production in the US.

Shader: Our international locations have been incredibly successful earning new business over the course of the last year. We’ve seen increased interest in our low-cost country operations including China, Costa Rica, and Mexico as we continue to invest and support our strong teams in those locations.

Switzer: International manufacturing locations depend on product volumes and the locations where the product is going to be offered. For example, if a customer has a main market in India or China, they might need to have the product manufactured closer to the end market. In the case where you have to produce significant volumes of a product, such as diabetes monitoring or drug delivery devices, it makes sense to have multiple manufacturing locations around the world to ensure redundancy and reduce risk in the event of another pandemic or natural disaster.

There are some facilities around the world that have a required expertise, such as high-speed manufacturing capabilities or the ability to manufacture very large and complex medical systems that will determine their use, regardless of their location.

M. White: Manufacturing closer to home, whether that be the final market for a product or where it is assembled, packaged, and kitted, for example, has its benefits. One thing the pandemic has taught everyone in the medical device industry is that speed and efficiency without sacrificing quality control are imperative and will continue to be in the future.

Medical contract manufacturers with a U.S. base of operations have extensive networks of leading materials suppliers, fabricators, specialists, and advanced manufacturing expertise. These manufacturers are also often nimble enough that they can aggressively pivot to get through the regulatory process and to market quickly because they have the pieces in place to re-shore products that are needed now.

Fenske: Now that we are more than a year removed from the start of the pandemic, how have you altered your recovery plans to address a future problem?

Kaiser: Lead-times for capital equipment and some purchased items have been extending out, requiring more focus on future business planning. Donatelle has placed greater focus on program forecasting and order visibility from our OEM customers to allow added or increased safety stocks for longer lead-time and more critical items.

Shader: We’ve focused on efficiency and process, and have found ourselves stronger and more resilient today. If a similar challenge to a pandemic presents itself in the future, we would be able to do what we did faster and more easily. With the protocols we’ve put in place to keep our team safe and our business strong—including aggressive cost-cutting, at times—we’re highly confident we can weather any storm in the future.

Stotts: Prior to the pandemic, Teleflex Medical OEM had embarked on a risk mitigation project to address material and capacity constraints. The pandemic highlighted the value of that effort. Not all can be easily resolved, but we believe knowing constraints exist and mitigating them is important.

Switzer: A lot of work that Sanmina has already done on automation initiatives served us well over the past year as we navigated how to work with abbreviated manpower and new social distancing requirements. We had many technology resources already at our fingertips that were invaluable as the crisis unfolded, including cloud-based IT tools such as collaboration software that enabled thousands of employees to successfully work from home.

We’ve been able to optimize remote operations and structure projects to account for restricted travel, remote audits, meetings, document reviews, and electronic approvals. In addition, we’ve updated our business continuity plans with the latest health and safety procedures related to personal protection and physical distancing.

Fenske: One topic put on hold during the pandemic was corporate social responsibility. Post-pandemic, will this gain renewed attention within your company or are there other higher priority items ahead of it?

Bolt: Despite the pandemic, Integer never put corporate responsibility on hold, and we continued to advance our commitment. A few examples include formally implementing a diversity & inclusion program and naming a D&I leader, as well as making and donating 10,000 face shields to emergency responders and medical facilities. Additionally, our associates around the world maintained their commitment to giving back to our local communities through a number of creative, safe, socially distanced initiatives benefitting local nonprofit organizations.

Paulsen: Corporate social responsibility is a key component of Xometry’s culture and social mission. Xometry’s GoGreen initiative has offset the carbon footprint of shipping parts to our customers since early 2020. Recently, we have introduced ways for customers to select to partially or entirely offset their carbon footprint for manufactured products. Xometry has also appointed strong leadership, including members of its board of directors, to facilitate dialogue about access, equity, and diversity.

Sauey: The highest priority is providing reliable, quality supply at a recognized value to our customers. We will always conduct our business in an ethical and responsible manner. Performing our jobs and servicing our customers well is the primary social responsibility our company has.

Shader: Throughout this challenging time, we’ve been incredibly proud of our teams around the world as they became even more involved in helping their local communities, including fellow team members who needed help. We’ve seen great examples of our teams stepping up in various ways, such as sponsoring food, clothing, and blood drives. We have a corporate focus on social responsibility, but we also allow leaders at our 24 sites globally the autonomy to support their local communities in ways that work best for each location.

