Medical devices: an area of great promise
Dr Margaret Chan
Director-General of the World Health Organization
Your Excellency, Prime Minister Abhisit, honourable ministers, distinguished delegates, representatives of professional societies, patient groups, and industry, ladies and gentlemen,
I am pleased to welcome you to this first Global Forum on Medical Devices. I thank the government of Thailand and its Ministry of Public Health for hosting and supporting this event.
You represent a diversity of disciplines, interests, and country experiences. This diversity is important given the complexity of the task before us. This is the first meeting of its kind, and you will be exploring some new territory where the best way forward for public health is largely uncharted.
The field of medical devices is large, diverse, competitive, and highly innovative. This is an area of great promise, sometimes spectacular promise, sometimes seductive promise. It is also an area with a number of problems and pitfalls, some familiar, others unique.
As many have noted, the field of medical devices requires, and deserves, its own unique agenda. Health officials and hospital managers in all countries, at all levels of development, need guidance.
The medical devices industry produces high-tech high-cost diagnostic and therapeutic equipment, but it also produces the basic supplies and devices that keep any health facility running smoothly on a daily basis.
The field also includes devices that aid functional ability, like wheelchairs, hearing aids, eyeglasses, intraocular lenses, and artificial limbs. The vital role of such devices in improving the quality of life is obvious, though often overshadowed by the attention given to more spectacular devices.
We are here to help set the agenda for a more rational approach to the acquisition and use of medical devices in their full range of applications.
We are here, in part, because of concern about runaway health care costs and pressure to contain these costs. As noted in a 2007 World Health Assembly resolution, health technologies, and medical devices in particular, represent an economic as well as a technical challenge to health systems.
That resolution expressed concern about the waste of resources caused by investments in medical devices that do not meet high-priority needs, are incompatible with existing infrastructures, are irrationally or incorrectly used, or do not function efficiently. This tells us some of the pitfalls.
But we are also here because the unquestionable benefits of medical devices are so unevenly distributed. I wonder if there is any other area that illustrates so profoundly the great difference in the ability of wealthy and developing countries to reap the benefits of advances in medicine and technology.
As one example, a recent WHO survey showed that the availability of mammography, an important screening tool for breast cancer, is one per 47 000 people in high-income countries, but one per 5.7 million people in low-income countries. The availability of CT scanners is one per 170 000 people in high-income countries, but one per 3.8 million in low-income countries.
In some countries, shortages of needles, syringes, and sterilizing equipment mean that up to 40% of injections are unsafe. As yet another example, some 30 developing countries do not possess a single radiotherapy machine for cancer treatment.
I believe you will agree: too many people are being excluded from the benefits of medical devices, and this is a challenge we need to address.
I can suggest some reasons for this great imbalance.
The most obvious one concerns resources and costs. Technological advances nearly always come at a price higher than conventional technologies, and some medical devices are obviously priced for the financially privileged few.
One figure illustrates the magnitude of the affordability problem. Worldwide, annual government expenditure on health ranges from well over $7,000 per person to less than $10. Low levels of expenditure on health help explain why many medical devices are considered luxuries.
Yet high cost alone is not the only explanation, the only excuse for such inequitable access. Many badly needed and affordable devices, like electrocardiographs, are still not widely used in low-income settings. This may reflect how priorities are set, with medicines and vaccines having a higher place in budgets.
A second problem is inherent to the industry. These are medical devices, produced for a medical market, largely focused on financially profitable diseases, and almost exclusively designed for use in wealthy settings.
Currently, most medical equipment used in low-resource settings is imported from industrialized countries. About 70% of the more complex devices do not function when they reach their destination.
A third problem follows logically and is deeply familiar: lack of capacity. I mean lack of infrastructure and funds for recurring costs. I mean erratic power supplies, uncertain water quality, a crippling shortage of health personnel, limited training capacity, difficulties getting spare parts, and limited budgets for maintenance and for purchasing consumables.
Under such conditions, a technological miracle can rapidly become the worst nightmare of service providers: wasted resources and risks to patient safety.
