Regulatory Affairs, Patent & Reimbursement Actions
The US market represents huge profit potential for an innovative company, but not if unexpected FDA issues impede the launch, or reimbursement issues and adverse patent actions interfere with the success of the product. Employing our hands-on management experience with numerous product launches, we use expert approaches to address and solve these issues before they affect the opportunity.
For example, an effective 510k filing, prepared by experienced individuals with CDRH device backgrounds can get a product on the US market in 90 days versus 2 years. This dramatically reduces costs and increases total sales over the product lifecycle. Similarly, working on the appropriate coverage, coding and payment issues prior to product launch assures that product is accepted by customers, and will be reimbursed through the DRG/CPT systems. We time our activities and these processes to reduce financial exposure and ensure maximum peak sales.
In managing the patent preparation and application process – as well as the IP attorneys, we bring a collective 60+ years’ experience. Our objective is to assure that your technology and product investments are protected. For European and Asian companies, it is particularly important to use a US business-experienced manager who is familiar with the laws, processes and attorney management options.
Examples of recent successes 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.
- Researched and prepared pricing models for a therapeutic agent considering the impact of the managed care market and payor reimbursement policies and procedures.
- Assessed the worldwide patent options for a unique surgical product so the client could devise a more effective partnering strategy.