Client Forum – KCI

Headquartered in San Antonio, Texas, KCI develops and markets innovative therapeutic systems that deal with wound healing, address skin breakdown, pulmonary complications and circulation problems associated with patient immobility. KCI's systems include specialty beds, mattress replacement systems, wheelchair seating and related devices. KCI serves hospitals, nursing homes and home care settings both in the U.S. and abroad. HBS Consulting which is currently working alongside KCI, spoke with Frank Di Lazzaro, Vice President to discuss the major issues facing the European wound care market.

HBS Consulting: Irrespective of the setting within which wound treatment takes place, whether it be in the primary or secondary healthcare sector, there seems to be no standard approach to treatment. Would you agree that lack of information or lack of interest in what is actually happening within the wound bed can lead to surgeons or nurses adopting an attitude which suggests that they will use whatever products are at hand rather than specifically using products that are ideally suited for different types of wound?

KCI: I think wound healing is a very complex process and by its very multidisciplinary in nature (in terms of the science that underlies our understanding of wounds and how products are developed to treat them) there are a number of people involved in the treatment process. There are many different scenarios where carers are confronted with a patient presenting with a wound, the wound is surgically created, or complications have arisen with a wound, which is already undergoing treatment. Within such settings there is never one individual totally responsible for treatment or management of the wound. Due to differing care settings and differing patient complications effective treatment can be bypassed. Some of the more successful wound healing programmes are those that involve input from multidisciplinary teams. There is a wound healing team in the University Hospital in Denmark under the direction of Professor Finn Gottrup, which is one of the first of its kind. The basic functioning of the team is to raise educational awareness of the types of products available and in which situations they should be used in the most cost-effective manner.

In Professor Gottrup’s department, team members come under his supervision and the team has a number of beds dedicated for patients with wounds and any patient presenting with a chronic or complex wound falls under their care. They have developed treatment protocols that standardize their approach in treating wounds.

HBS Consulting: You mentioned Denmark as an example of a country where a specific approach to wound treatment is taking shape. Within the European market do you see other countries where wound healing is perhaps more advanced, comparatively speaking or where levels of wound care are different?

KCI: I think that there is certainly a hierarchy in knowledge and usage for the treatment of wound care amongst countries in Europe. You can rank them in terms of expenditures and the level of visibility of the problems in dealing with wounds. One might consider the UK as the more sophisticated and the more aggressive when it comes to confronting the issue of wound management, they have lead the way but the other countries are quick to develop their own programmes. The UK has develop a group of speciality nurses, Tissue Viability Nurses (TVN) who comprise specialised units for the treatment and management of wounds. Other countries have not elevated the issue to a high priority based on recognition of wound healing as a major healthcare problem or one involving a high level of costs. I would say that from the viewpoint of levels of sophistication for treating particular wounds that the UK and Germany would be at the top end and France, where the use of very old technology is high, would occupy a low position. The factors, which impact on this view, are partly based on level of interest and partly on the reimbursement situations.

HBS Consulting: When we consider the use of sophisticated products or treatment protocols in wound care do you believe there is a difference in the approach dependent upon whether care is given in the hospital or community?

KCI: I think that there is a very distinct barrier between treatment of complex wounds in the hospital and how such wounds are treated in the community, with the approach being mainly driven by how products are reimbursed. It is very difficult to manage the transition of new technology, new devices or advanced wound healing products from the hospital to the home or community setting. This is because of the lack of coordination between care settings and how funds and budgets are set. The visibility of patients in the community is much less than in the hospital. If you have a patient with a wound in a hospital bed for long period of time the situation is clear whereas if you are treating a patient in the community the time frames within which the patient is under treatment are less clear. Within the community the patient could be treated with the old saline and gauze products; there is a price sensitivity in this setting and there is an educational or knowledge base that is greatly different. I would say that the transition from hospital care to community care has not progress as rapidly as it should. The UK does not have a national programmes and there are regional variations regarding community-based wound care treatment. I think in Germany dressings are reimbursed as part of their reimbursement systems but it is really, again, not a national programme. There is no real national approach, dictated from the governmental level, on how to deal with wounds either within the hospital or at home and more importantly how to transition from care settings.

HBS Consulting: What do you see as the key difference between the US and the European markets? Have there been any major developments in the area within the last few years?

