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September 25-27,2024 | SWEECC H1&H2

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Power Pairings Drive Medical Device Electronic Manufacturing Services

After dutifully conforming to gender and generational expectations for much of her life, the self-described “fitness junkie” is now shattering societal norms with her viral exercise videos on social media. In them, Rischko flaunts her fine fettle through synchronized dance moves (Dolly Parton/Kenny Rogers, Ben E. King, Sanika, Taylor Swift, and Famous Sally & YB, among others, provide the music), circuit training, spin classes, pull-ups, ab rollouts, and planks (her personal best was eight minutes, 40 seconds).

In the four years she’s been sharing her workouts with the world, Rischko has amassed 1.7 million Tik Tok followers and 117,700 Instagram fans.

“The response was just overwhelmingly positive, which I have found very uplifting, as I have been very insecure all my life. I am really honored and humbled that younger people are being inspired by me,” the former homemaker told “Good Morning America” several years ago. “If I can change the stereotype of old people being boring or not being active just a bit, that makes me very happy.”

Rischko, 84, is more than a norm-bender. She’s a testament to the physical benefits of regular exercise and the psychological blessings of youthful thinking. Both have had a hand in keeping the Langenfeld, Germany, native fit, though fresh food, alcohol/tobacco abstinence, and a calorie-carefree attitude have contributed too.

Rischko’s clean living lifestyle has not been totally foolproof, however. Her well-worn knees—held together with 20-year-old implants—limit her involvement in aerobic activities. “That’s why I can’t jog and jump as well as I used to,” she admitted to TAG24.com, “but other things work.”

Most of the time they work. About six years ago though, Rischko’s back wasn’t working the way it should—simple movements like walking or bending over were suddenly dreadfully painful. Walks in the city became less frequent, as did strolls along the beach, while exercises like ab rollouts, mountain climbers, and side planks became virtually impossible to complete. Rischko’s active lifestyle quickly ground to a halt.

Rischko first tried soothing her aching back with medication, but abandoned that regimen after more potent doses triggered stomach issues. “So one thing led to another. I looked at the doctor: ‘Can’t you give me an injection somehow?’” Rischko recounted in an online post. “‘Nah,’ he says. ‘I won’t do that. That’s over. That’s what they used to do.’”

Instead of an injection, Rischko’s doctor recommended spinal cord stimulation (SCS) therapy, a solution that uses low electricity levels to relieve pain. SCS is usually prescribed for chronic intractable pain in the trunk or limbs, including unilateral or bilateral pain associated with failed back surgery, Complex Regional Pain Syndrome Types I and II, intractable low back pain, and leg pain. SCS is most commonly used to treat low back and lower extremity pain.

Spinal cord stimulators (also called pulse generators) are implanted near the buttocks or abdomen and connect to thin, flexible leads that sit near specific spinal cord nerves. The leads act as a conduit for the stimulator, delivering tiny pulses of mild electric current to the nerves to interrupt pain signals heading to the brain. SCS therapy does not eliminate pain, but rather changes the way the brain perceives it.

Rischko’s brain eventually altered its perception of pain with the help of Boston Scientific’s WaveWriter Alpha SCS System. Approved by the U.S. Food and Drug Administration (FDA) in December 2020, Spectra WaveWriter stimulators feature advanced software and leads with up to 32 contacts that cover a wider area of the spine than conventional systems. The Bluetooth-enabled devices—which gained FDA approval last fall for diabetic peripheral neuropathy treatment—offer expanded personalization based on patient needs, including rechargeable/non-rechargeable options, and access to waveforms that cover multiple areas of pain, according to the company.

The WaveWriter Alpha implanted in Rischko provided the fitness influencer with immediate relief. “She was able to practice her sport again,” stated Marcel Prymka, M.D., chief physician of Spinal Surgery at St. Josef Hospital in Wuppertal, Germany. “…you could see it in her face. Since then, she really smiled again and had a sparkle in her eyes.”

That sparkle likely emanated from Rischko’s return to the gym, where she’s continued to outperform, out-lift, and outlast fitness junkies more than half her age—pain-free.

“Now is real—without pain,” Rischko said, grinning, in a Boston Scientific online video. “I go to the gym with pleasure, I know that I can do a lot of things again. I walk around and do all kinds of things, and I’m really only grateful again and again. The zest for life is back.”

