Managing Risk in Clinical Investigations

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations.

They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.

Interested in sponsoring an episode? Click here to learn more!

Watch the Video:

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key Timestamps

• 00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.
• 00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.
• 00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.
• 00:28:30 - Challenges of enrollment and protocol design.
• 00:35:45 - The impact of regulatory changes on clinical investigations.
• 00:49:10 - Addressing the integration of artificial intelligence in medical devices.
• 01:03:15 - Closing thoughts and call to action from Helene Quie.

Key Takeaways

1. Insights on MedTech Trends:

• The increasing importance of data in justifying product safety and efficacy.
• The shift from intuition-based to evidence-based risk assessment.
• Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.

2. Practical Tips for MedTech Professionals:

• Ensure that risk assessments are detailed and backed by solid data.
• Consider the practical aspects of clinical trial protocols from multiple perspectives.
• Stay updated on regulatory changes to adapt protocols and product development effectively.

3. Future Predictions in MedTech:

• Enhanced scrutiny and requirements for clinical investigations.
• Greater integration of AI and digital tools in medical devices.
• Potential regulatory adaptations to accommodate innovations.

Links:

• Helene Quie on LinkedIn

• Etienne Nichols on LinkedIn

• QMED Consulting

• Questions to ask for Clinical Preparation

• EUMDR and MDD Comparisons: Insights into how regulatory frameworks have evolved and their impact on medical device development.

Memorable quotes:

• "It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie
• "Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie
• "We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene Quie

Feedback:

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

Transcript

Etienne Nichols

00:00:32.250 - 00:00:53.690

Hey everyone, welcome back. Today I get to speak with Helene Quie and I am excited to talk to her because she has a lot of interesting background we'll make.

We may get into that a little bit later in the episode but for now I'd like to talk to you a little bit about risk management, particularly when it comes to clinical investigations. What is your approach to risk management with clinical investigations?

Helene Quie

00:00:54.090 - 00:03:36.540

Thank you very much.

It's, it's, it's a very good question because I see it as a two-legged activity for me when looking into a new project which is a clinical study or clinical investigation. First, we have the risk management part which is related to the safety of the product. So. Exactly.

If you've been involved with developing medical devices you, you know you have to do risk assessment according to the standard.

You know, you are developing a product, you want to make sure that it's safe and performs and there are, when you do this assessment there will always be some residual risk or not always, but many cases you will have residual risk and these residual risk is what you actually would like to test out in the clinical investigation.

So, what's left that an engineer or an engineering team are not able to fully conclude during their verification and part of the validation you will transfer that as risk into the clinical investigation. So, we make sure that these residual risks, so the output from the risk assessment is implemented into the clinical documents.

So that is the protocol and the investigators brochure, it is the instructions for use and it's also the benefit to risk assessment and maybe some other documents that, where you put this information in.

But these four documents are the most important when you are applying for the approval of a risk assessment at the competent authorities and or the ethics committee because they look at what are the actual risks towards the patient, what is the critical aspects here and they will outweigh that with your understanding or your description actually the presentation and the documentation of your benefits.

So, if you, you need to explain that the risk that you are, that the patient will face is outweighed by the benefit that you have a justification for that. So that is where you bring the development into know. This is why we do the investigations.

I know from a company you are thinking commercial and physicians, and you need to earn money and, but at the end of the day you are going to provide Data to close down some risk, mitigate some risk. And you can only do that by testing the product in patients I like. So that's the one leg that I.

Etienne Nichols

00:03:36.540 - 00:03:46.880

Like, the way you explain that.

Because that residual risk, sometimes we just try to explain that away and say, well, it's, it's a low risk, but that, the bringing that in and focusing on the residual risk, that's powerful.

Helene Quie

00:03:46.880 - 00:05:01.680

Yeah, it's, you have to take them actually one by one now. So that is because, yeah, I'm a, I'm a little old, so I know in the old days it was kind of stomach feeling. This is fine. And yeah, this will.

The risk is not significant.

