October 5, 2023
When Dong Li, the Director of Clinical Affairs (CA) for Beckman Coulter China, left the United States and moved to Shanghai with his family, he was on a mission to build a top-notch clinical function to help Beckman Coulter China gain a competitive edge in the country’s In Vitro Diagnostics (IVD) industry. With an increasing focus on collecting clinical evidence for both product registration and market access, Clinical Affairs has become the “gatekeeper” before vital diagnostic products go to market. The approval processes can be lengthy and complex, but Dong knows that the most effective change is incremental, and Danaher Business System (DBS) tools have been serving him well. Below, read about Dong’s leadership—which has now expanded to CA for several Danaher operating companies in China—how his team at Beckman improved the complex clinical study process with DBS tools, and his take on the future of CA in China, a market with massive global potential.
I’m on a mission to build the clinical muscles for our business in China, so to speak. In the past five years, China has ramped up its regulations around IVD clinical research. The National Medical Products Administration (NMPA)—which is the equivalent of the FDA in the United States—wants to ensure the quality of all the medical products that come through China, which means very stringent inspections for companies running clinical studies here. My role is to build a strong, reliable, Clinical Affairs function that not only improves the clinical study execution—meaning delivering high-quality clinical projects on time and within budget—but also creates a competitive edge for our business through innovation.
Beckman has been working on a variety of products to make diagnostic testing more effective for critical issues like sepsis, tumors, and cardiac diseases. In 2020, we had several products successfully licensed in China, including assays for cardiac and infectious diseases. And we’ve engaged some of the top hospitals in China to run more innovative clinical research on diagnostic products to help doctors deal with healthcare challenges more efficiently and effectively.
In China, we talk about three elements of success: the geographical advantage, the favorable climate, and the people. Essentially, that’s being in the right place at the right time with the right people. When I joined Beckman Coulter China in 2019, the timing and place were just right to start pushing high-quality clinical research in China. That left the right people, and once I met my future colleagues, I knew Danaher offered that, too.
I actually learned about Danaher back in business school. I’d always been intrigued by how DBS empowered a wide variety of businesses, and I wondered about its secrets. So I think that was the last piece of the puzzle that brought me back to China after 20 years living and working in the U.S. and Europe.
One of the main metrics we use is on-time delivery (OTD) for our clinical trial cycle time; that’s a good surrogate for our products’ time-to-market. When I started, the number was in the single digits. Part of my mission was to improve the execution—to speed up the OTD while maintaining quality and keeping an eye on the budget. We used DBS and kaizens—weeklong sessions where we work though specific problems—to make a series of incremental changes to improve this metric. We also worked closely with our vendors and our clinical research laboratories, and now our OTD is at 100%.
We also used a kaizen to create a formalized process for integrating the China requirements into the early stages of product design. The requirements in China are different from the U.S. or Europe, so this kind of review will have a huge impact in terms of getting our products to the Chinese market. Instead of having to backtrack later, we’re building in the China requirements from the beginning, which makes developing the clinical study protocol more effective.
When it comes to innovation, people often refer to technologies and products, but innovation can also happen elsewhere. In the clinical research field, this is especially true for process innovation. We’re currently trying to reduce our clinical evaluation timeline by 50% without impacting the project budget and quality.
Of course, advancing technology is also critical to helping us achieve our innovation goals. For example, digitization in IVD clinical research in China is relatively behind, but we’re catching up. This year, we’ve started several digitization efforts across our team, including an electronic data-capturing system in our clinical trials and a new clinical trial management system to help us digitize our paper-based documents. Our statisticians and data scientists are also investigating opportunities in Artificial Intelligence (AI) algorithms with our clinical data.
The word that comes to my mind is bamboo because it has attributes that a great team carries—it’s flexible, resilient, and grows quickly. The regulatory environment for IVD clinical research in China is extremely dynamic; in terms of requirements, cost, and timelines, it’s very different than even five years ago. And because this trend will probably continue in the next decade, a flexible and adaptive mindset is the key to staying competitive in this market.
In terms of resilience, IVD clinical research in China can be very complex and nerve-wracking. Our team needs a strong support system—with DBS as our foundation—so we can deliver under pressure.
And we also need to grow quickly, just like bamboo does—and just like our industry. We have a narrow window of opportunity to develop and grow a leading-edge clinical research function to catch up to the drastic growth of China’s IVD industry, so it’s especially exciting that in 2020 our Clinical Affairs team doubled in size.
I don’t have a crystal ball, but I’m certain of the demand for clinical-based research in China’s IVD industry. So we’re looking at all kinds of ways to innovate to meet that demand, from global multi-center trials and real-world evidence studies to overseas clinical data and the digitization efforts I mentioned.
How do we prepare and get ready for what comes next? One thing we’ve been advocating for in the Clinical Affairs team is the concept of a “learning institute.” Essentially, we’d like to create a learning environment similar to an MBA program within our team, where team members with diverse industry and educational backgrounds can share knowledge and ideas, with a good mix of hands-on work and classroom training.
I’m also sure that a diverse talent pool will empower our learning institute; the more diverse our team, the greater it becomes as a source of innovation, where creative thoughts can clash and spark. I really believe that diversity and inclusion should be our core competency—the solution to current and future challenges. I hope that a diverse Clinical Affairs function will not only bring a competitive advantage to the Beckman China business but also create value for each of our associates in the future.