CardioSource WorldNews - Page 32

is,” explained Dr. Lotan to audience members. “A good example is Henry Ford who said: “If I had asked my costumers what they wanted, they would have told me a faster horse.” If you don’t define the need, you’ll go looking and just find better horses. But, Dr. Lotan said, if you better define the need as requiring something else entirely, “then maybe you will find a better solution.” To further teach this process, Todd J. Brinton, MD, gave Academy attendees a detailed talk on needs assessment. Dr. Brinton has been the Fellowship Director for the Stanford Program in Biodesign since 2006. He arrived at Stanford in 2000, planning to pursue a track designed for residents interested in a career as a physician-scientist and happened upon the new Biodesign program under the leadership of Paul Yock, MD (Biodesign’s Director and the inventor of the over-the-wire Rapid Exchange angioplasty and stenting system, which is the primary approach used worldwide). The program’s multidisciplinary approach and focus on medical technology innovation appealed to Brinton; he joined as a fellow in 2004, after completing his medicine and cardiology clinical training, and later as faculty in 2006. He is also an interventional cardiologist. Many people assume that the greatest innovators—and Dr. Brinton noted here the accomplishments of Tom Fogarty, MD (founder of more than 45 medical device companies), and John Simpson, MD, PhD (who invented and commercialized the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty), are just untouchably brilliant individuals. “Which in fact they are,” said Dr. Brinton. “But I’ve had the opportunity to work with both of them and I’d say the thing that they do that is unique is they have a process. This isn’t just a one-off idea in the shower; they in fact have a process where they work through and develop their ideas, and understand the fundamental value that it brings to the patient.” This process involves looking with both broader and more narrow lenses at the issue, generating multiple needs, winnowing down those needs based on possible clinical impact, stakeholders, other treatment options, and market characteristics, and finally, after filtering your multiple ideas through multiple filters, defining in one sentence your “needs statement,” said Dr. Brinton. He stressed not ignoring the market assessment. It may seem “capitalistic and harsh,” but not understanding this is often a stumbling block for physicians who “just want to help their patients.” The simple fact, said Dr. Brinton: “You will not have an impact if you can’t build something, borrow some money, and develop a technology that will ultimately return value to them and to patients.” Another common problem for physicians who turn to innovation is failure. “As a physician you’re expected to be perfect and your career will be defined by, hopefully, how few mistake you make,” 30 CardioSource WorldNews said Dr. Brinton. “But the thing about innovation is that your career will be defined by, hopefully, the few successes you have because failing is an everyday occurrence in innovation. You have to be prepared to fail and don’t be afraid to fail.” Heck, don’t even think of it as failure: Thomas Edison’s point of view was, “I have not failed. I have just found 10,000 ways that won’t work.” Superseding needs can also derail great innovation. So, if an innovator is working for 10 years on a way to prevent stroke in patients with atrial fibrillation and by the time the technology is ready to come to market someone has figured out how to cure atrial fibrillation, well then, “you’re out of business,” said Dr. Brinton. “So keep in mind that if someone’s a little bit lower on the limb of the tree and they’re working a little closer to the fundamental problem than you are, that’s a superseding need. Doesn’t mean you don’t have a novel technology, but be aware where others are climbing.” And finally, Dr. Brinton said: “Don’t lie to yourself. Don’t do the things that go past it to the next processing level without asking the difficult questions. Is this the right project to be working on? Only then can you assess the long-term viability of the project.” a new solution that is much easier, much cheaper, lower technology, less invasive.” But don’t ignore intellectual property. “Nobody ever remembers who was second,” said Dr. Lotan, who related a personal experience to participants where he was beat to the patent by another innovator and ultimately lost any chance of marketing his innovation. Prototyping is another part of the invention stage that can throw clinicians. Julio Palmaz, MD, famously prototyped his coronary stent with a metal lathe that a workman had left in his garage, but most clinicians aren’t quite so industrious. Nevertheless, prototypes impor tantly help reduce risk and increase the probability of success, according to Dr. Durfee. They are also crucial for selling your idea to investors. For example, 3D printers have revolutionized this field and there are several organizations that can help produce a physical or virtual prototype of your innovation. Virtual prototyping is a way to “reduce, but not eliminate” the need for expensive and time-consuming animal experiments, noted Dr. Durfee, and it is an approach that has been embraced by the FDA and device industry. “Part of their mission is to promote and advance computational modeling and simulation as a means for providing safety and efficacy data for the regulatory approval process,” he said. ➍ Design an Entry (Startup) and Exit Plan “Don’t lie to yourself. Don’t do things that go past it to the next processing level without asking the difficult questions.” -Todd J. Brinton, MD ➌ Go Invent! Once an opportunity has been identified and a “needs statement” created, it’s time to create the solution. This is where all parties have something to contribute: the technology folks, the clinicians, and those money people who keep their eye on the ball. “You have to have fresh eyes on the problem,” said Dr. Lotan. “If you come with fresh eyes and new technology, you can definitely come up with To help inform the startup process, the Academy of Innovation Day brought in Kathleen A. Marshall, the Founder and President of MAXIS, a clinical market development provider that helps medical device companies with clinical research, market development, and early commercialization needs. Ms. Marshall focused her comments on five key concerns that need to be answered by any startup: when and how to invest in clinical proof; how to negotiate regulatory obligations; when and where to commercialize; how to get financing; and how to increase value? In other words, “How do I get the value of my startup on an ever increasing level, which comes back to investing in clinical proof,” said Ms. Marshall. According to Ms. Marshall, some of the mistakes common to inexperienced innovators is getting stuck with their technology (“plan to iterate”) or indication (“it’s going to narrow and change”); trying to commercialize too early (“CE does not stand for commercialize early!”); and not managing relationships with investigators properly: “These individuals are on a journey with you to quantify a clinical and scientific value… and will advocate for you about the value of your invention.” In the startup process, she said, as in the needs assessment process, it remains important to embrace failure. “The sooner you fail, the faster you’ll succeed, and that is as true in the clinical world as it is in the R&D development world,” said Ms. Marshall. “People often want to do one big clinical, but it is much February 2016