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Eur J Cardiothorac Surg 2004;26:S19-S24
© 2004 Elsevier Science NL

Review

View from industry

Cardiac Surgery Division, Medtronic, Inc., Minneapolis, MN, USA

^* Corresponding author. (Email: robert.guezuraga{at}medtronic.com).

	Abstract

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
The transformation of the cardiothoracic specialty requires a complete mind-set and skill-set change such that the specialty repositions itself in this era of complex cardiac disease, increased competition, technology innovation, financial constraints, rationed access to technology and increased scrutiny on clinical outcomes. The future offers a variety of surgical treatment options for patients suffering from disease states that have traditionally not been treated by cardiothoracic surgeons such as ablation for atrial fibrillation and cell therapy for heart failure. In addition, patient expectations for prolonged and quality-improved years are higher as they educate themselves on options that are less invasive. Failure to build a new repertoire of skills will mean diminished access to patients because referrals will be made to those cardiothoracic surgeons who are seen as innovators. Time is of the essence, as market dynamics are taking their toll. Cardiothoracic surgery today is still one of the most profitable specialties within the hospital and therefore, hospitals should be willing to support and differentiate their heart programs through new technology adoption. But cardiothoracic surgeons need to be open to explore new methods for treating cardiac disease and to work with industry in proving the efficacy and patient benefits of new procedures. At a higher level, pan-European approaches to new technology adoption need to focus on increased governmental spending on healthcare and on reimbursement strategies that make this possible. The medical device industry continues to invest heavily in new techniques and technologies and should be viewed as a strategic partner by individual surgeons as well as by the surgical societies. As industry continues to focus on areas such as research, product development, market development, professional and resident education, reimbursement, and patient access issues, it is imperative for surgeons to work collaboratively with industry to drive change for the cardiothoracic specialty and to maximize the resources that each offers to the other. Though not always understood, a common unity of purpose does exist and constructive methods to dealing with change can be developed together. Frost & Sullivan predicts a medical device industry compound annual growth rate of 8% in the next 12 years. Achieving that same level of growth specifically across cardiothoracic surgery would be tremendous.

Key Words: Technology innovation • Revascularization • Valves • Atrial fibrillation • Heart failure • Minimally invasive

	1. Introduction

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
The professional societies representing cardiothoracic surgery have traditionally focused their efforts intensely for the purpose of advancing education in the field of CT therapy, for promoting research, and for disseminating the results. However, in today's changing times, it is incumbent upon the members of EACTS and cardiothoracic surgeons worldwide to evaluate some increasingly important issues, and to become a lobbyist for the cause. Some of these issues, such as marketing the practice and involvement in political action, are typically not the lessons learned in medical school but they are necessary today, in light of the forces of change facing the specialty. Cardiothoracic surgery needs to be repositioned in the era of new technologies and financial constraints. The root cause of many of the dynamics seen today in cardiothoracic surgery is the dependence on the status quo and in the routine practice of treating heart disease the same way for decades.

Rapid technology innovation has caught some surgeons by surprise. Some have embraced it and have succeeded in creating growth opportunities for their practices, but the majority have become complacent with the standard way of practicing or perhaps, have simply been overly cautious. Earlier this year at the STS Meeting in Toronto (2004), Bruce Lytle, MD of the Cleveland Clinic made a statement from the podium, "Did we really think we'd be doing surgery the same way we learned in medical school over 20 years ago?" Similarly, during his Presidential Address, Robert Guyton, MD challenged every surgeon to learn at least one new procedure per year, stating that innovation=survival. This is one significant step in the direction of keeping the specialty positioned well in the eyes of its members, referring physicians, other specialties, medical students and ultimately, patients.

	2. The current practice

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
The cornerstone of transformation lies in the need for a complete mind-set and skill-set development change on the part of cardiothoracic surgeons. The worldwide medical device market represents $175 billion, of which Europe accounts for 26% [1], however, Europe spends a proportionately lower percent on healthcare as a % of GDP. Foreign governments need to be convinced that spending in this industry is valuable to the economy in terms of reduced mortality, disability, hospital stays and ultimately, extended life expectancy. A recent study in the US performed in part by AdvaMed (Advanced Medical Technology Association) demonstrated that for each dollar spent on healthcare, a tangible health gain of $2.40–$3.00 was seen [2].

