Medical Devices are subject to increasing standards and regulations. Though this may be perceived as a nuisance sometimes, it’s certainly no unnecessary luxury. The past years, various cases have shown that things could seriously go wrong, endangering the health and lives of patients worldwide. However, every threat brings about a new opportunity. Let’s look at the challenges and possibilities in the world of Medical Devices.
The trigger to start with Medical Device directives was the scandal at Poly Implant Prothèse (PIP), a French company that produced silicone gel breast implants. The company was liquidated in 2010, following the revelation that it had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone. Due to this lack of quality control, hundreds of thousands of women were exposed to serious health risks, which in some cases even resulted in fatalities.
Scandals like these prove that regulations are necessary to protect patients against any negative impact on their health caused by Medical Devices. A minimum of quality requirements is therefore required. Of course, the amount of potential health risks also depends on the type of Medical Device.
Moreover, an important practice to reduce risks is post-market surveillance: monitoring the safety of a medical device after it has been released on the market. It’s the ideal way to avoid that the same type of incident is repeated in a different place at a different time. Thus, the manufacturers are held responsible for the proper functioning of Medical Devices.
All for the patient
The necessity to commit to regulations related to Medical Devices, highly depends on the classification of device, as well as the size of the company. The higher the risk, the higher the stakes, the higher the efforts need to be. However, rather than an extra effort, investing in quality management of Medical Devices is most essential. It’s a way to make your product safer for the patient. These regulations are not there to make a company’s life miserable, but to protect your customer – the patient – from any possible negative impact.
The regulatory burden concerning Medical Devices for startup businesses might be the most rigorous of any industry, and with good reason: making products for implantation or use in the human body means hurdling a pretty high safety and efficacy bar. Overall, it’s clear that building a regulatory strategy from the very beginning is crucial.
Looking forward to new possibilities
Though the future is filled with opportunities when it comes to Medical Devices, digitalization may entail new challenges. Moreover, the definition and functions of Medical Devices are rapidly evolving. Take the ongoing shift from curative to preventive healthcare. To prevent, you need to measure data, something Medical Devices are perfect for. However, it’s clear that standards and regulations will need to keep pace with these evolutions.
Medical Devices are also an asset in the diagnostic area, as they help to reduce the amount of invasive examinations and human interpretation errors. But whatever the future looks like, the challenges will stay the same: integrating quality in both the device and the processes to make sure that patients and manufacturers gain from it.
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