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My experience working in the medical device industry under the MDR

Medical Devices

12/30/2023

My first acquaintance with the Medical Device Regulation (MDR) goes back to the summer of 2016. I just started to work for a class III medical device manufacturer offering antibiotic-loaded bone cement.

You might ask what is so special about that. Well, it is the degree of complexity stemming from combining

  • an implantable medical device with the purpose of bone fixation, with a
  • medicinal product aiming at reducing local infections

The MDR was on its way and finally published in April 2017, and we were uncertain how it would affect our product portfolio. The dry MDR text is hard to translate into actionable work items, without the body of guidance documents having appeared much later.

The tightening of scrutiny by the Notified Bodies (NB), the EU Commission, and local authorities, especially for manufacturers of implantable medical devices, had far-reaching consequences.

One of them was the availability of sound clinical evidence for

  • safety,
  • performance, and
  • medical benefits

of the medical device.

Products like hip prostheses or ventricular assist devices have been in the market for decades with a well-known safety profile. Efforts within the manufacturer's organization had to be directed at consolidating existing clinical data, spread over various locations and sources. Importantly, all experiences, whether favorable or not, published or not, must be taken into account to provide unshakable evidence that the benefit outweighs the risk associated with the use of the device.

In some cases, expensive clinical trials had to be planned to fill prevalent gaps in evidence.

The in-depth monitoring of manufacturers by the NBs of their

1.) clinical evaluation,

2.) risk management,

3.) post-market surveillance and vigilance

were to be strictly enforced under the MDR, as a main goal set forth by the EU Commission.

In 2017 Dr. Bassil Akra, at that time representing the Notified Body TÜV Süd, conducted a great in-house training. Apart from many valuable explanations and interpretations of the MDR, I remember two statements very well:

  • "The MDR provides job security"
  • "Read the MDR!"

These words still resonate with me today, and I would like to share with you the results of my reflections from 6 years of professional practice after that.

"The MDR provides job security"

The migration of processes, activities, and documentation from the Medical Device Directive to the MDR entailed an increased workload on the existing workforce in medical device companies. As suitable experts cannot be easily found on the job market they reassigned tasks to individuals from other areas, such as development. The capacities of highly qualified employees are tied up, having a detrimental effect on the innovation potential and development pipeline.

The growth of costs incurred from regulatory requirements, logistics, and supply chain environments diminish the profitability and capability to maintain a broad product portfolio. Product lines with smaller revenue or profit margins are candidates for closure.

In the light of these trends, the notion of job security is not entirely true anymore.

According to the German Federal Statistical Office, total sales in the period from January to August 2023 were nominally 8.5% higher than in the same period of the previous year for the German medical device industry. At the same time, however, producer prices also rose by 6.8% (source: Spectaris, Dec 2023).

Inefficiencies and a high level of bureaucracy and overhead are detrimental to the quest of the companies to counterbalance increased costs.

Digitalization, the transformation of processes using digital technology, to reduce redundancy and inconsistencies in the vast data dispersed over various sources has only recently picked up momentum.

Coming back to "job security", I have arrived at the following conclusion:

  • my job in medtech is only safe to the degree that I am willing to go through continual training and self-development (also outside of work!)
  • it is important to build a strong foundation of knowledge, encompassing regulatory, quality, technical, and clinical
  • choose to become a distinguished expert in one of the three domains in which the EU Commission has applied increased scrutiny (see above)

Working in the medical device space is fascinating. The variety of medical devices used for diagnosis or therapy is staggering. Developing safe and reliable products with a strong positive effect on healthcare is a very complex undertaking.

Operating them and observing their performance on the field requires a streamlined process so that the acquired, validated data support the incremental product improvement, or open the possibility for a leap to a new generation of products. This is accomplished by people with devotion to their work, and a willingness to learn!

If you can find a mentor or are lucky to have an experienced supervisor listen carefully to what they say. Critical thinking and drawing your conclusions on how their advice applies to your situation are essential. Contemplating productive criticism is a great way to develop personally. Being honest about, and looking openly for blind spots in yourself is the nurturing force of self-development.