Industry is ready and willing to invest in cardiothoracic surgery and to make it a growth market, but this requires collaboration and commitment between surgeons and industry. A profitable device industry fuels further investment in research and education, thereby potentially offering promising new income streams for surgeons looking to revitalize their practices.

Looking forward, European cardiothoracic surgeons have a unique growth opportunity in that the EU is considered the ‘oldest group of countries in the world’ as currently 16% of Europe's population is over the age of 65; this is expected to grow to 25% by the year 2020 [3]. These patients will continue to require surgical intervention for the treatment of complex cardiac disease that carries with it, numerous other co-morbidities.

However, being a cardiothoracic surgeon today has its challenges. Many issues are outside of a surgeon's direct control and are having an impact in the access to and ability of surgeons to treat patients with the appropriate therapy. Some of these include:

1. A reduction in CABG case load volume due to drug-eluting stents, statins and changes in life-style.

2. Increased demand for improving the standards of clinical outcomes including public reporting and new quality initiatives.

3. Increasing cost containment pressures from hospitals who are rationalizing healthcare spending.

4. Flat, declining or no reimbursement for new technology adoption.

5. Patients driving the demand for certain procedures. The desire of any patient is to have a successful procedure that offers the least amount of invasiveness and allows for a rapid return to normal life.

6. Economic cycles that have delayed the ability of some surgeons to retire. In mid-2002, Shemin, et al. reported in the Annals of Thoracic Surgery that 50% of practicing surgeons intended to retire by the year 2010 [4]. This shift in workforce requires attention to the fact that current residency programs are seeing vacancies for the first time, which has also been affected by the current image and long-term prospects for the specialty.

	3. Drivers for change

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
As quoted from the movie Apollo 13, ‘Failure is not an option’ [5]. Failure to embrace the winds of change will result in observation rather than participation in new therapies that are having a dramatic impact in patient's lives. A strong sense of leadership is needed on the part of each individual to consider what contribution he or she can make so that the entire profession benefits. Many surgeons today are differentiating themselves, and taking market share from less innovative surgeons, by embracing new procedures, committing to the associated learning curve and marketing their practices to those that can impact their referral sources.

Industry continues to partner with cardiothoracic surgeons to drive minimally invasive surgical intervention across multiple fronts; this also provides patients with procedures they demand. Some of these areas of focus include the following.

3.1 Customized revascularization procedures
Up until now, surgeons have either identified themselves as on ‘off-pump’ or ‘on-pump’ surgeons, with only a small percent performing both procedures equitably. The continued penetration of OPCAB as a percent of total CABGs performed across the world, begs the question of just how much more morbidity could be eliminated from avoiding the pump. This thought process has fueled manufacturers to create a ‘better bypass’ through mini-circuits that are heparin coated [6], avoid air-to-blood interfaces [7] and reduce hemodilution [8], and through right-heart assisted approaches which can avoid aortic cannulation and provide stable hemodynamics while still offering the patient benefits of beating heart surgery. The one-size-fits-all CABG is a paradigm of the past and will not be attractive to patients nor serve as a point of differentiation. As the population grows, along with obesity, diabetes and other complex cardiac disease, more patients will require CABG surgery and surgeons will need to customize their CABG procedures based on patient-specific needs. This requires a repertoire of skills that need to be learned, practiced and refined.

3.2 Endoscopic procedures
Call it MIDCAB, MVST or TECAB, endoscopic procedures represent the next wave of innovation in CABG surgery. Although these procedures will not have a direct impact on CABG volumes for the next several years, surgeons who are coined ‘early adopters’ are learning this technique and are working diligently with industry to refine the tools required to make this a standard of care. Patients who currently prefer drug-eluting stents over surgery are thinking twice about their options when offered small incision surgery that allows for a quick return to normal life and offers the durability of surgical grafting. Do not underestimate the effects of patient demand and marketing; surgeons who adopt this procedure will be sought out and this technique may also provide a common ground for hybrid procedures that broaden the working relationship between surgeons and interventional cardiologists.

