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 entry strategies must also account for local healthcare systems, reimbursement structures, and regulatory frameworks. “It’s not easy,” Maria acknowledges. “You take into account what the reimbursement rates are, what types of insurance plans are available. There are many different factors, but what you want to be sure of is that you’ve got guardrails in place.”  Communication presents another critical challenge. Even with her own French language skills, Maria insists on working with specialized medical translators for international research. “I would never interview somebody in French and rely on my own French speaking skills,” she says. “I want to be sure that I get every single little nugget.” This attention to detail is particularly important in medical device marketing, where misunderstandings about product specifications or usage could have serious consequences.  While AI translation tools can be helpful for basic understanding, Maria stresses the importance of human expertise in medical translation, particularly for critical communications and research. High-quality translation from subject matter experts should be used for anything affecting revenue, liability, or the company’s bottom line. For translation, interpreting, and research, for example, Maria looks for linguists who understand medical terminology in both source and target languages.  Maria’s experience in North Africa crystallized for her the importance of understanding local market conditions. Learning the Arabic word “makesh” (meaning “there isn’t any”) taught her that assumptions about product availability and market needs don’t translate across borders. “In the United States, you can get almost anything, but that’s not true in the rest of the world,” she observes. “Makesh is almost the standard.” This insight underscores why thorough market research conducted by experts who understand both the medical specialty and local healthcare environment is essential for successful global expansion.  For companies planning international expansion, Maria recommends a methodical approach:  Find consultants with relevant medical specialty expertise  Ensure all research and communication is handled by qualified professionals with appropriate language and clinical knowledge  Develop market entry strategies that account for local healthcare systems and cultural nuances  While COVID-19 accelerated many changes, Maria notes that these shifts were already underway. Industry leaders like Medtronic and Boston Scientific have evolved beyond traditional multinational models to become truly global organizations with unified branding, marketing, and communication strategies. The path forward is both challenging and clear, she says, adding that success will require moving beyond surface-level market research toward a deep and nuanced understanding of local healthcare dynamics, especially when “makesh is the standard.”  Links: Website: https://www.medi-vantage.com/  LinkedIn: https://www.linkedin.com/in/mariashepherd/