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Medical Devices – What Does the Future Hold For Compliance?

发表时间:2021-09-27 09:32作者:Clare Goodwin

KPMG Advisory stated in April 2021: “While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the future industry landscape…” The medical device industry is a fast-growing, lucrative industry however, are product manufacturers able to keep up? With many new regulations and evolving legislation for products globally, medical device manufacturers must act now to ensure the viability and longevity of their products into the future.


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Medical device manufacturers were presented with an opportunity in the initial economic shock of the COVID-19 pandemic. For many industry insiders, the impact on the medical technology sector particularly has been the acceleration of trends that were already underway.


Increased advancement in artificial intelligence technology, device connectivity, and data collection have enabled medical technology companies to adequately respond to the demand for critical products such as personal protective equipment (PPE) and ventilators.


The medical device industry is poised for steady growth, with global annual sales forecast to rise by over five percent per year and reach nearly US$800 billion by 2030 (KPMG, 2021). With these projections, increased demand for innovative new devices unlocks a grand potential in emerging markets such as China and India.


Traditionally, medical device companies have delivered value primarily through manufacturing and selling their products. However, as pressures on the healthcare system increase, the care delivery model is also shifting, essentially pressuring manufacturers to integrate services and data intelligence into products in order to offer holistic solutions.


Arguably, the biggest challenges within the medical device industry are political in nature. The last decade has seen a widespread backlash against globalisation (and by association globalised supply chains), from nationalist politicians and their support bases. Changes to trade agreements have far-reaching implications for the industry however, time will tell as to just how far these implications reach.


Earlier this year, the European Union’s Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) were enforced in order to set standards and oversight requirements for manufacturers of medical devices and in vitro diagnostic solutions that intend to distribute their products in the European Union. This was done in order to replace the decade-old regulations that were outdated. However, these new introductions also have posed some significant challenges to healthcare technology organisations, including higher costs and longer timeframes for developing new products.


There are a lot of potential growth opportunities that exist in the medical device industry, especially with major advances in robotics technology which have led to a huge spike in demand for minimally invasive robotic surgery (MIRS), causing the surgical robot market to experience double-digit growth. This trend is set to continue on an upward trajectory, with the global number of MIRS procedures set to more than double to 2 million by 2025, while the market is predicted to grow from $5.5bn to over $24bn (SRG, 2021).


Medical device manufacturers, while being faced with some new challenges, are also positioned with enhanced opportunities to develop new and innovative strategies that will allow them to thrive in the new and rapidly changing regulatory environment. The key is to be prepared, aware, and to think ahead. With these measures, the world of medical devices and compliance can go hand in hand, and essentially support the other to thrive in a rapidly evolving world.


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Certification Experts is an independent product compliance organisation with over 27 years of experience. If you or your business are seeking further information on how to future proof your medical device, then get in touch with us today.


欧洲CE认证公司(Certification Experts B.V.)位于荷兰,并在德国和中国设立有分公司,能够针对客户所遇到的复杂情况,提出量身定制的解决方案。我们致力于提高客户产品的安全等级,从而为创造一个更安全的世界而努力。


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