How does ...
the FDA approval process make it harder to start a biotech company?
The costs of getting a biomedical business launched are much greater than traditional products. A typical medical device venture will need to attract between $15 million and $25 million in funding before it is able to generate sufficient revenue to sustain its operations. The funding is used to support product development, clinical studies and economic analyses in preparation for FDA clearance and reimbursement coverage. In addition, the company must file for and maintain a broad intellectual property portfolio to protect its inventions.
— Baiju Shah, president and CEO of BioEnterprise
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