#FutureInYourHands – This motto properly describes how TÜV SÜD empowers its employees. It’s best to hear from TÜV SÜD executives and staff members what their personal experiences are working for TÜV SÜD.
For our newest Employee Spotlight, we sat down with Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service. With a background in research, development, regulatory approval, and quality management of medical devices, Dr. Akra is a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert, Dr. Akra presents worldwide on the European requirements and is involved in development of many guidance documents and standards.
Can you describe your role within the company?
In addition to my role of Vice President of Global Strategic Business Development for TÜV SÜD, I am also a member of the Management Board of Medical Health Systems (MHS) for the company. I deal mainly with global strategy and politics for the organization and focus on steering our activities in the high risk business areas i.e. Class III and active implantable medical devices, as well as cover the clinical expectations within TÜV SÜD.
One of my main focuses presently is helping our company and clients transition to the new European Union Medical Device Regulation (MDR), which will end its transition period in 26 May 2020. This means that any new and existing products will need to be certified under the new legislation through a Notified Body listed on the NANDO Webpage of the commission for the MDR 2017/745. Currently, there are only seven Notified Bodies that can provide certification for this regulation in the EU- TÜV SÜD is one of those Notified Bodies.
What are some market trends you’re keeping an eye on?
What we’re seeing being developed now for the medical device world is the evolution of artificial intelligence. This is really going to change the world of medical devices and medical therapy. Relatedly, minimally invasive therapy will truly evolve the healthcare field. Nowadays, we’re not interested in big surgeries- we’re trying to avoid this. With the technologies available and being developed, minimally invasive therapy will truly re-shape things.
We’re also seeing an interesting collaboration between big data and the medical devices industry. With sound medical knowledge, robotics can be used in surgery and therapy of patients on an individual level, while also increasing efficiency.
How did you choose this career path?
My background is in medical engineering; I hold a biomedical and medical engineering degree. I began my career on the side of invention and research on developing medical devices and combination devices. During my time at the University Hospital I got in contact with regulatory requirements since we were planning to open a bio bank. We needed to receive approval to place products which are deemed pharmaceuticals on the market. This was my first contact with understanding the necessities for documentation and expectations for product approvals. Notified Bodies like TÜV SÜD contacted me to support them during device conformity assessment processes. I found this a very interesting process and I saw this as a challenge I could expand my knowledge in. I continued to work with regulatory bodies and product experts. I’ve worked with TÜV SÜD for eight years and my career has evolved to where I am now.
What do you enjoy most about your job?
The most interesting part of my job is in regard to influencing legislation, standard and guidance with the focus on the patient needs. It’s a balance, but you see how you’re adding value to both the healthcare system and the patient. From an education standpoint, you also have the opportunity to share your knowledge with other interested parties. This helps them, in turn, understand their own value.
What can be challenging in your role?
When you deal with regulations you have to amend your expectations regarding timelines. Regulations cannot change over one day- you have to work hard, and long, to implement the changes. You also need to ensure that legislature understands the differences between the devices covered in the regulations- this can be a big challenge as new technologies evolve and differentiate depending on the product.
What advice do you have for young people considering entering this field?
My biggest piece of advice is to make sure that you love what you do. Give your training a year and if you don’t love this field, then don’t do it and find another passion. In this industry we’re playing with people’s lives. If we don’t test products correctly, we put our customers and the public in danger. This is a fantastic industry- it’s exciting, innovative and you meet dedicated coworkers and customers. Also, do not be afraid to jump into field work, as this is the best teacher.
What do you think this industry will look like 20 years from now? How will it change?
There are current trends that I see continuing to develop into the future. One of these includes an increase in home-based therapy; innovations and procedures where you would not need to go to the doctor. This will be partly enabled by the development of electronic applications, such as monitoring of patients over apps, wearable devices and electronic systems. I also foresee an increase in personalized medicine based on big data. By compiling all of this data from electronic systems, we will be able to enable and improve clinical outcomes, while also considering individual needs.
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