Jennifer Doggett writes:
Media investigations can play a vital role within the health sector in raising awareness of issues that might otherwise be ignored and creating a platform for debate, with the ultimate goal being policy or regulatory change.
For example, the Implant Files investigation by an international media consortium into the medical device industry (undertaken by a collaboration of media organisations) has given consumers access to information on safety issues and posed some important questions for industry and policy makers about current regulatory practices.
However, for investigations like this to lead to longer-term policy and regulatory changes, which deliver real benefits for consumers, they need to be based on an accurate understanding of the issues involved.
Medical technology is one area in which knowledge can be lacking as, for many reasons, the medical technology sector is not well understood by many journalists (or policy makers or politicians).
In particular there is often some confusion between the differences between medical devices and pharmaceuticals. Pharmaceuticals are a higher profile sector, (although the medical technology sector actually produces a much larger and diverse range of products) and what works for pharmaceuticals is often assumed incorrectly to work for medical devices.
Of course, the end goals of policies and regulatory processes for medical devices should be the same as those for medicines, e.g. access to safe and high quality products for the community.
However, the pathways to achieving these goals needs to reflect their very different characteristics. Trying to shoehorn medical devices into a system designed for medicines will not achieve the goals that community wants from medical technology.
The following six points highlight some of the key differences between these two sectors. These need to be taken into account when identifying problems with the current system and proposing solutions.
1. Diversity and complexity of medical device sector
The MedTech sector is far more diverse and complex than that of pharmaceuticals. There are more than 500,000 different types of medical devices produced globally, compared with only 20,000 medicinal products.The diversity and range of medical devices is also much greater than within the pharmaceutical sector. The difference between an aspirin and a chemotherapy drug is much less than the difference between a bandaid and an MRI machine (both classed as medical devices). This means that policies and regulatory processes for medical devices have to be much more diverse than for pharmaceuticals. A ‘one size fits all’ approach, with minor variations for level of risk, may work for the regulation of medicinal products but is far too simplistic a model for medical devices. It can also make it difficult to compare processes across different categories of medical devices – what is appropriate for one type of device may not work for another.
2. Different mechanisms of action
There are fundamental differences in the way pharmaceuticals and medical devices work. Pharmaceuticals are chemical in nature and are designed to actively interact with the body’s metabolic or immune system. Medical devices generally work via mechanical means, without interacting with or changing the body’s biochemistry. This means that the risks associated with pharmaceuticals are very different to those from medical devices and that therefore different regulatory approaches are needed. It also means that a much greater range of expertise is required to regulate medical devices as these typically involve multiple technologies and areas of knowledge, including physics, materials science, bioengineering, electronics, information and communication technology and biomechanics.
3. Dynamic development process
The average lifecycle for medical devices is much shorter than that for pharmaceuticals. Once developed, medicines are generally used without modification for years, if not decades. However, the development of medical devices is a much more iterative process with improvements often being developed simultaneously with the approval seeking process. The average lifespan for a medical device, is only 1-2 years, due to the rapid pace of technological improvements. Therefore the regulatory model for medical devices cannot be a ‘set and forget’ model but needs to be a much more dynamic process which occurs in tandem with product modifications and post-market surveillance.
4. Post-market monitoring vital
The ‘gold standard’ medical research model – a double-blind, randomized, placebo-controlled clinical trial – was developed for medicines and does not work when applied to most medical devices.Particularly for implantable devices, such as pacemakers, there are a raft of ethical and practical issues involved with attempting to run trials based on this model. Standards for medical device research need to be as high as possible, while reflecting the nature of medical devices and balancing the benefits to the community of access to innovative technologies. The limitations of pre-market research in medical devices also mean that there has to be a greater focus on post-market monitoring than there is for medicines.
5. Differentiating the clinician’s role
The role of clinicians is also vastly different in relation to medical devices than it is in relation to pharmaceuticals. A medicine will have the same effect on a patient, regardless of whose signature is on the prescription. However, the efficacy of an implantable medical device, such as a joint prostheses, can vary widely according to the process of implantation. A poorly designed product, in the hands of a skilled surgeon, can produce better outcomes than a high quality product, implanted by an inadequately trained or sub-standard practitioner. In assessing the performance of medical devices these two components need to be considered together – a ‘device failure’ may in fact be a failure of surgical technique.
6. Manufacturing process is critical
Similarly, the manufacturing process is more critical in medical devices, compared with pharmaceuticals. For example, pills that are 0.1mm larger or smaller than each other or with slightly different shapes will have the same effect, as long as they have the same level of active ingredient. However, a 0.1mm difference in size or a slightly different shape can result in a vastly different outcome for a medical device. This means that the manufacturing process should also be considered as an integral part of the device’s performance.
Understanding these, and other factors that make the MedTech sector unique, will help build on the findings of this investigation and support changes to strengthen policies and regulatory processes to improve patient safety and health outcomes.
Disclosure: Jennifer Doggett provides consultancy services to the medical technology sector.