It’s back courtesy of a technological advancement that was more science fiction than science fact when Rischko first entered a gym nearly 30 years ago. Since that time, medical devices have increasingly become smaller, smarter, and more digitally connected, with the Internet of Things (IoT) driving much of the transformation.

The advancement and integration of digital technologies like IoT, big data, machine learning, and artificial intelligence (AI), along with the quick deployment of 5G networks, has given rise to the Internet of Medical Things (IoMT) ecosystem. The COVID-19 pandemic—with its heavy reliance on telehealth services—helped accelerate this shift toward IoMT and consequently fostered the rapid growth of medtech’s electronics manufacturing services (EMS) market, a sector currently worth about $6.39 billion. 

Vantage Market Research forecasts a 6.5% annual growth rate for the sector this decade, culminating in a $10.58 billion valuation in 2030. Data show the Asia-Pacific market expanding most rapidly, and North America retaining its top market size spot. Growth factors include rising demand for consumer wearables and ventilators, persistent adoption of telehealth solutions, and a hearty penchant for point-of-care and remote monitoring services.

“As more people manage more of their own health, the devices they use to do so will need to become more advanced and intuitive,” noted Chris Johnson, senior director, Medical Technology Business Development at Jabil, a St. Petersburg, Fla.-based engineering, manufacturing, and supply chain solutions provider with offices worldwide. “Sensors, advanced communications, edge processing, and cloud storage are becoming commonplace—even in disposable medical devices. Technologies from the consumer products space have been migrating into healthcare at a much faster rate than they have historically. EMS providers have the engineering expertise and numbers to facilitate this transition.”

That combination proved crucial during the pandemic, as companies in almost every industry banded together to create SARS-CoV-2 diagnostics and treatment tools. German photonics firm ams OSRAM, for example, tapped Jabil in early 2020 to develop and commercialize a digital point-of-care COVID-19 test. At the time, ams OSRAM was working on a lateral flow testing solution for numerous applications but as the virus spread, the company decided to incorporate its highly sensitive sensor technology into small, rapid COVID-19 antigen and antibody assays.

With its core competencies limited to sensor technology, LED science, and high-volume miniaturization, ams OSRAM needed a partner that was proficient in manufacturing digital healthcare devices at scale—particularly one that could manage the pandemic-induced volatility in demand and component availability.

Jabil successfully rose to the challenge, connecting ams OSRAM with suppliers capable of delivering huge volumes of components in a very short time. The company’s global manufacturing footprint (more than 30 ISO 13485-certified facilities) supported production across all time zones in nearly every market, and its design for manufacturing and precision injection molding capabilities helped ensure the jointly designed printed circuit board—which incorporated optical sensor and LED features—could withstand the rigors of mass manufacturing.

The printed circuit board assembly, manufactured by Jabil, leveraged ams OSRAM’s spectral sensing technology. A light-emitting diode (LED) illuminates the lateral flow test, and a highly sensitive spectral sensor reads the color of the line, providing an objective “positive” or “negative” result. The connection module sends that result by Bluetooth to a cloud-based smartphone app that clearly states the patient’s COVID-19 status.

Both companies currently are exploring potential applications for the device beyond COVID-19, from diabetes and cardiac conditions to veterinary testing.

“Customers are looking for [EMS] providers that have a global footprint that will allow them to scale as they grow and optimize their manufacturing network for cost and risk. Extended services, such as sterilization, finished pack, and procurement as a service, are becoming a bigger deal, but I think the industry is still learning what it takes to deliver those services successfully,” Johnson explained. “Perhaps the most important quality has been and always will be trust—a proven track record of quality, patient safety, and service will never be replaced at the top of that list.”

Probably not, but the partner attributes that follow those list-toppers are important, too. Reliability, clear communication, regulatory knowledge, and program management prowess are a few of the other traits attractive to EMS customers.

