Jón Ingi Bergsteinsson, Co-founder & CCO at SMART-TRIAL, sat down with Natalie Yeadon in this Fireside Chat. Among other things, they dived into the barriers to, and benefits of, digitalization of clinical operations and trials in the MedTech industry. Jón also shared his insights into how the shift in regulatory focus on clinical data in Europe and the fact that global healthcare customers are putting more focus on value-based care have impacted the need for clinical evidence for MedTech companies.
Here is a sneak peek of our conversation:
Q: When somebody starts leveraging your platform, what are some of the modules or tools that enable them to do the data collection? Do you differentiate yourself from other platforms, with some sort of KPIs? Is there a faster completion rate? Tell us a little bit about what your platform is designed to do and what the advantages are.
A: That’s a good question. Thank you, Natalie. What we really address in the core is the data collection forms that they need to have completed by clinical staff members or even patients. Usually, when you do a clinical study, you have decided that when the device is used in the clinic, you need to understand whether a certain parameter gets better or worse, whether a person feels better or worse by using the device. The way that you do that is by having questionnaires that are then answered by a patient or a healthcare professional.
What SMART-TRIAL does is that we offer you the toolbox to create these questionnaires. But the thing is that, when it comes to clinical investigations or clinical studies, you can’t just use a questionnaire with a free text field where everybody can enter whatever they like. It has to be standardized. There needs to be quality assurance in the software and when you enter the data into the system, that same data is also what comes out of it. You need to have some quality procedures from the software side of things that ensure that doesn’t happen.
What we offer in core is the toolbox to create these questionnaires for the clinical experts to complete during the course of the study. Traditionally, these kinds of platforms that have been created for pharmaceuticals have been engineered by software engineers and maybe people with experience within the clinical field. A lot of these solutions that have been created and are available out there have been designed for pharmaceutical trials. All trials in the pharmaceutical world usually go through the same phase (1,2,3, or 4 pathways). When it comes to devices, the pathway isn’t that straightforward.
It depends very much on the type of device you have and the studies are as different as the devices are managed to be honest. Because when you have a device, if it’s an implantable device, you’re not only interested in some measurement parameters. You also need to understand whether the surgery went well, what methods did you use in the surgery, or who was involved because a lot of these parameters impact the use of the device and practice. This is not the case in pharmaceuticals. You can very much standardize the way that you collect data in the pharmaceutical world much better because usually it’s a pill that you digest and then there are some measurements being done to the body to ensure that it works as intended.
When it comes to devices to address this flexibility that’s needed, we, as a platform, offer pre-configurable modules that you can arrange in ways that fit your device. What we’ve done is that we’ve broken this down into very simple pieces for everybody to understand. For example, if you want to create a study in SMART-TRIAL, you only need to do three things.
First of all, create at least one form. A form is just simply a data form that has one or many questions. So, whether you want to ask that same form once or multiple times is then up to you. The second step is to create what’s called a process which is somewhat of a timeline for your studies where you have like time point one – that’s where we implant the device or use the device- and then we have a time point two – that’s where we do a follow-up or observation. Then we use that same form by dragging and dropping in the SMART-TRIAL platform. We request the person that is supposed to be responding to the form to complete it at these two time points. Then the third step is to create what’s called a site which you then appoint to users to create the user logins and then they can log in and recruit subjects and enter data.
All that is done by using modern design methods and user experience methods that enable people to start off by creating their own studies from day one. This is very different from what you are otherwise used to in the industry because often when it comes to clinical trials in the pharmaceutical world, you need engineers to set up these studies. You need them to code them, there needs to be a software code that needs to be input into a software system. Doing that takes a lot of time.
One of the things that we do well is shorten setup time but the crucial differentiator between smartphones and other platforms that are available out there, especially for pharmaceuticals, is the fact that we focus on MedTech. There are features in our platform that are very much related to devices only. It says how you report adverse events or side effects with devices. They’re standardized in one way so there are features and functionalities in our system that mirror this focus. Then second of all is our take on compliance. Software such as SMART-TRIAL needs to be validated and documented thoroughly. Whether you’re doing pharmaceuticals or medical devices is very different.
We’ve said, “if we’re focusing on MedTech let’s do as much as possible we can do in producing documentation, compliance templates, quality assurance files, and so forth, that we know that medical device companies need to have within our platform. Then, provide that as part of our services instead of just offering them the software and then having them take care of everything.” These two combinations of differentiators, plus the way that we launch the product and so forth, make it very unique for devices to use.
For more of our discussion, you can watch the whole Fireside Chat with Jón Ingi Bergsteinsson, or listen to the podcast version, below.
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