Addressing trends in healthcare needs

In the UK, patient access to the latest innovations in medical device technologies, biotechnology and pharmaceutical interventions is lagging behind a number of other countries in the EU, Canada and the US – an issue that the Government is now attempting to address. Lord Darzi has identified the need to speed up adoption of new technologies and innovation within the health service, while the Government has placed an increased emphasis on the life-sciences industry, in general, as a key strategic sector for the future of the UK economy. Colin Morgan has an influential part to play in driving forward the Government’s ambitions in this field – both through his role as co-chair of the Ministerial Medical Technology Strategy Group (MMTSG), and as managing director of Johnson and Johnson Medical. The global spend on R&D by the Johnson and Johnson group as a whole was a total of $7.6 billion in 2008. He commented: “It is unclear why the UK is slow to adopt technologies once they have been proven – it may be a cultural issue, a tendency to be risk adverse, or due to barriers in NHS procurement processes. However, it is apparent that there are issues preventing access to technologies that have been available for around five or six years. Laparoscopic surgery, for example, was introduced in the late 80s or early 90s, but adoption for some procedures has continued to prove slow.” In the case of laparoscopic surgery, he pointed out one of the key issues is the fact that the cost of the equipment is often not matched with the benefits achieved within primary care through reduced complications and faster recovery. “Payment by Results is now trying to match costs with outcome benefits, but, at present, it is less than receptive to the addition of new technologies in the way it is deployed. Therefore, a review is underway to establish how the existing funding mechanism can be made more responsive to new technologies coming onto the landscape,” he continued. The Government, the health service, and industry, have been collaborating to identify trends in the market and establish exactly what will be required from a planning perspective to meet the healthcare needs of the future. Obesity and ageing demographics have been identified as key challenges for the healthcare sector in the 21st Century, and are becoming major focus areas for medical device innovation. These are reflected in Johnson and Johnson’s research and development plans, which were recently presented at its European Summit. Senior managers from Johnson and Johnson’s medical devices and diagnostics business provided an insight into how the company plans to address unmet healthcare needs and the key challenges facing the healthcare sector – both from an economic and patient care perspective. In particular, the early diagnosis an treatment of age and lifestyle-associated conditions (such as diabetes, cancer, osteoarthritis, heart disease, and vascular conditions) were identified as important target areas for investment, along with technologies aimed at advancing bariatric surgery. “There is greater scope for diagnostic tools to be used much earlier in an individual’s life, which would allow patient care to be planned more effectively and enable the prevention of comorbidities – including those associated with diabetes which may result in vascular and cardiac surgery. It would also reduce the need for long-term wound care,” Colin Morgan continued. “In the past, we used to accept the limitations imposed by old age. Today, we are a lot more demanding of our bodies and do not want to change our lifestyles, so the demand is increasing for new medical treatment to enhance our quality of life,” added Diogo Moreira-Rato, international vicepresident, Johnson and Johnson MD&D, Western Europe and Middle East. He further commented that with these opportunities also come challenges: “Given the current climate throughout the world, at present, we foresee there will be price pressures across the areas where we operate. There will be a lot of questions around access and affordability. “Patients now have access to more information from the internet and are more in charge of their healthcare – they want the latest techniques and approaches, but this has to be delivered within the context of finite resources and increased demands on health services.” Other key focus areas for Johnson and Johnson will be advancing minimally invasive surgical approaches (with a view to speeding up patient recovery, reducing hospital stay, and minimising trauma), as well as prevention and control of healthcare-acquired infections. Technologies that reduce the economic burden on the health service will be increasingly important, along with those that offer the potential to move the site of care to more costeffective locations outside of the acute hospital setting.
 

