Liza Bobrow wasn’t too concerned about her sudden penmanship difficulties. She had, after all, reached the half-century mark —a biological turning point—and such senescent changes seemed only natural. 

“I’d turned 50 so I thought I was just getting old, do I have arthritis?” Bobrow recalled thinking in an online video. 

It may have appeared that way at first, but as her handwriting grew increasingly smaller and then disappeared altogether, Bobrow suspected a condition more savage than arthritis or aging was afflicting her body.

Bobrow’s internal aggressor identified itself around the time of her 52nd birthday, effectively admitting her into the unforgiving fraternity of Parkinson’s disease. Afflicting more than 1.1 million U.S. residents annually, the progressive neurodegenerative disorder damages and destroys the brain cells in charge of movement, leading to unintended or uncontrollable actions (i.e., shaking, stiffness) and balance/coordination difficulties. Symptoms usually begin gradually and worsen over time.

Bobrow attempted to slow her progressive decline through medication and movement therapy but encountered some “disruptive difficulties” with the pharmaceutical treatment. Her doctor recommended deep brain stimulation (DBS) but Bobrow felt such an invasive intervention was unnecessary. 

“I had heard about DBS as a therapeutic option, but it was so far away, I’d never had surgery in my life,” she said. “Put it this way—to me, DBS didn’t seem like a procedure that somebody at my state of disease would need or want. I felt terrible, but brain surgery…it didn’t make sense to me.”

It did, however, make sense to Bobrow’s physician, who urged her to try the decades-old treatment. First approved by the U.S. Food and Drug Administration (FDA) in 1997 for Parkinson’s disease (PD) tremor and in 2002 for more advanced symptoms, DBS uses electrical stimulation to treat movement disorders associated with PD, essential tremor, dystonia, and other neurological conditions.

DBS therapy uses electronic signals to block some of the messages the brain sends to trigger the tremors, stiffness, and slowed movements associated with PD. A neurostimulator surgically implanted through a minimally invasive procedure transmits electrical signals to specific parts of the brain affected by Parkinson’s disease and other debilitating neurological disorders. 

“…my doctor did explain to me that DBS is a procedure, but then my doctor explained to me that more and more often, the procedure was being offered to patients who are at relatively early stages of disease progression,” Bobrow noted. “And the way she put it to me was, ‘You could get 10 to 15 years of like, better quality of life. How does that sound to you?’ And that kind of reframed it for me in my mind.”

Buoyed by the promise of a largely normal—if somewhat constrained—life with PD, Bobrow initiated DBS therapy using Medtronic technology. The multinational behemoth boasts the largest installed base of DBS systems globally, having helped more than 1800,000 PD patients control their symptoms.

Medtronic’s Percept lineup features BrainSense Adaptive deep brain stimulation (aDBS), which personalizes stimulation therapy based on patients’ brain activity in real time—both inside and outside the clinic. It provides enhanced therapy personalization for symptom control that automatically adjusts, thereby minimizing the need for patients to manually modify their stimulation.

The FDA approved Medtronic’s aDBS and the BrainSense Electrode Identifier (EI) last winter; the latter tool optimizes initial DBS programming by precisely identifying the strongest signal location. Research indicates EI helps clinicians conduct more accurate initial programming that is 85% faster than traditional electrode selection.

Medtronic further enhanced its DBS capabilities in December by earning FDA approval for expanded dystonia clinical labeling. The authorization transitioned the therapy from Humanitarian Device Exemption status (obtained in 2003) to full effectiveness labeling, supported by clinical evidence.

The labeling approval encompasses management of chronic intractable primary dystonia, including generalized dystonia, segmental head and neck dystonia, cervical dystonia for adults, and primary generalized dystonia in patients ages 12 or older. The expanded clinical labeling also provides physicians and patients with stronger evidence, clearer treatment pathways, and more predictable access. The third most common movement disorder, dystonia affects an estimated 300,000 people in the United States, though experts believe that figure is conservative due to underdiagnosis and its varied presentations. Dystonia is characterized by involuntary muscle contractions that force certain parts of the body into repetitive, twisting movements or painful postures that may interfere with such everyday functions as walking, sleeping, eating, and talking. 

Medtronic claims its DBS therapy has helped more than 200,000 patients with movement disorders (including dystonia) over the last 28 years. Bobrow credits the technology with pain relief and a general “feeling of relaxation and comfort.”

“I had an incredible experience,” she stated in her video. “The dystonia that I experienced that was so painful pretty much just stopped. I had less motor fluctuation and in general, it’s just a feeling of relaxation and comfort in my body that I just didn’t have without DBS.”

