Technology innovation in plastic surgery: a practical guide for the surgeon innovator

Introduction

Innovation drives the advancement of medicine. Recent medical innovations, from evidence-based medicine and information technology to robotic and laparoscopic surgery, have revolutionized the practice of medicine. In the surgical arena, innovation has led to increasingly effective and less invasive therapies resulting in better patient care.

What separates invention from innovation? Invention is the formulation of new ideas for products or processes, while innovation creates the application of new inventions. In business, invention uses cash to create a product and innovation takes a product and creates cash. In medicine, invention is an attempt to create a solution to a clinical problem and innovation drives the solution to the bedside – analogous to the process by which translational research applies basic science to clinical problems.

Plastic surgeons, by trade, are innovators. We devise innovative solutions to difficult problems. Our competitive advantage lies in innovation. Unlike the neurosurgeon or cardiologist, we do not lay claim to any one part of the body. In the hospital we are called upon for our creative solutions to the neurosurgeon's need for calvarial reconstruction, the cardiac surgeon's need for chest wall reconstruction, and the orthopedic surgeon's need for hardware coverage. Our innovative spirit transcends beyond innovative surgical methods and encompasses innovation of novel technologies as well. Historically, microsurgery, distraction osteogenesis, tissue expansion, endoscopic plastic surgery, liposuction, and laser technology have all served as platforms for expanding the scope of our practice, as well as expanding the scope of what we can offer our patients.

The expansive breadth of plastic surgery exposes our field to multiple competing subspecialists. Dermatologists, otolaryngologists, ophthalmologists, obstetricians, and internists are increasingly involved in aesthetic surgery. Similarly, general surgeons are competing for abdominal wall reconstruction, breast reconstruction, and wound healing. Otolaryngologists compete for head and neck reconstruction. Orthopedic surgeons compete for hand cases. Each of these fields involves important new innovations, and subsequently opportunities for patient care, research, and revenue. Aesthetic surgery is riddled with novel technologies including skin resurfacing techniques, noninvasive body contouring, injectables, and laser therapy. The attractive revenue stream in this cash-based field is obvious and draws in more and more competition. Similarly, abdominal wall reconstruction has been revolutionized by the introduction of new biomaterials. Breast reconstruction is changing with the introduction of new breast implants, fat grafting, and dermal substitutes. The field of wound healing has dramatically changed with negative pressure wound therapy. Head and neck reconstruction has seen the introduction of bioabsorbable plates, screws, and alloplastic bone substitutes, while PyroCarbon arthroplasty and artificial nerve conduits continue to expand the offerings of hand surgery. Innovation is the sustainable competitive advantage for plastic surgeons in this competitive clinical reality.

Today, however, the arena of medical innovation is far more complex than it was 50 years ago. There is more scrutiny from the US Food and Drug Administration, an exponential growth in the number of patents filed, and more complexity in regulatory pathways for new medical products. In the setting of a healthcare and economic crisis, it is harder to justify increased development expenses with increased competition for limited investment funds. When the surgeon is asked to innovate, he/she also faces a plethora of challenges unique to the surgeon innovator including conflict of interest concerns and navigating within the confines of the intellectual property claims of universities. The challenges faced by today's surgeon innovator are captured well by Machiavelli's The Prince : “There's nothing more difficult to plan, nor more dubious of success, nor more dangerous to manage than the creation of a new order of things. Whenever his enemies have the ability to attack the innovator, they will do so with a passion of partisans while others defend him sluggishly so that the innovator and his party are likely to be vulnerable.” The enterprise of surgical innovation may receive little support and face many barriers, however it can create new technologies that may revolutionize a field and impact millions of patients. To overcome today's barriers to surgical innovation we must create and use a systematic approach to translate ideas based on a human problem into a product that can change clinical practice. This chapter sets out to discuss a systematic approach to surgical innovation and gives a few examples of new technologies in our field.

The idea

Mark Twain said, “The name of the greatest of all inventors is accident.” In 1957, Mason Sones accidently injected the right coronary artery with dye; he immediately recognized the problem and pulled the catheter out while the injection of dye continued. He later said, “That day I realized that I had discovered something very important.” He then went on to refine the technique that led to coronary angiography. On the other hand, Plato's frequently cited proverb “necessity is the mother of invention” hints that innovation certainly does not need to rely on an accidental discovery.

Today, there are calculated and systematic innovation paradigms that start with the identification of a clinical problem. The problem should be an unmet clinical need. The scientific knowledge in the arena and the limitations of the current solutions should then be explored. The clinical problem can be taken to the laboratory or into multidisciplinary think boxes where a solution is systematically developed, with the hope of translating it back to the operating room. Robert Frost thought that ideas are feats of association, “Having what is in front of you brings up something in your mind that you almost didn't know you knew.” This paradigm of discovery may describe why the majority of surgical devices are rooted in the ideas of observant surgeons. The timeless story of Dr. Thomas Fogarty's development of the Fogarty catheter started with a defined clinical problem and was assisted with “feats of association”. Fogarty was a scrub technician and witnessed acute limb loss as a result of surgery to remove blood clots. As a medical student of the University of Cincinnati, he started to work on a solution to the clinical problem he had identified years previously. In his garage, he developed a balloon on the tip of a catheter that could be inserted through a small access incision and passed through the artery beyond the blockage. Once past the blockage, the balloon could be inflated and the clot dragged out of the artery. His ability to invent and prototype this novel device was perhaps facilitated by his prior association with surgical tools as a scrub technician. He met much criticism from his mentors but went on to patent the balloon catheter, built the device in his garage, and worked tirelessly to have the catheter adopted by vascular surgeons. The Fogarty catheter has since revolutionized vascular surgery and led to a platform for innovations in minimally invasive techniques.

Whether accidental or systematically created, the idea behind an innovation can lead to the development of two broad categories of innovations: a novel method or a novel device. Because the majority of the chapter discusses medical devices, we will briefly discuss the innovation of novel methods. Delos Cosgrove describes his idea for a novel surgical method: “Several years ago, in preparation to perform aortic valve replacement, I found the ascending aorta entirely calcified and both femoral arteries occluded. Recognizing the danger of cannulating either one of these vessels, I raised the patient's arm to expose the axillary artery, which I used as the cannulation site. The aortic valve replacement was successfully performed.” Bruce Lytle expanded this idea and refined the process of cannulating the subclavian artery for this problem. Substantial changes to a surgical intervention are reviewed by the Institutional Review Board (IRB), funded through academic sources, and described in new academic publications and presentations. The surgical community generally shares new methods without recovering royalties for the benefit of patients, even though novel surgical methods can be patented if desired.

Determining the value

Value is the subjective relationship between the perceived benefit and perceived cost of a product or service:

As physicians, we are constantly assigning value to our therapies as a means of deciding how to provide medical care. We define the value of a given therapeutic intervention as the potential benefit to the patient in relation to the potential risk. Based on the risk–benefit ratio, we decide to proceed with or abandon a given therapy. Similarly, as surgeons we define the value of a surgical innovation as the potential benefit to the patient in relation to the potential risk. Based on the risk–benefit ratio, we decide to adopt or not adopt an innovation. In today's healthcare arena, before any novel surgical device is even available for use at the patient's bedside, its commercial value must be demonstrated. The commercial return on a device must outweigh its development risks in order to have a realistic chance of having the device available for patient use. To understand the value of an innovation, it is important to understand the perceived benefit the innovation has on (1) patient care, (2) technology, and (3) commercial impact ( Box 33.1 ). We will review some of the terms used to describe an innovation's perceived benefit in these arenas.