Mark Dohnalek, CEO and president of Pivot International, outlines how risk can be reduced in developing medical devices.
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Risk management
Here’s what we know. Launching any new product is a potentially risky affair and medtech is no different. That is why C-suites think long and hard before allocating resources for research and development. Yet moving forward is critical for growth as we are operating in a time of unprecedented market opportunity.
The key to medtech development success is in deploying effective strategies with cost-effective solutions to dramatically reduce risk, clear roadblocks, and increase the odds of significant ROI. Below are four features to include in your strategic plan to create a pathway for success in your medical device development.
1. Pay attention to SWAPc. All medtech innovations face SWAPc challenges related to device size, weight, power, connectivity range, and cost. Each represents a potentially competing variable that must be solved with the right combination of product solutions to balance the larger SWAPc equation. This requires access to a diverse arsenal and expertise of wireless applications that include WiFi 6, LoRa, Bluetooth, NB-IoT, CAT-M, sensor technologies, and more. With the proper team who are current in compliance, distribution, and production issues – it can be done.
2. Be prepared for integration. Once the SWAPc equation is complete, your design and engineering teams must also sync up integration of device applications, networks, and specific product use-case. If your inhouse talent is not experienced in this area, it will require bringing in the expertise of a development partner who knows how to evaluate and deploy strategic tradeoffs without compromising functionality, performance, and UX, or deviating from strict safety standards and product requirements.
3. Take the time to learn the ecosystem. It’s true that SWAPc comes first in the execution phase but once you decide to allocate resources to “the idea” itself, a sophisticated understanding of the product ecosystem is necessary. Your team must have a grasp of the ways a new medical device will be deployed to create a foundation for the next steps which all subsequent development rests. Lacking this “X-ray vision” has the potential of creating challenges, requiring additional costs and time, that could have been avoided. Do your homework and build a team with the technical expertise so your final medtech innovation will seamlessly interface with complementary devices, patient-care practices, and business processes and systems for maximum durability and marketability.
4. Embrace DFM and Digital Twinning. Design-For-Manufacture (DFM) integrates design and manufacture by critically examining the limits and liabilities of manufacturing methods and technologies. This protects product development from “back to the drawing-board” scenarios that happen when a design appears flawless on paper but proves cost-prohibitive when it gets built. DFM also safeguards new product development by determining which parts, components, and materials are readily procurable, functionally ideal, and cost-effective for a given innovation. If or when roadblocks appear, DFM teams will need to marshal their efforts to remove them by reconfiguring product parameters to accommodate alternative supply chain solutions. Lastly, DFM drives innovation and fuels product differentiation by precluding options that would otherwise be left on the table. Following this stage in the process we look to Digital Twinning which is a route to flexible manufacturing options. This makes it possible for companies to scale production to fluctuating market demand and to toggle fabrication between different sites to optimise distribution costs.
The entire manufacturing and supply chain industry have been rocked by global disruptions with chip shortages disproportionately impacting medtech companies. This has resulted in parts and component shortages, extended lead times, logistical bottlenecks, and rising distribution costs. Yet the industry has never been more invigorated as healthcare moves forward, technology advances, and DFM is becoming more prominent in the process. Build the right team, find the right partners, and full assess the landscape for touchpoints of your product and you will be on a pathway to success and substantial rewards will be reaped. Good luck!
