MedMarket Diligence’s 2009 report #S175 is an analysis of the companies exploiting medical devices targeted at the surgical securement market to examine the products they market and the timelines associated with their approvals.
A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the United States, a new medical device is usually marketed after the FDA approves a pre-market application (PMA) or clears a 510(k) pre-market notification submission. Through a conscious effort by the FDA, the time required for the agency to carry out this approval has been steadily reduced and is now around 3 months for a 510(k) and 13 months for a PMA. The FDA has also worked to make the approval process less arbitrary.
Regulatory bodies in Europe and Japan also have achieved significant advances in the last 10 years to streamline their approval processes so that clear guidelines are given for approval and reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.
We also found that all medical device businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer-term, more risky breakthrough opportunities.
MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."