That sense of ease wouldn’t have been possible without major technical advancements over the last several decades. Since Medtronic first entered the deep brain stimulation arena nearly 30 years ago, healthcare has undergone a radical transformation characterized by patient-centered therapy, evidence-based medicine, and ambulatory care delivery. Concurrently, the industry’s rapid digitization has further reshaped the ways in which therapies are developed, delivered, and optimized, amplifying the pace and scope of innovation.

Connected technologies have significantly improved patient care and streamlined facility operations through real-time remote monitoring, artificial intelligence (AI)-driven diagnostics, and more intelligent use of medical data. In addition, the Internet of Medical Things (IoMT) has given rise to smart networked solutions encompassing built-in sensors and other circuitry necessary for communication between medical devices and healthcare IT systems.

Rising demand for these smart tools has given rise to a burgeoning electronics manufacturing services market, currently valued at $15.45 billion. Global Growth Insights data projects the sector to expand 4.8% this year to $16.19 billion, and reach $24.69 billion by 2035, driven by an escalating prevalence for wearable diagnostics, desire for high-precision medical components, and the penchant for outsourcing complex medical electronics.

Similar factors—including device miniaturization and an insatiable thirst for both enhanced connectivity and data-driven solutions—are increasingly prompting medtech companies to outsource electronic manufacturing services (EMS). The market’s value is forecast to swell 9.5% this year to $82.13 billion and top $118 billion in 2030, Market Report Analytics stats show.

“The EMS outsourcing landscape continues to accelerate,” declared Brett Freeman, chief sales officer for Providence Enterprise, a North Providence, R.I.-based contract manufacturer specializing in electronics, electro-mechanical assemblies, and high-volume disposables. “OEMs are under pressure to get products to market faster, manage costs, and build resilience into their supply chains, especially after years of material shortages and geopolitical uncertainty.”

To accomplish such tasks—amid continued material shortages and geopolitical uncertainty—OEMs must partner with EMS providers that act as a base for business, manufacturing, and operational innovation as well as supply chain efficiency and control.

A tall order, no doubt. But not an unattainable one.  

Successful EMS outsourcing alliances are crafted by providers and OEMs that share similar business profiles and product development strategies. Flexibility and discipline also are important traits to consider when selecting an electronics manufacturing consort, experts claim.

“Here are some aspects they [OEMs] value most: speed to market, transparent communication, regulatory and quality discipline, flexibility across regions, and a partner willing to ‘lean in’ early and solve problems, not just quote parts,” Freeman explained. “OEMs want a supplier who makes them feel like the most important customer.”

OEMs want honest, trustworthy suppliers as well.

“Successful CMO partnerships are based on trust, which is earned over time,” stated Brett South, vice president of Business Development for Coastline International, a San Diego-headquartered full-service contract manufacturer with expertise in medical devices and electronics. “Quality, price, and delivery are all always critical, but if you can deliver on those values with honesty and communication throughout, trust is the result that becomes central to the relationship.”

Trust, honesty, flexibility, and open communication also are central to navigating fluctuations in customer demand. Flexibility is particularly crucial, as medical electronics manufacturing can be hampered by overall workload, product volume, and product mix.

To overcome these production hurdles, OEMs must align with an EMS provider/supplier that maps and scales well to its own needs. In addition, OEMs should have a solid understanding of the kind and amount of flexibility needed from their partners.

Multinationals with business volume that bobs like a seesaw, for example, are best matched with EMS providers that can seamlessly handle wildly fluctuating production volumes. Conversely, suppliers that can churn out large quantities of a single unit are better suited for low-mix, high-volume production.

“We see the outsourcing relationship as a partnership,” explained John Sheehan, president of SigmaTron International Inc., an Elk Grove Village, Ill.-based electronics manufacturing services provider of printed circuit board assemblies and completely assembled (box build) electronic products. “When a customer has an uptick in near-term demand, we work with suppliers to do our best to support it, because we recognize the importance of ensuring our customers are able to meet upside demand from their customers. At the same time, we ask our customers to avoid pushouts on forecasted demand within 30, 60, and 90 days because of the negative impact it has on business.”

Demand restrictions are not the preferred solution at Milwaukee Electronics; instead, the 72-year-old EMS provider relies on Lean manufacturing principles to manage customer needs. One key tenet—the Pull System—has been instrumental in addressing vacillating demand.