3.3 Surgical treatment of AF
The ability to surgically ablate cardiac tissue in the treatment of AF represents a new area of specialty for cardiac surgeons. These procedures are now made easy with innovative tools and are reproducible, offering patients with debilitating symptoms an actual ‘cure’ for a disease state that is widely prevalent and costly to the healthcare system. Surgical ablation has rooted itself as a new niche for surgeons because of excellent clinical results, something that pharmacological therapy or catheter ablation have not achieved with satisfactory outcomes. Surgeons need to continue to collect data on the efficacy of this procedure, determine the appropriate lesion patterns, and to share these outcomes with referring physicians. Concomitant surgical procedures are estimated to more than triple in the next few years and the ultimate goal of treating lone AF through a minimally invasive incision is being evaluated judiciously by industry to ensure the development of easy-to-use tools for the surgeon. Key market drivers for this procedure also include:

• Education of surgeons to allow them to migrate from an open chest/open heart to a closed chest/epicardial approach

• Education of referring physicians

• Reimbursement mechanisms

• Patient education and demand

• Speed to market of enabling technologies.

Industry is highly committed to training and investment in technology, and must be partnered with to drive support for reimbursement through various political activities.

Efficacy data will make this an attractive growth vehicle for both academic and community programs.

3.4 Increasing valve caseloads and movement towards minimally invasive or percutaneous implants
Traditional valve repair and replacement has previously been the untouchable domain of the cardiac surgeon, yet this area has elicited extreme interest on the part of interventional cardiology. Yet surgeons have ensured incredible levels of safety and surgical technique in this area, so why consider changing the gold standard? Europe indeed has pioneered the development of minimally invasive approaches to valve replacement and repair (now considered critical to maintaining a strong presence within the market) and is probably best suited to evaluate the efficacy of percutaneous procedures and to determine patient selection criteria.

Industry has entertained the notion of developing percutaneous technology from the standpoint of treating patient populations that are too sick for surgery; industry does not view this technique as one that would cannibalize the volume of current open-heart procedures (perhaps only by 15–30%) [9]. The overriding drive towards more minimally invasive procedures also applies in this area and can be compared to growth (and demand) of stents and AAA grafts (a new learning curve for vascular surgeons). Transcatheter valves are estimated to be a $1 billion product market within 5 years, with the mitral valve market being the largest and the aortic valve technology being the most challenging. Industry estimates that with close to two-thirds of valve procedures being performed with concomitant CABG procedures, cardiac surgeons will be highly engaged in this area. These procedures also ensure a steady stream of CABG volume. Someday, valves may be delivered on a stent during a beating heart procedure.

A major obstacle is determining how to test the efficacy of transcatheter valves and how to drive reimbursement. Surgeons need to be engaged in the development of this procedure so that they ensure the broadest procedural options available to patients and ownership of the expertise.

3.5 Treatment of heart failure (HF)
Over 5.3 million patients suffered from heart failure in 2000 and this is expected to grow by 50% over the next 15 years [10]. Surgical treatment of heart failure is an exciting opportunity that is now in its infancy phase. Along the continuum are options for involvement in cardiac resynchronization therapy (CRT) through minimally invasive techniques such as epicardial lead placement; Europe should be well positioned to continue their participation in this area due to the fact that surgeons have not migrated away from performing pacemaker and ICD implants as has happened in the US. Industry continues to evaluate different investments in HF therapy such as mechanical support/reshaping devices and encourages early intervention in mitral valve surgery for regurgitation, to prevent LV remodeling and its progression towards HF. Ultimately, the goal for surgical heart failure therapy is closed chest procedures that may include endoscopic deployment of left-sided leads, stem cell delivery and VADs.

A new paradigm is emerging that marries two distinct markets and offers promise for cardiothoracic surgeons: devices and biologics. Medtronic and Genzyme have recently announced a joint venture to target cardiac repair (see diagram) [11]. Research in heart failure therapy is being well funded because of the prevalence and incidence rates of this debilitating disease. In the US market, biotechnology funding raised $12.3 billion in the last 12 months (second only to software in venture capital investments); additionally, R&D expenditures were >$22 billion worldwide in 2002, excluding pharmaceuticals [12].

