Lack of FDA and QA/RA knowledge, coupled with a drive forward on the device design towards commercialization can spell disaster. With upwards of 75% of US-based, early-stage MedTech companies and products as well as 40% of added functionality never seeing success, bringing an innovative technology to market is a Colossal task. Succeeding in this space isn’t easy, but you can be a success story if you plan the process properly and execute it with the proper experts to inform and guide you.
A deviation from the proper process early in the product development lifecycle is one of the key causes of underperformance and failure.
The DV7 Engineering team, recently shared some simple ways to avoid these fatal mistakes and plan for quicker commercialization and market success.
THE FASTEST WAY TO A SAFE AND QUALITY PRODUCT
- Discovery, make sure you have a finite understanding of the market, where the technology fits along with economic data. Get this early to guide the design and leverage the investments you’re already making. This will help provide the design and plan for the product roadmap from a usable, market driven perspective and provide requirements that can be used for design through testing for traceability
- Design according to the requirements requirements with a funded design path and regulatory buy in, which draws together expertise and allows for consensus around the optimal path forward.
- Develop with an ROI mindset. Maintaining a cost mindset and a Product Roadmap with a HW and SW design that will enable faster market access and payback now, with future scalability designed in. Cutting corners and cost early, will cost you exponentially more later.
- Verify at key intervals that you are designing and building the product correctly according to the requirements. * Note- the requirements can change as needed to meet safety, design and performance specifications
- Validate to insure that you have built the correct product. This should be driven by the finalized requirements hardware and software along with performance trials based dovetailed with risk mitigation.4&5-The IV&V will provide objective evidence from the design, development and testing. The FDA and the marketplace want to see a track record of evidence. Independent- Objective evidence is the key!
- Document this started at the very beginning of this process, is now finalized, and delivered to the FDA. The documentation will be between 60% and 85% of this entire process. This is where seasoned professionals can significantly cut the time and costs involved.
- Deploy the product to the market. Continue the roadmap, release updates using the same process, and you will insure a smooth road-map
There’s plenty of opportunity for missteps throughout the product development lifecycle that can set you back millions of dollars and several years – or worse, leading to the downfall of your company. DV7 and our decades of experience will help you and your product become a success story. That’s The DV7 way!