Differentiate between user and/or other stakeholder requirements and needs, and the actual technical requirements that are written to an engineering level of detail. 

During design validation, make sure you test the technology using the same setup customers would be working under. That includes putting the device through usability testing. 

Conduct a careful risk-benefit analysis, and compare your device to similar ones that are already on the market. 

To achieve production equivalence, use product builds with the same design, components, processes, and materials you used in the design validation process, so they can be expected to perform the same. 

Be strict about document control. Have a dedicated document management system to track design changes, process changes, etc., and evidence of who signed off on each. 

Be a stickler about intended use. Make sure you only use your device for the use FDA has approved. 

Develop a clinical rationale for your technology and explain it. Many companies don't. 

Triage device nonconformances with a CAPA escalation. Consider the risks to the patient, the device's regulatory status, and the business; the frequency of the issue; and whether it would result in a significant regulatory problem such as medical device report, recall, etc. 

If you are an investor or want to attract investors, have an independent party perform due diligence on your technology.