Critical Questions for the Medical Device Industry

Is your company ready for the regulatory and market access challenges of launching a product globally? Quintiles Consulting has found that the best way to maximize the long-term value of your company and product is to develop a global launch strategy that goes beyond the historical requirements of efficacy and safety.

Innovative medical technology is playing a major role in addressing important societal problems while also improving the efficiency of healthcare spending. This growing importance of the medical technology industry within healthcare systems worldwide has meant that stakeholders are now scrutinizing the industry more closely.

These stakeholders (including: investors, regulatory agencies, health authorities, governments, health technology assessment bodies, healthcare payers, healthcare providers, clinicians, patients' associations, to name a few,) are also increasing their demands for evidence to approve and reimburse these exciting new medical technology products.

To help your company prepare for a successful product launch, Quintiles Consulting has developed a list of questions.

• How shall I demonstrate the economic value of my technology?
• What will be the process of obtaining funding & reimbursement for my technology?
• Have I demonstrated that all risks have been addressed and mitigated to an acceptable level? What is acceptable?
• Do I need post-market studies to support the launch of my innovative device in Europe or the USA?
• What post-market vigilance will be required once the product has been launched?
• Will CE-marking of my device be sufficient to launch it successfully in the European area?
• What clinical data do I need to obtain CE-mark in Europe?
• Should I set-up direct operations, appoint a distributor, or out-license my technology?
• As a U.S.-based company, do I need an Authorized Representative in Europe? Should it be the same as the distributor appointed to sell and distribute?