M. White: DEI has always been an important part of our DNA and we plan to continue to promote diversity, equity, and inclusion in all we do at TEAM. I think some things over the past year have highlighted areas we can improve as a society and TEAM is committed to being a force for good for improvement in these areas.

Fenske: Sustainability was gaining momentum pre-pandemic and will undoubtedly return to prominence. How is your company addressing this trend?

Bolt: Sustainability initiatives are a key area of focus for Integer. In 2020, we strengthened our commitment to environmental, social, and governance (ESG) programs by establishing a formal ESG Committee, led at the executive level. We additionally took steps to decrease our carbon footprint, reducing our annual CO2 emissions by nearly 1.8 million pounds in 2020 compared to 2019.

Larsen: We continuously monitor global sustainability trends and conduct research to better understand the needs of our stakeholders, including customers, investors, employees, and our communities, as well as industry-leading practices. This outside-in approach helps us to consider a range of evolving trends and practices and inform our sustainability initiatives and activities.

Sauey: Sustainability, to me, is a much-used and probably overused and misused term that has a vague meaning and application. We live a conservation ethos and, as such, we are committed to responsible and best use of resources we deploy in all that we do.

Shader: Sustainability is a key focus for Viant. We’re actively pursuing energy-efficient solutions and are continuously improving production methods to reduce waste and lower energy use. Throughout our organization, we both incent and recognize efforts around sustainability and will continue to build a culture that will minimize negative environmental impacts.

Fenske: When faced with an OEM customer who presents consistent requests for a percentage cost reduction year over year, does it cause a rift in the relationship or a re-evaluation of whether the customer’s business is worth it?

Kaiser: This has become a normal mode of business for some long-standing customer relationships. In order to sustain those relationships and achieve cost-down goals, there needs to be a high level of collaboration and willingness to apply resources and make those changes to achieve the goals. This environment of continuous improvement can help drive new innovation through alternate manufacturing methods. When true costs and significant costs can be taken out of the processes, it becomes a win/win for both parties.

Sauey: Year-over-year mandated cost downs can absolutely put a strain on the relationship. It also introduces an incentive for gamesmanship at the outset of a relationship or program. As we have seen recently, times like we are experiencing that have dramatic surges in costs of inputs (material, labor, whatever) make it untenable to even hold, much less reduce, costs and still remain a viable and sustainable supplier. There needs to be a means to address responsible pricing—upward as well—and not just to try and protect the OEM’s cost structure.

Shader: Customers are always looking for high-quality services at a fair cost. They also consistently look for annual price-downs. We work very closely with our customers to ensure they understand our processes and our approach, and we’re most successful when we work collaboratively with our customers on cost savings.

If we don’t manage this process effectively, it can lead to a difficult relationship. However, transparent communication from the beginning of a program can help prevent this. There are times when a customer wants a specific price and we cannot offer our services at that rate and maintain a strong business, which ultimately would also not serve our customers well. At times, requests for cost-downs are presented in parallel with increased needs or requirements, which makes cost-downs unrealistic or unfeasible.

M. White: I think it all comes down to partnership and making sure you are working with true partners. The relationships where a customer always beats on a supplier for year over year cost reductions with no level of participation to achieve that are temporary relationships in my mind. Those customers that recognize—and desire—that a supplier make a fair profit for their product or work, and are willing to participate as a partner are the ones we like. Lower pricing for the customer and steady/improved margins for the supplier are not mutually exclusive. With the right partner, both can win in the long run. You just have to trust each other and be committed to working together to achieve it.

Fenske: The industry is experiencing a shortage of skilled labor for many production positions. How is your company addressing this and what are you doing to attract/retain talent?

Ana Abina: Flex offers competitive wages and benefits and, equally important to our employees, are opportunities to work on projects that span international boundaries. We believe our focus on development opportunities including on-the-job training, online training, classroom training, rotations, and cross-functional project exposure is what continues to attract great talent to Flex.

Bolt: Attracting top talent requires a strategy that takes into account all stages of the talent cycle to ensure we not only appeal to external job seekers, but we can engage, retain, and grow them once they’re here. From an external market perspective, we find we have to be proactive. Aside from a diverse job advertising strategy, we really seek to engage our local communities in open houses, job fairs, and recruitment outreach to ensure job seekers know who we are, and what we do. We try to make applications and interviews intuitive and streamlined to ensure our hiring process remains appealing to all candidates. During our interview process, candidates learn even more about our company and values, and gain a better understanding of what separates us from others. The entire approach helps us mitigate the macro talent challenge that all production organizations are facing.

