In this day and age, an idea by itself has little or no importance. It is the implementation of the idea, its ease of use, accessibility, and acceptance by others that turn it into a successful innovation. The healthcare industry has not benefitted from innovative technology to the same extent as other industries; perhaps, due to the many challenges faced by healthcare innovators. These include patentability, clinical study requirements, regulatory approvals, reimbursement, market dynamics, hospital and physician adoption, data security, technical feasibility, and team relations.
Health technology innovation is a highly challenging, iterative and dynamic process.
In the words of Dr. Thomas Fogarty, who co-founded over 30 companies and was inducted into the National Inventors Hall of Fame in 2001, “The path to successful innovation is very often lonely and frustrating. Innovation, by its very definition, means something different than what exists. Basically, we are defying standards and, sometimes, basic concepts. Be prepared to be criticized, ostracized, called crazy, inappropriate, outlandish, stupid, intolerable, and bound to fail.”
Unfortunately, there is no guaranteed method to develop and launch a successful healthcare innovation. So where does one begin as an innovator? Are there any guidelines, lessons or tips to improve one’s chance of success?
In this context, I want to talk about the Biodesign Innovation Process1 developed at the Stanford University Byers Center for Biodesign. Created for aspiring innovators, this is a proven, repeatable process for the innovation of health technologies, including medical devices, diagnostics, drug delivery systems, imaging tools, and digital health solutions. One of the pitfalls of innovation in academia is trying to fit one’s technology and research into a problem.
The Stanford Biodesign process takes the opposite approach, asking the innovator to start by investing time and resources to identify and characterize an important problem (need area) first. Only after developing a deep understanding of the problem does the innovator start to think about inventing a technology to address it. The Biodesign process also focusses on creating value by taking cost into consideration from the very beginning, so that part of the decision about what need to solve is whether or not a solution would create economic benefit.
Even though the process is both field and technology agnostic, it has a strong link to cardiovascular medicine, since the program was initiated by Dr. Paul Yock, an interventional cardiologist, and serial entrepreneur. Dr. Yock is the founder and director of the Stanford Byers Center for Biodesign. Over the past 17 years, Stanford Biodesign has trained 160+ Innovation Fellows (scientists, physicians, engineers, and business people) and nearly 2,000 graduate and undergraduate students.
Starting with identifying important unmet healthcare needs and inventing around those, the process teaches the art of translating concepts into relevant products for both patient care and physician use in an ever-changing healthcare ecosystem.
Whether you are an active researcher, a budding entrepreneur or on the lookout for your next innovation, the Stanford Biodesign process can enhance your ability to be more successful at commercializing your ideas.
The “3Is” – Identify, Invent and Implement
The process has three distinct phases referred to as the “3Is” – Identify, Invent and Implement. Each phase is further subdivided into two sub-stages. In this article, we’ll focus primarily on the first phase, Identify, since getting the need right is the essential first step in successful inventing.
The Identify phase starts with the identification and exploration of a specific focus area. Choosing this strategic focus is an imperative decision that involves extensive research and observations in this specific area, with the goal of identifying gaps in the care paradigm, or problems with no existing solutions. In defining a strategic focus, it is crucial to rely on your skill set, assess key strengths and weaknesses, and begin thinking about how to complement your skills with those of different team members as the process progresses.
If I had an hour to solve a problem I’d spend 55 minutes thinking about the problem and 5 minutes thinking about solutions-Albert Einstein.
Following this painstaking effort, the innovator then develops need statements that frame the observed problems in an actionable way, as, – “a way to address a (problem) in a given (population) that generates a desired (outcome).” It is important to avoid need statements that are too general, too specific, stuck in current practice, and/or have an embedded solution. The next steps involve screening through multiple needs based on further research on the anatomy, pathophysiology, and mechanism of disease of interest. To get a better understanding of the clinical presentation and improved outcomes that are needed, it is advisable to collaborate with a clinician early on. After gaining a working knowledge of the disease state, existing and emerging solutions can be evaluated to get a sense of the competitive landscape and where gaps exist. Analysis of all stakeholders involved is critically important to determine who the decision maker will be in determining whether or not to adopt a new solution, and who is most likely to resist a change in established treatment paradigms.
