Failsafe Your Medical Device Development Process with a Comprehensive Project Plan

 In Design Strategy, Engineering, Medical Product Design

The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps along the path to a new product launch. Companies that are attempting to produce their first medical device are likely to feel paralyzed and confused. And even more experienced medical device companies may have trouble keeping all the details straight. In this context, a detailed and thorough medical device project plan can spell the difference between smooth sailing and choppy waters.

In our work with clients, MPE (Formerly Mindflow Design) acts as a sort of medical device development sherpa. We show our clients what they need to do — and then lead with them through each step until we reach our destination. The fully customized project plan that we create for each of our clients is the equivalent of a GPS system. It tells clients what to do and when. The project plan charts a detailed course of activities, assigns roles and responsibilities, and ensures that the device’s development process fulfills the FDA’s requirements.

The FDA’s Design Controls and Your Medical Device Development Project Plan

The majority of medical devices must be developed under the FDA’s Design Controls (also known as 21 CFR 820.30). Design Controls are the means by which the FDA validates the safety and efficacy of medical devices on the market. Design Controls are an important safeguard. In practice, however, Design Controls are also a thorny tangle of requirements and documentation that account for the exceptional complexity of medical device development.

Design Controls requirements can at times appear murky. There’s enough room for interpretation that it can be hard for medical device companies to know for sure whether they are doing it all correctly. This same murkiness extends to the project plan. A project plan is a required component of the Design Controls submission package. But there are no formal blueprints dictating the details of a project plan’s structure and content.

This lack of clarity presents a twofold challenge for less experienced medical device companies. They know they need a project plan to guide their team’s efforts and ensure they are jumping through all the necessary hoops. But in many cases they aren’t certain enough about what those hoops are to put together the comprehensive plan they so desperately need.

It’s a bit of a catch-22. And that’s where MPE (Formerly Mindflow Design) steps in.

MPE (Formerly Mindflow Design) ’s Medical Device Development Project Plan

MPE (Formerly Mindflow Design) ’s project plan is structured to reflect the FDA’s Design Controls requirements. It provides an overview of each of the requirements and a map for meeting them.

At the same time, it is fully customized for each client based on the work we do in the initial strategy phase. The strategy phase includes robust research and opportunity-mining exercises as well as a discovery workshop. The project plan is what emerges from all of this preparatory work. The goals of the plan are to:

  • Describe a detailed development plan for the medical device.

  • Create a realistic budget and request approval of the resources necessary to execute the project plan.

  • Assign roles and responsibilities.

The Benefits of a Strong Project Plan

There are many benefits to having MPE (Formerly Mindflow Design) produce your team’s medical device development project plan. These include:

  • A full understanding of what needs to happen and when. MPE (Formerly Mindflow Design) s’s medical device development project plan eliminates confusion. It gives your company a complete roadmap of all the necessary activities that must take place before a product’s successful launch. MPE (Formerly Mindflow Design) brings its deep expertise and extensive experience to bear on your project to ensure that your project plan is airtight with no missing details. The MPE (Formerly Mindflow Design) project plan curveball-proofs your development process.

  • The knowledge that you are on track to meet FDA requirements. Because MPE (Formerly Mindflow Design) ’s project plan tracks with FDA requirements, you can be confident that your device is on the road to FDA approval.

  • Clearly defined roles and responsibilities. The typical medical device development team includes several contributing parties in addition to the medical device company itself. This may include consultants, test labs, contract manufacturers, and FDA consultants — as well as a medical product design agency like MindFlow. With so many players, it can be hard to know who is responsible for what. MPE (Formerly Mindflow Design) ’s project plan clearly defines roles and responsibilities so that each person knows what she is responsible for and when.

  • A realistic timeline. MPE (Formerly Mindflow Design) ’s project plan includes a reality-based timeline for the project. The project plan’s timeline is trustworthy because it takes each step into consideration.

  • Access to tools and templates to accomplish the work. The MPE (Formerly Mindflow Design) project plan is much more than just a to-do list. It also includes a set of valuable templates and tools that help your team navigate each step with ease.

  • An accurate budget. Your budget will never be accurate unless you have a comprehensive understanding of the project requirements and the resources needed to meet them. Gaps in your project plan equal gaps in your budget. MPE (Formerly Mindflow Design) ’s comprehensive project plan gives medical device companies the ability to budget accurately.

  • The ability to build your device correctly the first time around. The success of your medical device depends on the strength of your plan. MPE (Formerly Mindflow Design) ’s project plan is customized to each client, but it’s structure is proven. Follow it, and you’ll be sure to design and build your device correctly the first time around.

Medical device development is complex. Without a trustworthy map, you risk getting lost along the way. In today’s competitive market, wrong turns equal wasted money, lost time, and forfeited opportunity. Having the right project plan in place is critical to charting a path to success.


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