Later that year, Laënnec was examining a woman with “general symptoms of a diseased heart.” He was unfortunately unable to glean anything further via application of his hand to the chest or using percussion. He was hesitant to attempt diagnosis with immediate auscultation—placing the ear directly on the patient’s chest—because of the patient’s age, sex, and corpulence. With humiliation rising and all options exhausted, Laënnec suddenly remembered the amusing game he had observed earlier that year.
“I recalled a well-known acoustic phenomenon: if you place your ear against one end of a wood beam, the scratch of a pin at the other end is distinctly audible,” he recounted in the preface of his 1819 treatise De l'Auscultation Médiate. “It occurred to me that this physical property might serve a useful purpose in the case I was dealing with. I then tightly rolled a sheet of paper, one end of which I placed over the precordium (chest) and my ear to the other. I was surprised and elated to be able to hear the beating of her heart with far greater clearness than I ever had with direct application of my ear. I immediately saw that this might become an indispensable method for studying, not only the beating of the heart, but all movements able of producing sound in the chest cavity.”
Heartened by the thrill of discovery, Laënnec spent the following three years testing materials to make tubes and polish his design, listening to pneumonia patients’ chests. His first complete “mediate auscultation” device was a portable 3.5 x 25 cm hollow wooden tube fitted with a plug that could be disassembled as needed. Using his invention, Laënnec examined the sounds of the heart and lungs. Observations made in autopsies supported his diagnoses.
His invention is now one of the most widely recognized medicinal symbols, worn around the necks of multitudes of doctors—the stethoscope.
Physicians are perhaps the best equipped to recognize unmet medical needs because they actually perform the procedures that bring up specific challenges requiring a solution that isn’t yet in their toolbox. Rather than assessing the market and conducting interdisciplinary and exhaustive research to find the answer, the unmet need manifests in a tool that would aid in an operation or otherwise benefit their work in a meaningful way.
But inventing on the spot as Laënnec did isn’t feasible with the environment surrounding modern surgery; surgeons could face serious legal recourse should an untested, experimental device harm a patient. If surgeons find themselves lamenting the unavailability of a particular tool, they must tread the winding, mildly treacherous path of medical device commercialization. The transition from practicing clinician to inventor and/or entrepreneur is a weighty endeavor, but the two surgeons in this article have done the seemingly impossible and each scheduled a time slot to invent a groundbreaking technology.
Virtual Reality Surgical Training
Modern surgical technology is astounding. To avoid the risks of an invasive procedure, laparoscopic instruments for surgical procedures can enter the body through tiny incisions in the skin. Heart valves can be placed via a catheter in the femoral artery rather than opening the chest. Surgical robots can automate or assist in certain surgeries. Technology’s push to simplify life surely simplifies saving lives, right?
The catch is, newer procedures rely heavily on technology and can be technically complex to perform. New technologies necessitate clinicians to continuously evolve their knowledge and expertise. And innovative devices will only benefit patients if surgeons have been properly trained to use them. But the issue is:
“The current model for surgical training developed by William Halsted around the turn of the 20th century hasn't evolved much beyond the apprenticeship model,” explained Justin Barad, M.D., a practicing pediatric orthopedic surgeon. “What has changed is the increasing number and complexity of the procedures we as surgeons are expected to learn, while the time we have to learn them is becoming scarcer. This phenomenon is called the training gap. This is especially an issue when we are learning newer surgical techniques that often involve complex medical technologies. The longer learning curves involved limit the adoption of newer technology.”
In addition to staunching innovation, this augments the risk of harming the patient. After all, how is it determined that the learning curve has been met? Physicians are responsible for the training and expertise to know a procedure is safe, and setting standards this way is troublingly subjective.
“It was during my own surgical training that I realized we in the medical profession were rapidly approaching a situation where surgeons graduate from programs undertrained,” Dr. Barad said. “The focus of training was shifting outside of residency to independent clinical practice.”
More extensive training would appear to be the immediate solution, but the resources to accomplish that are scarce.
“Typically, to learn new procedures, surgeons will attend a one day ‘course,’ with a few hours to practice on a cadaver,” he said. “Then, there is typically a four- to six-month gap before performing the procedure on a patient. The data shows these early cases go very poorly for both patient and physician, with revision rates sometimes 300 percent higher than proficient surgeons, and it takes 50-100 patients before surgeons will reach proficiency.”
Surgeons definitely rank among the lowest on the scale of professionals who should be “learning on the job.” One day of true practice followed by a minimum four-month gap before operating on a patient is like studying for a final exam once—during the first class. The marked absence of a repeatable training method prior to surgery on live patients inspired Dr. Barad to devise a solution.