Finally, the innovator performs an assessment of whether there’s a viable market for a new solution. All of this research enables the innovator to appropriately refine the need statement and develop an expanded need specification so that the most important take-aways can be used to directly guide concept generation during the Invent phase.
The second “I” – the Invent phase – includes ideation and an initial concept selection for potential solutions. A preliminary screening of generated concepts based on IP, business, regulatory, and reimbursement basics follows. A final concept is then selected leading to the third “I” – the Implement phase, which is focused on product development and business planning to bring the new technology into patient care.
The Case of Acclarent Inc.
A compelling example of the Stanford Biodesign process, and one that emphasizes the value of getting the need right is Acclarent Inc., a medical device company founded to develop technologies to improve care for ENT patients1. While observing surgery for patients with chronic sinusitis, the innovators saw that the procedure required the removal of a significant amount of healthy bone and tissue because it was in the surgeon’s way. For the patient, this resulted in significant post-operative pain and bleeding.
Recognizing the need for a less traumatic and invasive approach, the Acclarent team ultimately developed a disruptive technology; balloon sinuplasty. By 2010, the company acquired 20 patents and had 120 patent applications pending. Acclarent’s revenue in 2009 was $95 million, and it was acquired by Ethicon Inc., a Johnson and Johnson company in 2010 for $785 million, making this the biggest exit of that year and creating a buzz among fellow entrepreneurs.
How did Acclarent become a huge success? The answer may well be the Biodesign approach; the innovators identified an important unmet need, researched it deeply, and ultimately developed a solution that dramatically improved the patient experience. Understanding and utilizing the Biodesign process for innovation of medical technologies can be a good starting point. As an innovator, you should customize and adapt each step based on your personal goals, style, and emphasis. Hopefully, iteratively modifying and executing your version of the process will help you navigate this tumultuous journey of innovation with confidence.
The Process of Biodesign has been Detailed in the Following Book
Yock, Zenios, Makower, et al., Biodesign: The Process of Innovating Medical Technologies, Second Edition. Cambridge University Press.
Author
Chhavi Jain obtained her Ph.D. in experimental cancer therapeutics at the Swiss Federal Institute of Technology Lausanne, Switzerland. She is passionate about the translation of innovative cancer therapeutics and healthcare solutions from the laboratory to the clinic. Currently, at the Lerner Research Institute of Cleveland Clinic, Chhavi is managing translational and clinical R&D for the Cancer Immunoprevention and Immunotherapy Program. She previously worked in regulatory affairs & data management for first-in-human, clinical research studies in solid tumor oncology. Prior to moving to the United States, she worked in business development for a cancer healthcare start-up company in India (onco.com). She loves scientific communication and has written several articles on the latest developments in preclinical and clinical oncology (https://www.mdedge.com/authors/chhavi-jain).
Editors
Aparna Shah (aka @Neuro_Musings in the Twitterverse) is currently a Postdoctoral Fellow at Johns Hopkins University, Baltimore, MD. She is exploring the role of microRNAs (or gene-silencing ‘second messengers’) in regulating neuronal function. While she is fascinated by both order and disorder in the brain, she has spent the last decade obsessing over the neurobiological underpinnings of depression, Parkinson’s disease, and drug addiction. She is passionate about science communication, education and outreach and believes that the best way to learn something is to teach it!
Rituparna Chakrabarti is the Editor-in-Chief at CSW. She pursued her Ph.D. in Neuroscience from Georg-August University (Göttingen, Germany) and is currently a post-doctoral fellow at the Center for Biostructural Imaging of Neurodegeneration (BIN), Göttingen. For her, the interface of Science and art is THE PLACE to be! To unwind herself she plays mandolin and eagerly looks for a corner at a coffee house to slide herself in with a good read or company. Follow her on Twitter.
Image Sources: Cover image and inset image for cogwheel of innovation are from Pixabay, The inset image depicting the 3 distinct phases of the Biodesign Innovation Process, is used with permission from Stanford University Byers Center for Biodesign obtained by the author
Acknowledgment: The author is thankful to Dr. Paul Yock, Stacey McCutcheon and Lyn Denend from the Stanford Biodesign team for their valuable feedback on the article.
Blog design: Rituparna Chakrabarti and Chhavi Jain
The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs {A US Non-Profit 501(c)3}. (PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).
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