Global Medical Device Research - Show #143

Maria Shepherd is the founder and CEO of Medi-Vantage, which helps companies develop disruptive medical devices and marketing strategies. Every strategy is designed to decrease risk, disrupt existing markets, and drive market share while improving patient outcomes. With clients from Japan, Australia, several EU countries, and the United States, Medi-Vantage has developed a comprehensive approach to global market entry, with services encompassing everything from developing engineering marketing specifications to conducting clinical due diligence for acquisitions. 

As a guest on The Global Marketing Show, a Rapport International podcast, Maria shares her best advice from over 16 years of medical device strategy research, covering the commercialization continuum from marketing specifications through reimbursement, pricing strategy, and go-to-market planning. She also provides a roadmap for bringing medical devices to global markets: careful research and strategic pricing built upon a deep understanding of local healthcare systems. 

The Complexities of Global Medical Device Pricing 

Maria reports that thanks to increased transparency in the digital age, the days of setting different prices for different regions are essentially over. When a medical device is sold at a significantly lower cost in India, for instance, in the US, Germany, France, or Japan, economic buyers can easily access that information. 

Transparency has forced companies to develop more sophisticated approaches to market entry in different regions. Some strategies include providing complementary capital equipment with the purchase of disposables or the implementation of subscription models. These approaches must be carefully considered, however, as some markets (like US hospitals) are known to resist certain pricing models. The key is finding a balance across different healthcare systems while maintaining profitability and market access. 

Medi-Vantage develops budget impact models to help companies determine pricing and demonstrate value. Maria describes a recent project involving a device to help OB-GYNs make more informed decisions about C-sections. The model factored in: 

• Current C-section rates (36% in the US versus 24% globally) 
• Hospital costs associated with C-sections 
• Potential complications and ICU stays 
• Impact on mothers and babies 
• NICU costs 
• Associated litigation risks 
• Long-term implications like cerebral palsy 

A comprehensive analysis quantifies immediate and long-term cost savings, making it easier for healthcare providers to justify the investment. Such models are particularly valuable when introducing disruptive technologies that require changes to established medical practices, Maria says, adding that: 

We quantified all of those and put them into the budgetary impact model because, oftentimes, nobody really sees an alternative to C-section. They don’t sit down and figure out, what if we didn’t have to do this C-section? Then there are the costs to the mother, of complications, death, extreme impairment, or long hospitalization. 

Clinical Due Diligence in Global M&A 

Medi-Vantage also conducts clinical due diligence for medical technology companies considering acquisitions. Maria says it’s not unusual for a surface-level appeal to fall short of reality, describing a rare instance in which she resisted an acquisition. A new technology promised to reduce a procedure requiring two in-hospital procedures to one hospital procedure plus one office visit, a clear win for efficiency and cost reduction. 

During the due diligence process, however, the Medi-Vantage team uncovered significant resistance from both physicians and hospital administrators. The physicians were concerned about losing control of the second procedure to another specialist; hospital administrators worried about lost revenue. The feedback proved invaluable to their client’s decision-making process, highlighting the importance of understanding local healthcare dynamics and stakeholder interests. 

Advice for Global Market Entry 

Medical device companies seeking global expansion face a complex web of challenges that extend far beyond basic market research. Standing out in a competitive market requires working with consultants who have deep expertise in specific medical specialties, she says, and a network of partners who understand both the clinical and business aspects of the device industry. 

“It’s important to seek out the people who can do the best for you, who understand the medical device specialty,” be it interventional cardiology or gastroenterology, regulatory requirements, translation, or another aspect. This targeted approach helps to prioritize the steps toward market acceptance based on unique workflows and decision-making processes. 

The complexity extends beyond clinical knowledge. Market ent