Medical Device Trends and Innovations in 2021
Medical and life sciences industries began 2020 like any ordinary year, however, as we now know nothing was ordinary about 2020. Life sciences organizations worldwide placed plans on hold to meet the demand of slowing the spread of COVID-19 and advancing research to develop a vaccine.
In this two-part series, Welocalize Life Sciences explores how industry trends and innovations will shape 2021 for the life sciences industry.
Regulation of Medical Devices
Medical Devices and Brexit
The UK began its transition period out of the European Union on December 31, starting their new relationship under a new agreement. As of January 1, the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for the UK medical devices market.
For pharmaceutical and biotech industries, the deal provides provisions to support trade between the UK and the EU, though businesses will find additional challenges with barriers that are now in place since the agreement. The deal lacks mutual recognition of medical device standards, meaning products in the UK will require further certification to enter the EU market. The MHRA has published various guidance documents to support businesses through the transition period explaining the clinical trials and medical device regulation process.
The New EU MDR
And, finally, as the deadline for implementation of the new Medical Devices Regulation (EU) 2017/745 (MDR) fast approaches, many in the industry are preparing for new safety, performance, labeling, and post-market surveillance requirements. These new regulations may create a tremendous demand in the translation industry and procuring qualified linguistic resources will be at a premium for the 24 EU-recognized languages for EUDAMED.Are you ready for the new #EUMDR requirements? Welocalize has over 20 years of clinical and regulatory translation expertise, including the translation of package leaflets, IFUs, and dossiers. #meddevices #medicaltranslations… Click To Tweet
Artificial Intelligence Enhancing Medical Procedures
2020 has forced organizations worldwide to rethink its operations, for the life sciences industry; this included the management of clinical trials and patient treatment. With the COVID-19 vaccine success, there will potentially be greater demand for future rapid and effective clinical trials.
AI solutions in the pharmaceutical and medical industries ensure more effective and rapid testing results; surgeons now have more significant opportunities to adopt AI-based technology to enhance their medical procedures.
AI technology trends will continue to drive innovative clinical trial planning and development throughout 2021. Read more on this topic: “How AI and Technology Address the Need for Speed in Clinical Studies.“ Contact us for information on our language services and AI-enabled technology solutions for highly regulated industries.
Internet of Medical Things
Connecting healthcare to IT systems, the Internet of Medical Things (IoMT) allows healthcare providers to make effective decisions, maximize patient outcomes and creates further reductions on medical care costs.
Businesses producing medical devices are continually looking for technological opportunities to develop and improve IoMT results and analysis.
An example of IoMT includes tracking patient medical orders, and the location of patients admitted to hospitals. These alternatives allow healthcare providers to track patients more effectively and update patient information accordingly depending on their condition.Welocalize's life sciences team explores key industry trends and innovations predicted to shape the organization and operations of life sciences industries for 2021. #medicaldevices #IOMT #EUMDR Click To Tweet
Increased Cybersecurity Requirements
2021 predicts an increase in remote medical services and technological alternatives; however, this has provided new vulnerabilities to cybersecurity threats to patient, device and manufacturer information.
Medical devices such as computer systems can be vulnerable to security threats; manufacturers have the opportunity to reduce these cybersecurity risks. Only through consistent monitoring to identify and address potential threats, can manufacturers ensure the safety and effectiveness of the production of medical devices.
How Welocalize Can Help
Security, compliance, technology, regulatory changes, and quality continue to be of paramount importance to medical device companies. Welocalize holds four ISO certifications, a quality portfolio found at only 8.57% of language services providers (Source: Slator), and is uniquely qualified to support the multilingual initiatives of highly regulated industries. How can Welocalize help your team manage its medical and clinical translation and interpreting services in an ever-changing environment? Contact us.