Heart failure with chronic MI represents approximately 730,000 patients worldwide who would be candidates for skeletal myoblasts to repair damaged myocardial tissue. The initial research has been very encouraging and currently, the MAGIC Phase 2 clinical trial is being conducted in Europe. This trial is designed to determine whether cell therapies can be used to reverse damage done to cardiac muscle following a heart attack, or to safely halt a patient's further progression of heart failure; 300 patients will be enrolled. Next-generation cell therapy approaches include the use of genetically modified cells, allogeneic cells, and advanced biomaterials designed to enhance cellular engraftment and survival.

	4. Options for progress

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
Priorities for cardiothoracic surgeons can be categorized as technology-based solutions, and non-technology-based action.

4.1 Technology-based
Surgeons must understand that industry truly represents a solid vehicle for partnership. Surgeon willingness to embrace technological innovation will drive further investment in this specialty and industry continues to fund not only technology, but research, market development and cardiothoracic societal and educational initiatives. Get involved with industry by:

• embracing technology, learning new procedures and committing to becoming an expert in an area of interest

• training other surgeons

• becoming engaged in defining the tools (devices) necessary to grow the adoption of new procedures

• allowing access to and funding for surgeons for post-graduate education at major meetings

• seeking input for formulating product/procedure training curricula for residents and for courses offered in the US and abroad

• providing access to hospital executives and purchasing departments to educate them about the long-term benefits of technology investments (potential for improved clinical outcomes and economics due to more effective use of hospital resources)

• embracing the concept of merging life sciences, physical science and information technology and commit to the discovery of new knowledge

• supporting the STS database and the development of the European Cardiac Surgery database (to include clinical outcomes and benchmarking capabilities); also supporting the ECTSIA (European Cardiovascular and Thoracic Surgery Institute of Accreditation)—these measures will instill the confidence across the specialty regarding the efficacy of new procedures and serve as a point of differentiation.

4.2 Non-technology-based

• helping to fund any political action committees sponsored by EACTS; get involved personally, and focus on quality and patient-centered care

• lobbying for reimbursement mechanisms for new procedures and or technologies

• building relationships within the hospital...

take a leadership role in driving costs out of healthcare through improved efficiencies at the hospital

know your referral physicians and keep them informed of new advances in cardiac surgery

...but defend your right to utilize advanced technology; giving up costs today makes it much harder to get funding in the future

• becoming a mentor to junior surgeons and promote the practice of CT surgery

• employing effective marketing strategies to drive referrals (advertising, web casts, speaking engagements for patient audiences, cardiology dinners, etc.)

• monitoring and benchmarking clinical outcomes and disseminating the information.

In conclusion, cardiothoracic surgery demands a re-definition of how best to provide care for very sick patients. Previous knowledge on how to run a practice is not working to advance the specialty or to build upon the success and durability of surgical procedures whose historical clinical outcomes are undisputed. The time to act has come. Get engaged. Be a leader. Embrace change. And enjoin industry to be a navigational partner to guide towards new horizons.

	5. Key issues

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 

1. Is EACTS willing to accept the risk associated with the learning curve of surgeons during a period of transformation and skill development and how can the society work with industry to create opportunities for training?

2. How do we ensure that new procedures and technologies are being taught during residency?

3. Why is Europe so open to trial new procedures or products (with the majority of clinical trials are done in Europe), yet they are typically the last to adopt these as a standard of care? How do we address this?

4. What are the mechanisms for introducing new technologies in Europe? (reimbursement issues, for example)

5. Should cardiac surgeons navigate their way to becoming cardiac interventionalists—creating for themselves an armamentarium of invasive and percutaneous procedure options for patients?

	Appendix

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 
Conference discussion

Mr B. Keogh (Birmingham, UK): You started your talk by saying that when you took over the post you looked at future options and that you discarded a lot of the options that surgeons were putting forward, or that was your implication. Why, and where do you think the ideas for the future options could come from, and what makes an idea clinically strong and financially compelling, in your view?