KCI: There certainly have been some developments, primarily in the recognition of the different problems associated with chronic wounds as opposed to acute wounds and the understanding that wound care poses problems both from the social and economic perspectives. No-one has really addressed these issues effectively to date but at least with the recognition of the problem there is room for movement on the issues. Ten years ago there was thought to be very little cause for concern, but now problems have been identified and there are moves to implement methodologies to address these problems. I believe that the USA has always been further down the road in terms of its understanding and recognition of the difficulties with adequately treating wounds, and part of this lies with the litigation processes associated with improper treatment. Even when someone acquires a pressure sore while staying in hospital there is potential for the hospital and caregivers to be faced with financial liability. As the UK is probably moving towards being the most litigious of all the European countries the issue in that country is perhaps a little more advanced. The legal system is driving the recognition of wound problems. This can be the consequence of whether wounds/infections are being acquired in the hospital as a result of a patient’s consideration that they are not being treated as effectively as they should.

HBS Consulting: Are you saying that the recognition of the problem might not be coming from surgeons but rather is dictated more by the pressure of litigation?

KCI: I think that litigation is making the problem visible and forcing the community to review their practice. I think that Physicians will always want to solve the problem but how they deal with it sometimes depends on the type of wounds, which confront them and the resources available. Some might consider that chronic wounds are not sexy, no surgeon really seems to wants to deal with diabetic foot ulcers and the care of the actual wound may really fall under the nursing responsibility. Nursing environments are now constrained with budget restrictions and how much can be spent on wound care products to the extent that they may not necessarily be at the most advanced end on the market place. Surgeons and physicians get involved in really high end dressing - we have had AppliGraf or Dermagraft and skin substitutes are really attractive and surgeons and physicians are getting involved in that. But I doubt that there are very many surgeons that make the decision on whether to use one hydrocolloid versus another company’s hydrocolloid or an alginate.

HBS Consulting: So do you think then that technical innovations might have been moving the market from a commodity market of simple gauze dressings for example to a more sophisticated market by engaging the interest of the surgeons in the area?

KCI: I think the numbers will vary from country to country but still if you were to look at the usuage of products , I would say 70% of wounds are still treated with standard old-fashioned gauze dressings. The advance wound dressings are continuing to make market gains because of the increasing knowledge on dealing with complex wounds. In the hospital side you will probably see the standard of care resting on the side of advanced wound care dressings. The community approach will still be wet and dry. The level of education in the process is slow and time consuming. To get a physician interested, to bring a specific dressing to them is not going to create excitement. However, if you can address a surgical issue or you have something that is an innovation, as I have stated like the skin substitute type products, then the physician sees a clinical need that they feel they can address and the results are visible.

HBS Consulting: One of the complaints of physicians regarding wound care products is that there is not enough clinical evidence to back product claims. Therefore they find that sometimes it is difficult to not be sceptical about newer innovations.

KCI: I think the clinical evidence in wound care has always been open to challenge. They have been very poor and lacking appropriate scientific appraisal. However, the truth is that is very difficult to carry out double blind randomized trials on any particular type of innovative dressing or device. Difficulties lie in matching sample sizes for example. Classing identical wounds requires a very large sample size due to the very subjective nature of the assessment…the assessment of wound sizing itself is also very subjective. It is very difficult for companies to provide good clinical data as there are no clear consensus which allow people to agree that a wound has been effectively treated and where one can say that the use of a particular treatment has brought about a fundamental change. As a company involved in this area we continue to try to create the most effective protocols which might provide good clinical evidence of the effectiveness of our treatments but again there is always a problem with subjective assessment of results. So there are very few studies that are published that would really survive the scrutiny of a good scientific and clinical review of the trial protocol. Overall the science on a cellular level is fairly straightforward but that has not really solved the mechanism of wound healing and how we should intervene in the process. The goal for treating physicians lies in assessing how to transform a chronic wound into an acute wound because then an acute wound has a normal wound healing protocol and it is in the transition to a normal wound healing process and it think that’s where products can play a part.

There is an element of hit and miss in the process for companies and the products that they supply. Do they add a growth factor, do they take proteases out, do we know whether something can be effective in a particular stage of the wound healing cycle or is it negative in another stage of wound healing. There are a number of intricacies in the whole wound healing phase which renders the whole process very complex. With these complexities one is left wondering how to create a clinical study within which you can show that you have a product that can work very well. If your study phase takes place from start of treatment to complete closure the nature of the change in the wound may vary from patient to patient. These are valid criticisms levelled at some clinical studies and the result may be that the studies present little in the way of compelling clinical evidence of treatment success. Most physicians are basing a lot of their choice on which products to use on personal experience.

In some countries wounds are treated with honey and one can ask…why? There is some speculation as to what is occurring at the cellular level when using this particular treatment but the exact same treatment does not work for all patients. Some clinicians believe that certain methods work in their hands but not in others. That is why we have a variety of treatments differing from country to country.

