Interview with Qserve's consultant Femke Valkenburg
1. Tell us a bit about yourself.
My background is in the field of Neurosciences, in which I completed my Master’s and in which I am currently finishing my PhD. During this time, I have used various medical devices and have also worked with the regulations concerning animal experimentations. I have always been very interested in the regulatory and ethical side of clinical investigations in new (medical) technology. For me, this is an ideal field, as I can work within the interplay of new (exciting) medical devices, the clinical background, and the regulatory and ethical framework surrounding this area. Additionally, it gives me personal satisfaction to know that I have enabled market access of products which improve the life of patients in need of them!
2. What does an average work day look like for you?
Currently, I am finishing a presentation for a training for a Clinical Evaluation, according to the MEDDEV 2.7.1/rev 4, that Qserve is preparing for a medical device manufacturer. For this project, I designed training slides suited to the products that the company manufacturers. I am also working on another project relating to the new MDR and have also participated in discussions with colleagues concerning a clinical evaluation being prepared for an application to the Canadian market. Finally, I have been working on PMCF for the new MDR. Obviously, each day is very different, and whether I am visiting a client, presenting a training, writing CER’s, or investigating clinical data, I see or learn something new every day!
3. How would you describe your experience as a Clinical Evaluation Consultant at Qserve so far?
It has been a great experience so far! I really enjoy my position, especially the variety of medical device manufacturers with whom we work, and the rapid regulatory changes that the medical device industry is currently undergoing. As a clinical evaluation consultant, I see a tremendous amount of clinical data, from pre-CE, animal or bench studies, to literature studies and post-market clinical follow-up studies and registries. Every device is different, with varying levels of clinical evidence, and therefore each one requires a unique clinical approach. One of the strengths of our team is being able to provide a tailored strategy to our clients, while sharing our knowledge to support manufacturers in making the right decision to obtain clinical data in a practical and scientifically sound manner.
4. What is your specialization & area of interest?
My specialization is medical writing, literature searches, setting up clinical studies, investigating and analyzing clinical data, and clinical strategy development. I am particularly interested in this clinical “area”, as no two devices are the same, and I love diving into the underlying mechanisms and background of a new medical device while investigating whether sufficient clinical data exists. I am specifically interested in, and have the most experience, with implantable and/or active devices as they relate to neuroscience and imaging.
5. What do you hope to contribute to the team?
I hope to share my enthusiasm and knowledge concerning neuroscience or neurology-related devices (e.g. EEG, deep brain stimulation, probes, etc.). I expect that this field is going to expand significantly over the next decade, and I am passionate about sharing my knowledge because of my expertise and background in this area. My analytical thought process and previous experience setting up experiments will help improve the quality of clinical investigations.
6. What are your ambitions for the future?
I definitely hope to expand my knowledge concerning the new medical device regulation, while becoming an expert in the field of clinical investigations. It is my ambition to eventually present trainings, which will help medical device manufacturers increase the quality of their device manufacturing practices.