In my experience, a product’s best chance at successful commercialization is to ensure it follows a Five Step Development process. Company value, and user safety will rely on the due diligence required within each step of the process. The engineers who develop these frameworks live and breathe Murphy’s epigram, “Anything that can go wrong will go wrong”. Your investors and customers will thank you.
Whether you are pioneering a novel medical device or offering an improvement on an existing platform, the idealized prototype-to-mass-production methodology for medical device development remains the same. Its aim is to show where your extant design, funding, controls, and risk analyses dovetail into an initial bird’s eye view consultative and subsequent hands-on design transfer to create a common understanding of the best path forward.
It does not matter where you are in the prototyping, marketing, or regulatory stages. Knowing how to optimize development is the sure path to added value.
You must address device development from two directions, one with an eye towards fulfilling regulatory requirements, and the other towards taking your prototype to successful commercialization without having to reinvent the design and manufacturing control process.
The Five Stages of Medical Device Development
There are typically five critical stages involved in taking an idea for a novel or improved medical device to market. The names and details of these complex stages vary from methodology to methodology but in broad outline, they roughly involve:
- Concept Phase (Marketing & Fund Raising)
You’ve got a novel idea, but . . . Have you established a compelling value proposition? What is the value that your device will bring? Is there proprietary information to protect your investment? Do you have what it takes to see this process through?
You’ve determined there is a viable market, but . . . Who is your target market and what is the market cap? Are your sales limited to $10M or $100M? Will you disrupt the market?
This stage will dictate how much time and energy you want to invest. Do you know how not to get roadblocked and keep moving forward?
- Feasibility and Planning Phase (Hazard Identification & Risk Management Planning)
You can’t do this alone, but . . . Do you have a partner with the expertise required for immediate turnaround? The right partner can reduce time to market and perform your Research and Development activities directly from your POC (proof of concept) device.
You have a target sales price, but . . . Have you determined your final COGs and costs of scale? An optimistically priced product with an overpriced build cost is the end of most new startups.
- Design Development Phase (Design Controls, COGs determination, Intellectual Property)
You have developed your design, but . . . Do you know how to adhere to regulatory requirements? Have you defined the controls required to ensure long-term patient safety while maintaining an attractive profit margin?
You will need to create devices for test and user evaluation. Many New Product Introductory tools are available for those who live and breathe design development. Those who don’t follow these steps or ignore lessons learned will be relegated to the “zombie” category.
- Design Transfer (Manufacturing Controls, Validation, Regulatory approval)
You have completed the design, but . . . this is only half the job! Now you must migrate the ideas of controls, risks, and cost with a manufacturing mindset.
Once you have prototype and pilot run with data collected and V&V activities complete, it is time to submit for approval, but . . .
Most devices these days are approached with a 510(k) approval process for speed and ease. Do you need PMA (Pre-Market Approval) or 510k (a shortcut using other products that have successfully passed a PMA to create a category where you need to show equivalency via the 510k clause in the FDA’s rulebook)?
- Commercialization, Release Phase <-> Monitor Residual Risk <-> Risk Management Review
You have launched and your product is on the market, but . . . now you must focus on consistent quality, on-time delivery, and drive towards lowered costs. You must be vigilant to maintain and/or improve upon the status-quo.
Our clients typically engage somewhere in the first two stages with varying degrees of preparedness. The product and extant documentation are input into Design Development and Design Transfer to determine oversights and mitigating best practices in terms of optimizing the hand off.
Mercifully, the days of startups having to recreate the wheel from concept-to-customer are gone. If you have an idea and have gained traction to fund the endeavor, you are already on the path to success. But… Your product’s best chance at successful commercialization is to ensure it follows a Five Step Development process like the one I have described above.
Glen Farrell is a former Manufacturing Program Manager at StarFish Medical. Glen has twenty years of experience in Medical Device development and manufacturing. He has helped build medical device start-ups with several successful FDA and Health Canada submissions. Skilled in new product introduction, process development, and quality management, Glen has launched dozens of new products into the Biotech, Defense, and Marine markets.