Paulsen: Xometry hires professionals across manufacturing disciplines and industries. With its distributed manufacturing partner network, it also provides a revenue stream to small manufacturing businesses. There is significant underutilized capacity across the globe so that talent may be there, but the connection has been an issue.

Sauey: We offer an energetic and inviting work environment that stimulates and challenges our people so they grow in their chosen field of endeavor. In addition to offering a competitive package of compensation and benefits, we also provide education reimbursement and ongoing training and interaction across functions to give our people better insight into the business across the company and help them grow in their understanding of and impact on our business.

Shader: For Viant, the most important thing we can do is to build a company where people want to work and a culture of which we can be proud. In line with that, referrals are one of the most successful tools we have for hiring great people. It’s also important to us to keep the great people we have, so we’re working hard to continue to develop our current team members.

A. White: We have a very strong Operational Excellence program throughout all our companies to assist with creative automation, and more importantly, ensure our production jobs are interesting and challenging. We remove repetitive tasks where possible and focus on the employee’s ability to learn new skills. Our ownership structure allows us to have a long-term focus and continue to reinvest in state-of-the-art equipment, competitive benefits and pay, as well as unique benefits like profit-sharing.

M. White: We instituted a theme over a year ago called “ONE TEAM. Many Opportunities.” We highlighted the benefits of working in our climate-controlled facilities and the benefits we offer our team members. In addition, we partner with local technical trade institutions as well as high schools and colleges in the communities where we work to promote technical education and let people know they can make careers out of technical trades in companies like TEAM. We have actively been hiring on a regular basis.

Fenske: What recommendations do you have for OEMs currently seeking new CMO suppliers? How can they best evaluate a prospective partner and what traits should be considered most important?

Bolt: There are several traits to consider but the most important attributes include speed to market, breadth of capabilities and vertical integration, a proven track-record of high quality and on-time delivery, deep subject matter expertise, ability to seamlessly scale production volumes, innovative technologies and processes, and the financial strength and resources to invest with OEMs.

Riccardo Butta: Regardless of the current environment, we believe OEMs should know the answers to seven questions when considering prospective suppliers. 1) How can my company remain competitive amid constantly changing environments? 2) Can my manufacturer help me “design for excellence”? 3) Does this potential partner adopt the latest (e.g., Industry 4.0) manufacturing technologies? 4) How can I be sure my manufacturing partner can meet my complex needs? 5) Does this manufacturer support sustainability across the lifecycle? 6) What standards and methodologies should they have expertise in? 7) Can they help me get to market quickly without sacrificing product quality?

The pandemic has added three equally important considerations: 1) How did the CMO respond to the pandemic: Did they successfully manage responses and handle supply chain shortages? 2) Can they be flexible with drastic changes in customer demand? For example, demand for certain devices drastically dropped due to the pause in elective procedures. Lastly, 3) When travel is prohibited, can the CMO effectively launch programs virtually? The CMO’s answer to these same questions illustrates that it can be an ideal collaborative partner.

Kaiser: In many cases, a past relationship between someone within the OEM and the prospective new CMO starts the interaction. There’s already a certain level of trust in the relationship, which is very important. Things OEMs need to consider are the CMO’s certifications and their level of experience in the type(s) of products to be outsourced. The OEM also needs to gain insight into the CMO’s new product development processes—the amount of resources available and the amount of attention they will receive. During the early stages, Donatelle has found success when various functional levels interact with each other to develop those relationships. This results in a better understanding of the cultural fit between the companies and a longstanding partnership.

Paulsen: I always go back to the five R’s of resilience: robustness, redundancy, resourcefulness, response, and recovery. How your new supplier holds up to these measures can highlight both strengths and risks.

Sauey: I recommend OEMs seek out and verify CMO suppliers who have early engagement capabilities that can help address early-stage requirements, thus, help improve quality, functionality, and value of any given product. In addition, seeking suppliers who have turnkey or downstream capability can help alleviate many concerns and challenges OEMs need to address over the course of the development of a program, as well as with the launch and continued supply of production.

Shader: Having a relationship with a supplier you can trust is critical. To trust them, you have to believe they care about your program as much as you do. It’s also important to talk to their subject matter experts to verify they have the required expertise for your project—that they have a team that can truly deliver.

Be sure the company—specifically, the management team—shares the same beliefs around the importance of serving you as a customer. It’s really important to ensure you see eye-to-eye with the management team, that you believe in the culture they’ve created.

