In the November issue of Discover, the article “Reckless Medicine” opens with a dramatic story about Lara Keeton, who suffered debilitating complications from synthetic mesh that had been implanted to correct minor urinary incontinence. She experienced raging infections and 16 subsequent surgeries to remove the mesh and repair the damage it had caused. Keeton later learned that the problems she experienced were widespread among patients who’d had surgical mesh implants like her.
The article suggests that poor treatment decisions like Keeton’s can result from lack of adequate research, “misleading marketing” by drug and device companies, and flawed decision making on the part of doctors. It states that the Institute of Medicine determined in 2007 that “‘well below half’ of the procedures doctors perform and the decisions they make about surgeries, drugs, and tests have been adequately investigated and show to be effective.”
Without question, it is extremely important that medical device companies and representatives maintain an ethical commitment to the well-being of patients. There are instances unfortunately when this does not happen, but there are also many instances when sales representatives are providing valuable information to surgeons about products and treatments that result in enhanced outcomes for patients.
Moreover, I’ve interviewed a number of sales representatives who have been willing to risk their relationship and business with a surgeon to prevent a product from being used incorrectly.
Case in point, a representative I interviewed this past summer described a conflict with a surgeon in the operating room. The surgeon was insistent about using a particular product off-label in a case. As all of the other staff in the operating room looked on, the rep showed the surgeon the warning label and told the surgeon in no uncertain terms not to use the product. For a rep to challenge a surgeon like this is difficult, but if it is essential, the confrontation should not be avoided.
The rep said, “It caused some turmoil between us. When I saw him a week later, he had settled down and admitted it wasn’t the right thing.”
The best sales representatives are knowledgeable about clinical studies. They engage in an open and honest dialogue with surgeons about the the strengths and limitations of their products. When reps and surgeons work together in this way, they work together to support the best outcome for patients.
In the end, the Discover article offers a important reminder that surgeons, sales reps and medical device companies need to “first, do no harm.”
“Every day, surgeons are faced with uncertainties. Information is inadequate; the science is ambiguous; one’s knowledge and abilities are never perfect. Even with the simplest operation, it cannot be taken for granted that a patient will come through better off- or even alive.” ~ from Complications, A Surgeon’s Notes on an Imperfect Science by Atul Gawande
I received this great question and enlisted the input of some experienced O.R. sales reps for answers.
“In the med device industry, while in the OR and working with Surgeons, what is the best approach to tell a surgeon they are making a mistake or doing something wrong without losing their business and them going ballistic on you?”
While it is not necessarily true that a surgeon will go ballistic if corrected, situations like this need to be handled tactfully, especially during moments of stress. Here are three different responses, each with useful thoughts on addressing this challenging scenario in the operating room.
The Direct Approach
It sometimes depends on which Dr you’re working with. You have to have a feel for the way they are while in the OR. I have found that the best way for me is to speak up very loudly and clearly about what I am going to tell them. Don’t be hesitant in your voice. If you know something is wrong, be very confident in the way that you speak and be very clear for them to understand. I think the more you speak up in the OR the more respect surgeons will give you.
All surgeons are different and react differently so there’s really no right or wrong way to speak to them in the OR. Over time you just have to get a feel for how to talk to them while in the OR.
The Proactive Approach
In response to your question I would agree the scenario you pose is a challenging position to be in. I’ve personally been in that situation several times and I’ve found it is always better to be vocal with the surgeon even though it is a fine line to walk. A bad outcome or a poor reflection of your product is not worth biting your tongue during these instances and losing a potential user.
Before the case even starts it is important to use your time wisely to educate your surgeon on proper use (surgical pearls) of your product and any pitfalls you’ve experienced with new users. Educating the staff e.g. techs, circulators is also important for set-up and understanding how product works. It is also helpful to state that you the rep may be a little more vocal during the first few cases if necessary and ask if your input is welcome. Most doctors appreciate this proactive approach and it gives the rep an opportunity to offer product expertise and chance to differentiate yourself from the competition. If by chance you do see a problem about to occur or misuse of your product you have already set the stage for providing input. Soliciting feedback from the surgeon throughout case is also a good idea to make sure product is meeting expectations. If a problem does arise offer techniques that you have seen work best for other surgeons and explaining why is an effective way of not insulting intelligence or ego. Following up with the surgeon one on one after the case is also a non-threatening way of delivering a message without being confrontational.
The Diplomatic Approach
One experienced rep I spoke to told me that he will sometimes talk to the tech loud enough so that the surgeon can hear him. That way, the surgeon gets the information without the rep correcting him or her directly. When the rep is “teaching” the tech, the surgeon can draw his or her own conclusions and adjust before things get too sticky.
