From life-saving medical devices to our standard smartphone, any technology we use goes through some level of regulatory testing. For the most part, this is a benefit, as it gives us peace of mind. But do these strict regulations hinder as much as they help?


The benefits of Healthcare Regulations

Without question, the MedTech space has grown rapidly. A recent article in MedTech News stated that global investors completed a record-breaking 96 deals in the subsector in 2021. Coming to a total value of $40.8 billion. With this increased exposure, however, comes heightened expectations. Manufacturers have heavily moderated quality assurance and regulations to remain accountable. Without this, manufacturers might rush to launch products faster to keep investors happy, which can lead to mistakes.


Whether driven by money, scientific advancement, or simply improving the lives of patients. These motivations can cloud our judgment and lead to emotive decisions. One of the greatest benefits of regulatory boards (such as the FDA and EMA) is they have clear guidelines. They take the emotion out of the decision-making process.


Finally, and possibly most importantly, is trust. The government approval of a medical device or technology helps to bridge the gap. Building faith between manufacturer and user. Without this assurance from a third party, it would be difficult to assess how reliable and safe the product was.


The Negatives of Healthcare Regulations

We’ve talked about the benefits of regulatory boards within MedTech, but how do they hold back scientific growth?


Firstly, there is a massive cost associated with regulatory affairs. Mainly due to 60% of regulatory affairs work being outsourced. Which is due to rise to 65% by 2028. This costs the medical device industry an estimated £4 billion per alum that could be spent on product development.


Although the straightforward approach of regulatory boards can help keep emotion out of decision-making. It also doesn’t allow for much wriggle room. They can often be overly cautious with emerging technology, working against innovation.


The most frustrating part of regulatory affairs is time. The MedTech landscape is fast-paced. It can be challenging enough to keep on top of industry trends without being held back by the quality control and regulatory affairs processes.


Is Regulatory Affairs a friend, or foe?

Honestly – it’s both. Jumping through hoops to receive government approval could test anyone’s sanity. But at the end of the day, it’s so important to have these guidelines in place. As they ensure the MedTech industry continues to put patient care first.


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