Book reviews, and reviews on literature regarding innovation in Surgery can be useful tools to help decide where to spend our scarce time. Here, we review a very useful text book called Bio-Design: The Process of Innovating Medical Technology. This book serves as a great template for how to innovate in the field of Surgery.
This text was published in 2009 and has contributing authors including: Stefanos Zenios, Josh Makower, Paul Yock, Todd Brinton, Uday Kumar, Lyn Denend and Thomas Krummel. About 5 years ago, Dr. Krummel spoke near Center Valley, Pennsylvania, at the Lehigh Valley Health System. It was there that I was exposed to just how process-oriented the Bio-Design system had become. In short, Dr Krummel and his colleagues at Stanford demonstrated a nice pathway for how to evolve, rate and create companies out of the talented surgical residents and interdisciplinary teams they helped form. This Bio-Design text mostly captures a sketch of that system and makes it a readily available template for other centers across the country.
One of the most useful portions of the text is its organization. It is clearly organized from brainstorming and conceptual phase down to licensing and beyond. Some of the more interesting facts that you can glean from the text include the idea that the Stanford system has this innovation pathway mapped to such a level that the staff maintains a computer database with which they attach ratings to different ideas and potential startup teams.
Why is this pathway so attractive? There are at least two reasons: (1) effective innovation can help more patients than we could ever help in our day-to-day work, and (2) innovation provides a non-patient volume-based revenue streams that is very effective. That is, each of these medical devices has the potential to return multiples of investment. Therefore, in years where patient care numbers are decreasing or have issues, these non-patient volume sensitive revenue streams are even more useful.
What I especially like about the process described in Biodesign is that it leverages human capital to a very full degree. The text clearly conveys how the program achieves this end. It highlights how this system takes motivated future/current physicians and plugs them into a process that gives them the ability to create their own medical devices and companies. Again, they can leverage these companies to help more patients with amazing designs and devices than they could otherwise help in day to day practice seeing patients in the office.
Other hightlights of the book include thoughts and quotes from known innovators. Dr. Thomas J. Fogarty, of Fogarty catheter fame, is one of the Stanford physicians and his comments throughout certain portions of the book are insightful and relevant.
The book also contains several directly useful tools. Some of these include sample non-disclosure agreements and other legal documents. The FDA regulatory process, both for compassionate use and other pathways, is clearly explained such that even a person inexperienced to the process can come to understand some of the various regulatory issues and challenges in bringing a device to FDA clearance. Of the various textbooks on medical device innovation and biodesign I cannot recommend this text strongly enough. Its ease of use, clear organization and practical tools makes it an excellent primer for healthcare executives and clinicians who have an interest in the bio-design process and who have an excellent idea that they might want to bring to market. If you have a moment visit Amazon.com. You will find the textbook available for download as a Kindle textbook or available for purchase as a hardback.
Note the author has no financial association with the publisher of the textbook, the various surgeons and clinicians involved, or any association with the university mentioned.
One of the regular features on our blog includes 3D printing as a vehicle for surgical innovation. This year’s consumer electronics show (CES), in Las Vegas, highlighted multiple new 3D printing technologies. Some of the more interesting ones include the 3Doodler, the new series of Makerbot 3D printers and the new Chef-Jet 3D printer series.
This blog focuses on potential applications of technology similar to Chef-Jet in the field of surgical innovation.
Some of the at-home applications of 3D printing include PLA or ABS plastic based creations. Both PLA and ABS have interesting structural characteristics, and PLA has become the plastic type of choice owing to ease of home use. However, new print media are already coming. Just as 3D printing represents disruptive innovation for multiple existing technologies, the new 3D printers and possible new media are evolving this cutting edge industry at an exciting pace.
For example, new hardware is already displacing certain elements of the market. The 3Doodler, which recently arrived at my home (see photo above), is a handheld pen which utilizes PLA filament so as to allow the user to create plastic objects via additive manufacturing by hand. See the photo above. Letters made in about five minutes with the 3Doodler. These by-hand prints are often not to the resolution of most non-freehand, “traditional” (amazing we can apply the word “traditional” to 3D printing at all) 3D printers. However, these can serve as rough sketches for later, more definitive creations, are rapid, and are amazing in terms of what can be produced quickly.
