Management of Regulatory Affairs,
Patent Actions & Reimbursement

The US medical device market represents a huge profit opportunity for an innovative product -- but not if the launch is impeded by FDA problems, reimbursement delays or patent actions. Through “C-level” experience and numerous product launches, TCG Principals understand the importance of selecting the best experts and optimal approaches to regulatory, payor and intellectual property issues. An effective 510k filing, written by individuals with direct CDRH background, can get a product on the US market in 90 days versus 2 years while cutting development costs. Similarly, planning for coverage, coding and payment is critical to assure that when the product is approved by FDA, it will be reimbursed through the DRG/CPT systems. Unfortunately, many firms consider these issues too late in the development process causing significant delays. The TCG experts can help clients avoid the FDA and CMS pitfalls to launch faster and cheaper. TCG Principals also have 60+ years interacting with trained IP attorneys and patents to assure that your technology is protected to maximize its value for you and potential partners.

Examples of success stories include:

• Assisted an EU company in obtaining FDA registration and distribution for its orthopedic products.
• Oversaw the strategy for 510k filings for a German dental firm which gained US clearance in 76 days for three products.
• Conducted a new pricing model for a therapeutic agent in context with the impact of the current managed care and reimbursement dynamics and payor policies
• Assessed the worldwide patent options for a unique surgical product so the client could devise a more effective partnering strategy

Getting FDA approval is the first crucial step in bringing a product to market. But negotiating reimbursement with the payers should have the same priority. This TCG White paper discusses the Do’s and Don’ts.

"Commercialization is all part of brand management, how you build a brand. The companies who specialize in this may prove very helpful" says Dr. Robert Keefer. Read Companies Supporting Other Companies from The State of Life Sciences in North Carolina (Supplement) in The Scientist. To view the full article, click on The Scientist, April 2007.