Scott Frey grew up watching multiple sclerosis slowly ravage his mother’s body.

Frey recalls the muscle weakness, the spasticity, and lack of balance that stripped his beloved parent of her independence, but mostly he remembers the loss of hand function that rendered even the simplest tasks next to impossible.

“...one of the things she struggled most with as that disease progressed was the use of her hands,” Frey, Miller Family Chair in Cognitive Neuroscience at the University of Missouri, recounted in an early January podcast. “I remember as a child being very aware of just how important it is to have good hand function in order to live independently and to do all those things that when we’re healthy, we really take for granted—dressing, caring for the house, and taking care of business; most of those activities to some degree involve our hands. I was, in essence, my mom’s hands from the time I was really little and I think that planted the seed in me...”

That seed eventually fostered Frey’s interest in brain-hand communication and the complex neural networks involved in basic motor function. His career in neuroscience has yielded quite a bounty of accomplishments—more than 100 scholarly articles on brain-hand behaviors, and groundbreaking research about neuro-rehabilitation (in 2019, he and a study team at MU found proof that human brains can rewire themselves after a trauma like amputation).

Frey’s latest undertaking could prove equally as trailblazing: He currently is harvesting real-time data on hand function to help craft personalized treatments for severe upper limb injuries. The information collection system he devised uses small wireless sensors embedded within a wearable device (similar to a commercial fitness tracker) to monitor limb function among non-amputees.

Leveraging a $1.5 million federal grant, Frey will use the sensor-generated data to compare standard lab-based assessments for hand behavior/function with real life, daily limb use.

“We can record data with these wireless sensors across numerous days and boil that down to a unique personalized profile of how a person is using their limbs or their prosthesis in the real world,” Frey said, “and then ideally we’ll be able to work with clinicians to develop more effective interventions and evaluate the effectiveness of those interventions in these individuals.”

“This is kind of a new adventure for me,” Frey continued. “This is an area that has grown out of my interest in connecting brain science with real-world behavior.”

The conduit for that connection, of course, is the wireless sensor, an Internet of Medical Things (IoMT) byproduct and hallmark of digital medicine. Sensors are just one of the many upshots of an IoMT-induced connected ecosystem that increasingly is being driven by healthcare data management, value-based care reimbursement models, and personalized medicine.

IoMT devices use embedded electronics and sensors to collect, record, and communicate real-time patient data. These electronic components have become smaller, more customized, and in some cases, more powerful to better facilitate interventions and reduce unnecessary clinical visits. The latter objective—now critical in light of the coronavirus pandemic—has spawned skyrocketing demand in the past year for telehealth services and remote patient monitoring technology.

Such demand consequently bolstered the role of electronics manufacturing services (EMS) providers as they worked to maintain device connectivity and helped customers navigate supply chain snafus and essential equipment shortages in COVID-19’s infancy.

New Hope, Minn.-based Versa Electronics, for example, boosted its medical electronics manufacturing and increased its device production last spring, while Milwaukee Electronics prioritized coronavirus diagnostics- and treatment-related work.

As demand spiked for critical care equipment during the pandemic, companies turned to EMS providers with the expertise, capacity, and supply chain infrastructure in place to quickly source and assemble electronic components. Such competencies enabled ControlTek (Vancouver, Wash.) to accelerate the fabrication of Maxtec’s critical care oxygen sensors, used in hospitals worldwide.

Similarly, Firstronic became the surrogate component supplier to an infrared thermometer manufacturer whose Tijuana facility was impacted by COVID-19 restrictions. Firstronic completed an 800-piece validation order in less than 10 days and began production in less than two weeks.

“Our biggest lesson learned [from the pandemic] was that the process development, equipment capabilities, and IT investments we’ve made paid dividends in this type of environment,” Firstronic President and CEO John Sammut explained. The Grand Rapids, Mich.-based firm is a specialty provider of electronics manufacturing services, including turnkey electronic assembly and materials management services to electronics industry OEMs.

“We were able to compress production launch time without sacrificing validation steps. And, I believe that skillset will continue to be valuable in serving customers with dynamic product development schedules in a post-COVID-19 environment.”