I know the whole tech sector section that you use to put in your patient information and your protocol, but now it's actually expected that you have, you have defined your risk and that you know the size or the severity of the risk and that this is compared to what you can actually find, if it's possible in the literature or in your own data, where do you have that number from? Or you know, anything which is measurable in a way, you will have to compare that with something that you can measure, which is a benefit.

And this is where you have to do the benefit risk assessment. It doesn't go up one by one. You know, it's not an equation.

But you have to, based on this, these amounts or these sizes or data, be able to justify why you think it is safe to continue into a clinical investigation, testing your product in patients.

Etienne Nichols

00:05:02.800 - 00:05:40.660

That's a really good point that I think sometimes we forget because there's no one risk that is so risky that we couldn't accept it if the benefit wasn't high enough. So really, it's all about the benefits, truly that, that, that we have to just make sure the benefit's great enough.

But I wanted to ask you, do you see companies doing something, particularly when it comes to making that risk, because you talked about the risk being measurable, or you have to be able to measure the impact to compare it to the benefit? Do you see companies consistently doing things that, that make that more difficult than it could be, or what are the best practices in that regard?

Helene Quie

00:05:42.020 - 00:07:44.650

I think it's always difficult.

When you continuously over some years look at a certain product and development you get, you might not be objective as you need to be and that this is why I think it's so important to start having really it coming down to numbers and that you have to be able to, every time you state something, especially in your benefit risk assessment, that you can lead that back into something that you have either collected in the literature or that data that you have collected yourself. Because it's especially the benefit analysis have previously been, as I mentioned before, the stomach feeling. This is a fantastic product.

It will save the world and therefore any risk that comes in. I know I'm exaggerating a little bit here, maybe a lot, but this is how it's been for many years.

But now by having so much focus under the MDR on the clinical evaluation and this section which is called the state of the art where you describe how is this disease being treated today, it gets really very clear, you know, what is it that I'm comparing up against when I'm designing my product.

And we have, when we are submitting our clinical investigations on behalf of some of our customers and partners, we get pushback from ethics committee and competent authorities if we are not really clear on this balance, because they do not want us to do studies that are not ethically towards the patients. So, you really have to dig deep to get the data in front of you and explain why you think that this device, which always have a risk, right.

Anytime a patient gets into a hospital, you are actually providing some risk or giving some risk towards that patient. Infection risk and other things. So just by entering the door. So how are you going to justify that with what you bring towards the patient?

Etienne Nichols

00:07:45.520 - 00:07:50.880

Okay, so that's the first leg. What about the second leg you mentioned with risk management for clinical investigations?

Helene Quie

00:07:51.280 - 00:11:32.860

Yeah, the second leg is the risk assessment which is. I really rarely see this assessment very clearly described in the documentation that we see.

But I think it's very important and we do that internally here when we have our overall assessments on how the studies are going or the projects is that you actually do. It's kind of a project risk assessment.

And when it's on studies, so it will be the risk which is applied by the actually protocol towards the patient, the user and the third parties.

So, you look at the risk from kind of the other side, that it's not any longer the product, but it's that you are setting a structure around the treatment of the patient which is different from standard of care. For some part of the process, you ask the patient to come in for extra follow up, you ask them for the consent to use their data.

That means that the GDPR and privacy and all these things, you kind of open up that box. The risk towards that and there is a lot of, especially if you are conducting clinical investigations on what's it called, a subgroup of patients.

So, patients that cannot consent themselves. If it's children or underaged elderly people or disabled people in general, there are specific risks that you do with a protocol in itself.

You apply to, or I'm not sure the right word is applied, but there are risks then connected with activating the protocol towards the patients and also towards the company.

When, when you get, when you are clear around these risks that you will identify linked to the protocol, you will be able to also connect that with, with a more project company related risk. So as an example, if you are including patients within a certain group, for instance, say in children or people that patients that cannot subject.

It's called subjects that cannot consent themselves, you are at risk of not having the enrollment rate into your study that you know these are too risky population. So there is a high chance that when you explain the study to these groups, one cannot understand it.

