Developing any complex product comes with challenges, but one can argue that medtech takes these challenges to their limit. And understandably. Few other product categories face stakes measured not only in market metrics but in human lives. By definition, medtech occupies an intersection of opposing tensions (this vs. that questions) that represent uniquely formidable obstacles to successful development. The key to success lies in taking an integrative, whole-systems approach to reconciling these tensions.

Top Medtech Challenges

Hand in hand with digital health, medtech is the fastest-growing healthcare sector. The race is on to capitalize on mushrooming market opportunity. Companies will have to successfully solve the following challenges to be among the first to cross the finish line.

Product Solution and Use-Case Challenges

Wireless and cellular medtech applications (product solutions) are shaping the future of healthcare. These applications include WiFi 6, LoRa, Bluetooth, NB-IoT, CAT-M, and sensor technologies. Each product solution has strengths and limitations regarding connectivity range, device size, weight, and power consumption.

Reconciling the tensions between various product solutions is difficult, but it’s only the beginning. Design and engineering teams must also reconcile tensions between device applications, networks, and specific product use-case, making the equation dizzyingly complex. At Pivot, our design and engineering teams are masters of discerning the strategic tradeoffs that must be made between these variables to control costs — all without deviating from safety standards and product requirements or compromising functionality, performance, and UX.

Ecosystem Visibility Challenges

Solving the technology and use-case challenges discussed above begins with deep insight into the broader product ecosystem in which a medtech device will be deployed. Development teams that lack this “X-ray vision” stand no chance of creating a device that interfaces seamlessly with complementary devices, patient-care practices, and business processes and systems. Taken as a whole, these challenges make it imperative for development teams to work closely with key stakeholders. At Pivot, our highly collaborative approach to product development ensures the high levels of ecosystemic visibility and coordination required for developing successful medtech.

Supply Chain, Manufacturing, and Innovation Challenges

Although supply chain and manufacturing challenges are not unique to medtech, they are currently among the thorniest. This makes DFM (Design For Manufacture) one of the most sought-after capabilities in medtech development. DFM is a specialized area of expertise that integrates supply chain and manufacturing considerations into the broader product development process.

DFM begins medtech design with a survey of the supply chain landscape to determine which parts, components, and materials are readily available, functionally ideal, and cost-effective for the device in question. When desired parts, components, and materials are found to be unavailable, in short supply, or too expensive to procure, DFM actively seeks to reconfigure product parameters to accommodate alternative supply chain solutions. At Pivot, our DFM teams can solve a significant percentage of problems using this strategy.

DFM also approaches device development to the limitations of manufacturing methods and technology. This prevents the development of devices that meet product requirements, perform flawlessly, and are UX-optimized but cost-prohibitive to manufacture at scale.

Last, in a highly competitive and increasingly crowded market space full of would-be copycats, DFM delivers a crucial advantage that extends beyond supply chain and manufacturing benefits. By narrowing the field of available product options, DFM teams place themselves in what is essentially an innovation incubator. This forces them to devise novel solutions that result in superior products and heightened brand differentiation.

Preparing to Launch a Successful Medtech Innovation?

At Pivot International, we are the proven one-source partner behind some of the world’s most innovative and award-winning medtech. For more than 50 years, our integrative approach to NPD has provided leading-edge solutions for medical, industrial, and consumer products. With FDA registration and multiple ISO and IEC certifications (ISO 9001:2015, ISO 13485:2016, ISO 80079-34, and IEC 60601-1), we are the go-to partner for medtech design, engineering, and manufacture. With advanced DFM expertise and 320,000 square feet of company-owned global and domestic manufacturing capacity, we drive results that position our partners for market leadership.

If you’re seeking a US-based global leader with extensive medtech experience and all the right certifications, Pivot is the partner you’ve been looking for. To learn more about how we will help you successfully scale, contact us today.