Project Diagnostics: Understanding the Crucial First Step in the Medical Device Development Process

Medical product development is a long and complex journey. Whether your company is an ambitious startup or an established industry leader, of course you already know you need to have a plan. But not all product development plans are created equal.

In order to be successful, your development plan needs to anticipate and address the many details, requirements, and potential roadblocks that may arise. Gaps and oversights come at a high cost in terms of time, money, lost opportunity — and even reputational damage. It’s not a stretch to say that the success of your product may depend on how well you plan.

The best way to lay the necessary foundation for a complex development process? Start with a project diagnostic that leaves no stone unturned. In this article, we’ll explain what a project diagnostic is and how you can use one to build a rock-solid product development plan.

What is a Project Diagnostic, and Why Is It So Important? 

A project diagnostic is a structured assessment of your project. It is used to build a detailed and highly accurate product development plan. For obvious reasons, the diagnostic should be one of the very first steps in the product development process.

Over the course of a project diagnostic, your goals are to:

• Comprehensively assess the project’s needs and requirements

• Define roles and responsibilities

• Identify risks and resources

• Uncover regulatory requirements

• Identify gaps and opportunities

• Bring internal teams into alignment around a shared vision

• Ensure budgets are accurate

• Establish a realistic timeline for the project

• Refine your team’s understanding of how your product will meet users’ needs

By uncovering all of these details at the start of your project, your team takes a more proactive and knowledgeable stance toward medical product development.

But that’s not all. The project diagnostic also enriches your team’s understanding of your intended product and the requirements of the product development process. This is especially true for start-up companies for whom the project diagnosis can serve as a valuable education.

Long-established medical device companies on the other hand benefit from a strong project diagnostic in a different manner. By bringing internal teams together in an intentional way, these companies bridge any silos that may have unwittingly formed over the years. In addition, the diagnostic process forces more established companies to operate beyond assumptions by getting them out of autopilot mode.

Finally, medical device companies working on accelerated timelines (often in response to competition) are frequently tempted to skimp on the diagnostic phase. This is a mistake. Investing up-front time in a project diagnostic pays dividends for fast-paced projects by ensuring that details aren’t lost in the race to bring your product to market.

The main output of your product diagnosis a comprehensive project plan. This plan should guide your team toward an efficient, cost-effective, and successful development process. This plan will:

• Include a comprehensive list of all activities that need to take place as part of your product’s development process

• Clearly assign roles and responsibilities for each of those activities

• Delineate a project schedule, including the sequencing and timing of all activities

• Cover a detailed and accurate project budget, broken out by fiscal year

How to Structure a Project Diagnostic Workshop 

You can approach a project diagnostic any number of ways. We recommend structuring it as an intensive one or two day-long workshop that brings all of your internal teams together in a purposeful way.

Make sure to include a representative from each of the major divisions in your medical device company, including:

• Human factors and/or marketing

• Business executives

• R&D/engineering

• Regulatory

The project diagnostic workshop isn’t just another meeting. Make sure you come to the table with a thorough and highly structured agenda that maps to the goals of the project diagnosis and includes input from each of your functional teams.

While the overall agenda should be customized to suit the specific needs of your project, we recommend beginning every diagnostic workshop with a simulated use case or interaction featuring your intended product. You can use a prototype, a similar competitor’s product, or a current-generation version of a product you are updating. But whatever you do, don’t let your sales or marketing staff do a demo of the product. You should bring in an actual user (ideally one that isn’t associated with your firm) to demonstrate the use case. Instruct your user to run through the full use case without skipping anything.

Beginning your project diagnostic with a user test case is a powerful way to get everyone looking at the product through the eyes of your users. It clearly illustrates (sometimes for the first time) issues or challenges that your users may experience in using your product. And it ensures that your users remain top of mind as you work together to lay the foundation for your medical device’s development.

Whether you conduct a project diagnosis internally or hire an agency to help, be sure you include this crucial first step in your product development process.