Cover Story | by Debra L. Beck

Innovation sizzles. It conjures an image of things modern, high tech, cutting edge, creative, shiny, and exceedingly useful. It suggests an advance beyond natural progression and, as health care continues to be roiled by massive change, it’s being demanded at every level: in hospitals, clinics, careers, and leadership; from bench science to clinical trials to day-to-day practice. In science, it used to be publish or perish; today, the expectation may be more accurately described as innovate or die.

“It’s not so much thinking outside of the box as it is redefining what that box is,” as Jeff DeGraff, PhD, puts it. He is the dean of innovation at the University of Michigan and runs the Certified Professional Innovator (CPI) program that is certified by the University’s College of Engineering. He refers to three defining characteristics that differentiate innovation from all other forms of value:

• Innovation possesses a time-based nature; it happens in the future for which we have no data now. (Often an uncomfortable zone for people who rely on data for most decisions.)
• Innovation involves positive deviance, replacing what we expect to see—continuity between today and tomorrow—with discontinuity that drives to a future that works.
• Innovation happens horizontally, cutting across all the boundaries and disciplines of business practice.

In a recent three-part posting for Psychology Today, DeGraff looked at “Innovating Innovation Strategy.” He wrote, “How do you make plans in a world where plans were meant to be changed? Innovators are adaptors. They’re flexible leaders who run multiple experiments at once and make adjustments along the way. Rather than create something completely new, they build onto things that already exist.”

To be clear: innovation can no longer be considered a luxury or even an option; rather, it is a demand of every aspect of medicine, patient care, and research. (It’s every field, really; it’s Innovation Nation or else.) As the population ages and the incidence of metabolic disorders rises, and as payers, patients, and governments demand more effective and less expensive care, innovation presents the way forward. While the need is obvious, the process requires crystallization, finessing, and education.

According to Merriam-Webster, we define innovation as “a new idea, device, or method” or “the act or process of introducing new ideas, devices, or methods.” Fairly straightforward, yet it begs the question of how innovation differs from other scientific pursuits, say, plain old research, and why is it important to better quantify and understand innovation in our work and in our science?

Innovators Are Made, Not Born

While certain habits and personality traits prove helpful, as a discipline, innovation can be broken down into discreet steps and taught. (See Building a Better Innovator.) This was the goal of the Academy of Innovation Day that directly preceded the December 2015 Innovation in Cardiovascular Interventions (ICI) annual conference in Tel Aviv, Israel. An international conference for innovations in cardiovascular systems, ICI focuses on the heart, brain, and peripheral vessels as well as the high-tech life science industry and emerging mobile health solutions.

Introducing the Academy program, ICI Co-Director, Chaim Lotan, MD, FACC, called innovation a subspecialty. “You cannot be an innovator if you don’t understand the entire process,” he said. To this end, the Academy of Innovation Day offered lectures by top industry leaders on different parts of the innovation process and sought to facilitate networking among participants.

Dr. Lotan is the Director of the Heart Institute at Hadassah-Hebrew University Medical Center in Jerusalem, Israel, and the Chief Medical Officer of InspireMD, a developer of advanced technologies for vascular intervention. He noted that many administrators ask themselves “how can it be that we have such fantastic brains in the hospital” but nothing innovative or transformative ever emerges? The answer: “Because you don’t have the intermingling of physicians, engineer, business people, et cetera.” Dr. Lotan added. “Only if you can create the right milieu, will it be successful.” In other words, silos are great for storing things, but no farm ever succeeded because of its great silos.

The Academy of Innovation Day was run by William K. Durfee, PhD, and Paul A. Iaizzo, PhD, both from the Medical Devices Center at the University of Minnesota, MN. Said Dr. Durfree: “All innovators have this vision of having a new idea and they simply have to go to Tim Laske from Medtronic [VP of Research and Development—AF Solutions] and walk up to him and say, ‘Hey, I’ve got this great idea!’ and Tim is going to whip out the Medtronic checkbook and give you $100 million. That’s not exactly the way it happens...” The use of Medtronic as an example is understandable given that 99 of the top 100 Medtronic products originated with MDs.

Innovation: Savior or Disruptor?

