Qserve offers medical device manufacturers training at all regulatory, quality, and clinical levels. As a global medical device consultancy with offices in Europe, the United States and
staff offers years of international experience, with both broad and specific expertise for a wide range of medical devices and IVD's. In this interview, we highlighted several questions for Stefan Menzl
, Executive Director of Qserve Group Deutschland GmbH.
What are the most common questions that Medical Device manufacturers have?
The coming into force of the European Medical Device Regulation raises many fundamental and detailed questions on how to comply with the new requirements and what is the best strategy to get into compliance. Questions like ‘what do I need to do to maintain market access for my existing products in Europe?’, ‘How do I use the transition period most efficiently?’, ‘Do I transition all my products at once or do I rather take a stepwise approach?’ and many more.
One can only answer these questions based on a solid knowledge of the MDR requirements and what strategies are available. However, MDR is only one example of new or changing requirements. The medical device industry continues to be challenging in areas, such as MDSAP and the 2016 version of ISO 13485.
In a rapidly changing environment training presents a prime opportunity to expand the knowledge base of all employees. In a heavily regulated environment like the MedTech industry knowing the requirements and all options to meet them rapidly becomes a matter of survival.
What are your expectations?
I expect that there are several manufacturers that totally underestimate the impact of e.g. the MDR on their company and the overall medical device market. However, there are also more general aspects to training. Training and development provide both the company as a whole and the individual employees with benefits that make the cost and time a worthwhile investment.
An employee who receives the necessary training is better able to perform his/her job. She/he becomes more aware of best practices and proper procedures for basic tasks. The training may also build the employee's confidence because she/he has a stronger understanding of the industry and the responsibilities of her/his job. This confidence may push her/him to perform even better and think of new ideas that help her/him excel.
Qserve is here to help medical device manufacturers manage the challenges of changing and in many cases increasing regulatory requirements. One important element to this is training. <<Check here for our Training Program 2018-2019>>
What are the biggest challenges that Medical Device manufacturers are facing in the current environment?
Thanks to the recent technological advancements, the medical device industry is growing by leaps and bounds. To keep an edge over the competitors, healthcare manufacturers around the world need to fast-track their products to market, juggling the high-quality while minimizing the design and manufacturing costs.
Speaking of technology, digital device technology will continue to set the pace for the medical device industry. This will be especially true for software-enabled products in disposables as well as reusable devices. The inclusion of software in medical device development means medical devices are becoming more complex. Standalone software is now considered a medical device with all consequences.
The Medical Device Industry is challenged to ‘Prove’ compliance. This means more data needs to be collected, appraised and analyzed, a real challenge for products that have been on the market since decades. In many cases these products have been placed on the market without having conducted a clinical trial. Clinical data today can only be retrieved from literature or so-called post-market clinical follow up.
Regulatory Authorities push for ‘human factor engineering’ respectively ‘usability engineering’.
The push toward reducing or eliminating user errors includes guidelines contained in ANSI/AAMI/IEC 62366, which focuses on the safety aspects of usability engineering. This can only successfully be performed by a team consisting of people from relevant specialty areas. Also, certain human factors issues can only be validated in the actual use environment because simulated use testing might not be sufficient.
However, there is another huge challenge besides design and manufacturing costs, which is the rapidly changing regulatory environment. Regulators around the world are increasing requirements for medical devices. The European Medical Device Regulation is only one example for this.
The impact, however, might be dramatic. Certain products that have been around for decades might have to be taken off the markets, since it will be too costly to bring them into compliance. Due to the need for more clinical data to bring new products to the market, SMEs might not have the financial strength anymore to actually market their latest developments. This might have a significant impact on the MedTech market.
Knowing and managing regulatory requirements most efficiently might become the key differentiator between successful MedTech companies and those that will not survive.
Please read part 2 of the interview here.
Open Training - Frankfurt: IVDR Transition
Open Training - Frankfurt: MDR Transition