While the medical technology and pharmaceutical industries are both essential to health, it is important to acknowledge that the two are extremely different. Medical devices work only if they are used correctly. Their effectiveness relies on the skills and experience of the physician using them, the quality of the hospital, and many other factors. Pharmaceuticals are chemical in nature and are designed to actively interact with the body’s metabolic or immune system. Pharmaceuticals either work or they do not. Effectiveness is relatively straightforward to prove.
Devices are by-and-large mechanical in nature and have an inert effect on the human body. Pharmaceuticals are chemical in nature and are designed to actively interact with the body’s metabolic or immune system. Therefore the risks to the body from pharmaceuticals are of a different order and magnitude than the risks to the body from medical devices.
There is also a vast difference in numbers and uses. More than 500,000 different types of medical devices are produced globally – compared to 20,000 medicinal products - each in service of vastly diverse health objectives. Medical devices range from simple and everyday consumer products such as spectacles, dentures and sticking-plasters, to incontinence and ostomy care products, syringes and bandages, to hip implants, MRI and X-Ray equipment, and pacemakers. The technologies concerned also extend far beyond those of pharmaceutical science to include materials science, bioengineering, engineering, electronics, software, information and communication technology, nuclear, aerospace, plastics technology, surface technology and many more which are applied across all areas of clinical practice and homecare.
Research and development models also vary greatly between the two industries. Driven by technology, device improvements are typically available to users and patients within 18-24 months of previous iterations. Medicinal products on the other hand, are pharmaceutically based and tend to have longer product lifecycles with improvements measured in decades.
Much like pharmaceuticals, medical technology is a unique industry which requires its own unique regulatory system. The revised MDD must consider the unique characteristics of the industry while avoiding misconceptions and comparisons with pharmaceuticals.
One frequently heard misconception centres on the difference in availability of clinical evidence for pharmaceuticals and medical devices, including (inaccurate) claims that no clinical data exists for medical devices. Clinical data and evaluation of that clinical data is a clearly and explicitly defined legal requirement for medical devices. In particular, for both implantable devices and high risk devices, the clinical evaluation must be based on data obtained from clinical investigations unless it is justified to rely on existing clinical data.
When it comes to requiring the same type of clinical data for devices as for drugs, it is worth highlighting that unlike in pharmaceuticals, randomized clinical trials are not the ‘gold standard’ on how to assess effectiveness and safety in medical devices because:
- Most devices cannot be evaluated with randomised clinical trials as it is hard to blind and randomise devices due to strong ethical and practical issues in the choice of the ‘comparator’ (e.g. what would have been a comparator for an implantable cardiac defibrillator? How would one implant a placebo hip?).
- Device impact depends heavily on clinician training and experience, patient selection and the care delivery setting. This varies per doctor, hospital and country and is thus nearly impossible to predict with any precision. We therefore believe that ‘real world’ data from observational studies performed under routine conditions are equally important (structured post market surveillance).
In summary, medical technologies are part of the whole healthcare delivery system and their efficacy relies on the skills and experience of the physician, the quality of the hospital, and many other factors (contrary to pharmaceuticals).
Getting regulation right
In its resolution of 13 June 2012, the European Parliament called for - although with a thin majority - a Pre-Market Authorisation (PMA) system for medical devices, as is the case for pharmaceuticals. Adopting a pharma-like system for devices would not address the different nature and innovation cycles of medical technologies. Moreover, it would not lead to an increase in patient safety, but may cause years of delay in the availability of medical technology solutions to European citizens and a loss of European innovation competitiveness compared with other regions.
Today, Europe already has a pre-market approval mechanism in place for high-risk devices which has proven to deliver a high level of safety and provides European citizens with access to innovation 2-3 years before their US counterparts. Indeed, the procedure has been part of European legislation since 1993( see Directive 93/42/EEC)
…whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorisation with regard to conformity is required for them to be placed on the market;
Commissioner Dalli rejected the call for PMA and put forward a pre-market scrutiny mechanism for the quality of Notified Body assessments for high risk devices. Industry does not support such a mechanism as you would achieve everything that the scrutiny is trying to achieve if you were to properly implement the current regulatory system. Hence, in an ideal implementation a ‘scrutiny’ mechanism is not needed.