THE GLOBALIZATION OF MEDICAL DEVICES AND THE ROLE OF U.S. ACADEMIC MEDICAL CENTERS

BY KATE Y. JIANG AND HEITHAM T. HASSOUN

The global medical device market has been growing by over 4 percent per year (CAGR) since 2015 and reached $457 billion in sales in 2019. The market is estimated to decline in 2020 due to the negative impact of COVID-19 pandemic on manufacture and supply chain. The United States remains the largest contributor and consumer, currently accounting for 44 percent of medical research funding and 40 percent of total sales globally.

However, is it sustainable in the market landscape today and tomorrow? As emerging economies start to enter the medical device market, we believe that globalization is the pathway to success in the future.

The emerging economies are bringing both opportunities and competition into the medical device market. The growing and aging population, as well as increasing prevalence of chronic diseases have been the main drivers for healthcare expenditures in the emerging markets. The medical device markets in China and India are projected to be over $200 billion (ranking #2) and $40 billion (ranking #5) respectively in 2030.

Other emerging markets should consistently be evaluated as they continue to grow over the coming decade. On the other hand, medical device companies in these emerging markets have long been overlooked. In 2015, 12 of the top 20 medtech companies based on sales are from the United States, followed by Germany, Switzerland, the Netherlands, France, Japan, and the UK. None of the major players are from the emerging countries.

The imbalance between the purchasing power and innovation power is pending for change in the future dynamic environment. Diverting our attention from the medtech giants, the majority of the players in the market are small and medium-sized enterprises (SMEs) and startups. There are a growing number of medtech SMEs from the emerging countries in Asia, the Middle East, and Europe. They are sometimes well-funded and targeting at specific niche markets, where they can develop competitive advantages over the global leaders as they are closer to the users and more familiar with the local health system.

The days of simply manufacturing a device and selling it to healthcare providers via distributors have long vanished. Well-planned global collaborations can bring the companies closer to their global customers, end users, and patients

The days of simply manufacturing a device and selling it to healthcare providers via distributors have long vanished. Well-planned global collaborations can bring the companies closer to their global customers, end users, and patients, creating value and inspiring innovations. Global collaborations can be introduced to different phases in the life cycle of a medical device, from clinical development, regulatory approval, manufacturing, distribution, all the way to marketing. Academic Medical Centers (AMCs) in the United States, as the hub for translational medicine, have the resources and talent to play an important role in enabling these types of collaborations.

One example is a collaboration between Cedars-Sinai Medical Center in Los Angeles and Seoul National University Hospital (SNUH) in South Korea who aim to showcase the outstanding value of globalization in medical device research and development. Faculty from Cedars-Sinai Medical Center and their colleagues from SNUH are launching a new collaboration to advance the treatment of gastrointestinal cancers, which disproportionately affect Korean patients.

The partnership between Cedars-Sinai, Seoul National University Hospital, and healthcare technology company InTheSmart will allow investigators to explore how new augmented reality imaging systems might be used in gastrointestinal surgeries. It also calls for an educational exchange program to allow physicians and trainees from both hospitals to benefit from one another's experience during implementation and adoption of this technology.

Global collaborations aren’t limited to knowledge transfer and education, but are instrumental across the entire innovation life cycle. EndoStim, founded in 2009 in St. Louis, is a medtech start-up that developed a proprietary implantable medical device to provide long-term solution for acid reflux. The idea of globalization was deeply rooted in its DNA and bringing in values to all phases in the product life cycle. The company was inspired by two immigrant doctors from Cuba and India, funded by St. Louis venture capitalists, and managed by a CEO from South Africa.

In addition, the device was built by engineers from Israel and manufactured in Uruguay, and the clinical trials were carried out in Argentina, Chile, Colombia, Brazil, Hong Kong, India, Denmark, Germany, the Netherlands, and Switzerland. The start-up was able to reinvent the modern assembly line integrating resources and talents from all over the world, in a lean, hybrid, and dynamic way.

A Vision for the Future

The medical device market is experiencing a changing landscape as players from emerging economics join the competition, and this will only be accelerated with the global pandemic. It is time for players in the United States and elsewhere to build upon existing advantages and lead in this field, incorporating and integrating resources from other countries.

Global collaboration, however, is not an easy, short-term solution. Innovators need to deal with complexity, bureaucracy in the distributive network, and stringent regulatory practices, and learn from mistakes. U.S. AMCs, as a reservoir for knowledge, talent, and resources, are well poised to serve as the conduit for these types of global collaborations.

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Kate Y. Jiang is the international team lead for China at Cedars-Sinai.

Heitham T. Hassoun is a Pacific Council member and Vice President and Medical Director, International, at Cedars-Sinai.

The views and opinions expressed here are those of the authors and do not necessarily reflect the official policy or position of the Pacific Council.