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From Feasibility to Design Freeze: 5 Key Risks in Medical Device Development

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Moving a medical device from “napkin sketch” to commercialization is a complex business requiring a wide variety of skills. Most risk should be mitigated in the feasibility phase, where all aspects and options for design are researched and explored. The key overarching risk in medical device product development is moving from feasibility to design freeze and development too quickly. This inevitably costs more time and money in the backend when problems are encountered requiring “do-overs” of various steps.

During feasibility, there are five primary risks to mitigate prior to design freeze, make sure your R&D team is well-informed in these areas:

1) Team: Your R&D team must have all the skills and knowledge to follow the design program from start to finish. A competent program manager should lay out the entire project with resource and time requirements. Be sure your team has the two most important qualities: Experience and breadth of skill. An inexperienced team, or a team that is too small and lacks breadth of knowledge, will often find themselves deep into product development, after design freeze, before problems arise. A team with deeper knowledge and experience knows what problems to look for and the processes that need to be followed in order to solve them earlier rather than later.

2) Materials: This is a critical risk factor that must be resolved during feasibility. Again, experience is a key factor. What are the materials that will produce the best outcome for the patient? How do materials interact with each other? Often a team, especially a contract manufacturing team, is very knowledgeable about what they do best, but lack experience with the materials required for the entire device. This narrow experience can lead to problems with materials compatibility.

3) Supply chain: Determining which materials to use in a laboratory is one thing; understanding the availability of materials for manufacturing is another. Often this is overlooked until late in the process, but supply chain issues need to be explored during feasibility. Are the materials you need abundantly available? Are any of the materials “exotic,” and if so, can a less-exotic (less expensive) material be substituted? What about the materials suppliers themselves… are there several to choose from? Are some suppliers superior to others in terms of consistent quality and auditability?

4) Testing: Without a thoroughly planned and well-documented testing protocol, your project can hit the skids when it comes time to pass audits and gain regulatory approvals later. Bench testing, anatomical model testing, early feasibility clinical studies, and accelerated aging testing are all important aspects of the research phase. With extensive testing prior to design freeze, you can address any issues head on, saving time and money later. This is where an experienced team with varied skillsets brings a lot to the table by anticipating potential problems and testing through them during the feasibility phase. No less critical is the team’s access to a lab well-equipped for testing. If your team has the ability to do most of the bench tests, anatomical model tests, and accelerated aging tests in-house, you will save time and money on your project.

5) Documentation: Keeping detailed and extensive documentation is critical from the moment a project launches. A compliant quality system implemented on day one eliminates a great deal of risk. Unfortunately this is often pushed off to the end, and it becomes a huge catch-up activity when you find your product’s DHF (design history file) is not ready for an audit. By establishing documentation protocols early on, you have the revision history and quality control information necessary for the product approval phase.

Your napkin sketch may seem months away from design freeze, and product approval in the even more distant future, but risk mitigation begins when your project begins. Don’t wait to put the processes in place to make your project plan flow as smoothly as possible.

If you need an experienced, full-time R&D team with expertise in all of the above, don’t hesitate to give us a call at 951.696.3933, we’d be happy to talk to you at any phase of your project. We can get your project back on solid ground if things have gotten a bit shaky, or if you have a new product, we can start you off on the right path, guiding your exciting new project through to commercialization.

Eric & Phil