10 tips for leading successful medical device development projects

Even though it can seem difficult to plan, integrating a project’s commercial, clinical, and functional aspects with the usability and regulatory aspects of medical technology from the beginning prevents repetition. The time saved downstream as a consequence typically gives enterprises a significant competitive edge.

In cross-functional medical product expansion projects involving medication delivery, physical devices, patient data,  electronics, applications, and software, a solid strategy with crucial resources provides a reasonable basis for managing increasing complexity across multiple technical disciplines. It’s similar to cooking a delicious multi-course meal for a date: if you don’t prepare ahead and double-check specific requirements, you can end up with a fire in your kitchen, cold food, and your crush in anaphylactic shock.

It’s challenging to keep track of a new medical device’s development, and there are many moving parts in the process, as well as risks and errors to watch out for. Our top 10 recommendations for finishing a medical device development project are based on our years of experience helping life science businesses translate strategy into long-term success.

  1. Explain the product vision to the entire team.
  2. Create a strong business case.
  3. Select a project manager with outstanding leadership skills.
  4. Pay attention to the larger picture.
  5. Continue to communicate with the production and manufacturing departments.
  6. Learn from mistakes quickly.
  7. Maintain clarity in the design history file.
  8. Keep the majority of decisions at the level of the core team.
  9. Uphold the needs of the user.
  10. Only escalate when necessary.

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