OEMs need suppliers who understand that everything we do touches human lives—suppliers who can serve as an extension of their team. At Viant, our team understands that the products we develop, manufacture, assemble, and ship for our customers could mean the difference between life or death for a patient. You need a supplier who understands that and takes it very seriously and has the tools to deliver.

Stotts: We believe OEMs should evaluate what they need. Are they comfortable with low-cost manufacturing geography? Do they require expedited development? How much design expertise? Do they want all of the above? Look at where the CMO is investing its resources and this should guide you to an appropriate partner.

Switzer: Look for a CMO partner that can provide services over the lifecycle of a product, all the way from design, prototyping, and NPI to manufacturing and repair. Many devices have an operational life that can span several years. Having a partner that already understands the product enables the CMO to support the product at later stages, without an additional learning curve. It also provides the OEM with flexibility to add other services as needed, turning more fixed costs into variable costs, even if they only start with outsourcing manufacturing and add other capabilities later.

When considering a new CMO, it’s also important to ask for examples of similar products they have already manufactured, as well as their regulatory track record and audit results.

A. White: OEMs should evaluate a prospective CMO partner by their communication, responsiveness, and flexibility. Another critical element is a CMO’s financial health and ability to quickly make decisions on long-term commitments like capital investments. A strong candidate will have a wide breadth and depth of technology and access to technical support at all stages of the customer’s product life cycle. Finally, a CMO partner must have deep industry knowledge, competitiveness in overall value, and support an OEM’s need to sustainably and transparently reduce risk in its supply chain. Overall, it should be easy for the OEM to engage and work with a trusted CMO partner.

M. White: Look for partners who offer a full solution, from product design to molding to specialties like bristling and kitting. We’ve found that by offering a complete end-to-end solution that includes services such as assembly and packaging helps to set us apart as a partner to take a product from concept to completion. It allows our customer partner to do what they do best, which is marketing/promoting/selling their products and it allows us to do what we do best, which is design/develop/prototype/scale to manufacturing. We both get to focus on what we do well.

Fenske: What steps must an OEM take in order to evolve from dealing with a CMO purely as a supplier to establishing a true collaborative partnership with that CMO?

Bolt: A true collaborative partnership is built on open communication and trust. A CMO cannot effectively serve as an extension of an OEM’s development and manufacturing organization unless there is transparency regarding product roadmaps, technical challenges, cost expectations, and timing expectations. Trust is built through open communication and consistent execution.

Butta: Empowering and trusting your supplier base is key to transcending the traditional supplier relationship and becoming a true collaborative partnership. When the OEM can treat the CMO as an extension of itself, and when both groups are giving each other relevant, timely information, this common level of understanding is the basis for achieving great things—and, ultimately, for delivering quality medical products to the marketplace.

Sauey: OEMs would be wise to engage a CMO in the conceptual, or at least design, phase of a program and explicitly set agreed to expectations and ground rules for engagement. Making clear the door is “open” for content and communication can make a big difference in getting full input and energy from a resource. Setting a fair direct supply agreement at the outset can also be helpful.

Shader: A partnership is a two-way street. Our view is that the only way we can truly have a strong partnership with a customer is if they’re ready to have that partnership as well. Nothing is more important than trust in that relationship.

Our goal is to earn our customer’s trust—which can take years—then to always deliver. We pride ourselves on transparent communication, and we need that from our customers, too. If we can have an open, honest dialogue, then we believe we’ve reached that level of partnership. Trust will stay solid in good times and bad times. The partnership will endure.

Switzer: For the best collaboration, having key CMO staff embedded within the OEM’s teams (e.g., design, engineering, supply chain) will enable cross fertilization early in the design phase. Providing full access to a preferred supplier list also enables the CMO to connect with the right suppliers early in the design phase.

A. White: An OEM should evaluate the CMO’s ability to support the OEM long-term and have mutual agreement negotiations to identify benefits for both parties. To transition from a supplier relationship to a true partnership, OEMs must engage the CMO early in the development or redevelopment process. An OEM should leverage their CMO’s expertise in design for manufacturability (DFM), supply chain management, quality and regulatory support, and other value-added capabilities.

M. White: First, ask the CMO what services they offer and look for a more complete solution; it can help fill in the gaps and provide the benefits of a more streamlined process of getting your product to market. It is important to stress the benefits that vertical integration—including offering an end-to-end solution—can have on the bottom line for OEMs. For example, offering the expertise of material procurement (finding cost effective materials) helps streamline the time to market for manufacturers.

Fenske: Conversely, what does a CMO need to do to illustrate to an OEM it is capable of being a collaborative partner in a medical device project?