You have to explain it to their relatives, and the other one is to the mom, dad and of this patient. And they will see this with other eyes, this protocol with other eyes than the actually subject.

One is the child who cannot answer, and the other one cannot answer because they're not awake. Having this extra layer means more people will probably not consent to the patient and your enrollment will be low.

How does that risk influence my protocol? This is the second leg that we try to analyze on critical protocols. I would say it's, it's very important.

Maybe not for standard cardiologist and project kind of thing or post market settings, it might not be of such a relevance, but for something that's in the outskirts, then I think it's important.

Etienne Nichols

00:11:33.580 - 00:12:20.500

I think any company that is doing a clinical investigation should be considering this for their own sake. I mean obviously the number one leg or, or the number one focus would be the product risk and the risks of the patient.

But you mentioned that, that slow enrollment, which if you do the risk benefit or, or just go down the path. Okay, what does that actually affect the company? That could be like you said, data becomes outdated by the time you actually get it.

Well, now we need to do another study or, or whatever. What are some of the other.

I'd love to hear any, I don't know ways of brainstorming these potential risks or, or if you just have categories, I don't know if it, or what you use. I mean I might even think of the investigator effect. You know, just what are all the different ones that you typically think about?

Helene Quie

00:12:22.100 - 00:14:32.570

We have actually together with a specialist created a standard list that we use to.

It's, it's a Tool like when we do benefit analysis, the key questions, and they are normally specific for the company and the product they're working with because then that will, that will direct the protocol design. And then we use these standardized questions like for a normal risk assessment on a product.

You run through that and then you know, does this protocol contain subjects which are vulnerable? Yes or no. And what does that mean? Well, it means this and this and this. And how critical is it for the outcome of the protocol?

Does it influence the patient, the. The user and third-party users? And how can we mitigate that?

So, you see, the process is like anytime that we do very simplified what we do in a risk assessment on the product, the thinking process is the same, is the same, but the questions are just slightly different. And then it takes the output from the protocol because you. Or the.

That's the focus point because you might even have that the mitigation is changing the protocol. You have to go back and.

Well, if these are children or these are, let's say an example with elderly people, we have put in a lot of follow ups because we would like to have a lot of data. Elderly people are not so happy about taking public transportation coming into the hospital. There is a risk that they will not come in.

Maybe some of these follow ups should be virtual or that someone should go to their home and pick up that blood sample that we would really like to have to collect data for our endpoints. Okay, we need to change the protocol.

So, this is the thought process, this is the thinking behind getting through these questions which are specific for the company and the products, having that established and then one more or less like a normal, you know, hazard traceability matrix, but just based on something the protocol, the study itself.

Etienne Nichols

00:14:33.210 - 00:14:48.170

Okay, Helene, I want to put you on the spot. I don't. I know we're recording, so I shouldn't do this to you, but that list of questions sounds really interesting.

Would you be interested or willing to maybe collaborate and build one of those that we could put in the show notes to give to the listeners?

Helene Quie

00:14:48.410 - 00:15:05.020

I think it actually we got it from. There is an organization that has the focus on this risk assessment. So, I will definitely. I can.

I just need to dig a little bit where the origin comes from. So, I better put the. The honor the right place. I didn't invent it myself.

Etienne Nichols

00:15:05.420 - 00:15:26.000

Okay, well, we'll try to put one of those in the show notes so by the time this, this episode comes out. Very cool. What are some. Have you run into companies where you have to do remediation because maybe they didn't do some of these things.

I'd love it if you had. I don't know if you have any specific stories, you can tell or mixed details for an anonymity, but any. Does anything come to mind?

Helene Quie

00:15:27.600 - 00:17:27.040

We have had a couple of protocols where, you know, when it. When we sit down and look at it, we normally call these practical problems. We just see that the protocol does not fit together.

This is not practically doing this. It can be. Is often linked to the product and how it's being used.

And we can see that the way that the design of the protocol, as I mentioned the follow up schedule towards the patients are not realistic. This is a risk towards the actually protocol. It will not happen. Or there is a high chance that this is of risk. These data. It can also be.

