David W. Lown, U.S. executive and general manager of Musculoskeletal Clinical Regulatory Advisers, thinks orthopedic market competitors should adopt an integrated research, development and commercial access strategy.
Here are five highlights:
1. The complexity of clinical, regulatory and reimbursement dynamics presents many unforeseen business challenges to experienced industry veterans.
2. While CMS, FDA and other governmental institutions have an influence on safety, efficacy and cost effectiveness, industries must execute their business strategies in an integration fashion in order for marketing claims to be consistent with regulatory claims.
3. Clinical evidence requirements are increasing on most technologies, increasing the investment required for successful commercialization, which puts additional strain on both companies and private investors to further invest in advancements.
4. Mr. Lown said, "Device companies must quickly realize today that industry-wide evidence requirements are quickly becoming analogous to the pharmaceutical industry and for those who invest properly both value creation and risk mitigation will be the reward."
5. MCRA works with 500 partners globally to design and execute integrated product development strategies.