Digital health has proven its worth in recent years by helping to keep the healthcare sector moving during the pandemic. From the widespread rollout of telehealth, including teleradiology and telepathology as well as remote assessments, to the adoption of remote communication systems and connected non-invasive monitoring in clinical trials.
Some things have now returned to face-to-face, but many of the benefits of digital technology in the medical devices and healthcare industry remain and continue to benefit patient care.
“There has been a shift towards digital health over the past six to seven years, with medical devices tying in with IT products and services,” said Matthew Moulton, Medical Devices Team Manager at Real Staffing.
The move towards digital approaches crosses the entire medical devices arena, from regulatory activities and cybersecurity, through wearables, diagnostics and software as a medical device (SaMD), to manufacturing.
Understanding the need
“We have seen clients wanting to implement digital-based regulatory systems, improve management of products and patient records through the cloud, and add in cyber security and data integrity programs and skills,” says John Lennon, Medtech Principal Consultant at Real Staffing.
Digital point-of-care testing, using artificial intelligence (AI) and machine learning, is one major growth area, driven by the desire to move healthcare from the clinic to the patient’s home or bedside. Pharmaceutical companies are increasingly adding on digital options to their therapies to create combination products, and they will need to pull in additional skills to support these projects.
“I believe we will see Internet of Things and digital health in all pharma and biotech products,” says Lennon.
Connectivity, allowing healthcare providers and researchers to collect increasing amounts of data from medical devices, is also on the rise. This brings an associated need for data analytics, software development, AI and machine learning to make the most of the data for patient management and product development, and for data management and cyber security technologies to protect the data.
In another change, medical device companies are bringing manufacturing back in house in a process known as reshoring. In the wake of the COVID-19 pandemic, this move reduces timelines, improves flexibility, and improves control over the product lifecycle. However, reshoring brings with it skills-related challenges as production becomes increasingly automated, and more dependent on microelectronics. Companies also want to be able to use predictive analysis tools that forecast how markets will change.
“Many companies are not well equipped to meet the demands of manufacturing an increasing volume of both innovative and legacy products,” says Moulton. “We have seen that companies are seeking process, validation, development and project engineers to work in their production facilities. These are particularly permanent roles, but companies are also opening up to contract workers.”
Building the digital skills base
The UK does not yet have a wide pool of talent in the digital health and connected health arena, so medical device companies will have to look further afield to find the talent they need. With more people now working from home, one option is to use contractors and permanent staff who live outside the UK, as they do not need to be on site. Recruiters are reaching out across mainland Europe, including France, Germany and Switzerland.
Another option is to look for people from other regulated industries that have transferable skills relevant to the medical devices industry and can be taught what they need to know about working in healthcare.
“We can pull in people from other regulated industries who are accustomed to working with international standards and who understand the importance of processes, such as the nuclear and aerospace industries, banking and food,” says Moulton. “Transferable skills are important. This includes people who have worked on devices outside medical technology, such as Ring doorbells and smart household devices like fridges, and on devices related to the Internet of Things.”
Moulton adds that while engineers are accustomed to working with specific methodologies, there is a big innovation gap in medical devices. “The industry needs fresh ideas.”
Candidates can improve their own skills through studying. “We advise candidates to learn about the area and the relevant standards, such as the international standard IEC 62304 on medical device software,” says Lennon. Other relevant standards include IEC 60601, which covers the safety and essential performance of medical electrical equipment, and ISO/IEC 27001, on information security management.
“We also need to look to students for innovation,” adds Lennon. “Universities in countries like Ireland and France are investing in digital skills education.”
Transferable skills exist within companies, and the industry also needs to nurture its own in-house talent. For example, looking at people working in software development and software architecture in other fields. Interested individuals can ask within their own workplace whether there are people that they can shadow, or roles where they can gain experience. Contractors coming in on a short-term basis can also upskill in-house teams. All of this does cost money, however, and companies need to be prepared to invest.
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