If you have been playing a drinking game every time the word innovation came up in this story, you better have given your keys to a designated driver by now. But this story mirrors what you hear every day because innovation may be one of the most overused words in modern parlance. For example, Kellogg CEO John Bryant was taken to task in a 2013 Wall Street Journal article for referring to a new Pop-Tart® flavor (peanut butter!) as “an innovation.” Perhaps the term “product extension” has become boring. But innovation is seen as a way forward for U.S. health care. Correction: the way forward. No one practicing medicine in the last couple of years has missed the fact that the world is changing and there is no going back. Innovate or die, indeed.

In a clever sidestep of this overused term, the folks at Singularity University (SU) instead exalt “Exponential Medicine.” Not an “expo” you just walk into: Exponential Medicine is an “application required” conference bringing together world-class clinicians, basic science researchers, academics, inventors, and medtech and biopharma executives to “break across traditional silos, cross-fertilize, understand, and leverage rapidly developing technologies to reinvent and improve many elements of healthcare and biomedicine.”

The 4-day event is a project of SU, the brainchild of Peter Diamandis, MD (Chairman and CEO of the X Prize Foundation), and Ray Kurzweil (Director of Engineering at Google [now Alphabet] and a noted futurist) and includes an impressive who’s who faculty of MDs, PhD, CEOs, CTOs, investors, and academics. Since its inception in 2008, SU has empowered individuals from more than 85 countries to apply technologies to address humanity’s grand challenges in the areas of education, energy, environment, food, health, poverty, security, space, and water. More than 100 startups have come from their alumni, partners, and members.

The goal of Exponential Medicine is to introduce a group of “highly curated” attendees to game-changing technologies likely coming to market in the next 2 to 10 years; all discussed in the context of the current explosion of digital information, big data, and connected and distributed healthcare. The 2015 meeting took place in early November in San Diego, CA, with about 700 participants.

Several cardiologists have spoken at recent conferences, including innovation rock stars Peter Fitzgerald, MD, PhD, FACC, Director of the Center for Cardiovascular Technology, Stanford University, and Eric J. Topol, MD, FACC, Director, Scripps Translational Science Institute and Chief Academic Officer, Scripps Health. In 2012, Dr. Topol authored The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care, considered a must-read book by many interested in health care innovation. In his new book, The Patient Will See You Now, he describes medicine’s “Gutenberg moment”: just as the printing press liberated knowledge from the control of an elite class; now, digital health technology is poised to do the same for medicine, “democratizing” it in ways that were unimaginable until now. Specifically, smartphones will perform blood tests, medical scans, and even do parts of the physical examination.

Need to rethink research? Thinking big requires that you imagine massive, open, online medicine, where diagnostics are done by comparisons of medical profiles (yes, computer-generated diagnoses and recommendations), enabling real-time, real-world research on massive populations. Dr. Topol makes it clear that the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result—techno optimist that he is—will be better, cheaper, and more humane health care.

For example, at the 2013 Exponential Medicine meeting, Dr. Topol introduced attendees to the idea of continual blood surveillance using an injectable nanosensor that can detect a genomic signal from a cell type that starts circulating in the blood during the early minutes of a myocardial infarction. That signal can then be relayed to a smartphone and the patient will receive a “Heart Attack Ringtone.” (While such a ‘call’ from your heart might be a touch stress-inducing itself, maybe it can convince people that what they’re feeling is not last night’s pepperoni pizza back for an encore, encouraging them to dial 911.) Similar technologies could be used to monitor autoantibodies to the Islet cells in the pancreas in children with high genomic risk for developing type 1 diabetes or plasma-detected cancer markers, said Dr. Topol. As he puts it: There are about 400 sensors in the average car today; why shouldn’t we have any in our bodies?

Another example: On Jan. 18, 2015, in the journal Nature, investigators reported on the development of tiny brain implants that do a crucial monitoring job after brain injury or surgery, then just disappear. According to John A. Rogers, PhD, a professor of materials science and engineering at the University of Illinois at Urbana-Champaign, “This is a new class of electronic biomedical implants [that] have potential across a range of clinical practices, where therapeutic or monitoring devices are implanted or ingested, perform a sophisticated function, and then resorb harmlessly into the body after their function is no longer necessary.”¹

How do we get from ideas to innovations like this? Daniel Kraft, MD, Faculty Chair for Medicine at Singularity University and Founding Executive Director of the conference. “Particularly in the health care space [...] technology is just the enabler. It’s really an integration of people, technologies, ideas, synergies, workshops, demos, where we can see not only what’s on the cutting edge today but where things will be in the very near future.”