It is going to be a really interesting meeting in July 2004 at the World Union of Wound Healing Societies Congress because there is a belief and hope that information will begin to be dispersed which will lead to clinicians worldwide starting to standardise the protocol for treating certain types of wounds in a more systematic fashion. We will still have people doing things at the local level which have been shown to work but which other people in other countries might be found scratching their heads wondering why a particular practice carries on. Debridement is a case in point, where surgeons use maggots to treat wound infections and this is again becoming more and more popular. Maggots have a debridement element and an antibiotic or antibacterial effect. This was very popular in the 1930s and 1940s until the discovery of penicillin, which then took precedence as the modern day treatment of choice amongst surgeons. So one wonders whether we are in a cycle. I don’t know.

HBS Consulting: What kind of changes have happened in the last few years in wound care?

KCI: I think through the late 1990’s, 1995-96 and 1997 traditionally all we saw in wound care was duplication, people were not looking at different ways of treating wounds but coming up with slight improvements on existing products so there was a proliferation of hydrocolloids then the alginates were introduced and there was a proliferation of alginates. Now we are seeing silver added to everything and the effect of silver on bacteria is well known, it has been used for centuries. So what we see are small changes but changes, which essentially do not really address what is happening in the wound.

No, I think there is a factor where people are looking at trying to really understand what’s happening in the wound site, to see how they can intervene and at what stage a particular type of intervention is called for. I think part of it is now understanding when we should be using certain products, for how long. I think the economics of the whole treatment phase is being addressed, it has not been resolved because I think the different dynamics in countries for how funding for healthcare is carried out varies, so the economic argument is going to be different fro country to country, but the lack of treatment is becoming an important factor to resolve the problem quickly. I believe there are still a lot of wounds that are not being treated, especially in the community. So I think there is an awareness now, in the economic sense. I think the direction lies in trying to be more selective as opposed to having one particular product as a panacea. I think in treating wounds (there) is no silver bullet and I think that there is recognition of this and people certainly realise that you have to be looking at the patient and creating a unique wound management programme. However, as far as innovation in the last 5 years, and this is to quote one of the leading professors of wound care Keith Harding, V.A.C. (Vacuum Assisted Closure) is one of the unique innovations to enter the wound care area over the last 20 years. We are seeing that having an impact on the marketplace.

HBS Consulting: Before we talk a little more about VAC may I ask you whether you feel that the lack of cost effectiveness awareness is still a barrier to market expansion in Europe?

KCI: I think it is still a very large barrier and no one has addressed it effectively because it is very complex to devise the economic model. In the United States length of stay is very important, the importance of length of stay varies from country to country. We have DRG systems in the US which drive efficiencies, or supposed efficiencies. One would consider in the UK with all the waiting lists, that to clear beds quickly would be an incentive to use technology that will treat the patient quickly and move them out of hospitals so that you can open up a bed. However, there are various ways of approaching that and that has never been documented in a cost benefit analysis, but you would think that there would be an incentive. In a number of other countries they are just not looking at how they measure cost effectiveness. It comes down to unit price, purchasing people look at cost of a dressing. One dressing is €5 another dressing is €10 … we bought the €5 one because where is the benefit in the unit €10 one? So companies are trying to provide decision makers with the clinical positives and then the cost benefit of using a €10 versus a €5 dressing. The success really varies from country to country. We have been successful helping surgeons solve surgical problems especially with the management of dehisced wounds that have high rate of mortality associated with them, so there is a really clear black and white even though we have to quantify to the exact euro the savings benefit. Intuitively, they know that these types of wound are very expensive to treat and manage and that the average treatment time is extremely long. So there is an intuitive ‘this is expensive’, so anything that is able to manage this type of wound is cost effective. When put down to actual dollars and cents, we have not been able to do it, I have not seen many studies out there that are able to tie that down and I think it is something that cargivers and companies will work towards, but we are not there yet.

HBS Consulting: How do you interpret the success of the VAC in this climate? Is success due to its proved clinical efficacy or to claims of cost effectiveness?