“If you have good rapport with the surgeon, they want you there and want you to critique, but it’s important not to be too cocky or aggressive,” the rep said.
As mentioned above, referring to the surgeons’ peers is another helpful way to deliver the message and lessens the chance the rep will be seen as presumptuous. If the surgeon begins to struggle with some part of the procedure, this rep might might calmly interject,
“A lot of people have found that they get better results in this stage of the procedure if they…”
Despite everyone’s best efforts, some cases are challenging. After a difficult procedure, the rep said he might approach the surgeon for a one-on-one conversation. He would say something like:
“Dr. So-and-So, I noticed you did (this or that), but I know you want to get the best results. Next time, you might try…”
“I would be doing you a disservice if I didn’t tell you this…”
With some personalities, offering suggestions can be really difficult and awkward no matter how you approach it, he admitted. Even with the most respectful phrasing, sometimes there is no getting around it.
“You have to be comfortable being uncomfortable in this job,” he said, “but if you have the patient’s best interest in mind, you’ll be okay 98% of the time.”
What do you think is the best way to head off trouble in the O.R.?
“The difference between a smart man and a wise man is that a smart man knows what to say, a wise man knows whether or not to say it.” ~Frank M. Garafola
It is sometimes hard to explain to those from outside the medical device industry the role that a surgical sales representative plays in the operating room.
I used to say that the rep was like the quarterback, but I now think it would be better to say that the sales rep is like the coach, calling plays from the sidelines. The surgeon is like the quarterback, executing the plays. The first assist or surgical tech is like the center, and the instruments are like the football being passed to the surgeon-quarterback.
Okay, it’s easy to get carried away with this sports analogy, but the pieces seem to fit together well. Then again, maybe that’s just because the last time I was truly an expert on football was when I was in second grade and Terry Bradshaw was the quarterback for the Steelers.
When something goes wrong in the O.R., it is the surgeon and the sales rep who need to figure out how to set things straight, just like a quarterback and the coach might confer about plays or strategies to regain control of a game.
Like a coach, a sales rep needs to remain calm under pressure. He or she needs to have alternative plays and needs to be able to think clearly and respond quickly, especially when everything does not go as planned. If a sales representative is able to handle the pressure, then he or she can gain respect of both the surgeon and the surgical team.
It would be hard to imagine a coach walking away from a team after one bad game, and yet there are sales representatives who are tempted to throw in the towel after a bad case. Some reps try to duck the surgeon’s frustration rather than analyzing what went wrong. No doubt, facing an upset, frustrated surgeon after a less than optimal case is not a whole lot of fun.
One rep I interviewed recently described a difficult case with a surgeon who was using his plating system for the first time. The surgeon disliked the instrumentation and had many complaints. Rather than heading for the hills, the rep analyzed how the case could be improved the next time. Over the next few cases, the rep swapped out instruments and refined the set to best meet the surgeon’s needs.
“I kept trying to take his objections away,” he said. After dialing in the instrumentation and identifying a particular plate that suited the surgeon’s needs perfectly, the cases began to go smoothly. When the surgeon’s patients began having great results, it was like the team had mastered the play and was scoring every time.
I admire this rep’s tenacity. Working through challenging cases to win a surgeon’s respect and trust is tough, but it is definitely a winning strategy. If a sales representative and surgeon work well together to solve problems in the operating room, in the end it’s the patients who are the biggest winners.
What do you think of this analogy? Is there a better one?
“If any thing goes bad, I did it. If anything goes semi-good, we did it. If anything goes really good, then you did it. That’s all it takes to get people to win football games for you.” ~ Paul Bear Bryant
I interviewed 2 great candidates who are currently in medical device sales. It made me think about some of the differences between medical device sales and a typical B2B sales position. When you move into medical device sales, it is definitely a step up in many ways- in responsibility, complexity and commitment
Both candidates talked about their efforts to convert surgeons from competitive products. Their success resulted from ferocious determination, research and a sophisticated level of clinical knowledge about their own and competitors’ products. In one case, there were 8-10 competitive plating systems on the market, and yet the rep was able to identify 5 competitive differentiators in his product.
A good product? Sounds like it. A rep who does his homework? Definitely. When you are a medical device rep you need to be as fluent as a surgeon on surgical techniques, clinical data and anatomy, and even more so on the options available on the market.
The other candidate talked about how there is zero room for error in medical device sales. Have to fidget with a copier or mailing machine that doesn’t work quite as expected during a demo? You can probably recover from that. Don’t have option C or D if needed in the OR? It might be the last time you’ll ever work with that customer.
