The medical device industry plays a pivotal role in advancing healthcare and improving patients’ lives. From diagnostic tools to life-saving implants, medical devices are a critical component of modern medicine and have a unique set of regulatory and medical writing challenges. Below, we delve deeper into how to overcome some common regulatory challenges faced by MedTech companies, particularly those who rely purely on internal resources for document development and regulatory submissions.
Constantly Adapting; keeping up with international regulatory requirements
Regulatory approval is the most crucial point of a medical device’s journey and is a prerequisite for bringing a medical device to market. The medical device industry operates under strict regulations, with agencies such as the FDA, MHRA, EMA, and Health Canada overseeing the safety and efficacy of these products. Navigating the complex regulatory landscape is one of the most significant challenges in this industry and will ultimately determine whether your device is approved or not.
Medical device regulations are not static; they constantly evolve to keep pace with technological advancements, emerging risks, and product development lifecycles. For example, not so long ago we saw one of the most significant changes to MedTech regulations when the MDD and IVDD transitioned to the MDR and IVDR, respectively. More recently, the UKCA markings began replacing CE in the UK. Keeping up with these changes is a considerable challenge for companies, and non-compliance results in costly delays or even product recalls. To avoid being left behind, companies must adapt to these changes and ensure their regulatory teams and writers are consistently up to speed with global regulations and best practices by implementing frequent in-house training or deciding to work with external regulatory affairs, medical writing, and publishing experts.
Medical device manufacturers often aim to market their products in multiple regions, each of which has unique regulatory and documentation requirements that must be adhered to. Ensuring compliance with the diverse requirements of international markets can be daunting and it is essential that medical writers not only have a good understanding of the regional guidelines but also have experience working within that regulatory environment. We are seeing a shift in companies moving away from full-time, in-house medical writing teams in favour of working with specialist vendors, like Morula Health, and consultants that have experience with the relevant regulatory agency and a good understanding of the specific regulations, in addition to the essential technical and writing expertise.
Too many cooks spoil the broth?
Regulatory submissions should provide a comprehensive, cohesive, and representative account of the associated medical device and often require input from multiple disciplines, each of whom has their own opinions and goals. When these documents are written in-house, it can get chaotic rather quickly and can become a case of ‘too many cooks spoiling the broth’. To overcome this and ensure documents such as Clinical Evaluation Reports (CER) are highly accessible to regulators, medical device companies often benefit from the support of an external medical writing team. It can be difficult for in-house teams to remain objective when writing about their device; external medical writers like ours do not have this issue. A common reason for submissions being rejected is subjective claims that are a result of personal biases. Morula Health’s writers’ lack of biases allows them to ‘see the wood for the trees’, write objectively, and think outside-the-box which increases the chance of first-time approval.
Working with external writers who have specific experience and expertise relevant to the device increases efficiency and results in well-written documents that include all the relevant information (and exclude the irrelevant parts!).
The medical device industry is at the intersection of technological innovation and rigorous regulatory oversight. Navigating the intricate regulatory landscape and addressing the unique challenges in medical device writing requires a strategic approach. By staying informed and leveraging expert assistance, companies in the medical device industry can overcome these challenges and continue to bring innovative, life-saving devices to market. In doing so, they contribute to the advancement of healthcare and the well-being of patients worldwide.
Morula Health’s global team of specialist medical writers has a wealth of medical device writing experience and can support the development of your Clinical Evaluation Plans/Reports and Post-Market Surveillance documentation.
What regulatory challenges have you faced? Keen to learn more about how external writers can help you? Speak to one of the team firstname.lastname@example.org