Soup to Nuts Advice from Beginning to End of the Product Approval Stage
- Advises angel or venture funded early stage medical device companies on product development
- Advises clients with later stage products on commercialization strategy
- Advises on issues at the intersection of FDA and Medicare regulatory law
Integrate FDA Strategy with Coverage & Reimbursement Strategy
- Reviews clinical trial design with the goal of revising clinical trials to maximize the chance for payer coverage and reimbursement
- Helps design clinical trials
- Advises on obtaining cost data during performance of FDA clinical trials
- Advises on product development program in relation to obtaining CPT codes
Artificial Intelligence and Software as a Device
- Assists many clients developing various types of artificial intelligence (AI) and software as a service (SaaS)
- Advises on whether AI and SaaS products have a Medicare benefit category
- Advises on coverage and reimbursement issues affecting AI and software devices
- Advises on obtaining CPT codes for AI and SaaS products
- Advises medical device companies on coverage and reimbursement issues related to acquiring or investing in AI or SaaS products
- Is familiar with the CPT AI taxonomy