Four Graduates Turn an Idea into a Business
Mark Lee Ford, PhD and Global Executive MBA ‘08, is the President of The Moneo Company, a management advisory firm based in Tokyo that has a physician's enterprise practice. In this role, he learned the ins and outs of Japan’s healthcare market and saw the potential of bringing U.S. medical devices into Japan. But it wasn’t until he was in the Global Executive MBA program that the dots connected and an idea became a business.
Leveraging Global Regulatory Differences
“In a global market, there are opportunities to exploit differences in regulatory environments,” said Mark Lee Ford. “For example, a regulation that is almost insurmountable for non-physician owned companies can serve to shield—even promote—physician-owned companies.”
In Japan and the U.S., there are high regulatory hurdles for introducing new pharmaceuticals and medical devices with no reciprocity between regulatory agencies. Japan’s Pharmaceutical and Medical Device Agency (PDMA) has no jurisdiction outside Japan, and vice versa for the United State's Food and Drug Administration (FDA), so even multinational pharmaceutical giants with FDA-approved products must still suffer PDMA review. However, Japan-licensed physicians have wide latitude under the authority of their licenses to use devices and therapies that have not been PDMA approved. In a physician-to-physician model, it is possible to introduce FDA-approved devices from U.S. physicians to Japanese physicians.
With this realization, Ford along with several other Global Executive MBA students—including Salvatore DeSena, MD, MBA ’08; Derick Du Vivier, MD, MBA ’08; and Siva Budati, MTech, MBA ’09—formed Nipponica MD, LLC to help small, rising-star U.S. manufacturers import, market, and distribute medical devices and therapeutics into Japan’s $32 billion device market.
A Small and Agile Team
Nipponica is a joint venture between the companies of the founders: New York Teleradiology (President, DeSena; based in Staten Island), The Moneo Company (President, Ford; based in Tokyo), and The American Clinic Tokyo (Medical Director, Dr. Frederick I. Shane; based in Tokyo). Nipponica’s principals came from medical, science, and/or engineering backgrounds and shared the same Duke MBA degree and network. Ford said, “It was natural to apply our respective experience and talent to design, build, and launch Nipponica. Our team is small and agile and each member can work at an expert level on a wide spectrum of problems. Each Nipponica person has deep expertise in diverse areas.”
Leveraging Talents to Build a Medical Device Business Rooted in Patient Safety
Safeguarding patients and ensuring their well-being is paramount and immutable at Nipponica, so the team developed a stringent process for vetting high-potential products. Using its extensive networks in Japan, Nipponica engages medical Key Opinion Leaders (KOLs) to evaluate candidate products based on science, clinical utility, and business potential.
With the assistance of co-founder Shane, who has dual U.S. and Japanese medical licenses, Nipponica is able to leverage the network of The American Clinic Tokyo, where Shane has been the Medical Director for over 60 years.
As an anesthesiologist in the U.S., Du Vivier is constantly exposed to the latest medical equipment and trends while working in the operating room. He has a keen eye for identifying potential FDA-approved products for Nipponica’s pipeline. Presently, Nipponica has five products in the pipeline and exclusive licenses for marketing and distribution in Japan.
“Even before we get a chance to start Nipponica’s review process on a product, let alone launch it in the Japanese market, the eagerness of Japanese physicians sometimes surprises us. They have been known to jump the gun to say, ‘We need this now! How can we order it and how much does it cost?’ DuVivier has a knack for understanding what our Japanese surgeons want, which is perhaps one of the reasons why our physician-to-physician model is so compelling for Japanese physicians,” said Ford.
To round out the Global Executive MBA team at Nipponica, DeSena is in charge of Nipponica’s product pricing, regulatory compliance, and contract negotiations.
“Risks analysis and scenario planning is painstakingly undertaken to safeguard our patients and Nipponica. Dr. DeSena is in charge of this area,” said Ford.
The work of this team has opened a new market to bring innovative U.S. products to Japanese physicians while decreasing the time-to-market from years to as little as six weeks.
Paying Homage to Duke’s Global Executive MBA Program
In addition to the team being co-located in Japan and the U.S. and their extensive experience working with leaders in healthcare, Nipponica’s greatest success comes from their shared experiences in the Global Executive MBA program. As students, they learned how to work as a team in different time zones, navigate through cultural differences, and break through language barriers while doing business globally.
Ford concluded, “Had it not been for our shared experience in Duke’s Global Executive MBA program, we would have never connected the dots in this particular way and conceived of a venture with such great potential. Each of us brings a specific area of expertise to the venture; we have formed a team that is attempting to capture a slice of Japan’s multi-billion dollar medical device market.”
Read more about Nipponica MD in the Financial Times.