In addition to the 3doodler, other hardware is already evolving. We described in an earlier blog post the importance of creating an entire ecology around your innovation. As mentioned, Makerbot and other 3D companies have done this with different 3D scanners as part of their system. Makerbot recently released a 3D scanner, and presented an amazing new lineup of printers at the CES conference. These now feature heated build areas, which I can attest would make all the difference when I go to print objects in my cold office. The current Replicator 2, an amazing device itself, would be that much better with one of these heated areas.
One of the interesting, new technologies was recently debuted at CES. This is the Chef-Jet 3D printer. The Chef-Jet 3D printer prints in edible media including sugar, vanilla, chocolate, sour apple, sour cherry and watermelon. This is expected to begin shipping in late 2014. There will be both a professional grade and an at home grade Chef-Jet. Wedding cakes and at-home recipes may never be the same. At this point it is important to mention that the author of this blog post is a stockholder in 3D systems, stock ticker DDD. I have been a stock holder for about 2 years and did not know this technology was coming. However, now that it is here, I couldn’t be more interested.
Now, consider the logical extensions of printers and these new media: Now, surgical innovation is possible with resorbable matrixes and other resorbable scaffolds. That is, we will be able to create, cheaply and effectively, collagen scaffolds for things like drug delivery, eventual tissue ingrowth and other similar devices. Clearly this will make intellectual property and device manufacturing both paramount and in flux over the next several years. In fact, companies in Cambridge, UK, are already making bio-resorbable, implantable, printing filament. Importantly, these tissue scaffolds and similar issues have already been explored. For example, Organovo has explained that a 3D printed liver will be available for pharmaceutical companies on which it may test new drugs by the end of this year…truly amazing.
This blog post highlights some of the interesting twists and turns of what can be described as the 3D printing revolution. The different companies involved are poised to truly disrupt, in a positive way, the manner in which we have done things. In surgery, this is coming and, in fact, is already here. The new generation of 3D printers, some of which debuted in 2014 at CES are already here and soon will allow hospitals across the country to purchase the ability to make biodegradable implements. Indeed, there are already English manufactures that make filaments for 3D printers that are implantable. Check back in our blog often for updates regarding the 3D printing revolution and its impact on surgery in the coming months.
You may have heard the term “gamification” (pronounced game-ification) previously. Gamification is the process of taking certain elements from the world of computer and board games and applying these toward motivational and customer retention strategies for different groups. Game dynamics may also be applied to other important functions for different companies. Importantly, gamification is a hot topic and is even being taught in some business schools. It is currently thought that gamification will resonate with the millennial generation (“millennials”) and subsequent generations to a greater degree than, for example, Generation X and the Baby Boom generation.
There are multiple important strategies in gamification that we could discuss in this blog post. Here, we focus on several important game dynamics as they were applied to a general surgery residency in 2012. Our group used game dynamics for our section of trauma, emergency surgery, and surgical critical care to assess their impact on resident motivation and perception of quality of learning. Here, we will discuss the dynamics we used and different outcomes. Interestingly, we also utilized game dynamics for our team of surgical attendings. We agreed to participate in a similar strategy so as to demonstrate our support for this new approach.
The set up included the creation of a consensus group of behaviors by the trauma and emergency surgeons that the team wished to reinforce in residents. Similarly, the resident staff created consensus behaviors they wished to see demonstrated by surgical attendings. Many behaviors were already present to varying degrees, and the consensus behaviors were not a list of all new behaviors–rather, they were ones that each group wished to reinforce or make more common. Each group assigned certain point values to the behaviors. The point assignment was arbitrary and was contingent on several factors including the relative scarcity of the event as well as the importance of the event to our trauma and emergency surgery section as a whole.
We then set up an email address and surgeons were able to email from their smartphone each time they caught the resident surgeon doing something correct. This is a very new concept in residency education: “catching someone in the act” of doing something correctly. Interestingly we really focused on catching the resident in the act of doing something good.
