Radical, seemingly ripped out of Star Trek medical devices continue to be released faster than ever thanks to the COVID-19 pandemic and growing venture capital (VC) investment in the health sector. With this acceleration, a new dominant medical device original equipment manufacturer (OEM) structure has emerged, focused more on research and development-associated breakthrough talent and less on manufacturing know-how, experience, and scale. You can't blame companies that define the MedTech innovation pipeline, backed with venture capital cash and pressured by tight deadlines for growth. The MedTech unicorns of tomorrow focus on bringing their research to market in a minimally viable product (MVP) form to get core R&D breakthroughs ready for commercialization.
But here at Benchmark, with our 40+ years of experience in medical device manufacturing, we know what happens next: extreme difficulty converting R&D breakthroughs into reliably commercialized products produced in the tens of thousands of units. In this blog, we share three critical insights for medical device OEMs to successfully manage this transition to harness their potential to change patients' lives.
DESIGN WITH RELIABILITY AND COST IN MIND
As early as the prototyping stages, it is essential to keep your end design in mind. Design for Excellence (DFX) exercises like designing for manufacturability or reliability can significantly impact the successful deployment of your product. When looking closely at your bill of materials (BOM), are you using a group of products you can confidently procure despite ongoing supply chain shortages? Do your materials stand up to regular use? Does your design allow efficient use of automated manufacturing and testing? Just by scratching the surface of DFX principles and questions, it is clear that an experienced third-party consultative organization or candid and self-reflective engineer is critical in evaluating your medical device's design.
ANTICIPATE CHANGES TO YOUR PRODUCT OFFERING
When we ask the questions from the previous section, it's important to keep one thing in mind: the problems you are solving today might not be the problems you are solving tomorrow. Early-stage medical device companies must deal with a considerable number of stakeholders, each with the ability to completely change the direction of your product roadmap for company management, investors, advisors, patients, payers, and providers.
Trust us when we say that at Benchmark, we've seen it before. We've had companies change designs to pursue potential international growth opportunities. Others have had to quickly transition designs in anticipation of a downgrade to a non-medical certified device. And others have seen last-minute market influences like the pandemic open new business opportunities for technology initially designed to fulfill a different need.
When you're budgeting for the costs and risks associated with a full-scale commercial rollout, give some extra wiggle room for these types of challenges. Extra person-hours or manufacturing capacity and adaptability may be required to meet the dynamic needs of the market.
PROTOTYPE WITH COMMERCIAL-GRADE PARTNERS AS EARLY AS POSSIBLE
It makes sense that the earlier you work with the technology and suppliers you intend to work with during production, the better you will be able to pivot and adjust to changing market needs. Work on commercial-grade technology as quickly as possible and choose a trustworthy solution provider as soon as your product roadmap points confidently in a particular direction. We emphasize a ‘solution’ provider – one offering complete end-to-end services for hardware and software design, manufacturing, and lifecycle management.
An integrated solution provider can be a strong ally in the uphill battle medical device manufacturers can face in the international electronic component supplier market. Medical device companies usually source components at much lower volumes than consumer electronics companies, posing a disadvantage when supply is limited. An R&D engineer simply does not have the procurement expertise and network of contacts to navigate such a tight electrical component market successfully. On the other hand, Electronic Manufacturing Services (EMS) providers like Benchmark procure higher volumes of parts than a single early-stage startup can and have decades of expertise navigating the intricacies of the global supply chain.
When de-risking your go-to-market process, working with an industrial design house that doesn't possess manufacturing expertise can be dangerous. Often, a design house is more than happy to take your money to supply a user-friendly design. Unfortunately for your product, their know-how in concepts like 'design thinking may not be accompanied by knowledge of design for manufacturability principles. A visionary idea without a practical application might be suitable for the initial design stages. But eventually, you will have to present a more grounded final cost and method of manufacturing that is acceptable to your advisors and investors.
Advice in action
One real-life example of an R&D productization headache that we experienced recently involved obtaining visual displays. Our medical device customer provided a Bill of Materials (BOM) that included a display the OEM felt confident would fit their needs for years to come.
Much to their surprise, after some quick research from the supply chain team at Benchmark, the part was determined to not be a good fit for the application. Additionally, by connecting with supply chain contacts, the team found that the particular part was due to start its end-of-life process in a matter of months. The customer was shocked; like most medical OEMs, this Benchmark customer didn’t expect a product change for years. Now, they’ve learned they only had a few months of supply.
With our experience working with display suppliers and medical device customers, Benchmark didn’t hesitate to offer a replacement that exceeded requirements and was at the initial stages of its lifecycle. With a mid (product) life crisis averted, the OEM successfully deployed the device at an acceptable cost and has been successful for several years.
The right combination of innovative design and grounded go-to-market experience
The transition period between research and commercialization can be difficult for disruptive medical device companies. Engineering for reliability and cost, anticipating product change, and prototyping with commercial-grade partners are some of the most significant pieces of advice Benchmark can give in this case. Each suggestion is an integral part of a product introduction plan that can help fast-growing companies deliver on their promises to investors and patients.
Experienced medical device EMS companies with proven engineering and manufacturing experience applied to a wide range of innovative medical devices OEMs can offer a great middle-ground between the promises of tomorrow and the reality of today. Benchmark can help you navigate design for excellence evaluations, new product introductions, and more while using our global footprint to adapt to your product roadmap changes. Contact us today.