Faced with such harsh realities, we need to ask: what does a true “cutting edge” technology mean for the developing world?
The biggest breakthroughs are likely to come with technologies that use alternative power supplies, resist heat, humidity, and dust, relieve the workload, require little maintenance, and can be operated, with no risk to patient safety, by personnel with little specialized training.
Or with something so simple as glucose meters and test strips that perform well in the hot and humid homes of diabetes patients. Or with robust portable machines that extend the advantages of technology beyond the hospital setting or take it from cities to rural areas.
This is a challenge, but not an insurmountable one. During outbreaks, WHO has seen how portable PCR machines can vastly increase the speed and precision of containment operations.
You will be discussing technology transfer, which can help, and donations, which can be problematic. Developing countries are littered with unused, obsolete equipment and devices. Recent studies suggest that only 10% to 30% of donated equipment ever becomes operational.
A fourth reason is possibly the most important. That is, a failure to look at this rapidly evolving industry from a public health perspective. When we take a public health perspective, one priority is clear. First take care of the basics.
If we think about the health-related MDGs, and about what hinders progress, it becomes easier to define some basic needs. Blood transfusion services to prevent women in labour from bleeding to death. Anaesthesia machines, oxygen bags, and basic surgical equipment. Rapid point-of-care diagnostics for malaria and tuberculosis. Resuscitation equipment for newborns with breathing problems. Generators that keep equipment running when the electrical power shuts down.
I know you will be discussing MDG-related issues during the meeting, and will have many other ideas and experiences to contribute.
And we have another big-picture issue we need to address. Though resources available to invest in medical devices are vastly different, the main health problems facing wealthy and developing countries are becoming remarkably similar.
I am referring in particular to the rise of chronic diseases, like cardiovascular disease, stroke, cancers, and diabetes. Once associated with affluence, these diseases now impose their heaviest burden on poor and disadvantaged populations. This shift in the disease burden clearly demonstrates the need for fairness in access to medical devices, including those appropriate and affordable for long-term care.
Ladies and gentlemen,
You are tasked with setting an agenda for a more rational approach to medical devices. This is not an easy task.
It is tempting to seek guidance from years of largely successful efforts to rationalize the use of pharmaceutical products.
We can certainly draw some guiding principles from experience with essential medicines, namely the importance of focusing on priority health needs, and on affordable devices that match those needs. We can certainly repeat the commitment to fair and equitable access.
We can also identify some similar obstacles that limit the appropriateness of medical devices to priority needs in the developing world. Market forces, all by themselves, will not automatically shift the R&D agenda for medical devices towards unmet needs in the developing world.
As with pharmaceutical products, explicit policies are needed to move the power of innovation more directly into the service of international health development.
But here the similarities end. The diversity of medical devices is much greater than that of medicines. The pace of new product development is faster, and the lifecycle of some medical devices can be as short as 18 months.
The regulatory pathways are different. The approval process for medical devices is often less rigorous. Factors affecting the safety of medical devices are more numerous, including the competence and skills of product users. The potential for human error when a person swallows a pill is quite different from that when staff operate highly complex equipment.
Systems for reporting adverse medical device events and for conducting post-marketing surveillance are not yet so well advanced. These, too, are pitfalls in the midst of great promise.
Despite the challenges, a key achievement of this meeting is its strong public health approach. The organizing and steering committees have put together a public health agenda. The agenda is firmly focused on needs assessment and improved access to priority devices, especially in low-resource settings.
You will be considering the potential of these devices to reduce gaps in health outcomes, to relieve some of the pressures of the workforce crisis, to improve service delivery, and to strengthen health systems.
You will take a close look at the enabling environment: the role of health technology assessment, the management of medical devices through national health plans and strategies, and the need for strong regulation and enforcement.
You will explore the convergence of advances in information and communication technologies with advances in medical technologies. As practical guidance, you will consider a process of priority setting at the national level and look for ways to harmonize regulatory pathways.
Ladies and gentlemen,
Medical devices require, and deserve, their own unique agenda. I wish you a most productive meeting.