That won’t be the only capability likely to thrive in a virus-free world, however. Supplier resiliency undoubtedly will become a preferred proficiency as medtech manufacturers re-examine supply chain reliability and risk, and look to improve efficiencies. Flexible suppliers not only help their customers cut costs and improve cash flow, they also can help them overcome unexpected market disruptions.

Milwaukee Electronics proved its worth in the latter category, helping clients sidestep potential device shortages as the pandemic worsened through project transfers and the creation of a task force that monitored the global flow of vital medical equipment. The company divided the project transfers based on outcome—it rerouted some work from its coronavirus-impacted Mexican facility to Milwaukee- or Portland, Ore.-based plants to ensure production continuity, and sent others to new homes for better technical support.

“Most supply chain disruptions of the past relate to classes of components with unexpected high levels of demand or issues with a particular supplier,” noted Rick McClain, president and chief operating officer of Glendale, Wis.-headquartered Milwaukee Electronics. “We learned a lot about dealing with supply chain constraints in 2018 and it helped when we encountered spot shortages this year. We worked closely with our customers in identifying alternatives or utilizing their essential product classifications to ensure critical component availability. In this case [COVID-19], we had disruptions and/or shortages driven by regional shutdowns, transportation limitations, and unforecasted spikes in demand. Just-in-time inventory is great with a constant supply and predictable logistics. However, when every possible variable is in flux, you need to be nimble to successfully address that. You simply have to be nimble. Your team has to be able to react to the changing winds on a moment’s notice. If you move too slowly you lose.”

Companies lacking creativity also lose. Some of the most successful solutions born of the pandemic have also been among the most imaginative, even if they have not necessarily beget new innovations. Case in point: Last spring, Jabil’s chief technology officer for IIot (industrial internet of things) helped develop a ventilator testing system (VentMon) for open-source-built machines. The device plugs into the airway of a breathing circuit and measures the parameters of an operating ventilator. In addition to its design, the VentMon team published a data-sharing platform to facilitate collaboration between ventilator engineers.

Creative thinking doesn’t always involve such radical measures, though. Ingenuity can come in many forms and be as simple as process improvement. Consider, for instance, the Lean-inspired strategy SigmaTron International Inc. used to help customers vanquish the challenges triggered by intermittent regional lockdowns and reduced demand/travel during the pandemic’s early days. Rather than consolidate parts in large containers before delivery (the traditional choice), the company shipped freight “less-than-load” as soon as they became available. The switch allowed SigmaTron’s customers to bypass the bottlenecks that would otherwise would have occurred from consolidating shipments into large container loads.

“If anything, the challenges we’ve all faced in 2020 have created a more collaborative working environment. There have been demand shifts both up and down that fall outside of normal forecast windows and disruptions that have impacted operations around the world,” Gary Fairhead, SigmaTron president/CEO, told Medical Product Outsourcing. “Both EMS and customer teams recognize the uniqueness of the challenges we face, so the focus this year has been on finding viable solutions on a changing playing field.”

Among the most valuable of the viable has been contingency planning. Clearly, “black swan” events like global pandemics are virtually impossible to predict, but history has shown that such incidents are both inevitable and frequent. Moreover, research suggests these market disruptions could occur every 3.7 years and last for more than two months due to various causes, including “force-majeure” events (climate change or natural disasters), macroeconomic and/or political conditions (trade policy, regulatory changes), malicious actions (cybersecurity, intellectual property theft), and counterparty issues (i.e., financially fragile suppliers).

By those calculations, the next big market shock should arrive in August 2024.

Plenty of time for contingency planning. Or is it?

In striking without warning, COVID-19 exposed many vulnerabilities within the healthcare value chain, not the least of which was its lack of emergency preparedness. Medtech companies with significant supplier networks in China began scrambling for products last winter after lockdowns there closed factories. With manufacturing stalled, organizations were forced to conduct short-term contingency and business continuity planning.

Companies with strong supplier management systems in place fared best in the ensuing chaos, as their solutions enabled customers to better sense, respond, and anticipate coronavirus-related supply chain issues.