KCI: I think the success of VAC is that it truly produces very dramatic results very quickly and is a treatment and is not adjunctive in the sense that we are not adding to existing modalities but we are doing it instead of other modes of treatment. So, instead of putting hydrocolloid in, or ointment and so on a particular wound is just treated with the VAC procedure. So it is very clear what is working. The results are very dramatic and very quick so there is a point where the patient becomes their own study and we have had a number of situations where we have been able to treat one wound in the same patient one way and the other identical type of wound with VAC and this has served as kind of a mini clinical so it has been able to quite quickly show to the user a positive result that’s distinct. If it wasn’t for that I believe that the acceptance of the technology would have been much lower and the process much longer. However, because after two dressing changes the clinician is seeing something happening in the wound site and the amount of fluid that has been taken away from the wound is visually measurable that has served as sufficient clinical evidence to get initial users who have then become more proficient users of the technology.

HBS Consulting: At the moment, are you targeting the high end of the market, where the most difficult wounds are treated with this technology?

KCI: We are developing dressings that are wound specific and we are developing protocols for different types of wounds. If you recognise over the years that, as I mentioned earlier different products will have different impacts depending on whether they are used or not in different phases of wound healing, VAC is unique in that it has the ability to be able to provide a number of positive interventions in the wound. This is whether we are drawing fluid out, whether we are increasing blood flow, whether we are reducing bacterial load. There are a number of things in the mechanisms of action of VAC that addresses different areas of the wound healing cycle. So we understand now that we need to fine tune different dressings associated with the VAC system for different types of wound. Our dressing are becoming wound specific

HBS Consulting: Different types of wounds? Different stages?

KCI: We are certainly segmenting into surgical wounds and also chronic wounds, within chronic wounds different types being, diabetic ulcers to pressure sores and different surgical applications. VAC is used a great deal for the open abdominal wound and is also used for infected sternum so we are looking at those very specific types of indications following a specific type of protocol of different type of wounds. So we are addressing a very specific need on the dressing side and also on the clinical side.

HBS Consulting: What do you think has been the impact of the VAC machine within the advanced wound care market in Europe in the last 5 years. What parts of the market have you been able to capture and what are your plans for the future? What do you think will happen?

KCI: I think we have been very successful in addressing the surgeon’s needs and particularly with surgical complications that are associated with the incision and I think that has been the area where we have really come to the forefront. Our ability to attack surgical problems and complications that are costly and to manage the high risk to patients has made the acceptance of the therapy quite high. There tend to be people that have adopted the procedure and used it as part of their treatment modality when major complications have arisen. By establishing effective protocols VAC is moving towards becoming a standard of care for specific type of wounds.

HBS Consulting: Are there any other expansion plans from KCI either geographically or product wise?

KCI: I think on the product side we will continue to expand VAC on both clinical usage and different indications so that is pretty much our primary focus. Geographically we will continue to expand or evaluate long-term opportunities and expand according to the level of sophistication and the healthcare systems.

HBS Consulting: What do you think is the key challenge that wound care has to face in the next 5 years.

KCI: I think the problem associated with managing wounds is increasing. All the demographics show that it is going to be an increasing problem because of the ageing population. The challenge will lie with how we manage the increasing need cost effectively. Problems lie with how to assess which type of products, and which modalities are most effective in different scenarios. Due of the lack of good solid clinical comparisons and the subjectiveness of any trial it is always going to be difficult to have a black and white answer. I think all the wound care societies are really striving to educate, to develop standards because if you treat a patient one way and follow a systematic treatment protocol, and another specialist treats the same type of wound in a very haphazard way then it is very hard to draw comparisons in ay data that is being collected. The challenge is, and I think one of the things that societies are trying to do, is create a more standard mode of treatment worldwide…. a standard of prescription of wounds so that it makes more effective to make comparisons from country to country and from even hospital to hospital, so that everybody is speaking the same language. So the biggest challenge is to create a common language. I think key people in the wound healing societies all believe that that is what you have to do and so that we are now talking the same language so if somebody says I treated this wound like this, they all know what they mean and the end result was X. They all then have the same end point, start point but right now, a lot of what we read, a lot of what is discussed, a lot of what is being presented, there is an apples and oranges scenario. If we are able to create this common understanding then a lot of the issues and uncertainties in a number of areas where we are not being scientific enough will start to go away.

HBS Consulting: Which societies do you work with?

KCI: On an international basis we work with the International Wound Care Society. At local levels we participate with all the wound care societies. In fact KCI has been instrumental in helping certain societies get off the ground. Certainly, we have helped to develop and support the Asian or Singapore wound healing societies. Over the last ten years a number of these have just come to being. I think the societies are the important vehicles in bridging that gap in communication and education. So we have been active on this level. Other companies I think also are. Industry has recognised that to elevate wound care to it’s rightful level in healthcare we need to work very closely with professionals and clinicians and so the industry, the other companies in partnership with KCI have worked closely with the societies.