We see it often when there is a clash between the design of the protocol and the actual regulation. We see that often for acute studies when patients cannot sign themselves on the consent form.

There are specific national regulations that we were supposed to be under one hat and EUMDR and all these things didn't happen yet, and we have some delays again. But that means that we still have to consider the national regulations.

And I know, I'm from Denmark, the Danish ethics committees are very, very careful around consenting of acute patients. And I know that there are other countries that has the same.

So, it just means that the protocol design that was put up is at risk of not actually being successful in some regions where you would actually need the data to fulfill some wishes for both. You need the data for national approval afterwards or your health economics, you know, the whole stretch and the.

And the collection of data that is needed. So, this is some of the examples that we've been in touch with.

Etienne Nichols

00:17:27.520 - 00:18:11.580

That's a really good. That's a good example. I'm glad you brought that up.

When I think about reading this protocol, someone used the example or maybe the illustration that I thought was really helpful is put on these glasses. These are my regulatory glasses. And I read this through the regulations and it's good. I read it through the product risk.

I read it through the company risk. I mean there. And I use that as an illustration to see if you have any other glasses that you look at these through different lenses. I'm just.

I'll stall for just a moment while you think. But one other I could think of is if you're doing maybe a combination product, you're going to look at it through the lens of your sponsor.

If the sponsor is a drug company. But any other ways you look at this protocol just to analyze it, just to make sure that this is going to be the most positive result?

Helene Quie

00:18:12.220 - 00:20:13.930

Yeah, I have. I normally use an example where it was a client I worked for, and I have deep respect for all different departments in a company.

I know that they fulfill their own task, and they have their own goals, but it was just, it was an example where we worked for was a larger company. So many people involved in a very prestigious project and we've been working several months to combine a list of benefits.

So, what we need to weigh out with the risk. What is it? The benefits are what you also put on your homepage when you're going to sell the product.

So, marketing and sale was involved, and we worked very hard to agree upon a list of what we could actually state about this product. Was a very long list, it took months. And then we agreed it was signed.

And then the week after the sales and marketing called the project manager, we were sitting in the meeting also and they.

Or we were sitting in a meeting together actually asking, you know, it's very nice that we agreed upon this benefit, but can I do a slight translation of the. Can I just twist the word a little bit?

And this is just where I think then, you know, we, it doesn't fit together anymore, you know, and this is the, the, the, you know, the goals for the different departments. You have to agree upon these basic things, what it is and narrow it down to what you really can, can prove.

And as you say, put on the different glasses and at the end of the day we might not agree on, or we might just agree on the 10% of what we really would like to long term. Because just proving the 10% is really, really hard, especially for this product with the protocol we have put in place. You know, it's.

So that's the process, that's the balance for companies.

Etienne Nichols

00:20:14.570 - 00:20:37.700

Yeah. There's a phrase I've been toying with in my mind.

I've just trying to invent it properly I guess is we talk about risk management a lot but over the overarching theme should be the benefit. And we've already mentioned that. So, I almost think I've never heard anyone say anything about benefit management.

But benefit management is a big job in and of itself and they go hand in hand and so we'd always.

Helene Quie

00:20:37.700 - 00:21:54.480

They go hand in hand, and you need to ask everyone, you know, you really benefit is not. If you ask a physician and the marketing person. The benefits are two different things because they are two different.

They Use them for two different things. And at the end of the day, of course the safety of the patient is what's the most important. But it's also.

You have to think about that these projects are million-dollar projects. Right. So, there are other interests, of course, first the patient.

But there is a lot of money things here and interest that you also have to manage right underneath and thereby the benefits can be a little muddy.

But as you say, it's very closely linked to the risk, and you have to have a multidisciplinary team involved in both of the processes to get it going in the right way because you don't want surprises. Each claim cost a lot of money.

Everything that you put on or a claim which is also a benefit, the same as a benefit claim that you thought that you could actually prove and you have to take away again, you spent millions on trying to prove. This is a waste of money that you could have spent on something else.

Etienne Nichols

00:21:54.960 - 00:22:44.950

Yeah. So, I want to dial in just a little bit more on the. The enrollment because you mentioned enrollment and I wonder if.

If there are specific ways to write the protocol or different ways depending on who you think the biggest risk is in reading that. And, and what made me think of that is when you were talking about the parents. If my son, I have a 5-year-old.

If my son were about to go into an operation and potentially in the clinical investigation, I would probably read that through a certain lens, I guess to use that illustrate to. To. To kill that illustration. But to. I would read that in a certain way, maybe differently going doing it for myself.

And I imagine a physician might read it differently as well. How do you put yourself in that mindset to make it understood or amenable for these different audiences?

Helene Quie

00:22:45.510 - 00:24:05.500

Definitely it's. It's a matter of actually validating because I think that you can.

It's very difficult to set yourself in that situation if you haven't tried for instance with a kid to have a sick child. Right. What is the importance in that moment? Of course we would write that in a very direct.

And now I'm from Scandinavia, you know, that's why I say direct, and no fluffy things and you know. But we have to validate the text. Basically, find out by asking people how do you understand this text in relation to testing of this product?

I think that's the best method because it's really. It's again, it's about the glasses that looks at it.

I have an interest in being very precise and get an approval for my study where the parents as you say there's a difference comparing to be a parent or being at the table and going to have a stent implanted in your heart and you just want to sign and put that thing in me because, you know, I want this going quickly and then I can go home. There's two different scenarios and two different setups of the, of the text. And it, it requires the special glasses on to see if it's correct.

Etienne Nichols

00:24:05.980 - 00:24:33.080

And I think you brought this out and I just want to emphasize this. Putting the glasses on is one thing, but you aren't actually the person reading it. So put it in front of that other person and get their, their…

I think about this, if I go back to my product development days, I might think, yeah, this device is great because this, this and this. And then we go through a formative study and they, they and, or they weren't able to use it.

So, putting it in front of the actual user, that's kind of the equivalent in my mind. That makes sense.

Helene Quie

00:24:33.080 - 00:25:47.020

Exactly. I've done a lot of. I'm very late, actually. Now, you mentioned the formative study. Usability have always been, you know, in Europe.

It's, it's, of course it's important, it's part of the validation, but it's never really been that important that it is under the FDA approval process.

So after we started working more and more with the FDA and moving into the usability aspect, the fact that you have that very close connection between usability and clinical has really become very clear to me that both, I think it's very smart and clever and you can save a lot of money by trying to, in that middle space between these two silos called validation. Usability and validation clinical. If you start working together, maybe we could make things smarter.

But it really also makes sense towards actually the safety and performance and effectiveness towards the patients because you won't miss it. Right.

Or there is a lower risk of missing things by trying again to combine these specialties within medical device development and they are very, very close. Usability in clinical.

Etienne Nichols

00:25:47.710 - 00:26:39.760

Yeah, that's a really good point.

So I, maybe if we shift gears just a little bit, I don't want to zoom out too far, but I know kind of before we started recording, you were talking a little bit about your background and how you got started working on the Medical Device Directive in Europe and the amount of time it took you to get ready for that or how much time you prepared for that. Things don't always change as much as we, we think they do. You know, things it's Just it's, it's just more of the same.

But now we have EUMDR coming along and I just would love to hear your, your take on what you've seen over the years, especially specifically as it applies to maybe clinical investigations or risk management clinical investigations. But as you've seen these new directives or regulations roll out. What, what's your take on, on that regards to clinical.

Helene Quie

00:26:40.590 - 00:29:52.320

Yeah, I think that it was really.

When we started out with the MDD way back when I started in 95, it was both very different and the devices were many times and maybe it was just I started out at Cook Medical. They developed specific product for that physician and that physician, the special curve and the special. And that was possible.

So, I was part of making the first clinical evaluations for some of all these products, you know, specific products. And it, the detail level at that point was at a completely different level.

Now the clinical, both the evaluation and investigation has developed into and it, it actually goes hand in hand. The clinical. It's the same that we do, but it's almost a specialty in itself.

