June 1, 2022
June traditionally is when the American College of Surgeons (ACS) celebrates a surgeon who has developed creative solutions to surgical challenges with the presentation of the Jacobson Innovation Award. Considering the chief characteristics of a leading-edge inventor—tenacity and imaginative problem-solving—it’s unsurprising that surgeons often are at the forefront of transformative patient care. For example, surgeon-led innovations related to laparoscopy and thoracoscopy have resulted in new devices and treatment modalities that have enhanced these procedures and improved patient outcomes over the past decade. More recently, advancements in robotic control and 3-D visualization have enabled surgeons in multiple specialties to perform minimally invasive surgery (MIS).
“Surgeons work with patients who often have individual variability in terms of how they present with their diseases. And in the operating room (OR), we’re dealing with anatomy that can be atypical,” said Ali Tavakkoli, MBBS, FACS, chief, division of general and gastrointestinal (GI) surgery, and co-director, Center for Weight Management and Wellness, Brigham and Women’s Hospital, and associate professor of surgery, Harvard Medical School, Boston, MA. “In the OR, you have to think quickly about how to deal with these variations and adjust your approach and plan. I think that’s why surgeons are in a great position to lead innovations and advancements in patient care.”
Although taking an idea from napkin to marketplace can be a daunting, time-consuming process, with the typical time to market averaging 3 to 7 years, the global medical device industry continues to grow.1 A total of 33,376 patents were granted to applicants between July 2021 and September 2021, marking a 2% increase over the previous quarter, according to the GlobalData Patents Database. Analysis of these data also revealed that general surgery “was the most active technology application” in this category, with 952 patent grants during this period.2 For medical devices that made it beyond the patent stage, the global medical device market in 2020 has been valued at $456.9 billion and is expected to reach $603.5 billion in 2023.3
Several factors are driving surgical innovation today, including the shift to value-based care, which emphasizes the provision of standards-based care, capacity and resource limitations that surfaced during the early stages of COVID-19, and an increase in complex conditions, including more patients presenting with multiple chronic conditions than a decade ago.4
This article provides insights into developing and refining an idea and identifies pathways for advancing a concept through the patent process, intellectual property rights, Food and Drug Administration (FDA) approval, and prototyping.
“My personal advice for people who want to be an innovator is that, although need identification and brainstorming have been very successful approaches, there are other ways of doing it. You can take an instrument or a device or a procedure that already exists and think about how it can be used in a different setting or in different circumstances,” said Dr. Tavakkoli.
He did exactly that when his company re-engineered Sucralfate, a drug used to treat peptic ulcers, to create LuCI (luminal coating of the intestine), which can be used to coat parts of the intestine and control sugar uptake. Simply stated, AltrixBio, a biotech company Dr. Tavakkoli cofounded in 2019, seeks to replicate the results of gastric bypass surgery for type 2 diabetes in a pill.
In 2018, Dr. Tavakkoli and colleagues published a study that showed a single dose of LuCI lowered glucose response in rodents.5 In the January 2022 issue of Metabolism, this team demonstrated longer-term benefits of the drug on weight and insulin sensitivity in diet-induced obesity in rats.5,6 According to the article, clinical trials are expected to begin within a year.
“Think like an engineer,” advised Marc Bessler, MD, FACS, professor of surgery at Columbia University, New York, NY. “Surgeons typically think, ‘Oh, this is how I’m going to solve this problem,’ and run with the solution. And there are definitely examples of when that sometimes will work and examples of when it doesn’t.” Engineers, on the other hand, are trained to identify a problem, evaluate all potential pathways for solving the issue, and then focus on the top solutions, he said.
In 2015, Dr. Bessler cofounded EndObetes, a medical device company that develops endoscopic devices to treat obesity and type 2 diabetes.7 The EndoBypass device mimics the anatomic and physiologic changes of surgical gastric bypass, which delivers undigested food directly to the intestine, leading to increased release of insulin and satiety hormones to create dramatic weight loss and remission of type 2 diabetes. Dr. Bessler and team met with the FDA, resulting in a call for additional studies for longer periods of time.
“We’ve done some animal testing. The next steps are really to get it ready for human implantation and early feasibility testing in humans,” Dr. Bessler said.
Novice innovators should consider collaborating with a colleague, particularly in another specialty, noted Brian J. Dunkin, MD, FACS, chief medical officer, Boston Scientific Endoscopy, MA.
In 2016, Dr. Dunkin began pondering a novel approach to the surgery residency program selection process. These programs can have significant performance issues and attrition rates in part due to poor job fit, according to Dr. Dunkin. At the time, as a professor of surgery at Houston Methodist Hospital, TX, and the MIS fellowship codirector, he was observing poor satisfaction rates among fellows in the MIS program. After discussing this conundrum with friend and colleague Aimee Gardner, PhD, an industrial organizational psychologist, they founded SurgWise, which provides science-based assessments to surgical training programs to better inform candidate selection.8
“We actually used my own fellowship to pilot the concept. That’s why we formed the company,” Dr. Dunkin said. “We needed a commercial entity that the hospital could contract with in order to get us the research funds to start this up.” Dr. Dunkin said the SurgWise assessments created a much more efficient and effective process. “The faculty in our fellowship were spending a lot less time selecting the fellows, and we were doing a much more thorough job of identifying their competencies,” he said, adding that the process increases candidate diversity and on-the-job satisfaction and performance.