Mr Guezuraga : It is probably an overstatement to say that. Really the message I was giving was, I don't go to cardiothoracic surgeons and ask them to give me strategy, I don't even ask them to give me product solutions, even though there are some surgeons who really have a knack for ‘product solutions’. I marry those surgeons with my researchers and then my engineers, that then evolves into a product that we then can take into a broader community to do clinicals, and it is just my perspective on strategic direction. You called it wrong.

So unless we start doing things differently, then I have to continue to look at the problems that you identify as clinical issues within the community that you serve and does that allow Medtronic to make the investments with its corporate strengths. Now obviously, we are not going to get into too many things that we don't know anything about.

Dr J. Vaage (Oslo, Norway): Thank you very much for this very interesting presentation. I think that when a big company like Medtronic makes this decision to actually go very actively into cell biology instead of traditional cardiac surgery products, you must have done quite a lot of thinking about how you envisage the future of cardiac surgery. Where do you think cardiac surgery will be in 20 years? How much will be similar to cardiac surgery today?

Mr Guezuraga : I don't think it will be anything like the cardiac surgery that we have today. I think cells will be an important part of what is happening at that point in time. I think techniques that are less invasive, whether it is endoscopic or whether it is catheter-based, are going to be the direction. I think there will be components, whether it is the robotics that exist today or a subset of a new generation of robotics that will allow us to work with smaller incisions, with vision, and still be able to provide the therapy. I think there is going to be more technology brought into cardiac surgery than ever before, whether it is proximal and distal anastomotic devices, vision devices, devices to manipulate the heart, devices to deal with AF. We at Medtronic are not into LVADs, but that is certainly going to be part of where things are going in the future. I continue to evaluate that every year.

My prediction would be you won't be doing anything 20 years from now that you are doing today, other than hopefully interfacing with the patient.

Dr D. Birnbaum (Regensburg, Germany): Marriage with industry is unfortunately not always to the best. Our experience so far does not come out—at least not in all cases—to really solve our problem to do the best for the patients.

Valves have been developed as long as we perform cardiac surgery; hundreds of different types are on the market. But the key problem of a valve is not solved; the simple problem how to have no coagulation on the industrial valve. So my desire is that industry should support what we really need to know, the basics! However, investigation into basics is short thinking, and nobody likes to invest into short-term research with uncertain outcome for a product perspective. But I am convinced that there is absolutely a need that we start to understand things meticulously and then transfer this knowledge to a product, which is in favor. Allow me the example of scientific journals reporting about the myocardial revascularisation by laser technology. This was an investment of money. Paul (Paul Sergeant) just voted for economics in health care—how do these both perspectives matches? Investigation led to a product, which effectively did give no help to patients. Patients did not profit from this marriage.

These and other experiences should make us hesitant to new technology on cell replacement and repair. It is nice for the investigators to know that in a few years the valves will be implanted, which are tissue engineered. As clinical researchers we should have learned our lessons and be carefully with these perspectives for uncritical use of products by implanting in patients. Learn first what are the demands of a cell layer on a valve, what are the specific functions of these cells instead of seeding cells which are simply fibroblasts on some sort of scaffold. We should not follow the experience to implanted these news and stand-by to look whether it works or not and if it works for three weeks then go to the clinics and implant it into the patient. My question is on the industrial part, could it be possible that the investment of money should first go to level up our knowledge, and this by the step ‘back to the roots’, that is basic science. On this basis with a tied junction with the clinical researchers not uncritical utilizers—a new product will be realized to the satisfaction of all. Then you will have to profit because the product is worthwhile, will be used in great number and last for long periods.

Mr Guezuraga : The type of product that you are describing is not a product that is going to be out there the next three to five years. That is a product that has to have, yes, basic research, it has to have a lot of animal work done with it before we even begin—to use terms that we used today, we don't want to be experimenting on people.

At the end of the day, at a company like Medtronic, the most important thing that we live by, as it is a very mission-driven company, and that mission was written by the founder, Earl Bakker.