     Orthopaedic challenges
Alan Ashby, vice-president, global concept development, DePuy (a Johnson and Johnson company) provided an overview of trends and advances in the field of orthopaedics, spine and trauma treatments. In particular, the company has been involved with the treatment of osteoarthritis at the early stages and the end stage treatment through joint replacement. However, there is also an opportunity to focus more on the intermediate stage as the disease progresses. DePuy is now looking to achieve a “continuum of solutions” to meet the long-term needs of patients throughout their lifetime. Solutions for early intervention are being pursued by the DePuy Mitek business, through the development of treatments for soft tissue injuries using minimally invasive surgery. It is widely reported that those who have an untreated traumatic cartilage injury at a younger age are at risk of developing osteoarthritis later in life, and the company is currently pioneering in the field of regeneration systems for articular cartilage repair. It is also becoming increasingly involved with diagnostic approaches. In the spine, for example, methods have been developed to predict the outcome of scoliosis in the teenage adult so that personalised treatments can be designed to meet the individual patient’s needs. Another emerging area is the injection of acrylic cement to reinforce the degenerating spine resulting from osteoporosis and fractures. The main business area in orthopaedics, for DePuy, is arthroplasty, however, and key growth areas include hip and knee joint replacement. The company provides prosthetic implants and instruments required to perform such procedures. Joint replacement procedures in general have been highly successful, and knee replacement now offers around 20 years’ survivorship. This means that in 98% of cases the knee joint will be functioning in situ, providing pain relief and continuous performance for a 20-year period. Hip joint replacement shows similar performance in 95% of cases. It is also very cost-effective, with data pointing to $10,000 per quality life-adjusted year for total hip replacement. “This level of performance is unequalled across the range of surgery in the modern world, and has led some clinicians to describe joint replacement as the ‘operation of the century’,” commented Alan Ashby. “While an ageing population will provide commercial opportunities, we are not complacent, and the demands of the market are continuing to place extreme pressures on us. “Demographics are driving the increasing incidence of osteoarthritis as the population ages, while the growth in healthcare spending to address this increasing need is outpacing the growth in GDP. This will not be a viable situation in the long term,” he continued, adding that “diseases of affluence”, such as obesity, are also increasing in prevalence. “The pressure on us as a business is to ensure that we continually reduce the overall costs of treatment and improve the productivity with which these treatments can be delivered to the general population. Other issues affecting us are the expectations of patients,” Alan Ashby continued. “They expect to be able to continue to play sport and to enjoy a very active life, long into their old age, which means the performance demanded of prosthetic implants is continually being stretched.” He commented that the trend in orthopaedic surgery is to provide earlier, more customised intervention in younger, more high-demand patients, while patients are expected to be more rapidly rehabilitated after receiving prosthetic implants – ensuring a shorter hospital stay. Solutions for younger patients are also now expected to work harder, for longer. This has implications for the design of prosthetic devices, according to Alan Ashby: “As intervention is being provided earlier in a patient’s life, it is critical that devices maintain future options for these patients. It is also important that we consider the patient’s needs throughout their life, after their first intervention, and how subsequent solutions will continue to provide mobility.” R&D is currently focused on developing solutions that achieve greater bone preservation and more effective, long-term fixation into the skeleton. Another key issue is the need to optimise soft tissue preservation through the design of the surgical approach and the device, so that the patient can be rehabilitated as quickly as possible. “In an active patient, these implants can be used for up to 10 million cycles per year, which is a very demanding level of performance. The articulation between the two elements of joint replacement is a critical area of development, therefore. The latest products show a new configuration of ceramic against metal articulation which is designed to minimise the amount of wear debris that is created by the articulate couple and thereby minimise the effect on the skeleton. This ensures a long-lasting articulation that can give the patient 30-40 years of use – hopefully for the duration of their lifetime,” Alan Ashby commented. Treatment cost and productivity are also important considerations, as there is a drive for manufacturers to provide solutions that allow procedures to be performed by lower skilled practitioners, in less expensive locations. “It is not just about the design of the prosthetic components, their management of the bone, the kinematics, and the way they are ‘locked’ into the skeleton, it is also about designing the surgical process to ensure it is accessible to as many surgeons and as many cases as possible,” he continued. “We use a number of tools to help us achieve this, including computer-assisted surgery. Instruments can be effectively ‘tracked’ so that the surgeon can see exactly what he is doing against a plan created for the individual patient. The aim is to improve surgical accuracy and reliability in minimally invasive procedures where visualisation is limited.” An increasing trend is the use of custom patient instrumentation – a preoperative image is used to develop an implant device that is custom fitted to the actual anatomy of the bone of the individual patient. This reduces set up and turnaround times for operating theatres by eliminating the need to set-up multiple trays of highly variable instruments. “A time saving of 15 minutes per procedure, resulting in one or two extra cases per day, can make a big difference to a hospital’s capacity,” commented Alan Ashby. The custom-designed implants are currently used throughout the US, and there are now plans to introduce these into the UK. The devices have been used in around 12,000 cases out of 600,000 knee joint replacements, but the company predicts that utilisation will eventually reach 30%. While the main growth areas will be in joint replacement, trauma, and spinal products, Alan Ashby also predicted that, in the next five years, the market will see growth in the emerging areas of orthobiologic and regenerative technologies.

Cardiovascular solutions
 Nadav Tomer, vice-president marketing EMEA, for the Johnson and Johnson company Cordis, identified the treatment of cadiovascular disease as another significant area driven by an ageing population and obesity. In particular, research and development has led to some important breakthroughs in the field of coronary artery stent design. In 1999, Cordis introduced the Cypher stent – the first of an advanced generation of “drug-eluting” stents, which transformed cardiovascular care. Prior to the introduction of the drug-eluting stent, one of the side-effects of stents was the occurrence of restenosis – i.e. the re-narrowing of the coronary artery. The elution of drug therapy has overcome this problem. Cordis is now striving to address the remaining side-effects associated with surface-coated drug-eluting stents by developing the next transformational technology. Nevo uses technology that incorporates hundreds of small reservoirs, into which drug-polymer compositions are loaded. This design allows drug delivery from an implant – the surface of which is 75% polymer-free bare metal on insertion and becomes fully bare metal following drug delivery. The technology enhances control of the rate and direction of drug delivery, enabling a wider range of drug therapies to be delivered, and potentially increasing the range of clinical applications of drugeluting stents and other drug-device combinations. “We have improved the safety profile through the reservoir technology and through the absorption of the polymer. After being implanted in the body for 90 days, the drug and the polymer disappear. This is very important, as we suspect that the polymer is one of the agents that are responsible for the side-effect of the stent which causes inflammation in the vessel wall. By having a bio-absorbable polymer, the benefits of having a drug-eluting stent can be enjoyed with a low risk of narrowing of the artery and a high safety profile that is similar to a bare metal stent,” commented Nadav Tomer. He continued: “Two drugs can be incorporated into the same cell within the reservoir, or several drugs can be combined to treat several diseases of the artery from different cells. The ability to have multiple drugs loaded in the reservoir and different release controls can help us to create a disease-specific therapy. For example, this will enable us to reduce the risk of thrombosis, which is one of the side-effects of using stents in the artery, or a stent may be specially designed to treat acute myocardial infarction or diabetes.” he continued. The stent will use the same drug, sirolimus, as used in the Cypher coronary stent, which now has supporting data on its safety and efficacy over a six-year period. Clinical trials involving 40 sites worldwide have now been completed for Nevo, and the results will be presented later this year.