As for medical device development, Dr. Dunkin also played a consulting role for a former research fellow, Albert Huang, MD, who founded Allotrope Medical. This company produces StimSite, a device that provides obstetric-gynecologic, general, and colorectal surgeons with the ability to use existing surgical instruments to locate and identify ureters using electrical stimulation.9 Ureter identification is a critical step in safely advancing operations such as hysterectomies and colon resections. StimSite received FDA clearance in November 2020.9
Once an idea or concept has been refined and necessary collaborators have been identified, surgeon inventors should consider filing a patent to protect their intellectual property. According to the US Patent and Trademark Office, a patent holder has the “right to exclude others from making, using, offering for sale, or selling” the invention in the US for 20 years.10 Two types of patents are relevant to surgeon innovators:
“Patent protection is important. I think people intuitively know that, but it can be a confusing landscape,” Dr. Dunkin said. “Patents help protect an idea from others using it, and it’s important to do that because it gives you the ability to get some benefit financially.”
Utility patents typically are related to a medical device that is new and useful. “A design patent is really more about just that—design. And, so, it’s all about the ‘ornamental features,’” Dr. Dunkin said. “Let’s say you came up with some new device. You will have a utility patent that covers the hardware design, and then you could have a design patent that covers the interface with it—how it stylistically looks and feels.”
“It’s great to have a patent—that is a powerful thing—but keep in mind it doesn’t necessarily give you the right to make and bring that product to the marketplace,” Dr. Dunkin added. “To truly understand your freedom to operate in a particular space and ensure you are not infringing on anyone else’s patent is something a patent lawyer will help you determine.”
Today, many surgeons work for large hospital systems or universities, many of which have the right to claim ownership of their employees’ innovations.
“I work for Columbia University, for example, and they claim ownership of anything I do regarding an invention within the spectrum of medicine,” said Dr. Bressler. “I have to file an invention report with the university, and they have a finite period of time to say whether they’re going to take it forward and patent it or not and return it to me,” he said, noting that many healthcare systems have exceptions to this rule, for example if the employee is consulting with an outside company.
“I think working with your institutions early and keeping them informed as you make progress is important,” said Dr. Tavakkoli. “If you have a great idea, the key is to not do a public disclosure, such as presenting at a meeting, before some sort of intellectual property has been filed.”
“I think making sure you have a lawyer or an institutional representative who understands where you’re going with your idea is critical,” added Dr. Tavakkoli. “And I would say, although intellectual property ownership is really important, keep in mind that a lot of ideas never progress because people are too worried about protecting their concept. You want to be careful. You want to protect your ideas, but you also want to make sure this idea is communicated with others so that it can advance and progress.”
“If you are employed by a large entity, it’s likely that it has at least a claim to your ideas—and that’s not necessarily a bad thing,” said Dr. Dunkin. “I think people get worried that their idea is going to get taken away. But many institutions, particularly academic institutions, have technology transfer offices that can be quite sophisticated and can really accelerate protecting your idea and then bring it to life. The technology transfer office can be your friend, and it’s important to work with it, not only because it’s your obligation, but because it can help you.”
When Dr. Dunkin’s research fellow at Houston Methodist Hospital, Dr. Huang, came up with the idea that eventually became the StimSite device, their employer initially owned the idea. Working with the hospital’s technology transfer office, which helped patent the concept, Dr. Huang was able to license back the concept from the hospital, affording him the freedom to offer it as a commercial product.
The bottom line for novice surgeon inventors: If you are a hospital system or university employee, be sure to review your contract to determine your legal rights and obligations regarding intellectual property.
The FDA regulates medical devices in the US through the Center for Devices and Radiological Health (CDRH). CDRH’s mission is to “assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.” The center provides “consumers, patients, their caregivers, and providers with understandable and accessible, science-based information about the products [it] oversees.”11
The three medical devices classifications, according to the CDRH, are class I, II, or III. Class I medical devices generally are deemed low risk, and class III medical devices are seen as the highest risk.12 The FDA CDRH also uses two pathways to ensure device safety before marketing: 510(k) clearance and premarket approval (PMA). 510(k) clearance evaluates moderate-risk devices and relies on nonclinical and biomechanical and descriptive data, whereas PMA evaluates high-risk medical devices and requires clinical trials.12
“The 510(k) pathway says that I can show the FDA that this device is safe and effective because it’s substantially equivalent to another device that’s already on the market. For this pathway, I don’t need new clinical trials. I just need to show that this device is similar to a predicate device that’s already being used on patients. Then the FDA can use that evidence to determine that it’s safe and effective,” Dr. Dunkin said.