Not content to just present exponential technologies, the conference also addressed how to introduce and scale new technologies properly so they are accepted and efficacious. “Without fertile ground, exponential technologies will die on the vine,” wrote Forbes contributor Dave Chase, a speaker, entrepreneur, and investor who is considered a top influencer in shaping digital health today.

“Historically it has taken 17 years for medical research to flow into regular medical practice,” said Chase. Allowing some of the exponential technologies out there—which he terms health care “bunker busters”—to get bogged down unduly (assuming the science has been proven) would be bad. “Consequently, there is a shared interest among innovators to find the settings where emergent technologies can be given a fair and thorough review.”

Why “bunker busters?” Well, because current industries, let’s call them the “incumbents,” have built a $3 trillion fortress “to protect their turf,” said Chase, suggesting that this “under-performing healthcare bunker” is ripe for busting.

Minting Clinician Innovators

Academic medicine with its traditional tripartite mission of clinical care, biomedical research, and education has and will always generate much of the basic research that provides the foundation for healthcare innovation. However, not all academic medical centers are good trainers or supporters of the new breed of physicians who have been dubbed ‘clinician innovators.’

These newcomers still seek the usual board certifications and want to treat patients and maybe have an academic appointment. The difference lies in their background: some of these doctors-in-training have pre-medical school experience presenting to investors, filing patents, prototyping, or even doing an IPO or two. This innovation generation has a ‘virtual’ advantage, too, in that they come from a “digitally intuitive” generation, unlike their teachers. They arrive on the scene at a propitious time, as tight budgets and the Affordable Care Act of 2010 have compelled academic medical institutions to make their care delivery more efficient and cost effective, an area where high-tech innovations may be just what the doctor’s boss ordered.

In a Dec. 2015 “presidentially commissioned” Special Report in the Journal of the American Heart Association, Maulik Majmudar, MD, and colleagues (including the current CEO of the AHA, Nancy Brown, BS) discussed how to foster innovation in academia and the new designation of “clinician innovator.”² Dr. Majmudar is the Associate Director of the Healthcare Transformation Lab at Massachusetts General Hospital.

Dr. Majmudar and colleagues noted that training programs need to invest time and resources to this effort and offer didactic lectures, including lectures by innovators with a proven track record, covering a non-traditional range of topics “as diverse as healthcare economics, health information technology, health policy, quality and outcomes, lean startup methodology, human-centered design, big data, medical writing, intellectual property, innovation and entrepreneurship, as well as leadership and management.” As if that wasn’t enough, these programs also need “collaborative mentorship, action learning electives, and assignment of individual projects that are to be complete and presented by the completion of professional training.”

So where are such programs to be found? The Stanford BioDesign program is a leader in this effort, now in its 15th year of training fellows and with dozens of successful startups to its credit. More recently, the Healthcare Transformation Lab at Massachusetts General Hospital launched Co.Create, a program that seeks to “accelerate the translation of early-stage ideas into scalable and sustainable healthcare ventures.” Dr. Majmudar, the first author on the JAHA report, is the Associate Director of the Healthcare Transformation Lab. The spark of innovation can be found igniting in various other settings around the country—and world—as well.

While acknowledging the need for academia to support innovation, Howard C. Dittrich, MD, FACC, who wrote an editorial on the JAHA Special Report, contends that not every academic center is suitable for a would-be clinician innovator and that, even for those few institutions that are right for the role, “to believe that the ecosystem can be created and flourish solely within an academic center is folly,” he wrote. “Where would one find the innovators, entrepreneurs, risk-taking investors, etc.? (See TABLE.)

“The academic center must reside within a greater environment of innovation, not only contributing to it but also helping draw new people to the geography who may create technology outside but nearby the academic center,” said Dr. Dittrich, a self-professed “unrepentant supporter of the free market who proudly discloses his position as Chief Medical officer of Laguna Pharmaceuticals.”

There are numerous ways to succeed and, sad to say, probably even a larger number of ways to innovate right into the ground. “Besides an environment rich in the specialization needed to support innovation—legal experts, investors, entrepreneurs, technology experts, and industry members, to name a few—academic centers can undermine their innovators by imposing traditional metrics of advancement, denying promotion and tenure to individuals not performing according to the usual patterns,” wrote Dr. Dittrich.

Rather than adapt all or even most academic medical centers to the demands of innovation, he concluded, “There should be a cohort of academic centers nationally that pursue the clinician innovator track as described by [Majmudar et al.] but these centers should really only pursue this when they reside in a community where innovation is already in full bloom or on the verge of it.”

Even if You Build It, They Might Not Come

The Cardiovascular Round Table, founded in 2001, is a strategic forum for high level dialogue between industry (pharmaceuticals, devices, and equipment) and the leadership of the European Society of Cardiology to identify and discuss key strategic issues for the future of cardiovascular health in Europe. They published an article the European Heart Journal recently discussing barriers to cardiovascular device innovation, including fears from industry of decreased utilization of devices due to diminishing or unclear reimbursement (the lack of a specific code) and delayed market access.³

To support their arguments, the authors showed how transcatheter aortic valve replacement (TAVR) usage varies markedly, with a 14:1 ratio of TAVR procedures performed in Germany compared with Ireland and Portugal. “It would be foolish to state that the entire shortfall in TAVR penetration is a function of the reimbursement process, although they are strongly correlated,” wrote Pinto et al.

How might this impact innovation? Well, taking percutaneous mitral valve repair, for example, the impact might be important. Although it is noninferior to surgical repair, the MitraClip implant received a CE Mark in 2008 and has been recommended by ESC guidelines since 2012, the procedure still doesn’t have reimbursement approval in many European countries. A similar argument can be made for fractional flow reserve, which also has ongoing reimbursement issues in the EU.

The Cardiovascular Round Table “believes that a major element of the innovation process is under threat from declining investment.” There is anecdotal evidence, they said, that companies are already cutting R&D budgets in response to time-to-market delays and low adoption rates of proven technologies. They suggest an urgent call for “high-level consultation” to address this issue between representatives of the EU, national regulatory authorities, medical professional societies such as the ESC, and industry trade associations.

So will the cold, hard reality of budget cuts and utilization strategies box in future innovation? Only time will tell—but time is on the side of innovation, which is already, as Dr. DeGraff said earlier, redesigning that box.

References

1. Kang SK, Murphy RK, Hwang SW, et al. Nature. 2016 Jan 18. [Epub ahead of print]
2. Majmudar MD, Harrington RA, Brown NJ, Graham G, McConnell MV. J Am Heart Assoc. 2015;doi:4(10):e001990.
3. Pinto F, Fraser AG, Kautzner J, et al. Eur Heart J. 2016;37:140-44.

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Building a Better Innovator

Innovators can (and should) be trained to improve their understanding and skillset when it comes to innovation. There may not yet be a Cliff’s Notes or Innovations for Dummies available to speed the process, but according to William K. Durfee, PhD, and Paul A. Iaizzo, PhD, who ran the Academy of Innovation Day, the innovation process can be broken down into five steps.

1. Understand the Opportunity

First is the need to understand the opportunity. “Become knowledgeable about the disease state, the procedures currently used, the health care providers who participate, and the problems and opportunities for improvement,” they wrote in their booklet given out during the Academy day.

Physicians are in a great position to drive innovation because they really understand the disease state and the unmet need, said Uday N. Kumar, MD, in an interview with CSWN, but that doesn’t necessarily mean they have all the tools necessary for success. A lecturer in bioengineering at Stanford University, Dr. Kumar is the Founder, President and CEO of Element Science, Inc., which is developing a cost-effective wearable therapeutic device that mitigates sudden cardiac death risk. He is also the Founder of iRhythm Technologies, Inc., a medical device company focused on developing cost-effective new devices and systems for cardiac rhythm monitoring.

“There is probably a lot of things we could solve with behavior change, other things which have nothing to do with technology, but we often assume that since you have a hammer, we should use it,” said Dr. Kumar.

In a similar vein, Chaim Lotan, MD, FACC, noted that technology folks are sometimes not the best to determine the opportunity and need. “I have a lot of engineers coming to me, almost on a weekly basis, and they say, ‘Listen, I have this fantastic device, fantastic idea, do you have a disease that I can cure?’ And I try to tell them that first you come with a need and tell me the solution. You don’t come with the solution and then fish for a need.” Dr. Lotan not only co-directed the recent Innovation in Cardiovascular Interventions conference, he is the Director of the Heart Institute at Hadassah-Hebrew University Medical Center in Jerusalem, Israel, and the Chief Medical Officer of InspireMD, so he has vast experience with understanding that opportunity means not just taking the five steps, but doing so in the right order.

Understanding the opportunity, said Dr. Durfee, also includes knowing the potential market and your competition. However, and somewhat nonintuitively, an innovator does not necessarily need to keep their idea a big secret. Sometimes your innovation is not a thing, but an idea on how something can be done better and more effectively. If it is a thing rather than a process or approach, then Dr. Durfee said it’s fine to mention to a company that you have an idea you’re working on and ask if you can keep them informed. “This idea of forming collaborative networks as you take your innovation through the process is exceptionally important.”

2. Define the Need

“You have to understand that you have a problem and you have to define exactly what the problem 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, FACC, 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, FACC, (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,” 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.”

3. 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 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 importantly 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.

4. Design an Entry (Startup) and Exit Plan

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 more important, and safer, to do smaller, iterative clinicals, because your failures will become apparent much quicker. And you’ll be in a position with the resources left to be able to pivot, redesign, restructure, reorient, and move on to success.”

She drew an example of someone trying to make a left hand turn, but instead opting for three right turns, which offers the same end result. A simple Google search yielded evidence that right-hand loops lower vehicle idling time, reduce fuel consumption, and increase driver safety. “So who knew that going around in circles got you right to where you want to be.” (Case in point, UPS drivers are instructed to avoid left-hand turns.)

5. Regulators: Check in Early and Often

So, you have your great idea, it works, you are running clinical trials, obtaining funding, filing for a patent… and then there’s getting approval, or more likely multiple approvals in multiple regulatory environments.

“It’s complicated,” said Susan Alpert, MD, PhD. She should know: Dr. Alpert is the former Senior Vice President and Chief Regulatory Officer at Medtronic. Before that, she held a number of positions with the FDA including 6 years as the Director of the FDA’s Office of Device Evaluation. She is currently the principal of SFA Consulting LLC, a one-person firm focused on the strategies needed to place medical devices into the global market.

In her extensive comments on the process of obtaining regulatory approval for new devices, products, and more, Dr. Alpert’s one overriding message was the importance of defining a regulatory strategy early in the innovation process. This will inform testing, choosing a market, getting acquired by a larger company, defining your time frame, and determining costs.

“Medical devices are regulated differently than our pharmaceutical and biotech cousins,” said Dr. Alpert. “In biotech and in pharmaceuticals there’s basically one pathway and everybody’s on that same pathway unless you’re a generic: the product is discovered, it’s developed, it goes through clinical, it goes to market, and it has one regulatory pathway in each jurisdiction.”

Devices, on the other hand, are regulated according to the actual risk of the product and knowledge about controlling that risk. That said, “every jurisdiction in the world—and there are more than 50 of them—that regulate healthcare technology—each one of them has their own mindset about protecting their population,” so a would-be innovator has to understand how each jurisdiction will view the risk of their product.

“Most important… don’t wait… your regulatory strategy needs to be done early on,” Dr. Alpert stressed. “You have to be objective about the risks, and objective about the benefits. Craft your plans carefully because that’s what determines your risks and you’ll all be fine.”

Keywords: CardioSource WorldNews, Academic Medical Centers, Academies and Institutes, Agriculture, Biological Science Disciplines, Brain, Cardiovascular System, Crystallization, Goals, Government, Israel, Neuroaxonal Dystrophies, Patient Care, Personality, Telemedicine, Organizational Innovation

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