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Interview with Loes Pelgrim, Clinical Operations Consultant

We want to get you all acquainted with our Clinical Operations Expert Loes Pelgrim. An interview where we talk about her area of expertise, what her ‘typical’ workday looks like and which trends she observes in the MedTech-world. Discussing the things she love about the clinical area but also the obstacles she sees on the job. Ending the interview with valuable advice for everyone in the MedTech-World.

Let’s start with an all-round question! What is your main area of expertise?

My expertise is the clinical area. That contains: clinical evaluations, clinical studies, clinical activities pre-CE and post-CE, everything that has to do with clinical.

Which part do you prefer the most?

I really like the clinical operations part, that is also where I have the most experience. When a client decides: I need a study, I need to investigate my product in patients, then I will work together with them in setting everything up in a sufficient way, try to avoid any problems while doing the operational part. But before the operational part, we have strategic discussions, not only related to clinical but also, what is the regulatory strategy we have outlined with them? We first must talk about what they want, where the company wants to go, how far the product is, what they already know about the product, where this product stands in the market? This is what I like as well, because when you work on strategy you really go into more depth, we get to know the product really well. This makes it easier to work on the operational part and to write about it because we can ask the right questions. I like to become a part of their project!

What does a normal day look like during the operational part?

That is very diverse, I can work at the office and check if the documentation is up to date or if changes are needed? If yes, we make a proposal for this change. We submit to ethics committees; we make sure the investigators that work in a trial are aware of these changes and assure they implement these changes well. In the very early phase of product development, I work on strategies: looking at all the possible strategies and their consequences, pros and cons. Most of the time, there is not one good answer for the company so it takes a lot of time to discuss and decide. It can also be on-site monitoring where I go to the hospital and check if the site works fully in compliance with the protocol, if the site still understands everything that needs to be done, if they have enrolled enough subjects to the trial, so it can be in the middle of the whole operation. I personally prefer to see the whole context: the strategy, as well as the hospital and the team.

You work on the operations from beginning until the end? Yes, also post-market clinical follow-up (PMCF). As we have multiple clients in multiple stages of a products lifecycle, so it’s very diverse. With one client I’m in the pre-market phase, the other client wants an update of a certain report. With some clients we go through the whole path: regulatory strategy, clinical strategy, a study, doing data-analysis and report and then bringing the whole file to the Notified Body for their submission and going to market and we help them post-market. We can go through the whole life-cycle with a client, this can go on for years.

Do you prefer a specific type of medical device?

I do not have an absolute preference, but I like to say I am more ‘non-active’. The non-active things like bone-regeneration products, orthopedic products, all kind of tools that surgeons use, stents, these are the products I prefer. I am really interested in devices that interact with your system, like how can we let bone regrow with your own biological system? How can the product give support to failing or injured systems?

Which trends are topic at the moment?

I think clinical in general is trending. Clinical always existed, because every medical device goes to a patient in the end. It is not that it did not exist before, but the regulation was not so strict. Not a lot of trials have been done so far, or the amount of clinical data is limited. With the upcoming MDR, clinical is a huge topic. So clinical as a whole, I think, is much more ‘hot’ than in the past.

Because of the MDR?

Because of the MDR and then especially the question: do you have clinically sufficient evidence for your device? To be able to bring it to the market, and to keep it on the market, you need to show that you have clinically sufficient evidence. You need to have clinical data of an amount and quality that shows: yes, this product is performing as intended, it is safe, it is there as we would like it to be. But what is sufficient? When do you have sufficient evidence?

And that is a struggle for a lot of companies, especially for existing products. A struggle for legacy products, which are already on the market. Maybe they have a tube or a catheter, or whatever ‘easy’ product let’s say, already existing on the market for the last 20 years. The company may have never captured a lot of data, because it was never necessary, but now the manufacturers are confronted with feedback that their clinical evaluation is not good enough, there is no sufficient data. You have to come up with more data. And then the next question is: how? This product is safe, we sell hundreds of thousands of them daily. Nothing happens. I am not investing a million euros to investigate things I already know. How do we get sufficient data? Then we try to advise them in post market activities, like: can you obtain clinical data in your current client base, in your current patient population? Maybe with questionnaires, with surveys or with retrospective data analysis? Get data out of the market that can support your product. This is a time, relating to this clinical data, we need to be creative.

