Saturday, March 1, 2014

Factors to consider before a innovative idea to real market success in medical device.

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:
  1. 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.
  2. 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.
  3. Learn intellectual property. Obtain protection of own patent and avoid infrigement of other's patents.
  4. Conduct clinical trials as early as possible if necessary.
  5. Plan the regulatory strategy early. The better you understand the regulatory framework, the greater your chance of success.
  6. Understand the reimbursement landscape.

No comments: