In today’s fast moving, increasingly complex medical devices environment, organisations need strong regulatory literacy to get fast to market, ensure patient safety, and drive growth.
But what is regulatory literacy in medical devices exactly?
This blog post offers an insight into what it means, why regulatory literacy in medical devices matters, and how to improve it.
What is regulatory literacy in medical devices?
I haven’t been able to find any formal definition, but here are a few leads I’ve discovered.
In this article ’regulatory literacy’ is described as
knowledge of and fluency in the language of legislation and guidelines for the regulation of the medical profession and an understanding of the current regulatory regime.
The authors present regulatory literacy as how fluently patients and the general public are able to make complaints regarding medical issues.
In another example ’regulatory literacy’ is associated with a full understanding of regulations, which ensures compliance with quality and regulatory requirements.
According to the author, regulatory literacy helps for example to
- organise assessment-proof design files, design dossiers, and technical files,
- manage subcontractors efficiently, and
- create and implement PMS plans appropriately.
From what I can see, the knowledge and understanding of regulations, terms, concepts and guidances lie at the core of regulatory literacy in medical devices.
In addition, the ability to use that knowledge and understanding to conduct various medical devices regulatory tasks successfully, is critical to regulatory literacy.
What causes regulatory literacy gaps?
Regulatory literacy gaps are caused for instance by the following factors.
Lack of resources
You’re interested to learn more about medical device regulatory rules, but the right kind of training just hasn’t been available.
Lack of go-to support
You’d like to clarify medical device regulatory confusion, but you don’t have a regulatory expert to talk to and guide you.
Constantly changing regulatory environment
With the rapid pace of regulatory change, you’re having a hard time keeping up to date with growing regulatory complexity.
Time constraints
The time needed to grasp regulatory rules overwhelms you, as you need to take care of your primary job at the same time. You feel there aren’t enough hours in a day to maintain regulatory literacy skills.
Low awareness of regulatory literacy benefits
You’ve personally had negative experiences dealing with regulators or authorities. Or you use the negative experiences of others as a justification for why the regulations just aren’t for you. You haven’t actually taken the time to get to know the legal texts and guidances.
What are the effects of weak regulatory literacy?
When regulatory literacy is low, it can lead for example to the following outcomes.
Higher organisational risks
If the people in the organisation don’t understand the applicable laws, it can lead to all kinds of safety, legal, reputation and business compliance troubles. We’re talking about things like fines, loss of trust and increased surveillance by the authorities.
Slow technical documentation preparation and review time
It takes forever and a day to get the documents to the required level. Also, the review of the documentation by a notified body is taking ages (because the reviewer is struggling to make sense of the documents).
Frustrated team members and management
No one’s happy that the conformity assessment is taking forever. Or that people need to put their work on hold to answer lots of questions from the notified body. Project deadlines are at risk. You can feel the tension in the air.
Non-compliant clinical studies
The clinical investigations you conducted didn’t have the right endpoints or enough study participants to fulfil the regulatory requirements. Inaccurate, insufficient study results are not adequate for market entry.
More time spent on fixing than moving forward
Fixing what was incomplete or wrong in the regulatory submission, and re-doing it in a regulatory compliant way, can take a lot of time. It’s keeping you from fully immersing into new projects.
What are the benefits of regulatory literacy in medical devices?
The upsides of regulatory literacy include the following:
Go from putting-out-regulatory-fires to regulatory confidence
If you often find yourself managing urgent, unexpected regulatory problems, you might benefit from better regulatory literacy.
This could look like familiarising yourself with the definition of a medical device before starting to market your product as a wellness device. Or using the latest templates provided for free by MDCG instead of your own templates from 2005 to avoid extra questions from your notified body.
Regulatory literacy eases regulatory stress and builds regulatory confidence.
Efficient best practices for dealing with regulatory red tape
If you’re spending a lot of time creating processes and documents with the CE mark in mind, but the auditors keep on refusing to approve them, you could consider brushing up your regulatory literacy.