This is for a lot of companies a struggle. Sometimes they don’t have the budget, sometimes they don’t have the people or they don’t have the time. So it’s really like, okay we need something, but we have no input. We have no money, we have no time, we have no people, what shall we do?

Are you able to provide a solution for their problems in the end?

A lot of times, I think I am not directly solving it, but we are helping in this creativity and showing possible solutions. Like, what kind of options do we have or do we think you have. What are pros and cons of these options? How can you implement them? So, we are not directly solving the problem, but making it less complex or less stressful for customers: ‘let’s be calm and outline what we have, what we can do and then see how to move forward’. That is sometimes already a part of the solution. To stay calm and consider what we have and what we can do.

How do you stay up to date with everything that is happening in the MedTech-world?

I am pretty active on LinkedIn, not posting a lot myself, but keeping track of all kinds of groups. What does everyone post? Also, by having internal discussions with colleagues, like, sharing experiences: what did you see or do? Or hearing how they implement a certain solution that worked. I think being in the field, seeing multiple customers, hearing stories from colleagues and sharing. Also sharing the things that did not work. Or discussing a situation: I have this customer and they want to do it this, or this, or this way, what do you think? For example when I already have doubts, and my colleagues say: nooo, you can never do it like that! That gives me a sort of confidence that I am on the right track because I also had that feeling! So, I really like sharing, sharing a lot. And seeing practical situations, real situations at clients. I think that keeps me most up to date. New regulations and guidance’s, like the MDR or a new MEDDEV, or ISO standard: you need time to read it, to hear a couple of times from a colleague what they think, before you really have it in your mind. When they first publish it, you can’t directly think ‘okay now I am up to date, I can implement this’. It needs some time and practical use.

Discussing new regulations with your colleagues?

Yeah, like: what do you think? Oh, I thought they meant this? Oh, you have a whole different interpretation. Okay, interesting... That is also really helping.

One last question then... What is your advice for our customers?

That is a difficult one. Because, I think our advice in general can be like, tackle your problems early and don’t wait. When I’m with customers, I notice that their focus is different. At Qserve we are 100% of our time focusing on: what are the regulations? What’s new? What’s coming? But if you have a manufacturing company, you have regulations you comply with, that is most of the time a burden which you hate. And in the meantime, you have a production line, you have sales, you have clients, you have employees that need to be happy. You have so much other businesses going on. For Qserve, regulation is our core business. For our customer it is: okay we need to comply with it, but our core business is creating a product, selling a product. So, the focus from our customers is different.

My advice would be: keep good track on regulatory requirements, because when you have a problem all of a sudden, you directly have a problem with the sales-pipeline as well, because if you lose your certificate, you don’t have any business. We understand you have no interest in knowing every tiny detail, but you want this practical approach. It is nice that there are ten thousand rules, but what does this mean today, for you and your company? That is, most of the time, their question.

Not waiting, is maybe the best advice. Don’t wait or don’t look away from the regulations, because that will not solve your problems. Grab it and ask for help. Make sure your management is also aware of the importance. Because they decide the budgets most of the times. As long as there is no priority in the company, nothing is changing. The regulatory person will struggle to get something done. See your problem, see what you have, prioritize on it, don’t wait. Don’t look away and think it will be resolved automatically. It will not solve automatically; I am pretty sure.

Making them aware of what can happen?

Yeah, we see customers sometimes, looking away, like; ‘that is not well implemented but okay, let’s wait’. And sometimes you can go on for that, like years and years. Depends also on the product. But the moment the NB comes and gives you major non-conformities then you’re in a hurry. Then you need a lot of money and you have short timelines to solve the problems, try to avoid this, be ahead of real, big problems. Don’t wait! 

Thank you for your great advice and time! 

For Loes her full expertise-profile, click here.

Loes Pelgrim
Post date: August 19, 2019
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