It is easy to find ideas that appear to have promising business potential, but ultimately very few have the potential for real market success. Many factors need considered before we determine if a idea will have real impact. Serveral considerations which may increase the chances of success in medical device development are listed:
- A new medical device must solve a real clinical problem or substantially lowers the cost of treatment and decreases mortality or serious morbidity relative to the standard of care.
- Understand how large the potential market (size and growth) for the new product is, and how ready the clinical users will be to adopt it.
- Learn intellectual property. Obtain protection of own patent and avoid infrigement of other's patents.
- Conduct clinical trials as early as possible if necessary.
- Plan the regulatory strategy early. The better you understand the regulatory framework, the greater your chance of success.
- Understand the reimbursement landscape.
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