At Medtronic it starts with the patient, to make the kinds of contributions for restoring health, alleviating pain and extending life. That is part of the business plan at Medtronic, it is part of the strategy. But there are some products, whether it is visualization devices, whether it is stabilizing devices, whether it is conventional repair products, you don't need to have a 10-year life cycle within research and engineering.

Dr W. Klepetko (Vienna, Austria): I think the strategic concept that you have shown us for Medtronic to fuse the knowledge of a device-orientated company with another company which has more knowledge on the biological side is a very nice paradigm how we should act as surgeons.

In my opinion, we still are too much on the mechanical side of our profession. It really needs to expand this mechanical side to the other side, which is becoming more and more important throughout the last years, which is the biological side, and only if you are able to create concepts and education and activities in both fields together to fuse these knowledges, I think we really can go forward. It doesn't mean that we should avoid certainly or stop any activities on our mechanical side where we are very strong, but we have to really expand the activities in the other field much more as we do that right now and even much more as we most likely foresee it right now.

Mr Guezuraga : The thing that we can't let happen, which is happening in cardiac surgery, is to let it become a commodity. Now, the products that come into cardiac surgery have become a commodity. We talked about mechanical valves, when is somebody going to design a valve that doesn't require anticoagulants and drugs? Well, I don't think anybody is, and the problem is that these devices sell now so close to cost, there is nothing left to put back into R&D. If you look at the conventional cardiopulmonary circuits, there hasn't been much of a change in the last 10, 15 years other than a new system we just introduced, and the reason is, it has become a commodity.

If somebody from industry were to go into a hospital to try to sell a cardiopulmonary circuit, and before you get into the feature set, you are talking about cost, cost, cost, and you no longer have research dollars, because that is where it comes from. The sale of the product drives back revenue into the business to go into R&D, to go into basic research. It has to be earned, and if it doesn't get earned, then innovation doesn't come out.

Dr D. Cosgrove (Cleveland, OH, USA): Bob (Robert Guezuraga), you are in a very unique situation as one of the sole representatives of industry here, and if you look at us as a business and knowing that we are surgeons and we are probably not going to change from being surgeons, what do you think the single biggest opportunity for us is in the next five years?

Mr Guezuraga : I would say that you have to change, and I would give it a 20% probability that you are going to change. So I think you need to find drivers within your peer group. It is almost as if you have to hire a business manager to run the cardiothoracic industry such that we focus on how do you get growth in the number of procedures, how do you get growth in the revenue that is going to come into your hospital.

Dr Cosgrove : What would you have us change to?

Mr Guezuraga : Well, a little more of a risk taker, to move into the areas of less invasive quicker, to foster the younger surgeons to get trained to get into these areas that are a little bit riskier, and if you have a problem, that somebody is going to help you through it and it is not going to destroy your credentials. I don't think you can be risk adverse.

Now, that is very easy maybe for me to say because you are there dealing with a life and a patient, but so is a cardiologist. At the end of the day, I know when they go into the hospital, they want to do what is best for that patient also.

Dr A. Haverich (Hannover, Germany): I think it was a great talk covering pretty much everything I would have expected. I am picking two points. One is what you just mentioned, risk, conservative, not taking risk, and this is I wouldn't say an accusation but a criticism towards our group here. I would put that criticism back, and a little bit echoing what Dr Birnbaum said.

You purchase, get Genzyne, at a point where Phase I clinical trials were done.

Mr Guezuraga : We didn't purchase them. We formed a new company.

Dr Haverich : Okay, but before that you were not interested at all in terms of business regarding biologics. This was your first step into that arena at the time where Phase I was done. So if we as researchers and clinicians come with new ideas to the medical product companies like Medtronic and say, well, we have this idea, there are always two questions: what is the time line and the risk behind it and what is the market behind it? And very often, based on my personal experience but also based on the experience of others, the medical product companies are very late and are not taking much risk and are very conservative in dealing with that. And I would like you to comment on that, why not go earlier into these development stages and helping those academic institutions at earlier stages of developing new ideas that might turn out to be products?

And the second point is I think the take-home message, which is probably most applicable to Germany, that we have to deal with reimbursement issues and take care that reimbursement is kept at a higher level in order to get into a proper context with industry and also improved treatment for the future.