Anyone capable of absorbing and consolidating lots of information, identifying its relevance, and applying it to the situation at hand will thrive in this industry.

This learning culture is indispensable for any team to represent best industry practices (fostering the quest to always pursue "state of the art" in products and services). It provides a competitive edge to the whole company! This allows each individual to grow in an environment of positive team spirit and learning culture.

No single person will know all the answers, hence, teamwork is essential. Being able to have conversations with colleagues or auditors beyond the field of your specialist knowledge is invaluable.

Seeing how all pieces depend on each other and how they form a coherent, complete picture is the pinnacle of expertise. Is it achievable? I don't know, but getting closer to it is the key. This is a step way beyond securing a job. Instead, it sets the stage to become a leader and role model!

Let's look at the second statement of Bassil:

"Read the MDR!"

On-the-job training is often regarded by industry advocates as the ultimate way of acquiring tangible skills. I would argue that only by complementing this with

  • periodic (re-)training in certified seminars (with final exams), and
  • undisturbed spans of concentrated reading of statutory, normative, or guidance documents

ensure that complex challenges in projects can be mastered under time pressure.

Take the example of data privacy or cybersecurity in a software product. It could be an accessory to a medical device or a medical device in its own right (Software as Medical Device).

Learning how to apply Threat Modeling proactively in the design phase of a medical device allows "security by design". It is imperative for information security, and ultimately for patient safety.

Threat Modeling also promotes the efficient and cost-optimized operation of software products in the field. Finding out about avoidable vulnerabilities later can lead to a very expensive problem-resolution process (patching in the field, loss of reputation or money due to possible exploitation of vulnerabilities).

Cybersecurity is a constantly evolving field, as is the domain of clinical evidence generation. (Re-)Training and provisioning of ample time to become familiarized with the latest normative, regulatory, or guidance updates reduce the risk of project failure and deviations in audits. These usually cause stress and delays, and can have adverse effects on the workforce in terms of motivation.

Closing Corrective and Preventive Actions (CAPAs), and updating Standard Operating Procedures (SOPs) that were not written or reviewed carefully, require prioritized attention of employees who would rather focus on value-adding product development or launch activities.

Repetitive work and tasks that involve a high risk of human error will eventually be replaced by intelligent algorithms safeguarding the consistency and timely creation of all documents (e.g. for class III implantable devices seven reports need to be updated annually, with a high level of dependency and cross-referencing).

The best insurance against obsolescence in the job market is building skills to solve challenging tasks that cannot be achieved by an algorithm.

A business or entrepreneurial mindset facilitates decision-making in day-to-day work. Management will appreciate an attitude where patient safety, product quality, cost containment, and profitability have all been considered. Opportunities for professional development and advancing the career come naturally with that kind of posture.

Being active in associations or work groups discussing feasible solutions to industry-wide challenges expands the scope and gives new insights. Learning from other people, and how they interpreted and implemented difficult-to-read law paragraphs is very helpful.

In conclusion: what Bassil Akra meant - in my view - is to reserve ample time for reading, digesting, and comprehending information from all relevant sources. This is not confined to the MDR but also includes MDCG guidance documents filling in what the MDR failed to lay down, and about a dozen main standards that apply to medical devices. And then there is the FDA Code of Federal Regulations and the guidance documents around them...

When employees are given time to read and develop their skills, they are more productive, forward-thinking, and future-oriented. Besides, it elevates their self-confidence and motivation.

Did I read the whole MDR? Yes! Reading it sentence by sentence can be painful at times, because of the many references that need to be followed. It requires perseverance and genuine interest.

After having read the MDR with personal notes attached, I attended 5 seminars at the TÜV Süd Academy. The meticulous preparation for the final exam helped me to solidify my knowledge. Now I feel I can attain deeper levels of understanding, giving me a rewarding sense of accomplishment.

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