Bolt: CMOs develop strong partnerships with OEMs by consistently demonstrating value. Every OEM seeks a unique value proposition but CMOs are generally called on to accelerate an OEM’s time to market, de-risk a development or manufacturing strategy, reduce cost, or complement an OEM’s innovation. CMOs accomplish this goal by having strong capabilities, technical expertise, quality performance, development/manufacturing processes, project management capabilities, and cost controls.

Sauey: Demonstration of capabilities and presentation of “case studies” can be helpful to reinforcing the abilities of the CMO. An on-site tour with introduction of the team and company capabilities can also help demonstrate the willingness and ability of the CMO to fully collaborate.

Shader: I think a design and manufacturing services partner needs to bring the right combination of technical capabilities, reliable service, open communication, and a way of doing business that engenders trust. This all must be backed up by the full suite of solutions the customer needs to get the job done at the highest quality, on-time, and on-budget.

Switzer: Many CMOs are handling highly sophisticated programs that some OEMs may not be aware of. It’s up to the CMO to educate OEMs on the types of complexity and step function improvements they can accomplish. For example, Sanmina was able to work with one customer early in the design phase to develop a fully automated production line capable of manufacturing more than 50 million wearable blood glucose monitoring devices per year. That translates into one device per second. It was a complete disruption for the medical device industry.

Another challenge involved helping a customer outsource high-level assembly over a period of nine months while product designs were still being finalized. Sanmina had to introduce a number of complex, high-level assemblies with multiple complex technologies, while concurrently finalizing the product designs. In one program, 10,000 engineering change orders were required over a period of 18 months—that’s more than 30 changes a day. It was a major operation and one of the first of its kind to bring all of these complex systems into an outsourcing model.

A. White: A CMO must support an OEM’s need to reduce risk in its supply chain sustainably and [transparently]. It needs to be able to demonstrate a very high level of responsiveness, flexibility, and have the ability to make decisions on long-term commitments such as making capital investments quickly. They must also have strong financial health, a wide breadth and depth of technology, and access to technical support at all stages of the customer’s product lifecycle. Finally, a CMO must show deep industry knowledge and be competitive in overall value.

Fenske: Is M&A activity within the industry having an effect on the OEM/CMO relationship? If so, what is the impact?

Sauey: M&A activity is absolutely having an impact on the potential formation of a collaborative OEM/CMO relationship with large-scale OEMs. Increasingly, it seems OEMs have outsourced product and program development to the acquisition process rather than perform such development organically in-house. The onus of product and program development has been placed on startups and early-stage businesses with much of the risk and cost often being assumed by CMOs to assist such businesses in the successful completion of programs.

M. White: In our case, it certainly is having a positive effect. In fact, last year we acquired Baril Corporation, a medical device manufacturing company. This expanded our breadth of capabilities in the healthcare industry and positioned us well for future growth. By increasing our matrix of capabilities, we believe we become more valuable and useful for our partners. This U.S.-based facility added to our already robust portfolio of domestic manufacturing capabilities. Adding these complementary capabilities is a key part of our M&A strategy at TEAM.

Fenske: What trend(s) in medtech will you be following that you expect to become more important once we’ve had some sense of normalcy restored?

Shader: I’ve spoken to countless supply chain leaders who have outlined their plans to simplify and reduce the number of suppliers in their network. As medtech companies become even more focused on innovation and getting their unique devices to market faster, they need supply chains they can trust and empower them to achieve their goals. We believe design and manufacturing services partners that have scale and expertise can better serve these medtech companies and help them achieve their goals.

Switzer: Home-based monitoring of health conditions will become more prevalent, based on the increased popularity of telehealth services during the pandemic. Also, sensor technology is becoming smaller and integrated into wearable monitoring devices that are about the size of a smart watch. These sophisticated devices can monitor a wider range of health parameters than ever before, such as blood glucose levels and sepsis. Patients can conveniently share this personal health data with doctors from home via the cloud. This enabling technology could significantly change the way illnesses are identified, while reducing the amount of time and number of in-person interactions required to get a diagnosis.

A. White: I expect digitization, remote health monitoring and services delivery, global supply chain strategies, and healthcare cost alignments will become more important post-pandemic.

M. White: It seems that finished products in the digital realm will continue to be in demand including products such as sensors, wearables, and patient data collection devices. This highlights the importance of facilities such as cleanrooms with assembly capabilities and additional custom manufacturing capabilities to meet the needs of the ever-changing device market.