Many of my colleagues in Europe work in pharmaceuticals and want to know why medical devices typically don’t have an approval process based on randomised clinical trials. Medical devices shouldn’t require the same clinical evidence as drugs for both clinical and commercial reasons—and, in fact, they can’t.
Recently, I was looking at the new MedTech Europe website, produced by an alliance of medical technology industry associations that are working to “make innovative medical technology available to more people” and to promote “medical technology’s value for Europe.” I thought that it did a good job of explaining some of the clinical reasons why medical devices don’t have the same evidence requirements as pharmaceuticals do. For example, one MedTech Europe white paper outlines some dramatic differences between the medical devices and pharmaceutical industries:
- Effectiveness: Medical devices’ effectiveness depends on the physician or surgeon using the devices and the setting in which they’re used in. Meanwhile, pharmaceuticals’ effectiveness depends on the patient type, so proof of that effectiveness could be more straightforward.
- Risks: Devices are mainly mechanical and do not actively interact with the body’s metabolic or immune system. Risks to the body from pharmaceuticals are of a different order and magnitude.
- Variety: The hundreds of thousands of medical devices range from simple consumer products like sticking plasters or contact lenses, to syringes, hip implants, MRI equipment and pacemakers.
- Time to market: Pharma R&D usually is measured in years, with true advances measured in decades. Meanwhile, medical technology innovations can be rapid, with new devices and improvements coming to market within 18 to 24 months.
Here are yet more good reasons why you can’t evaluate a device in the same way as a drug. First, it’s hard to run a randomised controlled trial for many devices: What would you choose as a comparator for an implantable cardiac defibrillator? How do you implant a placebo hip? As MedTech Europe points out, there are both ethical and practical issues in comparing one device with another, or with another type of intervention.
Second, as mentioned earlier, the effectiveness of a device depends heavily on the person using it. Clinician training and experience, patient selection and the care delivery setting can all change the positive and negative impact of a device. This is clearly the case for a vast range of surgical equipment, but I’ve also seen this be an important factor for wound care, imaging and pain management, to give just a few examples. This means that “real-world” data from observational studies is far more important for devices than for drugs.
Rapid Approvals Make Commercial Sense
Going beyond the clinical factors, there are some solid commercial reasons why devices need to have a different level of evidence and approval process than pharmaceuticals. First of all, in many cases, a hospital is buying the device, so price differences and price pressures are more evident. Second, patent protection has less impact in medtech than in pharma. While medical technology patents exist, it’s much easier for competitors to get around patents because of the inherent nature of a device compared to a patent on a molecule, which is nearly impenetrable.
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Third, compared with those for blockbuster drugs, markets for medical devices are smaller, so investment is harder to earn back. Finally, because outcomes for medical devices rely on the skill of the user, the industry has an obligation to ensure that surgeons and users are properly trained, adding a cost to serve in many of our therapy areas.
Why is it so important for the device industry in Europe to spell out these differences? In 2012, the European Parliament called for a pre-market authorisation (PMA) system for medical devices, as is the case for pharmaceuticals.
A pharma-like approval system for devices wouldn’t be in the best interests of patients. Innovative technologies could be delayed for years, and there’s no reason to believe that patients’ safety would be increased. It certainly wouldn’t be in the best interests of the medtech industry, and it’s not in the best interests of payers, either: New technologies still need to demonstrate a benefit over the existing standard of care or a reduction in resources used.
And clinical evidence is, of course, very important for medical devices, but requiring the gathering of such evidence prior to launch in the same way as the pharmaceutical industry would unnecessarily hamper technological innovation and hinder healthcare providers’ effectiveness.