“As I saw the effect the training gap was having on my colleagues and patients, virtual reality (VR) was having a bit of a renaissance,” he recounted. “Thanks to a background in game development and design, I was involved in VR at a very early stage. I saw great potential when I put on the headset for the first time, but the ‘a-ha’ moment came when I hacked together the headset with an obscure and discontinued controller that allowed realistic interaction with the virtual world. I immediately saw realistically ‘hands-on’ VR as an incredible solution to a growing and critical patient safety issue.”
Dr. Barad made his VR surgical training concept a reality by launching Osso VR in 2016. The platform provides surgeons of all levels the ability to practice with the latest medical devices in an immersive, hands-on, VR simulator—solving the issue of training outside the OR without risking patient safety. Since its unveiling, Osso VR has been validated with a randomized blinded study at UCLA (where Dr. Barad received his M.D.) that found users trained with the platform exhibited almost double the surgical performance of traditionally trained surgeons.
One has to wonder how a practicing orthopedic surgeon finds time to start and run a business; Dr. Barad both co-founded and is the CEO of Osso VR. That’s not to mention the wildly different—even contradictory—atmospheres of the OR and the boardroom he must contend with.
“Being a surgeon innovator is extremely challenging and has been a bit of a journey. In the world of surgery, you can either take care of patients or do research,” Dr. Barad expressed. “There is no real structured role for a surgeon entrepreneur, and the pursuit of innovation is not often met with encouragement. Combined with the time constraints of clinical care and service and the already inherent challenges of entrepreneurship, it is certainly an uphill battle to make this type of career work, especially if you want to remain clinically active while innovating.”
As with any business venture, success is all about the relationships established. Though Osso VR’s inception was his, Dr. Barad credited his achievements to effective partnerships, tempered by a healthy dose of humility.
“The right mentors, growing your network (especially outside of medicine), and remaining humble were key components to some of my early success. The last point I can’t iterate enough—you may be a highly-trained clinician, but you start from scratch and must become a student once again in the world of startups. Be respectful and open to the various amazing people you will interact with outside of the medicine bubble.”
“Putting your team together, especially early on, is critical," he continued. “It can be tempting to just start working with whoever is willing to work with you, but I’ve seen this create major issues down the line. I’m so lucky to have the best co-founder and an incredible team that truly feels like family. It takes a lot of patience and time to find the right people, but it is almost always worthwhile and will lead to better execution.”
Dr. Barad also stressed a point that medical device manufacturers understand well—having an idea is only the starting line in solving an unmet clinical need. Additionally, there will inevitably be those along the way who decry a possible solution as, well, impossible.
“If people are seeing the same problems as you, it is likely they are thinking of similar solutions. We like to romanticize the idea stage of invention, but it is truly the execution and timing that makes all the difference—it is likely that several others are working on the exact same thing. The one exception is if someone says your idea is absolutely terrible; I was told several times that VR surgical training would never work. This is often an idea worth exploring because the human brain’s initial reaction is to dismiss it, so it is unlikely many people are pursuing it at that particular moment.”
He advised those wishing to follow in his footsteps to be willing to settle in for the long haul in bringing an idea to life. Medicine and entrepreneurship are among two of the most time-consuming, mentally fatiguing professions to take on. Anyone wishing to combine the two has to be unflinchingly dedicated and committed to every aspect of their work.
“When selecting the opportunity you would like to pursue, be patient and choose carefully,” he recommended. “Even what seems like the simplest endeavor can eat up five to seven years of your life. It’s a wild ride, and a lot of fun, but you want to ensure at the end of the day that this opportunity has the kind of impact you seek to make and will challenge you with the types of problems you enjoy.”
Rigidity and Compression
However, starting a company isn’t the only avenue surgeons can take in commercializing an invention. It certainly represents the opportunity for the largest financial windfall, but for most clinicians, founding and running a business is out of the question because of the immense amount of time involved. Partnering with a medical device company to assist in development and commercialization is another option for surgeons looking to advance their product. That way, the surgeon will still have an active role in product design without the accompanying headaches running a business might bring.
That’s just what Keith L. Wapner, M.D., chief of Foot and Ankle Orthopaedic Surgery and clinical professor of Orthopaedic Surgery at Penn Medicine did to advance his invention, the CP plate and screw system. But first, a little background about his brainchild:
“The idea came about while I was explaining the mechanics of bone fixation to my twin sons who were accompanying me on a surgical mission to Vietnam,” Dr. Wapner recalled. “One son is a lawyer, the other a senior policy analyst at Pew, and neither of them have orthopedic backgrounds. I was explaining the principals of compression with screws as opposed to rigidity with plates and they asked, ‘Why not combine the two?’ It occurred to us no one had really tried to create a plate with a countersink for a compression screw, but I had used similar concepts in furniture building. We then set about to draw up prototypes.”