SigmaTron customers, for example, gained real-time access to fluctuating demand, work progress, inventory levels, and materials status through the company’s proprietary iScore system, which links all its facilities globally. Additionally, the firm’s MRP (materials requirements planning) Share program provides suppliers with customer forecast visibility data as well as current inventory and material on order. iScore allowed SigmaTron to monitor its customers’ product development process and immediately adjust the schedule with suppliers. The system also highlighted any raw material shortages for essential production that wasn’t being “pushed out,” according to the company’s Q2 2020 newsletter.

In addition, as the virus spread, SigmaTron gave essential product developers an early delivery option for their finished goods in an effort to prevent potential delays from shuttered warehouses. Pulling inventory early helped eliminate the possibility that essential products would languish in limbo from an abrupt factory shutdown or shipping disruption.

TRICOR Systems Inc. took a proactive approach to COVID-19 crisis management as well, ordering critical supplies early, and keeping abreast of its vendors’ delivery capabilities.

“In the February/March time frame, TRICOR started looking at daily usage supplies that were necessary to continue operation to identify where shortages were sure to be,” noted Thomas Allen, vice president of the Elgin, Ill.-based electronics contract manufacturing firm. “Two such items were isopropyl alcohol—used daily—and disinfecting wipes, used to clean medical equipment. These items were quickly ordered. Other component parts for equipment builds became more challenging, so we reached out more frequently to vendors to get a better understanding of their ability to deliver. This helped not only in scheduling but in providing our customers realistic delivery schedules sooner rather than later.”

Timely delivery was also a hallmark of maxon group’s coronavirus contingency strategy. In early April (2020), the high precision drive technology developer launched a medical fast track process to ensure topnotch service for critical application needs.

The fast track system worked in real-time to expedite urgent product requests; a maxon management team from the firm’s Medical Business unit reviewed each request and matched it with a solution. The team prioritized global manufacturing efforts to ensure the rapid production and shipment of components and vital healthcare equipment.

“As a global company, we saw the challenges arise early on when lead times on raw materials increased and the slowdown of international travel impacted some of the logistics routes,” Christian Fritz, director of sales, Motion Control and Electronics, maxon Group, explained. “At that point, maxon quickly established a cross-functional team that proactively reached out to customers (medical OEM device builders) who provide critical equipment to the healthcare sector. We made sure to keep track of all of their needs and engaged them at different levels to see how we could best collaborate to overcome supply chain issues, streamline the logistics chain, and also engage the engineering teams if alternative solutions had to be evaluated. The lessons learned from these interactions were then applied to our broader customer base. We are continuing to learn from this situation and refining our strategy.”

Those strategic refinements are likely to include open communication and better stakeholder collaboration, as both operating procedures have proven invaluable in battling the virus. Certainly, the pair has long been a cornerstone of many medtech partnerships, but the pandemic significantly changed the nature of those unions, mostly for the better.

Besides breaking down long-established silos, the virus fostered collaborations among unlikely partners, with non-healthcare entities assisting in ventilator and PPE production, and regulators quickly approving life-saving devices through emergency use authorization.

Automotive and aerospace suppliers came to Jabil Healthcare’s aid last year to help the company source a ventilator product that was in high demand. Complicating the search was the fact the product contained thousands of components, some of which required engineering changes or were nearing obsolescence. “We had to create virtual clearing houses for our suppliers to be a part of to help us solve some of the component challenges,” said Brad Womble, senior director of Strategic Planning and M&A, Jabil Healthcare. “It just goes to show the type of relationship you need to have with your customer and your suppliers when you’re trying to solve a problem like this.”

In some cases, those problems led to partnerships that otherwise might never have been forged. Jabil Healthcare, for example, worked with doctors and anesthesiologists to fast-track a manual ventilator design.

“It’s not just deeper relationships with our customers. We’ve been interfacing with all kinds of healthcare stakeholders. We worked on a manual ventilator device with a couple of Johns Hopkins University anesthesiologists to rapidly develop a device. We were able to take it through the product development process within a two- to three-month window and the way we were able to do that was we engaged with the physicians that were actually doing it, we were engaging with our manufacturing folks, we were engaging with our design folks, and bringing all those guys together to the table at the same time. With our customers we’ve been interfacing with them but we’ve also been interfacing with their customers on an interactive real time basis, including governments and states. It’s actually powerful what’s happening with us and our customers. As a result of this crisis, it’s created a more tightly knit spiderweb of deeper relationships.”

