Roger Kuan is a Partner at Haynes and Boone and chair of the Precision Medicine and Digital Health Practice Group, where he counsels companies that are uniquely positioned in the convergence of the life/medical sciences and technology industries on how to successfully navigate the complexities of the intellectual property (IP), data rights and regulatory challenges they encounter.Roger has extensive experience in IP strategy and portfolio management (utility/design patents, trademarks, copyrights, and trade dress), data rights strategy, licensing and technology transactions, freedom-to-operate clearances, enforcement, monetization, IP due diligence, and dispute resolution. His practice is focused in the life sciences sector (e.g., research tools, analytical instrumentation/software, digital therapeutics, medical devices, diagnostics, biomanufacturing equipment, etc.) with an emphasis in emerging technologies such as Precision Medicine (e.g., genomic sequencing platforms, AI/ML, computational genomics/bioinformatics, molecular diagnostics, companion diagnostics, etc.), Digital Health (e.g., mobile apps, clinical decision support, software, digital therapeutics, AI/ML Imaging Diagnostics, wearables, etc.) and 3D printing/bioprinting. Prior to joining Haynes and Boone, Roger served as Director, IP Counsel at a multinational biotechnology company, where he managed a team to support the worldwide IP needs of the company’s life sciences tools, bioproduction/biomanufacturing, molecular diagnostics, and nucleic acid sequencing system/software platforms. Prior to finishing his law degree, he worked in the life sciences industry for several Fortune 500 pharmaceutical, medical device, and chemical companies. He has held professional positions in the R&D, sales, engineering, and regulatory affairs organizations.
Jenny: When was your first encounter with 3D printing like?
Roger: It was a plastic statue that a friend of mine designed and printed on a 3D printer at the university lab she worked in. She took me to her lab the next week and showed me how easy it was to print. I was amazed by how easy it was to create the statue out of a simple computer image.
Jenny: What inspired you to start your legal practice focusing on healthcare 3D Printing and bioprinting?
Roger: I’ve worked in and around the life sciences industry my entire career. What kept me around was my love of science and the promise of high tech to help deliver medicine to patients in a more tailored and personalized manner. So I decided early on in my practice to focus in on the personalized medicine and digital health technology spaces.
I see 3D printing as one of the many technologies that can allow for the more precise delivery of medicine to patients. I was fortunate enough to take in a few early clients engaged in applying leading edge 3D printing techniques to manufacture orthopedic implants and bioscaffolds to replace resected tissue. Now I work with 3D printing companies across the entire 3D printing workflow, from generation of imaging files used by 3D printers to new 3D printing techniques and applications.
Jenny: If you can go back 5 or 10 years, what would you have done differently?
Roger: I think I would have transitioned into law a bit earlier in my professional career than I did. Not that my early professional experience wasn’t helpful to my later career as a lawyer, but I really enjoy what I do and it would have been great if I had started down this path earlier.
Jenny: What drives you the most for your day-to-day work?
Roger: I think the pursuit of providing real value to my clients drives much of what I do day to day. Although I think that the ability to draft good quality patents that are compliant with the state of the law is a foundational skill set for any good patent attorney; I think it is equally important for a good patent attorney to have an understanding of how these patents are strategically utilized to further the interests of the client. I strive to provide both to my clients.
Jenny: The legal landscape is still unclear for emerging technologies like 3D printing and bioprinting, what do you think the biggest challenges are when it comes to IP/Patent?
Roger: I think that as 3D printing manufacturing technologies (as opposed to pure design and modeling) become more widely commercialized, you will start seeing more patent disputes arise involving 3D printing-related patents. How those disputes are resolved and how a patent holder is able to ascertain that a 3rd party is infringing its patents (particularly if they are method patents that cover the printing technique itself as opposed to a device or material) in the first place will be particularly instructive in the years to come.
Jenny: What are some of your accomplishments in 2019? And what are your immediate goals for 2020?
Roger: 2019 was a pivotal year for my patent practice. My practice doubled in size in 2019 and what I plan to focus on more in 2020 is to just provide good quality service and advice to the clients that I have now.
Jenny: How are you dealing with COVID19 situation at work?
Roger: My firm instituted a work from home policy in early March. I haven’t been in the office since the first week of March. Instead, I’ve been working from my home office, which has worked fine so far. But I do miss having interactions with my colleagues at work.
Jenny: Software, materials, or 3D printers. It has been an ongoing debate in the industry forever as to who is the most important player. Who do you think is the MVP in healthcare 3D printing?
Roger: I think companies that work with materials and 3D printing techniques will be the most important players in the 3D printing industry. Materials advances are particularly important for 3D bioprinting as the materials not only have to have structural properties, but also biological properties. Those two requirements often are not compatible, so significant advances are needed there in order to realize the end goal of fully functional 3D printed organs.
Moreover, new 3D printing techniques that can fully utilize these advanced materials and provide a degree of printing fidelity and accuracy necessary to recreate the complex vasculature details in a functional organ will be needed.
Jenny: What is the biggest obstacle in your daily work? If you have conquered them, what were your solutions?
Roger: I work with companies throughout the precision medicine and digital health technology space. Just keeping up with all the new developments and trends in the space can be daunting as innovators in those spaces are moving at lightning speed. I pride myself in being able to understand the fundamental aspects of all my client’s technologies, so I spend a lot of time studying and reading about them.
Moving forward, I think I will need to build out a larger practitioner team who can hopefully take some of those responsibilities off me and, instead, just draw on my knowledge and expertise as necessary.
Jenny: What do you think are the biggest challenges in 3D Printing? What do you think the potential solutions are?
Roger: At present, there is no clear FDA regulatory approval pathways for customized (“on-demand) 3D printed organs and medical devices. This takes away one of the critical advantages of 3D printing and needs to be addressed in order for there to be wide-spread adoption of 3D printing by clinicians to provide precision solutions for patients
Clear regulatory approval pathways for customized 3D printing devices and organs will need to be developed by the FDA. There have been a number of working groups that have been formed by the FDA to look into how this can be done, but to date, established regulatory approval pathways have been elusive.
Jenny: What advice would you give to a startup in healthcare 3D Printing and bioprinting space today?
Roger: First and foremost, make sure your technology or the solutions it enables actually works, is reproducible and has an addressable market. At the end of the day, that’s really the most important things for your company to demonstrate to investors.
After that, it’s critical that you develop protectable intellectual property around the technology, whether it’s through filing your own patent applications or acquiring rights to 3rd party patents. Investors need to know that you have robust barriers to market entry in place.
Jenny: What was the biggest risk you took in your career?
Roger: Moving out from being in-house counsel for 8 years at Thermo Fisher Scientific back into private practice. It is an atypical move as most in-house counsels never return to private practice.
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Roger: I enjoy spending time of with kids on my free time and studying military history is one of my favorite past times.
Jenny: What is your favorite quote? Why?
Roger: “I have not failed. I’ve just found 10,000 ways that won’t work”
I like this quote because it rings so true in all aspects of business and life.
Jenny: What does the word “3DHEALS” mean to you? =)
Roger: 3DHeals is an organization that brings together thought leaders in the 3D printing and bioprinting space. It’s unique in its global reach and in providing a forum for innovators in these spaces to learn about emerging trends and to connect and collaborate. Organizations like 3DHeals create ecosystems that are necessary for emerging technologies to develop into mature ones.