“You can’t make mistakes. #1 there is a patient on the table. #2 there are too many competitors,” the rep said. To avoid any errors, he double, triple and quadruple checks his instruments and implants the day before the strategy. If he has to drive 8 hours from his rural territory to retrieve a missing instrument in the middle of the night before a case, oh well, he does it. Without question. “If there is a mistake, you better catch it far in advance, long before the customer ever knows.”
Although medical device sales is sexy and exciting, you need to seriously consider if you are prepared to make this level of commitment. Many successful sales representatives consider medical device sales not simply a job, not only a profession- but a lifestyle. That is how complete and total the commitment must be in order for you to maximize your success in this field.
Are you ready for it?
My windows are open on this bright, cool morning. Outside, the breeze rustles the leaves of the aspens in my yard.
Eight weeks ago today, I fractured my tibia skiing. As I sit in my kitchen writing, my right leg is stretched out to the side, foot resting on another chair. I have a cold pack strapped to my knee. Someday soon, I hope to achieve a full range of motion again. This week, I will try to walk again.
My injury, surgery and recovery have given me an opportunity to cross over to the other side of the medical device industry, as a patient. The care I have received throughout this time, from nurses, my surgeon, the anesthesiologist, the physician assistant at the emergency room and my physical therapist, has been nothing short of terrific. I have tremendous respect for their knowledge, skill and dedication to helping me recover.
I have been as diligent as possible about following their advice. I have learned a lot about my body’s ability to heal and need for movement. My desire to be healthy and active again is insatiable.
During this challenging experience, I’ve encountered first hand products from many companies in the medical device industry. When I saw my surgeon for my 6 week check-up, he looked at me in surprise when I asked him if the buttress plate screwed to my tibia was from Synthes. He said it was. I imagine, and frankly hope, there was a company representative in the operating room when I had my surgery, who was well-trained and well-prepared with back-ups and alternatives, should they have been needed. This unknown person has also impacted the quality of care I’ve received.
The morning of my surgery, my surgeon stopped by to see me in pre-op. He was fresh from a good night’s sleep and clearly excited about operating. He had been planning and preparing for the different possibilities he might encounter. After all, surgery is what he had trained and worked so hard to do, through many years of medical school, residency and a fellowship. Medical device sales representatives, as well as those aspiring to the industry, often express a similar level of excitement about surgery.
I can appreciate enthusiasm for surgery, and I understand how such passion can contribute to a better surgical outcome, but these emotions are in stark contrast to my feelings at that time as a patient. Pain, fear, even despair would be the best words to describe how I felt in those first days surrounding my accident and surgery.
During this time, and since then, there have been moments of compassion that have been as important to me as any medical intervention. In particular, I think back to the physician assistant in the emergency room, who rubbed my arm and reassured me after I began shaking when the shock and reality of surgery and a long recovery hit home.
Sales people are measured by their ability to grow business, and to achieve and exceed a quota. Somewhere in this equation for success, there must be room for compassion. I think the best companies and sales representatives in the industry find a way to balance these two contrasting priorities. They live up to the full responsibility of their roles when they are thoroughly trained, current on the latest techniques and products, provide excellent service and support to their customers, and are well-prepared for every surgery. The final element of exercising compassion as a medical device sales representative is never loosing sight of the patient’s well-being. I hope that the sales representative who may have covered my surgery had this in mind.
One of the sales managers I have worked closely with over the last few years refers to this as “doing right by the customer”, and in turn, the patient. Although it is not a formal metric, at the end of the day it is how he judges whether a representative is successful or not. If a sales representative “does right”, growth will follow. A lot of business is won and lost based on the level of commitment sales representatives demonstrate toward their customers.
I am suggesting that compassion toward the patient should be one of the major reference points a sales person uses to guide their decision making and their behavior. Some sales people I have spoken to in the industry use the following question to remind themselves of this:
“What if the patient on the table was my parent, spouse or child?”
I think this question should be part of the criteria for every product developed, marketed and sold in the industry.
What would happen if companies did find a way to measure the compassion their sales representatives demonstrated toward their customers and their customers’ patients, in addition to measuring growth in revenue? What you measure, you can improve. What would be the associated impact on the company’s bottom line? I am betting they would find there is as strong a correlation between compassion and results as any other metric they use. Although it may be hard to measure, compassion is an imperative for long-term success in medical device sales.
This post is otherwise known as… “How to Stay Out of Trouble in the Operating Room.”
