Device Development
This is what we know. Launching any new product is a potentially risky business, and medical technology is no different. That's why C-suites think long before allocating resources for research and development. However, moving forward is critical to growth as we operate in a time of unprecedented market opportunity.
The key to successful medical technology development is implementing effective strategies with cost-effective solutions to dramatically reduce risk, remove roadblocks, and increase the chances of significant ROI.
Below are four characteristics to include in your strategic plan to create a path to success in your medical device development.
1. Pay attention to SWAPc. All medtech innovations face SWAPc challenges related to device size, weight, power, range of connectivity, and cost. Each represents a potentially competing variable that must be solved with the correct combination of product solutions to balance the larger SWAPc equation. This requires access to a diverse arsenal and expertise in wireless applications including WiFi 6, LoRa, Bluetooth, NB-IoT, CAT-M, sensor technologies and more. With the right team who are up-to-date on compliance, deployent and manufacturing issues, it can be done.
2. Prepare for integration. Once the SWAPc equation is complete, the design and engineering teams must also synchronize the integration of device applications, networks and the specific product use case. If your in-house talent is inexperienced in this area, it will be necessary to bring the expertise of a development partner who knows how to evaluate and implement strategic trade-offs without compromising functionality performance and UX or deviating from stringent security standards and product requirements.
3. Take time to learn about the ecosystem. It is true that SWAPc comes first in the execution phase, but once one decides to allocate resources to the "idea" itself, a sophisticated understanding of the product ecosystem is required.
Your team needs to understand the ways in which a new medical device will be implemented to create a foundation for the next steps on which all further development rests. The lack of this "x-ray vision" has the potential to create challenges, requiring additional cost and time, that could have been avoided. Do your homework and merge technical expertise so your ultimate medtech innovation integrates seamlessly with ancillary devices, patient care practices, and business processes and systems for maximum life and marketability.
4. Embrace DFM and digital twinning. Design-For-Manufacture DFM) integrates design and manufacturing by critically examining the limitations and responsibilities of manufacturing methods and technologies.
This protects product development from “back to the drawing board” scenarios that occur when a design looks flawless on paper but proves cost-prohibitive once built. DFM also safeguards new product development by determining which parts, components, and materials are easy to acquire, functionally ideal, and cost-effective for a given innovation.
When bottlenecks appear, DFM teams will need to focus their efforts on removing them by reconfiguring product parameters to accommodate alternative supply chain solutions. Finally, DFM drives innovation and encourages product differentiation by foreclosing options that would otherwise remain on the table.
After this step in the process, we look into digital twinning, which is a path to flexible manufacturing options. This allows companies to scale production according to fluctuations in market demand and to alternate production between different sites to optimize distribution costs.
The entire manufacturing and supply chain sector has been rocked by global disruptions with chip shortages disproportionately affecting medtech companies.
This has resulted in shortages of parts and components, long lead times, logistical bottlenecks and Increased distribution costs. Yet the industry has never been more invigorated with advancements in healthcare, advancements in technology, and DFM becoming more important in the process. Build the right team, find the right partners, and thoroughly evaluate your product touchpoint landscape, and you'll be well on your way to success and substantial rewards.