And the clinical evaluation is the basis for the clinical investigation. Where before it was actually more or less two separates. You, you can't.

Two separate specialties, you can't really do that anymore because these two documentation processes are very, very much linked. Like we had usability in clinical before. Now it's the clinical evaluation and the investigation and if I look and compare MDD to MDR, it's the.

I really think the MDR has improved the process.

It's no longer just a standalone thing that you had to do, but it's really something that means a thing for the development of the device and the investigation that you are going to design afterwards. So, I think that whole circle and how things fits together with the development is really, really nice under MDR.

What is a little critical is I started out mentioning all the, the devices and the special devices and also for children and other subgroups. It is a very, very high workload for very small designs, if you can call it that, for very small patient populations.

And I think that's the backside is that we would lose some of these.

It will happen; it already happened that some of these devices will disappear under the EU regulation because it's not possible to find the data and it's not possible to create the data within a certain amount of time.

So here again the risk comes in, the companies will have to do that risk of a complex study on data that are almost not existent in the literature because the population is very small or diverse, and then they will have to do that assessment and close down the product.

Etienne Nichols

00:29:52.960 - 00:30:37.890

Yeah, my mind's kind of thinking about how to solve that problem. Again, this probably not something we could do in this conversation necessarily, but there's different ways to solve any kind of problem.

Obviously, you know, if the regulation could have a way for very small populations or user populations to have an expedited path to market or maybe streamlined or when those products come off the market, just because I know we talk to a lot of different people or a lot of different types of people listen to this podcast to let those user populations know, hey, we're not no longer in the EU, but those of you on who are, a lot of times they'll have groups, whether Facebook groups or whatever, support groups. We're still pursuing these studies in other places. I don't know. What are your thoughts on, on that?

Helene Quie

00:30:38.610 - 00:31:55.260

I think that the. I think that there should be set up some different methods because again, it's different problems if it's the patients or the.

So, I think if it's possible to set up a regulatory framework around these products which are really directed to a very small population group of patients, I think we should definitely try and do that because it really saves lives. Right. Some of these products are really critical.

So, I think we should encourage the regulators to find some kind of really basis basic frames around this so we can continue some of these products. I think for some of the products where it was maybe a little more related to the physician and not so much to the patient.

Of course, some of these device companies have thousands of numbers in their catalog and it could be maybe nice to get that cleaned out. Maybe there is another product to use, but I think for the subpopulation of patients, we should try and solve that from the regulator's perspective.

Etienne Nichols

00:31:55.580 - 00:32:38.320

Okay, I appreciate you sharing your…Sometimes we don't always. It's hard to come up with a thought or opinion, but that's a good thought.

One of the other things that I wanted to ask about, as you're comparing the old to the new and the, the, the way you went through those clinical investigations with MDD and now we have an EU MDR. There’re other things that are coming onto the market now.

Where we look at them, we're like, okay, will that, will that fit into this regulatory framework? And what comes to mind is artificial intelligence, for example, or software as a medical device? What, what is your opinion on that?

Are there any specific risk considerations for AI that maybe don't apply to others? That we need to be thinking about with our clinical investigations.

Helene Quie

00:32:38.960 - 00:34:26.899

If I think about from the clinical investigation perspective, it is still so new. So, I see a lot of guidances coming out for sure to support the process.

But I haven't seen really the implementation of these guidances into actually devices because it's.

It is difficult and it's difficult for the regulators, it's difficult for the users or not the users, the people that, the companies that are developing the products. How to take these 21 or 27. We talked about it before guidances that came out just over the last, I don't know, six months.

How to actually read this and interpret it and find out. Guidances are to.

To look at and find out what does this mean practically to me, so have so much material and then transfer that into something which is something I can work with. I think that's really complex. And I see companies where at the edge of.

They actually would like to have AI implemented into the product and then say no, no, no, we are not going to touch it until this water is a little more calm. So that's what I see.

