HRA is…a resource for medical device companies

The continued increase in less invasive outpatient procedures, enabled by innovative technologies, has led to growth and opportunity in the medical device sector. With this opportunity comes many challenges including regulatory issues, reimbursement and market entry.  

We advise and assist our Clients in navigating this difficult environment with a wide scope of services including:

• Roll-out strategies, including sales force and distribution network development
• Manufacturing and sourcing, including “make versus buy” decision making
• Regulatory (FDA, Health Canada, EU, ISO)
• Reimbursement (Medicare, Medicaid and commercial payers)
• Operational start-ups and turnarounds
• Exit strategy identification and execution
• Technology transfer and licensing