The medical device industry has experienced significant growth over the past few years, especially over the course of the pandemic. Startups in this space raised almost $6 billion in the fourth quarter of 2020 alone. As a result of this growth, talent is needed in many areas of the industry, most urgently in the regulatory space.  

Regulatory expertise is in short supply in the medical device field, which means that qualified talent is hard to come by and even more difficult to acquire. Senior Regulatory Affairs Specialists, Regulatory Affairs Managers, and Directors of Quality Assurance/Regulatory Affairs are specifically hard to come by. Competition is high and hiring practices must change in order for employers to bring top talent on board.

In order to better respond to this phenomenon, we must first understand why the demand for regulatory talent in the Medical Device industry is so high.

COVID-19: Direct and Indirect Effects

Starting with one of the most obvious factors at play, COVID-19 has increased growth in many sectors of the Healthcare industry. Globally, there was an $80.6 billion investment in healthcare, which was record high. 

In addition to COVID-19 treatment needs, telehealth and digital solutions were paramount as many people could not see their doctors in person. This bolstered the demand medical device innovation to meet the immediate needs of patients and doctors alike. It seems likely that demand for these remote services will continue to be in-demand, as will the need for the devices that make them possible. 

Other, less direct, effects of COVID-19 were changes in hiring practices and attitude towards work. Those in the regulatory space of the medical device industry may have been impacted by hiring freezes that are now lifting. Employers are now looking for candidates with this kind of expertise and the competition is fierce.

On the other side of the coin, many candidates have grown used to flexible schedules and working remotely. If a business does not offer these benefits, they just may look elsewhere. This will make acquiring top regulatory talent even more difficult for some businesses.  

EU MDR

Another driving factor in the growing demand for regulatory talent is the introduction of The European Union Medical Device Regulation (EU MDR.) This became effective May 26, 2021 and introduced stronger, more stringent, rules regarding medical device implementation in the EU. 
Michael Page Senior Recruitment Consultant Daniel Hall explains the significance of this regulation: “Medical Device Manufacturers that are doing business in Europe must adhere to these new guidelines and become compliant … If they are not able to comply then they will be forced to pull out of that market.”

Before this, many American manufacturers would do testing and gather data in Europe before submitting to the FDA for approval. Europe’s less strict rules regarding medical devices made this possible. 

EU MDR not only effects new products, but also those already on the market. This means that medical device manufacturers need to ensure that the products they already have in circulation adhere to the new rules and regulations set by EU MDR. This responsibility falls on both quality management and regulatory teams. Hence, the immediate need for regulatory talent.

Limited Talent

Even back in 2014, before these factors were at play, experts predicted a regulatory talent shortage on the horizon. This is only exacerbated by the pandemic and increased governance. 

One of the causes for this talent shortage is the lack of students graduating from regulatory programs. In 2018, there were only 552 MS graduates and 4 doctoral graduates who specialized in medical regulatory affairs. A study was conducted to determine why so few people are choosing this an area of expertise and high tuition fees and tightening visa restrictions were found to be key contributors. 

Many other PhD programs tend to be subsidized donors and government funding. Some students are even partially or fully reimbursed by their employers for their education. Such things are not common in regulatory study, so students have little incentive to make such a high investment when there are less costly alternatives. 

The skills most in-demand have a rather high barrier to entry, as well. Besides the simple need for more experienced candidates, it is difficult for employers to find talent who can prepare and submit documents like the 510k and CE Mark to the FDA. Hall explains, “These documents can take several months to write and have strict guidelines. It is not an easy skill-set to teach or learn therefore, demand for experience is extremely high.”

With these factors at play, it’s very difficult to acquire top regulatory talent in the medical device industry. Partnering with one of our expert recruiters in this space may be the solution you’re looking for. Please reach out to one of our consultants today to discuss further, or browse our advice section for more insights. 

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