I think most manufacturers, especially smaller companies, will try and stay away from it until that they see a clear pathway through the regulation. And that means also for the investigations. I don't think if I was submitting a clinical investigation to the.

Some authorities here in Europe that they would actually really know what to do with it at the present time. It's still very, very early.

Etienne Nichols

00:34:27.459 - 00:34:45.059

Yeah, and that, that's a good point.

All of those guidances that come out, sometimes we look at those kinds of an interesting ways I look at it versus vertical versus horizontal, you know, that AI is something that can spread across multiple verticals. But if you're in orthopedics, just focus on the ones that are applicable to you.

Helene Quie

00:34:45.619 - 00:34:46.179

Exactly.

Etienne Nichols

00:34:46.390 - 00:34:46.950

So yeah.

Helene Quie

00:34:47.590 - 00:36:12.470

And I think also that I realized that quite late here we had a meeting with a notified body that I saw guidances as input, you know, inspirations and that you could follow. But actually, the notified body consider these quite as a requirement.

And you have to put that patchwork together and argue why I picked that one for orthopedics. Why do I think that this number 17 and 18 is specifically for me and not the number 15?

And that makes, you know, we have so many ISO standards and other guidelines and they all want to come together even with clinical investigations. I'm puzzled by.

We have the regulation now, we have the ISO guidance, ISO 14155 and also, we have the MEDDEV guidelines under clinical Evaluation and a new ISO standard also. So, all these groups around how to interpret the regulation all want to come up with their bit on how to read this and this regulation.

It's a little confusing to me, but at the end of the day we will have to sit down and do the patchwork, the puzzle together with the manufacturer and justify why do we follow this guideline halfway through here? And halfway is because it fits with the product. I think that's the way to go.

Etienne Nichols

00:36:13.030 - 00:36:46.030

That's a really good point because it is a little bit of a balance.

You have to follow certain amount of the standards and certain amount of the regulations, but you also have to not forget that you are the expert in your product and so defending. Defending. Yeah, that's a really good example. Well, Helene, thank you so much for this conversation.

Is there any other piece of advice or a question that you wish I had asked? Any last thing that you'd like to tell our audience or invite them to do? Any call to action or pieces of advice?

Helene Quie

00:36:46.590 - 00:38:01.930

I think that I don't have any questions, otherwise my popcorn brain will come up with something. But I definitely call for action.

I know it's a complex area and there are always so many good questions and comments to discuss and I just love discussing these, you know, difficult scenarios or people that get stuck on something. So, call to action is to reach out if there is anything, especially now under the MDR and clinical investigations or evaluations.

And I would be more than happy to help because it's, it's, it's. And that's the last comment and then I will try and be quiet.

No, but it, these are all, we are all people working on this very interesting topic and the people has a background and understanding of the regulation.

So, its notified body, the competent authorities and me and you and the company and all that together should be able to bring to, towards the patient safe product that performs and that at the end of the day, that's what makes this really, really a funny area to be within. So, and thank you very much for inviting me.

Etienne Nichols

00:38:02.250 - 00:39:07.130

Yes, thank you so much for being a part of the podcast.

We'll put in the show notes, your email and LinkedIn and people can, can reach out to Helene if, if you want to further the conversation, I definitely recommend utilizing that opportunity. In my past when I was in product development and people said you can reach out to me. I did reach out to them because it was very helpful.

They've, they've seen, I don't know, hundreds possibly of this same scenario where I am. I'm focusing on two, three, four of these different situations. We think we're so unique sometimes.

But in reality, when you talk to somebody who's worked with that many different companies, you realize, wow, okay, my problems maybe aren't so unique. So, it's very helpful. Last thing I'll say is the show notes.

Go ahead and look at those one more time as well because hopefully by now we have the downloadable by the time this episode comes out that we talked about where we talk about the risks posed to this by the study itself. I thought that was a could be a really powerful list of questions for every company going through clinical investigations.

All right, thank you so much. We will let you all get back to the rest of your day. Everybody take care.

Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never. Done that before, but if you're listening. On the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review.

It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better.

Thanks again for listening and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.