His technology was designed as a complementary modular system for internal fixation, reconstruction, and treatment of fractures in the foot and ankle for adult and adolescent patients. Indications include replantation, joint fusions, corrective osteotomies, and osteopenic bone. The plating system itself is comprised of four pre-contoured, anatomic locking titanium plates featuring a Cross Plate (CP) hole allowing partially threaded CP screws to compress across the fusion site—removing the need for separate, independent stabilization. The plating system also touts cannulated instrumentation and can be used with both locking and non-locking screws. The latest version of the CP plating system is CE marked as well.
“The CP plate addresses the issue of preventing fracture of the bone when adding compression with a screw, and combines the rigidity of plate fixation while allowing compression,” explained Dr. Wapner. “By allowing the compression screw to be countersunk into the plate, the plate then serves as a virtual washer to spread the load over the plate to prevent bone fracture at maximum torque. Once that maximum compression is applied, the remaining screw can be placed in the plate to assure rigidity of the construct.”
Instead of forming his own company, Dr. Wapner partnered with a large orthopedic OEM to assist in developing and marketing his invention. This eliminated some of the risks of an entrepreneurial venture—he didn’t have to invest as significant amount of money or time in his idea as he would have by forming and running a startup. But there were still challenges to contend with in aligning with an industry partner. There is usually some degree of politics at play when interacting with a large business. There are myriad directions to take in commercializing a product, and learning them all can be daunting. Even once learned, choosing the “best” path then requires careful consideration of possible ramifications in development as well as finances.
“I did not start a company, but rather had to find a company to partner with,” Dr. Wapner recounted. “I had to learn how to negotiate the politics of the instrumentation companies and the ever-changing landscape of individuals working for those companies. I also had to learn the different pathways that could be taken to get a product to market and the advantages and disadvantages of each from a development, royalty, and tax standpoint.”
Though he didn’t establish a business to progress his invention, Dr. Wapner’s experience as a surgeon was nonetheless conducive to the CP plating system’s design and development process. Surgeons are more likely to incorporate aspects of a device into the blueprint that a product designer with more of an engineering background might not have immediately considered. For example, a surgeon would be far more concerned about the accompanying instrumentation’s ergonomic needs.
“My experience definitely helps in design,” Dr. Wapner declared. “As surgeons, we have the best understanding of the clinical needs and the issues surrounding appropriate instrumentation to allow ease of application as well as maximizing the design for the specific surgical indication.”
Lessons for Future Innovators
For practicing clinicians with an idea, the path to medical device commercialization can seem more intimidating than even the most extensive surgical procedures. As a physician, requisite medical knowledge is a given, but an entrepreneurial endeavor challenges even the most seasoned medical professionals to broaden their knowledge in ways they may never have expected.
For example, clinicians are very aware of the legal landscape surrounding the medical profession, but will likely need some support in order to fully grasp the complex nature of the intellectual property and patent laws governing their invention. Further, clinicians seeking to enter the commercial medical device space by partnering with a company would benefit from picking the brains of others who have tangled with medical device firms.
“Start with a good lawyer familiar with the healthcare and instrumentation landscape,” advised Dr. Wapner. “Talk to other surgeon designers about the relationships they have with the companies they work with and how surgeon friendly they are. Decide how you want to handle patent ownership.”
For surgeon innovators seeking to start their own business, Dr. Barad’s main suggestion is to be absolutely sure there’s ample bandwidth for the ambitious undertaking. Starting a business is a full-time job to tack onto the already daunting load of a medical professional; halfhearted attempts simply will not do.
“Leverage your strengths, stick with what you know, but think outside of the box,” he encouraged. “Put together a multi-disciplinary team that can solve problems in new and scalable ways. If you are looking to get serious about this, make sure you are at a point in your life/career where you can go all in. No one is going to do the work for you, so be prepared to take the plunge.
Finally, Dr. Barad reminded others with similar ambitions that there are plenty of avenues to success, and offered a helping hand for their expedition ahead.
“While it was very challenging for me during my entrepreneurial journey as a surgeon, there are far more resources available today for those interested,” he concluded. “One of my life goals is to help others that are on a similar path, so I encourage aspiring surgeon innovators to please reach out to see if there is any way I can assist in enabling them to bring technology into the world that will help patients and providers.”