19 point plan to commercialize a medical device 

If your invention will ever be submitted to the FDA, then from inception, certain processes must be followed, otherwise - cost, schedule and technical reversals are risked on the submission side. We propose the following process, roughly in the order presented, as the lowest cost and most certain process to achieve success:

1.        File / achieve a patent.

2.        Create a business plan; choose a route to commercialization.

3.        Bring on-board a consultant who is cognizant of the FDA process.

4.        Develop a proof of concept model to validate the fundamental scientific claim.

5.        Create a schedule; organize a budget. 

6.        Identify potential, candidate business partners and marketplace threats.

7.        Solicit multiple opportunities to auction and escalate the potential value.

8.        Create a requirements specification for the system - functioning in its environment.

9.        Identify sub contractors with state of the art ability in designing the pre-production unit.

10.     Create a test plan to identify what sub-systems must be tested and how results will be analyzed.

11.     Construct functional sub-systems of the final system and conduct testing.

12.     Organize data and create engineering documentation to detail the proposed design.

13.     Create the engineering design and document a valid pre-production system.

14.     Submit an application to the FDA for marketing clearance of the device.

15.     Fabricate pre-production system{s}.

16.     Conduct limited clinical demonstration to validate unit in patient conditions.

17.     Meet with potential, candidate business partners and negotiate possible agreements.

18.     Meet with potential investors and negotiate possible agreements.

19.     Auction and escalate the potential value to potential investors and candidate business partners.

Most want to take a shortcut…

If you intend to take short cuts, this demonstrates your unfamiliarity as to the rigors of this process. We invite you to let other experts {and the marketplace} teach you - the above process is the lowest cost and the most certain actions to success.