Mechanisms of Tissue Repair
As recently as 10 years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. By 2003, many companies had abandoned this approach due to disappointing results.
A better understanding of the underlying mechanisms of tissue repair has led to the evaluation of more complex approaches, combining structural repair materials with active pharmacological agents, biologically derived and cellular components. This improved knowledge of physiological healing processes has led to formulation and adoption of new securement and adjunctive surgical devices, resulting in improved hemostasis, reduction in post-surgical adhesion (PSA) formation, and stronger and quicker biological repair.
MedMarket Diligence carried out a review 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.