Getting ready to add medical device engineering muscle to your development process? It’s going to require the teamwork and symphony of a chorus working in harmony.

If they’re any good, they’ll ask you these (or similar) questions before accepting your assignment.

Because it’s easy to take your money.

It’s harder to deliver what you want, on budget, and with minimal headache and rework along the way.

Ten Questions They Should Ask You
Before They Accept Your Project

  1. What documentation is available for your product or device?
    (i.e. specifications, CAD files, Flow Charts, Concepts, working models?)

  2. What will the device be able to do?

  3. How many systems need to be produced?

    1. Feasibility Prototypes

    2. Prototypes

    3. First year production units

    4. After first year

  4. What are your time frame expectations?

    1. When would you like to start project?

    2. Concept Phase complete?

    3. Design Phase complete?

    4. Prototype assembled and functional?

    5. Any show or special meeting for prototypes?

    6. Design revised and completed for manufacturing?

    7. Test Plan developed?

    8. System assembled and ready for test with documentation?

    9. Test stage?

    10. Full scale production run?

  5. Are there others in the development process with whom we would interface? If so, who are they? What will they provide?
    (e.g. electronics, software control, technology, commercially available component etc.)
    • Will we be asked to work with existing team members?

  6. Will FDA approvals or clearances be required?

  7. Do you presently have a quality system in place?

  8. What parts or modules will require invention or research? Are there subsystems to be validated?

  9. Is there an unproven that needs validation before moving to the design stage?

  10. In your opinion, what are the key engineering risks?