We would like to get you all acquainted with our Clinical Consultant. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
Let's start with a small introduction, could you tell me something about yourself?
I am Argentinian, although have been living abroad for the past 8 years (5 years in UK for my PhD and almost 3 years here in The Netherlands). I have always been interested in disentangling the way things work, that is one of the main reasons why I decided to study Engineering. I first studied Electronic Engineering and then deepened my studies in Biomedical engineering in order to develop and adapt technology to improve the living standards of the people. Engineering, like other Sciences, allows us to understand and analyze some of the most relevant problems of our times. But it is certainly unique in providing us with the tools to design and implement a solution, thus transforming our realities. It is within this context that my career transitioned from Engineering to Clinical affairs with a background that equipped me with a structured mindset that allows me to understand different kind of devices and strategically and critically tackle the issues encountered.
What is your main area of expertise?
My main area of expertise lies within clinical, developing strategies and plans in compliance with regulatory requirements, not only by preparing clinical evaluations (including CEP, CER, LSR protocols, DCR, PMCF) but also planning, designing, preparation and executing clinical trials.
Could you also tell me something about your experience before you joined Qserve?
Prior to joining Qserve, I worked on the medical device industry as a Clinical and Scientific Affairs Manager, where I developed and delivered clinical strategies and evidence to optimize product life-cycle, building and managing effective partnerships and ways of working within and across different businesses. I have developed multiple study protocols, planning, designing, conducting and reporting clinical trials in compliance with project standards, specifications and regulatory guidelines (GCP, ICH, FDA, ISO), ensuring these are in alignment with the clinical strategy, clinical development plan and resourced in the project charter. I have experience providing strategic input on regulatory submissions, clinical evaluations, support of complaint report determinations and health risk assessments.
Apart from my Biomedical Engineering and academic career, in early stages of my career I worked for large Telecommunication companies in which I had to use Engineering to provide client oriented solutions, working within an interdisciplinary group and being in charge of projects for important clients where I was responsible for designing the solution and making sure it is carried out efficiently.
I hold a BSc in Electronic Engineering, focusing on Image Processing and a PhD in Biomedical Engineering, where my main area of research has transitioned to biomechanics and how different conditions and environments may alter the way we walk (gait), especially in diabetic patients, by developing a multi-segment foot model fitted by data collected on clinical trials. During my studies (both undergraduate and doctoral), I worked in parallel as a Research Assistant in the dosimetry and image processing domain.
Which part of your job do you like the most?
Getting to know so many different devices and companies, which does not only expand my knowledge of the medical devices and the industry but also allows me to communicate with other professionals worldwide. Given that my field has always comprised both engineering and clinical background, I am acquainted with explaining complex information in a clear and accessible way for different audience, as well as developing collaborative relationships with KOLs, investigators and site staff.
How does a normal workday look like?
As I started at Qserve during Corona times, most of the work is related to clinical evaluations at the moment, so it involves lots of reading and writing. I have meetings with the clients to analyze and review the evidence that they hold and the strategy towards submission for different countries. We also have internal meetings to discuss different topics among the experts with different backgrounds.
Do you prefer a specific type of medical device?
I do not have a strong preference, as I believe that consultants we must be acquainted with all class devices and I personally find them all interesting. However, those devices that involve electronics or signal/image processing such as active implantable devices are closer to my background.
Which trends do you observe at the moment?
Undoubtedly COVID-19 is one of the hot topics right now. I believe in general the transition from MDD to MDR is and will be an important topic until its implementation.
How do you stay up to date with everything that is happening in the MedTech-world?
I read the posts that my colleagues post in the intranet and blogs. At Qserve we work in a very cooperative environment in which we also discuss with our colleagues the different challenges that we face so it is very frequent to, not only contact another expert, but also to post questions in Yammer that result in very interesting discussions where we can all provide our input depending on our area of expertise. On top of that, we also have regular internal meetings to discuss different topics (such as clinical evaluations or PMCF) among the consultants.
LinkedIn is also a good source to keep myself up to date by following MedTech experts.
What is your advice/message for our customers?
That it is never too early to start! We are here to support you with a practical approach, together with experts that can assist you in a variety of tasks from the Regulatory, Clinical and Quality domain.
Would you like to know more about Abigail? Click here for her full profile.