Next, residents were given a letter so as anonymize them. Each resident knew his or her letter only. The letters were drawn as part of a leaderboard which was displayed in the trauma and emergency surgery conference room. Therefore, at each morning report, residents could see their progress and point accumulation relative to the point accumulation of their anonymized colleagues. Certain threshold levels of points were set and were displayed on the leaderboard. That is, there were certain thresholds of points at which events took place. Some of these events include obtaining a new skill, such as the ability to clear a cervical spine. Residents would be educated in cervical spine clearance and the appropriate template cervical spine clearance note. They were then empowered to clear a cervical spine with the supervision of the trauma surgical attending. Other events would occur at different levels of achievement including a letter of support to the residency program director for the resident’s file and other important elements. Unbeknownst to the residents, the overall points leader at year’s end was given a special congratulations and a year end gift at the resident’s award dinner. This was the only time at which the resident point total was revealed, and each resident except the overall points leader was kept anonymous.
A survey was given to the residents prior to the institution of this motivational pathway. This was a validated survey which used a visual analogue scale so as to determine job satisfaction. This is called the Job Satisfaction Survey (JSS) and has been validated among emergency department physicians. All resident years participated in the system. All residents received the job satisfaction survey prior to and then after the year long process.
A statistically significant improvement was noted in a proportion of residents (two tailed p < 0.01 by Chi-squared test) who perceived the quality of their education to be excellent. These data were reported at a trauma and emergency surgery conference at Atlantic City, NJ.
This is one nice case study for how gamification is possible in surgical residency. This program leverages multiple dynamics including comparison for each individual to a peer group and a focus on positive reinforcements for appropriate behavior. Experientially, the trauma surgeons involved found this to be highly effective in improving resident behavior and reinforcing positive behavior on the service. Interestingly, some of the residents originally felt that the gamification may belittle resident eduction or somehow cheapen it. Instead, by the end of the process, these residents were reporting positive results and were receptive to the process. Again, this type of education is a far cry from typical resident education. The terminology of ‘gamification’ was felt to decrease buy in as some residents felt, as mentioned, initial feedback from a minority of residents included an idea that turning their residency into a game was not appropriate. However, once residents saw that this was merely an assessment tool that focused on positive behavior and reinforced it while maintaining anonymity, they became much more receptive etc. There was no ability to remove points from any participant in the system at any time, and, again, focus was placed on what the residents did appropriately according to the defined behaviors.
Experientially, from this, our team learned that gamification is achievable in the inpatient medical education world. We also learned that this innovative process was a true boon for the human resources portion of our section. It changed the dynamic and interaction between the surgeons and the residents for the better. Also, experientially, we learned that performance seemed to greatly improve. There was a constancy of expectation of the residents by the trauma and emergency surgeon and vice versa.
As mentioned, the trauma surgeons also participated in the system. Trauma surgeons were also anonymized and had a leaderboard. Each trauma surgeon was given a letter and each trauma surgeon only knew his or her letter. Point totals were accumulated as emails were sent from the residents to a third party who was not one of the surgeons who attended. These were then reflected on the points on the leaderboard. Many of the dynamics have names in the gamification world. For example, the system described above incorporates some of the most basic game dynamics including what are called PBL’s. PBL stands for points, badges and leaderboard. Points are self explanatory as is the leaderboard. These leverage positive peer pressure and reinforcement so as to increase performance. The badges are those things that are achieved to signify an improvement in level. Although we did not give true badges to be put on the physicians coat etc, stickers and other cues maybe options for other programs.
We did use another dynamic, that of “leveling up”, to allow this gamification process to recognize good performance and to increase point accumulation by allowing residents to obtain new skills independent of their year level. Although senior residents had certain skills grandfathered in based on year level, such as PGY-5’s ability to clear c-spines with supervision of an attending surgeon, younger residents were able to attain these and other skills via achieving a certain point total that demonstrated competency in the performance of similar tasks. This process makes for a competency-based method of advancement and attainment of new skills.
Surgeons and residents were greatly satisfied with this innovative system and it is one you may apply in your educational or motivational process. Consider applying the process to your team of surgeons, residents, or Advanced Practitioners.
Questions or comments? As always we invite your thoughts.