Traditional manufacturing methods—known as push production—depend largely on forecasts and fixed production schedules rather than real-time customer demand. Inventory management decisions in push production manufacturing are made based on forecasts, historical data, and future customer demand estimates. Such criteria, however, can lead to overproduction, excess inventory, and wasted resources.

A pull system, on the other hand, prevents these shortcomings by producing goods only when needed, based on real-time demand. Pull production methods commonly use kanban systems to determine timing for new inventory, enabling companies to quickly adjust to fluctuating demand, reduce waste, and reduce operational costs. 

“We utilize Lean manufacturing principles in supporting our clients. For example, we are min-max kanban with a client we’ve had for more than 35 years,” Milwaukee Electronics President Mukesh Dulani told MPO. “When they empty the kanban bin, it generates a pull signal and we replenish. In cases where we have customers with configure-to-order (CtO) needs over common subassemblies, we create a supermarket kanban of the base subassembly and then CTO finished goods as they place orders.”

Neither Lean manufacturing tactics nor demand constraints are the preferred strategies at Jabil Inc. for managing fluctuating market needs. Rather, the company employs a vertically integrated product development model that unifies all facets of the development process. 

Through its customer engagement model (also referred to as the workcell model), Jabil leverages its 38,000-strong global supplier network and visibility across 700,000 parts to gain a clear understanding of technology dependencies and geographic vulnerabilities, thus enabling the firm to proactively mitigate disruptions through multi-location manufacturing and dual sourcing. This integrated approach ensures continuity, flexibility, and resilience, even in the most constrained or volatile markets, according to the company.

“Customer demand will fluctuate as products are accepted by the market and have the right reimbursement codes. Jabil manages that fluidity through a truly unique customer engagement model,” said Ramy Awad, engineering lead for Jabil’s Healthcare division. “In this model, a business unit leader at Jabil works with their counterpart at the strategic OEM to provide a single point of contact through which communication between companies flow. Jabil’s business unit leader ensures seamless communication, alignment, and execution across the entire product lifecycle, gathering the correct resources for engineering, supply chain, and production—no matter where the production is taking place. They also ensure that a new product, transferred product, or even EOL product has proper visibility into market trends and adoption to plan accordingly. The customer engagement model ensures that the folks can move from one work cell to another seamlessly. This model is key to the success of every one of Jabil’s sectors and divisions.”

On Healthcare’s keyring, the customer engagement model is joined by tailored manufacturing methodologies, advanced optical module assembly, device reprocessing services, and electronic component obsolescence strategies.

Component obsolescence has become one of the most critical challenges facing EMS providers, thanks to rapid technological advancements and the increasingly short lifespans of electronic parts. Average integrated circuit lifecycles have steadily fallen over the past several decades, shrinking from 10-15 years in the 1990s to just five to seven years today. Advanced semiconductors lead a more fleeting existence, lasting roughly two to five years.   

Those truncated life expectancies are unbefitting for most medical devices, which typically remain in service for at least a decade or two. Pain management products, for example, contain electronic components with lengthy development timelines (up to six years). Such lifecycle mismatches necessitate proactive obsolescence management.

Strategies for addressing electronic component obsolescence can vary by part, product (device), and manufacturer, though inventory tracking, supplier diversification, redesigns, last-time buys, and reuse/recovery have previously proven successful. 

The basis for tackling component obsolescence, however, lies in good communication and strong supply chain partnerships, experts say.

“Early collaboration and lifecycle engineering reduce the impact of evolving components that make earlier components obsolete,” observed Darren Gilmer, senior engineering manager at Forj Medical, a St. Paul, Minn.-based vertically integrated contract design and manufacturing organization (CDMO) offering end-to-end capabilities to the medtech industry. “A proactive, early-stage partnership with your CDMO will reduce late surprises and risks. Bring EMS/CDMO engineers in early to identify risks and manufacturability constraints sooner. Use design-for-manufacturability, up-front testing/inspection strategies, and supply chain streamlining as part of a full-product lifecycle partnership with your manufacturer. There are regulatory pressures and a need for stable components, which is driving longer product lifecycles for medical devices, making early lifecycle planning essential. Integrating supply chain intelligence into early designs can help optimize and prevent challenges while accelerating on-time product launch delivery.”

Solid supplier relationships are key parts of component obsolescence strategies at Milwaukee Electronics and SigmaTron, but both companies also use software tools to help mitigate risks. Jabil leverages strategic partnerships as well yet also counts on its Retronix subsidiary to mitigate outdated part risk through such services as integrated circuit (IC) recovery/reuse, retinning IC leads, alloy conversion, and reballing (replacing the solder balls on a ball grid array package within printed circuit boards).