“When it comes to qualities that OEMs look for in an EMS partner, there are many to consider. Does the EMS firm use its own QMS to qualify the product or does it use the OEM’s QMS and transfer documentation back to them?”
asked Matt Valego, chief commercial officer for Lumitex LLC, a Strongsville, Ohio-headquartered medical device lighting developer. “An OEM might have a stable of six or seven engineering or [contract] manufacturing firms that they look to for outsourcing work, but each of those firms is a little different. One might be good at quality systems mitigation work, another might be good at software revisions, and still another might excel at created UX/UI design. It’s up to each individual EMS [provider] to stay on top of their game, know what their niche is, and convey that message to their partners so they know who to go to and when. No EMS firm does everything well but they all do something(s) well. The successful EMS firms know what their expertise is and how to articulate it so companies know that. If you focus your efforts and know what you’re good at, and you can adequately present that to the market, you’re going to gain business.”

Such an approach not only worked for Lumitex but also Flexible Circuit Technologies (FCT), the latter of which is a global supplier of flexible circuits, rigid flex, flexible heaters, flat flex cables, membrane switches, and plastic moldings, and value-added assembly including SMT and product module to complete product box builds for various industries, including medical.

FCT has helped numerous healthcare-related developers and manufacturers overcome design and production challenges to market their products. In one instance, the company lent its expertise to a North American electronics manufacturer that was struggling to create a medical light wand.

The project’s most formidable challenge, according to FCT, was the hand placement of a very small rectangle (less than 1/10th of an inch square) of thick heat transfer tape onto a very exact footprint to assure adhesion to the flex. FCT, however, successfully worked through these issues in the prototype stage.

“Tight spaces where the circuits must be deployed is driving overall circuit size to ever-shrinking geometries,” FCT vice president Carey Burkett said. “To shrink overall circuit size and at the same time increase functionality, smaller active and passive components are required along with the accompanying smaller traces, spaces, and pads on the flex circuit needed to support those small components. Ultra-small pitch SMT components can also significantly complicate the surface mount assembly process due to the dimensional instability on the flexible materials. EMS providers or flex manufacturers that perform assembly on flex must incorporate specialized skills, techniques, and fixtures to be successful at assembly on flex. Those who are proficient will help lower costs due to improved yields. Further, those who are accomplished may be fine with having many parts per panel where those who are not proficient may require fewer parts on smaller pallets, or may waste more material due to inefficiencies—which can lead to higher costs.”

Understanding medical device customers and their needs, and a commitment to competitive pricing certainly has worked for Lumitex. Branding itself as a medical device lighting provider, the company’s solutions have specifically been chosen for integration into MRI machines (interior), portable ultrasound equipment, operating/delivery rooms, cervical spine retractors, and IV infusion pumps, among others.

The latter opportunity arose via a medical device/laboratory equipment manufacturer that needed help developing a fiber-optic backlight for an IV infusion pump membrane switch assembly. The manufacturer envisioned backlighting a large membrane switch overlay with a cut-out for an LCD (liquid crystal display) screen in the middle of the panel, using only one 5 mm LED to illuminate the entire assembly.

Employing its engineering and production expertise, Lumitex developed a fiber optic lighting solution that selectively extracted light and illuminated only specific areas on the panel. The final design decreased the total number of fibral strands required to light the panel; the fibers were crimped into one brass termination, thus resulting in the need for only one LED.

Lumitex produced a prototype of the lighting device in less than one week, saving the customer significant time and money. Cost (not surprisingly) was one of the determining factors for choosing Lumitex, according to the company. The customer reportedly considered retaining another lighting manufacturer for the backlight technology but its proposed solution was too pricey, too noisy, and required a converter.

“Customers like the technological and clinical advancements we offer, as well as our cost controls and supply chain simplification,” Valego said. “We also have a solid program management function. Why is that important? Because no project is going to go 100% right, and it’s how a company responds when this happens that makes them who they are. If a program starts to go downhill and it’s our fault, we will restructure the program and share some of the cost. Qualities like this can only truly be understood in person. You’re not going to look at a website and find it or understand it through a phone call. You find it by going out to [a partner’s] locations and interacting with them, or even having a meal with them. Face-to-face interaction is important.”

So is dependability, open communication, and transparency.

“While reduced production cost remains important, the trend has shifted towards quality and reliability when searching for an EMS partner,” stated Ciprian Cherciu, electronic production manager for Marquardt, a German manufacturer of electromechanical and electronic switches and switching systems. “Clear communication, guidance, and consultation during the manufacturing process are becoming increasingly important for customer satisfaction.”

