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Device regulations are imperative for the quality and safety of medical care by ensuring patients are not exposed to harmful products. As such, medical regulatory bodies are focused on mitigating the risk of patient harm and ensuring the safety of devices used in treatment. In May 2021, the Medical Device Regulation (MDR) came into force leading to subsequent impacts on the legislative requirements of medical devices sold to the European Union.
Naturally, these regulations affect the rate at which new products emerge into the market, while also rendering other medical devices obsolete, therefore eliminating their market presence. This can have the capacity to reduce market innovation in the short-term.
Compounding the issue, following the COVID-19 pandemic, the focus on reducing infection risk has had an impact on the use of reusable and disposable medical products. Recovery after the pandemic has realigned the focus towards providing more sustainable healthcare.
Sustainability and product preferences post pandemic
The pandemic sparked a movement away from sustainability in the utilisation of reusable and disposable medical devices. Prior to the pandemic, reducing waste and responsible product use took priority, with less awareness of cross-patient contamination. Reusable solutions were considered more cost effective and largely dominated the majority of the clinical care markets. While product areas that require invasive medical action, such as infusion and intravenous delivery still largely used disposables, sustainability and the environmental impact of solutions was increasingly considered in purchasing decisions. The pandemic understandably caused a shift in priority, and reducing infection became imperative in lowering hospital utilisation. Many countries began disposing of products after single patient usage, to reduce risk of infection. More recently, the shift to disposables does appear to be slowing down, due to heightened awareness towards sustainability.
Many product areas will not be able to safely make the shift to reusable solutions due to their invasive nature, however, consumables within the patient monitoring sector that pose less risk to cross-patient contamination are likely to be influenced. The shift towards sustainability and waste reduction does not always correspond with health innovation, particularly in the patient monitoring market, where there is a defined trend towards improving patient mobility to reduce recovery times. Disposable and wireless medical solutions such as ECG patches and SpO2 sensors, that enable patients’ freedom of movement while delivering adequate patient monitoring, are being favoured over bulkier reusable solutions, despite their ecological impact.
Medical Device Regulation and its market implications
The EU Medical Device Regulation implemented in May 2021 places restrictive guidelines on the use of phthalate and increases clinical surveillance and evaluation requirements. These new guidelines focus on the composition of medical products, most notably DEHP found in PVC products. Due to the associated mutagenic and reproductive risks, its use in consumable products is under scrutiny. Medical bodies are increasingly looking towards more sustainable and biologically safe alternatives. The consequences of the MDR legislation are expected to be paramount, resulting in the removal of half of the medical products in use today. Concerns regarding how this will affect the medical device market are growing as the recertification of devices is a time and resource intensive task that is often costly to manufacturers.
The new medical legislation has had a troubling impact on competitive market trends, as some manufacturers will be focusing their attentions on providing global solutions in place of regionally specific products. Similarly, this regulation is expected to lead smaller manufacturers to exit the European market, as they reduce their presence in favour of regions with fewer restrictions on product material use. Additionally, significant reductions in private labelling seen throughout the healthcare technology market can be attributed to the new the MDR, as manufacturers are now required to provide Post Market Surveillance Reports and Periodic Safety Update Reports for OEM and off-labelled products.
Product recalls, monetary sanctions, and damage to a company’s reputation and perception are some potential penalties that come with any failure to fulfil the new MDR and other medical regulations. Many companies are driven to assess the benefits of investing into the recertification of products that produce limited profit or are soon be outdated. Arguably, this incentivisation does not extend to companies with less European market presence and penetration. Without the financial standing the key market players possess, the burden of meeting legislative requirements is arguably not enough to justify European market expansion and product innovation. Opposingly, companies with greater budgets and resource will have the capacity to innovate their product to ensure they meet regulatory standards. In this way, the MDR acts as a catalyst for company product strategy, accelerating decision making and affecting market dynamics.
Balancing patient safety and environmental health
While both the new MDR and shift towards sustainability prioritise patient and ecological wellbeing, their short-term impacts could also threaten the growth of clinical care markets. The MDR has unintentionally stifled product development, the emergence of new and innovative vendors due to costly processes, and the presence of regionally specific products.
The catalytic effect of these market trends appears to differ by company size and market penetration. Due to forced changes in strategic decision making, some companies are looking towards international product development and steering away from European markets that are not seen as economically sustainable. Profit-orientated thinking and concerns regarding product viability are likely to trigger decision making that reduces innovation and temporarily reduces healthcare value, and efficiency.
The balance between environmental, economic, and patient health must be considered and evaluated to ensure products are not only safe, but also offer the best and most advanced patient care possible amidst these rapid changes in market dynamics. For now, it seems that the MDR and trends towards sustainability are likely to widen the chasm between newly emerging and well-established manufacturers, shrinking the pool of smaller players within Europe, and thus creating space for the more dominant companies to monopolise.
As part of our ongoing research, our analysts are interested to hear your views regarding MDR and sustainability trends that you feel are impacting the market.
About the report
The upcoming report Patient Monitor Consumables – World – 2023 will provide a data-centric and global outlook of the patient monitor consumables market. The report will blend primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
About Signify Research
Signify Research is an independent supplier of market intelligence and consultancy to the global healthcare technology industry. Our major coverage areas are Healthcare IT, Medical Imaging and Digital Health. Our clients include technology vendors, healthcare providers and payers, management consultants and investors. Signify Research is headquartered in Cranfield, UK. To find out more: enquiries@signifyresearch.net, T: +44 (0) 1234 436 150, www.signifyresearch.net
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