And many of those unions have been spun within the confines of cyberspace. Pandemic-provoked lockdowns and social distancing measures have forced most medtech professionals (sans clinicians) to conduct business remotely for much of the past year, making it difficult to effectively collaborate on product development, manufacturing, and marketing.

That challenge is unlikely to abate anytime soon, too: Research indicates the massive shift to remote work will be permanent, with up to 16 percent of U.S. workers telecommuting at least two days per week. “This would represent a dramatic and persistent shift in workplace norms around work,” a National Bureau of Economic Research paper stated last June, “and has implications for companies, employees, and policymakers alike.”

Indeed, the implications would be far-reaching, particularly within healthcare. Such profound workplace changes will undoubtedly change the way manufacturers, suppliers, and regulators collaborate on product development. Online communication/partnering platforms like Slack, Communifire, Time Doctor, and Yammer (among others) could very well become standard practice, along with project management software tools such as Jira.

Ingenious solutions will abound as well. United Kingdom-based Team Consulting Ltd. hatched a particularly savvy solution last March after travel restrictions prevented the company from visiting a client’s manufacturer to help assemble an optical examination device it had designed. To facilitate the transfer of knowledge, the medical device design consultancy created a “remote lab” where team members guided the manufacturer through product assembly.

Regardless of the virtual collaboration tool used, however, medtech companies are likely to depend heavily on their product development partners for support in the post-pandemic, virtual worksite world.

“One of the big challenges we’ve seen is that when customer teams are forced to work remotely, it is easy for them to focus on their individual tasks and lose sight of the big picture,” said Georgeann Snead, president/CEO of Electronic Design & Manufacturing, an electronics contract manufacturer based in Lynchburg, Va. “We see our role as a central point that ensures all the pieces come together. It increases our engagement in terms of helping to drive the process. From EDM’s overall customer perspective, we’ve found that customers are looking for more support from their EMS providers. COVID-19 has intensified that as teams are forced to work from home. We’ve seen a significant increase in the need for test engineering support, because many of our customers lack the bandwidth to do that in-house, especially when their teams are working from home.”

SigmaTron customers, on the other hand, needed more assistance with supply chain solutions as product demand fluctuated throughout the year. “Maintaining strong communications channels has been critical because customers aren’t travelling to our facilities and our team isn’t travelling to them. We’ve talked through schedule changes and supply chain disruptions and worked through them, all virtually,” Fairhead stated. “This year has been a sequence of force majeure type scenarios on both sides of the equation. Customers have had demand on some products drop to zero, while demand spiked significantly on others. Everyone—customers, suppliers and our team had to work together to achieve viable outcomes and that has built a higher level of trust and transparency.”

That trust and transparency has even reached into the echelons of the U.S. Food and Drug Administration (FDA). As Steven Lassen, senior customer application engineer at LEMO USA Inc., reported, “FDA waivers for product substitution in a streamlined communication path has been able to expedite product delivery, especially for applications that involve respirator equipment.”

Clearly, faith, transparency, and resilience have all been earmarks of particularly challenging year in medtech. But probably one of the most important lessons EMS providers and their customers learned from these dark days is the value of open communication and close collaboration. maxon group’s Fritz perhaps summed it up best, noting:

“The impact of COVID-19 on the manufacturing sector have been varied, but deep. Component shortages, shattered logistics chains, and fluctuating demand created challenges that no company could solve alone.

“The collaboration between OEMs, EMS providers, raw material and components suppliers, and in some instances, even end customers (hospitals, government entities) was necessary to address the most critical needs and ensure the industry was able to overcome the disruption created by this unprecedented crisis. The companies that navigated this situation the best were the ones that took swift action and proactively started an open communication with all the key stakeholders, including their respective design and manufacturing partners. The renewed focus on establishing a closer collaboration and open communication will outlast the current crisis. Increased communication doesn’t just mean communicating more often, but also at different levels and including more of the job functions into the conversation.”

Alas, a lesson very well learned.