Op-Ed: Tinker, Tailor, Surgeon, Sailor

Op-Ed: Tinker, Tailor, Surgeon, Sailor

How physician inventors push medicine forward

Physician inventors throughout the ages have been the engine of innovation in medicine, developing some of the most important medical innovations, such as penicillin, catheters, artificial heart valves, pacemakers, and the HPV vaccine, to name a few.

Unfortunately, transitioning from physician to inventor isn’t as easy as it was a few decades ago for several reasons. Collectively, these reasons have driven down the proportion of physicians engaged in scientific research and invention to a dismal 1.5% of the physician workforce.

But innovation — the art of creating something new — is essential for the profession’s sustainability and growth. So how do we engage more physicians in the innovation process?

Embrace high-stakes breakthroughs

In my own practice, I have found that necessity is the mother of invention. In fact, a moment of necessity in my operating room sparked an innovation that is now useful to many of my colleagues here in the United States and around the world.

A professional baseball pitcher, during the delivery of a pitch in 2010, tore his right latissimus dorsi tendon completely off his upper arm bone. This is an uncommon injury for pitchers, but this was also an uncommon patient — a major league pitcher with an $18 million annual salary. In preparation for his surgery, which had been poorly described in the scientific literature and not routinely taught during advanced orthopedic training, I went to the cadaver lab and practiced for this high-stakes case. I had a solid plan to repair the damage.

Things didn’t go according to plan, however. The anchors used to bridge the one-centimeter-thick bony part of the humerus broke, one after another. I went through three or four different anchor designs, each one breaking because they weren’t designed and developed or the ability to penetrate the thick, hard bone. They couldn’t simultaneously remain fixed on the arm while providing a secure attachment of the sutures used to repair the torn tendon.  I could have defaulted to a different technique, but it would have increased the risk of bone fracture or damage to the nerves and blood vessels that were close by.

Finally, I successfully bridged the gap by taking an older style of anchor, modifying the method for inserting and securing it, and then using an unconventional suture technique. The solution worked well, but I saw the need for a better way forward in similar surgeries. If I could develop a new method with a new implant, other surgeons would not need to go through the same stressful challenge. Nothing like what I wanted was available yet on the market — yet I knew it could be invented.

Discover, prove, refine

The day after surgery, I returned to the operating room and thought about the different possibilities using currently available tools and implants, as well as identifying the need to explore new possibilities. On a piece of paper, I drew out each step, working through the process to achieve secure tendon fixation. Working through each step, I designed a new kind of kit that met every challenge of this surgical procedure.The kits would enable the insertion of multiple metal buttons, threaded with almost unbreakable sutures that would continue to slide through the button after it was inserted into the bone and rotated to fix its position.

A few months later, the Food and Drug Administration (FDA) approved the kits, and they became available for surgeons to facilitate a reliable and powerful method to repair this type of tendon tear. The kit was marketed as the pectoralis major button kit (a more common repair requiring a similar approach and technique). More than 10 years later, it is still the best kit in the world for this purpose.

Assemble your team

Physician inventors often need to collaborate with professional engineers and product development specialists to bring their ideas to life. A stellar team can appreciate the current tools and implants. They also understand the process required to accomplish the next level of innovation that will help surgeons improve their ability to solve these complex problems.

In 2001, I had the opportunity to work with a medical device company to help develop new orthopedic techniques and implants. What started as one project addressing one specific challenge later blossomed into numerous projects focused on my chosen area of professional expertise — shoulder, elbow, and sports medicine conditions.

While some physicians have found success independently putting together an expert team and developing innovations, I’ve found that a collaborative working relationship with an established medical device company has been key. Whenever I have a problem to solve or a new idea to try, I have access to an engineering team, a machine shop, a cadaver lab, and a team of intellectual property and patent lawyers.

While others may be concerned that they would give away potential value by joining forces with a big company, I knew that I needed the team’s resources to support my vision and desire to innovate. Together, we’ve brought hundreds of products to market, including tools used during arthroscopic surgery, instrument trays that support surgeons during open and arthroscopic procedures, fixation devices, and even a comprehensive system of shoulder reconstruction to care for patients with arthritis and severe rotator cuff problems.

Also, no matter how great a new product appears to be to the innovator or original designer, there is no guarantee that it will be approved by the FDA, embraced by colleagues, or distributed by a company that has the ability to provide promotion, education, and sales support. For many physician inventors, sharing profit and risk with an experienced medical device company may make more sense than flying solo.

Prepare for the regulatory jungle

The regulatory process is extremely challenging, and many believe it stifles innovation. But the solution is not to do away with the regulatory landscape. Regulation helps to protect patients by limiting the risk of faulty devices from reaching the market. However, practically speaking, it narrows options for innovators down to two routes: a long, slow, expensive slog through the regulatory jungle or minor tweaks to an existing product.

The vast majority of new medical device innovations are actually slight adjustments to available devices. Those currently approved devices are used as a predicate proof that the new device is likely to be a safe and equally effective device — and therefore acceptable for FDA approval.

Starting a project from scratch, which is not based on currently available devices, requires a very expensive and intense process that can take years before achieving regulatory approval. If the product is groundbreaking in any way, it will require highly structured and expensive clinical research trials — a process that, in my own experience, can take five or more years. The costs are prohibitive for most individuals, and the risk is often too much for companies. On a positive note, the FDA is now allowing some data from outside the United States to establish existing safety and efficacy. This may enable some devices to get to market faster.

Despite all the regulatory challenges, innovation will inevitably break through. Physicians can — and should — be part of it. Yet, as I know, in the heat of battle, it’s easy to get frustrated.

Channel all of that energy into seeing how else you could possibly tackle the problem. Try it. Prove it can be done — and then refine it so other doctors can do it, too. Your patients will appreciate your efforts to improve their care, and inevitably, the world will be a better place for your contributions.

Anthony Romeo, M.D., is one of the nation’s leading shoulder, elbow, and sports medicine surgeons with 30 years of clinical experience. Having spent his career in the pursuit of excellence for his patients, Dr. Romeo has pioneered new approaches to shoulder replacement surgery and developed advanced orthopaedic implants and surgical procedures that are supported by cutting-edge research and patient-focused outcomes. Dr. Romeo is also the chief medical editor of Orthopaedics Today and the executive vice president of Duly Health and Care’s Musculoskeletal Institute.