Joseph Lister, a British surgeon, established the founding principles of aseptic technique in the Lancet in 1867. Before then, surgeons did not wash their hands before operating or disinfect their surgical instruments. (Shudder.) In case you’ve ever sat up late at night pondering the origins of the word “Listerine,” you will be ecstatic to finally know it is named after this important surgeon.
Fast forward to today. Surgeons now scrupulously defend against infections by strict adherence to modern aseptic technique. Although we know much more about how to prevent infections, the battle against microbes in on-going. The Centers for Disease Control estimates that hospital acquired infections occur in about 1% of the 27 million surgical procedures performed each year. Annually, about 8,000 patient deaths result from such surgical site infections.
If you become a sales representative in the operating room, you will have to undergoing training in O.R. protocol, so that you will not create havoc in the operating room by contaminating the sterile field.
Here are a few basics:
1) The sterile field is the designated area which is “free of bugs that can infect people“.
2) The sterile field can include can include surfaces, instruments, even people. Once a surgeon, tech or nurse is “scrubbed in” (hands washed, adorned in sterile garb), then he or she is part of the sterile field. This means if you touch them, you compromise sterility.
3) The sterile field has a vertical dimension that is important to be aware of, as is illustrated so nicely in this picture. This means the “air space” above the sterile areas should not be violated. Doing so, by reaching over a tray of sterile instruments for example, could ignite World War III- or at a minimum make everyone in the operating room very grumpy with you.
One thing should be abundantly clear by now… contaminating the sterile field is a sure way to get on the wrong side of surgeons and surgical staff.
Some advice for staying out of trouble:
1) In the operating room, if it is blue (or maybe minty green) stay the heck away from it, by a good 12 inches or more. Absolutely do not touch it. It would be a good idea not to turn your back on it either.
2) If you think the sterile field has been compromised, tell the circulator immediately.
Hopefully, reading this will help you stay out of trouble, but the responsibility is really all yours to ensure you conform to proper O.R. Protocol. It is essential for the safety of the patient. To learn more, check out these additional resources:
According to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
They make is sound rather complicated, but basically it is anything that is not a drug that is used to treat, diagnose or affect the human body. The gamut includes everything from tongue depressors, to MRI machines, to hip implants. Medical devices are separated into 3 categories or classes by the FDA: “Class I includes devices with the lowest risk and Class III includes those with the greatest risk.”
Why does this matter if you are a medical device sales rep or marketer?
You could say that the classes in some way correlate to the level of product knowledge and skill required by the sales representative or marketer, as well as the level of responsibility and commitment required. Class III medical devices, subject to the most stringent review and controls, are designated as such because the failure of these products could seriously injure a patient or perhaps even lead to their death. Surgical implants of all varieties fall into this category. Whenever there is an incident of injury or, heaven forbid, death attributable to a medical device, a formal report called an MDR must be completed and submitted to the FDA. Of course, the regulatory system has numerous safeguards intended to prevent unsafe products from ever being sold. Still, even with safe products, things can go wrong.
It is worth stopping to think about a moment, isn’t it?
It really takes the idea of a “consultative approach” to a whole new level, doesn’t it?
Being a sales representative in the O.R. is exciting and rewarding, but it also comes with tremendous responsibility, to the patient, the surgeons and their staff. To recommend the right product for the particular need. To always be more than prepared. To uphold the highest ethical standards.
If you decide to pursue medical device sales or marketing, especially if you are dealing with Class III devices, be sure to keep this in perspective. It is not like selling any other product. Have respect for the learning curve. There is a lot to learn when you first get into the industry in order to be an effective representative, and more you must continue to learn to keep your knowledge current and skills sharp as you progress in your career.
A stunning number, isn’t it? The dramatic increase is predicted to occur in the next decade.
A number of factors could contribute to a rise in knee replacements to more than 3 million procedures annually, as noted in this article from the University of Michigan Health System.
Dr. Kenneth Mathis, from the Methodist Center for Orthopedic Surgery in Houston, cites the need for revisions as a major driver in the increase in annual knee replacement surgeries. Revision surgeries take place when an existing implant is replaced with a new knee implant. Revisions can be required when an implant begins to wear out after years of use, or from “alignment and implantation errors” as Dr. Mathis indicates.
From these numbers, there are a few implications that can be drawn for those interested in medical device sales and marketing:
1. Many more total joint reps will be needed! Among total joint reps I have interviewed, such revisions are more complicated procedures since they involve removing existing hardware. It may take a year or more before a total joint rep is sufficiently experienced to cover such a case.