Mr Guezuraga : At Medtronic, three years ago we didn't understand biologics, we didn't understand genes, cells and proteins, but we had new people come into the organization that had that skill set. They met with what is called the Executive Committee at Medtronic, which is basically the 10 most senior people within the company, and educated us, because, at the end of the day, we are device people; we think along the device side.

But we do spend a lot of time, and when I say ‘a lot of time’, if you would sum it all up, probably three or four weeks out of a year where we just think strategy and what is the disruptive technology that could be coming at us that could destroy the value of a company like Medtronic, a company that is 55 years old, that has a global presence, that has a fairly strong reputation in the industries that it serves today, and yet it is a company that plans to be around for another 55 years, and to be competitive in that environment, we have to also change. We have to re-engineer who it is we are as a company, and we think that is going to be part of it. And I could be dead wrong. You know, genes, cells and proteins could be 30 years away, but at least we are moving in that direction.

We will spend this year in excess of $1 billion in R&D. The gene–cell–protein company formed with Genzyne, it is not Medtronic and it is not Genzyne, it is a new group that we formed, and we will fund part of the research and development there, as will Genzyne. And, yes, we sort of watched from the side the early clinical trials that were being done, and it was because we really didn't understand it. There were people within the company who understood, but the device people like myself didn't understand until we got educated.

Dr C. Mestres (Barcelona, Spain): I really enjoyed your presentation so much, but let me challenge you a little bit. My feeling is that what you showed to us is basically the American perspective, if I am not wrong, is it? So the thing is how to approach a kind of market like Europe today. So your company made a big change five years ago because you are working for profit. I do work in a place and in a country in which we do not work for any profit at all. Now, our constitution entitles everybody to get free medical care. That is basically a human right. But it is a tremendous gift. There are so many reimbursement issues. The expenditures are going down, our salaries are also going down. At least in my institution, some colleagues over here, we have been asked to cut down everything for about 5% for 2004. The administrators, they don't really get interested in anything else, including the patients, only in cutting down costs.

The easiest way to handle patients with aortic stenosis in Spain is let them die on the waiting list because there is no implantable device to be implanted, something like that. It was an issue not so long ago in my country. And myself, after more than 20 years of surgical practice, I am getting less salary, I am getting everything less.

That is the point. Europe is getting bigger, much bigger than what you mentioned, those figures before, the incorporation of 10 more countries. So the cake is as big, but we have 10 more people trying to eat the cake, and they are not rich people. They are even worse than the Spanish. We used to be quite poor for years; we are still poor.

So how can you address those issues that you mentioned in your presentation? You mentioned that one of the ways to introduce new technology is talking about reimbursement issues and so on, but we are facing a critical time in Europe. I am talking about myself in Spain, in Barcelona, in a university hospital, which is supposed to be some prestige, but at the end, I am getting paid less, I am asked to do more with less, for less, and I am left to the discretion of everybody, from the prime minister to the cleaner, because they can scrutinize myself and everybody can sue me. So can you give me your input about what is going to happen from your American perspective in Europe for the coming 5, 10, 15 years in these current conditions?

Mr Guezuraga : I will come back to what I opened with, and that is, if you let somebody else control your destiny, you are not going to like the way it comes out. There are a lot of cardiothoracic surgeons in Spain. There is a Spanish Society. I have supported the Spanish Society for years. But that Society has to be proactive, it has to go out and lobby, and lobby is awareness by the patient so that you get an advocate who is coming through that front door and doesn't want to be on the waiting list and die, and that you and your Society, go to the government and you lobby for stronger reimbursement for procedures, for yourself, such that the best and brightest come into your profession and they don't go off to become software developers because they are going to make a lot more money doing that.

I don't have the answer, but my advice to you is just don't lie down and let it happen to you.

	Footnotes

 
Presented at the EACTS Symposium for the Future of Cardiac Surgery, Frankfurt, Germany, July 1–2, 2004.

	References

Top Abstract 1. Introduction 2. The current practice 3. Drivers for change 4. Options for progress 5. Key issues Appendix References

 

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