Patient safety and surgical innovation–complementary or mutually exclusive?

Abstract

Safety vs. innovationSafety and innovation are not and need not be antago-nists, but synonyms. If innovation is driven by safety, wecan hopefully accelerate the rate of innovation desper-ately needed in medicine.In the surgical microcosm, it is not infrequent to hearthe voices of surgical conservatism question innovation:why change the current device or method? It is provento work, it is vetted by years of clinical research, andshould therefore be chosen–because it’s safer. There’snothing wrong with that thought process, is there?There is no doubt that safety is the cornerstone of ourpractice. However, caution and prudence should not bedeterrents for innovation. On the contrary, if youngersurgeons or trainees have the luxury of being attractedto innovation, it is only because their mentors use estab-lished methods and strategies. This creates a setting ofsafety and security in which younger surgeons arerooted. The established surgical practice needs to be oneof absolute focus on safety; only then can the youngergeneration be comfortable enough with the currenttechnologies to look into its shortcomings.Just like creating a safe household and offering chil-dren a rigid set of ground rules and education, anchor-ing residents in safety is a critical initial step. But atsome point, your children will need to experience theirown life. And if you hamper that, your kids will neversurpass you… The role of mentors is therefore to teachand give trainees the tools to practice surgery safely.This will allow them to recreate the same environmentof absolute attention to safety for their own patients.Surgical curriculums are aimed at training residents toreach this stage, not to surpass it. It is good, but not goodenough. Once surgical training has been appropriatelyachieved, it is also the role of mentors to push trainees toventure out further and not fall asleep in the safe mode.They should be encouraged to keep searching. If we wantour field to evolve, we owe it to ourselves, to our patients,and to our trainees not to stop at simply reproducing whatwe have learned, but to improve it.It is thus our role, as teachers, to encourage a mindsetof innovation in medical students and residents, and givethem the tools to pursue innovation safely.Finding unmet needs in surgical practice?Innovation and surgery can be two facets to the sameperson, the same career. However, since the times of il-lustrious surgeon/inventors who could bring their inven-tions directly from the lab to the operating room, thingshave changed. Just like surgeons pursuing basic researchdon’t inject the stem cells they grow in their lab in thepatient they care for on the floor, clinical practice is not aplace to carelessly experience with innovation. And currentrules and regulations ensure that fact thoroughly. However,clinical practice is a unique set for identification of unmeetclinical needs. The surgeon has the unique “privilege” ofwitnessing the shortcomings of current treatments andtheir impact on patients. It is her or his duty to use this“privilege” to improve care. The best innovation, and thesafest innovation, is the one grounded in real problemsolving needs. Only if we identify problems worth solv-ing, will we develop solutions worth pursuing. And assurgeons, these solutions often take the shape of de-vices, which is exactly what medtech innovation is:Medical or surgical technology (Medtech) innovationrefers the process whereby scientific discoveries, whichcould solve clinical problems, are driven forward acrossthe translational gap into a device used in clinical prac-tice [1,2].Training to innovateSo you’ve identified an unmet need. Maybe invented asolution… Now what?Navigating the requirement of medical technology de-velopment is actually only getting more and more com-plex: what regulatory pathway is required in the US forthe device to be FDA cleared or approved, or CE marked