2. Since alignment issues are a major contributor to the need for revisions, computer assisted surgery will become more common. Most joint companies offer CAS systems. When a hospital adopts a particular company’s CAS system, it often leads to a significant consolidation in business.
Initially, the market seemed slow to adopt the expensive technology. As the benefits of CAS are established, it will likely lead to this technology becoming a standard of care. This implies growth in the sales of such sophisticated systems, and again the need for more skilled sales reps.
The use of custom cutting blocks also seems to enhance the precision of the procedures- another area of growth.
3. Total joint companies will continue to develop and market more customized joint solutions, such as Zimmer’s Gender Solutions Knee for Women, or individually customized joints.
It’s clear that the growth of knee replacements will continue to drive the need for innovation. As a result, this booming market will provide many opportunities for growth in medical device sales and marketing.
Back in February, I wrote about how my trip to the hospital and subsequent recovery had given me great appreciation for the great work healthcare professionals do.
Well, I’ve had another opportunity to do so again, this time in a way even more closely connected to the world of medical devices, specifically orthopedics.
About 2 weeks ago, I had a little skiing accident. Or that is what I thought it was, and everyone else did to. Apparently, I was pretty stoic when I should have been hysterical. The ski patrol said, “Eh, it’s probably a bad bump, but you should have a few pictures taken just in case.” They thought my bulging bursa was pretty cool. Maybe the fact that I could not bear any weight on my right leg should have been a clue for us all.
I was really really hoping it was nothing more than a bump, but the xrays at the urgent care proved otherwise. And back to the local ER I went. On the way, I called Linvatec’s distributor for Colorado. “Who are the good orthopedic surgeons in town?” I was really glad I had someone I could call to find out.
Fortunately, one of the surgeons he mentioned was on call. There was some debate about whether I should go into surgery that night. I had a fantastic PA and the same nurse I’d had before when I had visited for pneumonia. I asked about their frequent flyers club- I think I am eligible. In the end, I was sent home with some pain meds and plans for surgery early the following week.
I have a tibial plateau fracture. When I wasn’t covering my eyes, I watched with the foggy images of my bones on the computer screen in my surgeon’s office a few days later. He moved though the CT images, speculating on areas of concern. For all the amazing technology that is available, it is interesting that CT scans and xrays provide images that still leave so much to interpretation.
My PCL seemed to have pulled loose, but it was uncertain as to whether he would have to reattach it with a screw or if it could be recaptured by the hunk of bone it seemed to be attached to. The condition of my meniscus and other ligaments seemed unknown.
The existence of these uncertainties intrigued me. The mystery of it. One that could not be solved without cutting into my leg and peering inside. I think it is part of what makes orthopedic surgery so fascinating and exciting.
One thing reps in the industry say is that you have to be “on your game” in the operating room. Extra products and instruments, ready to support plans A, B and C, should the patient require it.
Surgery the next day was thankfully a blur. I now have a buttress plate with about 5 screws into my tibia. I was hoping at some point for a lucky break (probably a poor choice of words), for something to turn out better than expected rather than worse.
I got more than a few lucky breaks in the end, the first being a good surgeon. My PCL snugged back into place without a screw. My meniscus and ligaments are in reasonably good shape.
I have an insatiable desire to walk, even run, because I am feeling pretty darn good again, now 2 weeks post surgery. But I don’t dare, not yet. It would be against doctor’s orders. But I will again someday soon, and for that I am very, very grateful.
Today I spoke with a candidate who went on a ride-along last week as part of the interview process. From the way he described it to me, I think it may have been the perfect ride-along. He got to see a good rep in action and four surgeries in one day of the same product.
Here are a few things he shared with me about his experience:
1. Although product was the same for all four cases (actually it was our new SRS system, so more than a single item), every surgery was different. In fact, he said the anatomy of each patient’s shoulder appeared different, probably in part due to the individual variations of the injuries, but also because no one’s anatomy is “textbook”.
2. Because of these differences, each surgical procedure was unique. Each case called for some variation in the technique and instruments used for the repairs.
3. The rep played a crucial role in having different instruments and solutions ready for the surgeon and his team. The candidate commented that the rep “seemed part of the (surgical) team”.
The reason I think it may have been a perfect ride-along, is because his observations highlight the learning curve inherent in becoming a successful surgical implant rep. He saw just how much surgical technique can vary from case to case, and how important it is for a rep to be on their game. Developing this level of skill as a sales rep takes study, dedication and what I like to call “time in the saddle”. Being able to problem-solve in the operating room, while remaining confident and calm, is the hallmark of a seasoned rep who is an asset to his or her customers.