“The PMA pathway is used for device ideas that are very innovative,” explained Dr. Dunkin. “The FDA wants to see clinical trial data to support your claim that this device is safe and effective. It involves a lot of investment and work because you’ve got to run clinical trials in a responsible way in order to get the data that convinces the FDA that it should determine that this device is safe and effective.”
“Advancing a device or a drug through the FDA process is complicated and challenging,” added Dr. Tavakkoli. “But at the same time, there are companies that can assist you in doing this. And if your innovation is at a phase that requires that level of attention, I think connecting with experts in the field is important.”
Prototyping allows inventors to transform an idea or concept into something tangible. A prototype enhances the ability for partners and stakeholders to provide specific feedback, minimizing potential errors and other unanticipated issues. For medical devices, a couple of options are available for prototyping, including three-dimensional printing (sometimes called additive manufacturing) that uses “millions of coordinates to deposit small amounts of material in specific areas based on a computer-aided design (CAD).”13 Inventors can purchase software to build CAD files or they can contract with a prototyping company that provides access to this technology.
“I think prototyping was actually one of the biggest hurdles that we faced as our innovation team worked through the various ideas we had developed, and I believe it is an important step where many good ideas fail due to lack of funding, resources, or know-how,” said Dr. Tavakkoli. “However, I think that to create an early prototype that allows you to provide a proof of concept can be done relatively cheaply if people are imaginative and have access to some basic equipment.”
Proof of concept prototypes do not need to be constructed from end-use materials, according to Dr. Tavakkoli, which can be expensive. For a basic physical representation of the device, the model can be developed using materials such as plastic resin that are more affordable.
The costs associated with advanced prototyping—not to mention all the approval-related steps necessary to ensure successful product development—can be overwhelming. For developing more advanced prototypes, Dr. Tavakkoli suggests working with experts in the field. “I think to go from a basic prototype that can validate a concept to something more refined that can be presented to a potential investor can be challenging and often requires access to engineering expertise and certain machinery that is not readily available.”
“Sometimes you have the right idea and a solution to the problem, and you patent it, and you prototype it,” added Dr. Bessler. However, few companies these days are buying devices from a patent or a prototype. They want proof that it “has legs, that it gets traction, that it sells.” Dr. Bessler said one option is to partner with a company that can take ownership of the product and move it forward. In fact, finding a partner is often the best move for an inventor at this phase of development because of cost alone. Medical device development and rollout for FDA class I or II devices can average $31 million or higher, whereas class III devices, which are subject to the more restrictive PMA process, can average $94 million or higher to bring the product to market.14
What topic areas are likely to be the focus of the next generation of surgeon innovators as they work to transform the delivery of healthcare?
“Robotics obviously is already here—but intelligent robots that are able to actually do some of the steps of surgery are coming down the pike,” said Dr. Bessler. “Actually, I think any device or procedure that reduces patients’ pain, recovery time, and cost in a big way will be a driving force in surgical innovation.”
“I think in terms of surgical robots, we’re going to see just an explosion, and we’re at the very beginning of that,” added Dr. Dunkin. “Clinically, there’s an explosion now in the use of robotics, especially in the general surgery space. And I think you’re going to see that field continue to grow in all specialties in surgery. And endoluminal surgery—surgery within the gastrointestinal tract instead of causing incisions and scars—that’s really the next generation of minimally invasive surgery, and a lot of headway is being made there.”
“I’ve always been interested in the idea of image augmentation and enhanced visualization,” Dr. Tavakkoli said. “We do laparoscopic surgery by looking at a screen. There are probably opportunities for us to enhance or augment those images by using either computed tomography or other forms of enhancement.”
“Artificial intelligence is everywhere and it’s going to drive everything from decision-making at the point of care in the OR all the way to quality measures,” added Dr. Dunkin.
Surgeons are uniquely positioned to identify clinical needs and engage in innovative problem solving, no matter the specialty or topic area. Becoming a successful innovator and entrepreneur is a challenging undertaking. Taking the necessary steps to protect your idea and to strategically select collaborators to help advance it through the development and approval process will help turn your idea into a reality.
Attending a medical technology conference is a practical way for novice surgeon inventors to interact with like-minded colleagues, learn best practices, and stimulate idea development. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) will host its third Innovation Weekend, June 9–11, to provide a forum for industry and healthcare providers to exchange ideas about surgical technology and surgical practice. And in April, the American Gastroenterological Association (AGA) hosted its 12th AGA Tech Summit, offering opportunities for clinicians, medical technology companies, and others to identify opportunities for licensing, get updates on the latest innovations, and more. The ACS also supports the development of innovative technology with the annual Surgeons and Engineers: A Dialogue on Surgical Simulation, which returns to a full-day meeting March 1, 2023.