Green With Envy

Another important customer satisfaction determinant is sustainability and environmentally-friendly (a.k.a., “green”) initiatives. Mounting climate-induced disasters and ecological crises are prompting both EMS providers and their customers to adopt green manufacturing and supply chain practices.

Achieving a green supply chain entails creating a circular economy, where resource consumption and waste is minimized through the extended life of electronic components. To achieve that goal, electronics manufacturers must design their products with the end of life in mind, ensuring there is a viable pathway for its reuse or recycling.

Global supply chain and manufacturing solutions provider Flex takes a Design for Environment (DfE) approach to medical device development to create products that are “optimized for sustainability and use low-power technologies, less hazardous substances, and advanced non-toxic battery technology that allows for ecological disposal,” according to a DfE brochure written by Systems Engineer Stefano Vicenzetto. Flex considers DfE through three activities: lifecycle assessment, eco-value analysis (on existing products), and environmental value engineering (on new products). 

“Smart and sustainable design also allows for efficient assembly and disassembly to allow repair, refurbishment, and reuse of parts, and easy upgrades to firmware and hardware,” Vicenzetto concluded. “These elements combine to deliver a medical device with a minimized carbon footprint.”

Swiss component manufacturer and solutions provider SCHURTER, which manufactures and distributes fuses, connectors, circuit breakers, switches, EMC products, and HMI systems, is also working toward a circular economy with its Green Line connectors. Its collection of IEC 60320-1 appliance connectors contributes to fewer carbon dioxide emissions and lower material consumption, the company claims.

“The push toward ‘green’ business processes including manufacturing processes and product materials is important to selecting an EMS provider,” said Stephanie Elliott, marketing communications specialist for SCHURTER. “ This is an example of how expertise can contribute to the betterment of an OEM’s process/product. In the case of SCHURTER and its wire harness capabilities, for instance, the company is already well experienced in green manufacturing, having introduced its Green Line of IEC inlets and outlets. Here is an example of how a provider can contribute to an OEM’s ‘green’ initiatives. By way of the provider’s own experience and, in the case of SCHURTER, a clear vision and sustainability strategy, the OEM as a ‘go-to’ source for expert recommendations.”

Jabil’s pursuit of a circular economy is similar to its rivals—incorporating environmentally conscious factors such as sustainable materials and packaging into product design at the earliest possible stage. The company’s Materials Innovation Center in Chaska, Minn., helps fill the sustainable substances void by developing custom additive and injection molding materials with unique properties to meet customers’ specialized needs (flame retardant and compostable, perhaps, or completely biodegradable). Creating new options for additive manufacturing in countless verticals, these specialized materials can help customers in various industries develop more sustainable products through end-of-life.

“The direction of the EMS space is still largely driven by the goals and intentions of the customers we serve. We have always understood that OEMs can’t reach their sustainability goals without participation from stakeholders across the value chain, but the narrative has evolved in the last few years as EMS companies have assumed more responsibility in closing the loop,” Johnson told MPO. “At the beginning of the product lifecycle, we’re seeing exciting momentum around tools that drive more sustainable material management. Companies like Jabil are in a great position to help customers identify raw materials that reduce emissions and contribute to the circular economy. Five years ago, we saw very few design for sustainability requests in RFQs—today that would be a surprising omission—especially in consumer-focused markets like patient monitoring and pharmaceutical delivery systems.”

Indeed, the ever-increasing need for sustainable solutions will continue to shape medical electronics design and production for the foreseeable future. But a circular economy will certainly not be the only driving force shaping the medical electronics industry over the next half-decade or so. Marquardt’s Cherciu foresees more automation and faster integration of new designs, while SCHURTER’s Elliott and Lumitex’s Valego anticipate continued opportunities for outsourcing partnerships.

“One of the things we’ve seen as the macroeconomic climate changes, specifically a downturn, is that some of the big OEMs make moves to do a lot of EMS work in house versus externally,” Valego noted. “That waxes and wanes with the economy. In the last six months or so, we’ve noticed that these OEMs are starting to look outside again and from the firms I’ve talked to, the business opportunities are increasing compared to where they were six months to a year ago. Many OEMs are starting to focus internal resources on more strategic initiatives and open other new product development to the outside again. From what I’m seeing today compared to six months ago, the market is headed back toward outsourcing as a vehicle to drive new product development.”

Article Source: Medical Product Outsourcing