How has the Medical Devices industry changed?
The future of medical devices is intriguing. With factors such as development investments, MDR (EU Regulations for medical devices) and IVDR (In Vitro Diagnostic Regulation), and artificial intelligence progression, there are many exciting opportunities within the industry. We spoke with Real Staffing’s medical device specialists Matthew Moulton and Nathan Puxty about how these developments could impact the future of healthcare.
The introduction of MDR and IVDR
The introduction of MDR and IVDR has led to an increase in job opportunities within medical device companies. The change from standard MDD (Medical Devices Directive) has created an increase in clinical trials, and changes in classification of products. Medical devices without a medical purpose will now be regulated, for example non-corrective/aesthetic contact lenses. There will now be a legal requirement for at least one person in an organisation to take responsibility for managing the regulatory compliance of a product or project. This could lead to a demand for quality, regulatory compliance, or safety managers.
New innovations in the Med Dev industry
Some of the most exciting innovations within medical devices are the use of 3D printed artificial organs and implantable devices. Under IVDR regulations, the industry is seeing an increase in the use of software for medical devices. Matthew tells us, ‘My candidates and clients have both confirmed that, in line with IVDR, software devices are constantly having to undergo maintenance to strive for the most robust data security systems within their devices. These developments are having an impact on the medical device industry too.’ In order to ensure the security of data for these devices, the demand for data security professionals has increased.
The impact on recruitment within the industry
Nathan expands on this, saying, ‘As we get closer to the deadline in 2020 for the transition from MDD to MDR, we’re seeing a significant increase in the demand for quality and regulatory contractors from organisations we work with.’ Companies need regulatory professionals on a relatively short-term basis to prepare for the change to MDR and IVDR. This is especially significant in smaller medical device companies that work on a project-to-project basis and, as such, don’t have a requirement for permanent team members.
How have the regulatory changes in medical devices affected your business? Has the introduction of MDR and IVDR led you to look for a new opportunity? Contact our Medical Device team at Real Staffing and tell us how MDR and IVDR have impacted you.