Retronix not only helps Jabil mitigate component obsolescence risk, it also helps the company reduce electronic waste and improve energy efficiency, thereby supporting sustainability goals in an increasingly green-conscious medtech market.

“Implementing circular economy and sustainability practices are key initiatives at Jabil,” Awad noted. “Our comprehensive five-year sustainability strategy aligns our environmental ambitions with those of our customers, many of whom are globally recognized brands. Jabil operates a medical device reprocessing plant in Maple Grove, Minn., to refurbish devices for reuse. From early engagement in a new project, Jabil takes steps to improve and reduce materials and components within devices for less impact. “In fiscal year 2024, we reduced our Scope 1 and Scope 2 GHG emissions by 46% compared to our fiscal year 2019 baseline, which puts us well on our way to our goal of a 50% reduction by 2030 and carbon neutrality by 2045,” said Awad.

With e-waste projected to rise 32% to 82 million tons in 2030, medtech manufacturers expect their EMS partners to incorporate Environmental, Social, and Governance (ESG) principles into all facets of the electronics assembly process. Eco-friendly practices like material reuse, energy efficiency, and responsible sourcing can help device companies limit the impact of their manufacturing operations.

In some instances, sustainable EMS practices align with Lean manufacturing principles, enabling companies to enhance productivity and streamline costs while reducing their environmental impact. Other Earth-saving measures like investing in energy-efficient equipment and designing easier-to-repair products with longer lifecycles also help reduce e-waste.

“Waste reduction can happen through automation and process optimization to increase yield and reduce rework/scrap,” Forj Medical’s Gilmer stated. “Adapting Lean manufacturing and continuous improvement programs minimize risk. Material optimization and smarter procurement reduce the environment impact. Sustainability is becoming a core selection criteria for OEMs. Medical device companies expect their manufacturing partners to support environmental goals.”

OEMs also expect their partners to help them navigate ongoing supply chain volatility and geopolitical instability, both of which have escalated over the last year due to new conflicts and a renewed tariff war. 

After a brief respite, transatlantic trade tensions flared up again in recent months as President Trump intensified his efforts to acquire Greenland for U.S. security purposes. The president first raised the possibility of bringing the self-governing territory of Denmark under U.S. control during his previous term but Danish and Greenland’s politicians have repeatedly rebuffed Trump’s attempts.

In mid-January, Trump threatened to impose 10% tariffs starting Feb. 1 on goods from Denmark, Finland, France, Germany, the Netherlands, Norway, Sweden, and the United Kingdom. The levy would increase to 25% if an agreement is not reached by June 1, according to the White House. 

European Union leaders responded to Trump’s latest tariff threat with a powerful volley of their own—an anti-coercion instrument known as a “trade bazooka.” The move could restrict U.S. investment in EU nations, block access to public procurement schemes, and limit intellectual property protections.

Such potential repercussions are prompting medtech’s EMS providers to reconsider their sourcing strategies.

“The fluctuations in tariffs have impacted clients quite a bit. They want stability,” Milwaukee Electronics’ Dulani pointed out. “We are being transparent with clients and showing tariff impact as a separate line item in pricing. Because we have a USMCA-certified facility in Mexico, we are able to help clients mitigate tariffs by helping them get USMCA-compliant rulings on products built in that facility. The transparent approach we’ve taken helps clients determine whether a U.S. or Mexico build makes the most sense for them. In most cases, tariff impact is approximately 3% so comparing facilities can make sense.”

Comparing facilities is just one of the options available to medtech firms and their EMS providers seeking stability amid market volatility. Supply base diversity, forecast planning, flexible capacity, and local-for-local and/or region-for-region manufacturing are viable solutions too.

“We are definitely seeing the volatile tariff landscape affecting outsourcing decisions,” Coastline International’s South noted. “There has been an influx of inquiries for our Mexico-based facilities to evaluate and quote programs that were previously being manufactured in China. The overall trend has been to make efforts to nearshore the supply chain out of Asia and establish a more localized footprint in order to reduce or eliminate tariffs. There has also been an effort to approve alternate components and suppliers with specific Country of Origin in order to meet varied origin requirements based on HTS codes.”

“We expect to see continued effort toward establishing supply chains in more risk-averse geopolitical regions, which is a continued trend from the pandemic and nearshoring surge the followed,” South continued. “Tariff rulings and free trade agreements will certainly have an impact on how OEMs strategize and invest in their supply chain and sourcing of EMS suppliers.”  

Truth be told, those strategic changes have already begun.