Regulatory literacy assists you in identifying what’s relevant and good enough. You’re more capable of building the kind of processes and practices that support (and not block) your journey through the evolving regulatory complexity.
Faster conformity assessment turnaround time
If your conformity assessment with the notified body was not the breeze through you had hoped for, regulatory literacy can make the process easier.
Regulatory literacy helps you to prepare for working with a notified body. By paying attention to the notified body’s process, instructions and expectations, the conformity assessment process can be much less time-consuming.
Less barriers from bench to bedside
Struggling to demonstrate a clear regulatory strategy may mean a founder or a researcher fails to secure funding or strategic partners. Regulatory literacy facilitates building momentum at a critical time.
With regulatory literacy, early stage teams are more effective at designing smarter pilots and realistic roadmaps that link to the regulatory requirements. That clarity strengthens investors’ confidence and speeds up market access and revenue generation.
Piloting new technologies in a safe, compliant and scalable way
As exciting as it is to pilot new innovations, it’s also important to identify obligations, build trust and ensure safety and security from the start. Regulatory literacy can support this.
With regulatory literacy, it’s easier to determine the relevant regulatory duties and rules. Setting up the right monitoring and change control from the beginning will help you avoid late-stage rework and bottlenecks for scaling.
Solutions to improve regulatory literacy
Here are four options to develop regulatory literacy:
1.) Self-guided learning
Self-guided learning lets you decide what, how, and when to learn. By tracking free or cheap resources, you can keep the expenses low. Owning your regulatory growth builds regulatory confidence and resilience.
However, achieving and maintaining strong regulatory literacy requires many self-study hours. Do you have the self-discipline to stay motivated, when other pressing tasks are distracting you? Without internal or external regulatory expert’s oversight, you may overlook essential requirements or misinterpret details. This may cause regulatory literacy gaps.
2.) In-house regulatory expert
Using an in-house regulatory expert ensures you have someone with a sound knowledge of your company to guide your regulatory literacy development. An internal regulatory specialist supports long-term consistency and continuity. Quick help is provided when urgent regulatory issues arise.
Nevertheless, an in-house regulatory expert comes with high fixed costs. The continuous training to keep the specialist’s regulatory skills up to date can cause budget stress in particular for small companies. Yet without active professional development, the regulatory literacy managed by the in-house regulatory expert will soon stray off course.
3.) Outsourced regulatory expert (i.e. external consultant)
Using an outsourced regulatory expert (i.e. external consultant) provides access to best practices tried and tested with many other clients. A fresh pair of eyes can spot regulatory gaps in your processes and advise effective ways to close them. You can buy the expert service flexibly to suit your regulatory needs.
An external consultant does need some time and guidance to get to know the company’s devices, QMS, processes, and so on. If the company is unable or unwilling to share all the relevant company processes and documents, the outsourced expert may be able to provide only light recommendations on how to improve the organisation’s regulatory literacy.
4.) RegTech tools
RegTech tools automate manual workload and assist in cutting through the noise. Some tools help you to get started on the regulatory journey, others manage data, risks and/or a QMS. Some monitor PMS data and industry insights. Others may do all of the above.
While these technologies can help save time, they’re not without challenges. Choosing the right RegTech tool is one question. Integrating it into company’s legacy systems is another. Licenses and maintenance are seldom free. AI-powered tools tend to miss the nuances and the grey area embedded in regulatory. An experienced human oversight is required to confirm the conclusions and interpretations provided by the RegTech tools.
Regulatory literacy is a key to success in medical devices.
Without it, it is difficult to navigate the regulations skillfully, write sufficient technical documentation, communicate effectively with third party assessors, or conduct many other important regulatory tasks with good results.
What about you?
Do you ever feel like it’s hard to understand medical device regulations, and to apply the understanding in practice?
If you need any advice or hands-on support, I’m here for you.
I’m always happy to listen to what’s on your mind, and help you take the next step.
