A medical device clinical trials starter guide

Incorporating clinical studies prior to design ’freeze’ into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-defined goals, proactive collaboration between functional areas and discipline.

Ignoring the oversimplification of the flow-chart below, how can the Design Freeze stage-gate get postponed until immediately before the Pivotal clinical trial (i.e. utilize pilot clinical studies to refine a device design)?

Here are 5 actions towards earlier clinical evaluation:

1. Set expectations with upper management that a ’Development Pilot’ clinical study will provide the greatest opportunity for success and ultimately the most efficient timeline and budget. In addition, the management team will gain greater visibility sooner in the process.

2. Factor it into your project plan that a Development Pilot will be conducted before studies aimed at regulatory approval. This means a plan that includes design and testing iterations in parallel to early clinical studies. If the design doesn’t change significantly as result of the clinical learning, the product can proceed directly to a Pivotal clinical trial and the plan will be ahead of schedule.

3. Separate Essential Design Outputs from the complete set of product specifications that the design will eventually have to meet before market launch. Focusing on Essential Outputs for product release to early clinical studies allows the development team to insure that the product is safe, before clinical evaluation without pretending that the design is ready to go to production. By default, you are saying, ’we don’t know or are not sure what some of the performance specs are and we want to learn in the clinic, as long as safety risk is minimized’. Often times justifications can be made to support non-final design data being used for regulatory submissions. So, once the final testing data is complete and internal files updated, the product is ready to roll.

4. Gain buy-in from the regulatory and quality team members that the product can meet your internal quality system requirements and regulatory requirements for clinical study release prior to Design Freeze. If your internal process is too restrictive, you have more work to do to flex your system. If the U.S. regulatory pathway ties your hands too much, investigate options offshore.

5. Identify clinical investigators that understand the process of testing products that are not market-ready. Sometimes this means more procedural steps to accommodate design limitations. It also means having an engineer participating in every clinical case. And, that’s how you learn’

The 5 steps above each involve multiple sub-actions that allow a development team to truly incorporate clinical studies into the development process. This approach requires more upfront work to gain better outcomes and a more effective process. Plus, it’s just more honest.

Healing Innovation is a resource for clinician innovators. The main site – HealingInnovation.com – provides an overview of the various aspects and issues facing clinician innovators.