How we built it | Medicus gets its first CE mark
At Medicus, we are thinkers. Yet above all, we are creators and builders. Our all-new series “How we built it” provides insight into the way we work: how our products transition from ideas to reality, how the core of our offering is made. In this first-ever edition, we talk to Nisreen Hassoun, Research Team Leader, and Mouhamad Kawas, Chief Technology Officer at Medicus AI, about the journey that led to our first ever CE Mark for the Medicus mobile application.
Hello Nisreen, hello Mouhamad. Let’s start at the beginning… Why did Medicus decide to embark on the CE mark certification process?
Nisreen: An important question. CE certification gives Medicus a more profound sense of credibility, a stronger marketing position as a medical device, and guarantees that Medicus can meet the requirements set out in the European Medical Device Directives.
Mouhamad: At the end of the day, the fact that CE gives us credibility is secondary: first and foremost, compliance is about product safety. This is the most important thing for us at Medicus, and the CE mark proves we take it seriously. If we are going to develop our product as a medical application, this certification is a minimum requirement, not a nice-to-have.
Nisreen: Although CE is a European standard, the mark is also relevant outside the EU. At the Medlab Series exhibition in Dubai earlier this month, we received a lot of questions from interested parties around the world about how trustworthy our product is. I found that the most effective way to explain was through the CE mark: it’s a sign that is recognized by clients in the Middle East and beyond.
Mouhamad: The CE is a declaration of conformity, which is split into different classes depending on the intended use of the application and its risk. Currently, our current medical use-cases feature set puts us in Class I, but as we add more features with more serious medical use-cases, Class II will apply.
The CE mark is clearly important… and now we have it! What does the CE mark mean to Medicus?
Nisreen: This is the first regulatory approval for Medicus, two years in the making. I’d go so far as to say that this is our biggest achievement to date, as our solution is based on solid medical research. It is the result of many years of hard work by the Medicus team, so we are naturally very proud.
Mouhamad: For our conversations with clients, it is vital. The question is always the same: how do you ensure the quality of your product? CE not just about risk management and standard procedures, it’s also about the quality of the medical content itself.
In a nutshell, what does the CE certification process entail?
Mouhamad: First, you have to start with your intended purpose, which in turn defines which assessment and procedures you have to complete. The process in Class II is different from the one we completed in Class I. However, all our products are medical products so they all follow the same process. Once we had decided on the classification, we got started on compiling the relevant technical documentation that proves CE compliance according to the intended purpose.
Nisreen: Indeed. This is called technical file preparation. This file contains the information needed to demonstrate that all the requirements of the directive have been satisfied. Following that, we had to undertake a conformity assessment procedure and register our declaration with the competent authority.
In order to validate the performance of Medicus according to the intended use (chronic condition prediction and prevention), a database of patient profiles was used. The profiles were assessed by an internal panel of medical professionals, and compared with Medicus outcome.
As a digital product, what were the challenges we had to consider when applying for the CE mark?
Nisreen: In general, medical device classification includes hardware as well as software. We had to focus on the outcome of our product. Essentially, this comes down to ensuring that we avoid implying diagnosis, instead providing descriptive content that adheres to the predictive and preventive intended purpose in the CE declaration of conformity for Class I.
Mouhamad: The mark is usually awarded to physical products. As such, the focus is on distribution and usability when it comes to software: it’s not enough simply to consider the application as a working product. Resultantly, the declaration process needs to include technical documentation, which states that development is performed according to the correct processes. Currently, we work with agile methodology, which, in its manifesto, prioritizes “working software over comprehensive documentation”. The requirements of CE are the exact opposite. This was a huge challenge for us, and as we consider higher classes of CE marks, these challenges will increase.
Other than documentation, what was the biggest change we had to make in order to complete the CE conformity process?
Nisreen: When we decided to register our application as a medical device, we had to review all our content to ensure the validation was correct. This meant our generated content had to be re-verified while keeping it user-friendly and medically trusted.
Mouhamad: The product risks are high because the app relies a lot on user input. The CE process forced us to think a lot about risk mitigation, especially in how we communicate with the user. The user has to be truly at the center of everything we do. In order to do this, we redesigned our development process and pipeline to comply with the requirements in the technical documentation.
We are a tech company, but also a medical company and a content company. What aspects of the product or app does the declaration of conformity take into account?
Mouhamad: The CE declaration is a checklist, and all points need to be covered to complete it. Different aspects of the list apply to different parts of the product and how it’s built: the operations and procedures of every department at Medicus are called into action. It’s a holistic process that every department has to follow. It isn’t any single department’s responsibility, it’s all our jobs to ensure compliance.
Nisreen: Again, it comes down to classification. At this stage of the use-cases covered under the CE conformity, we’re focused on the prediction of chronic diseases, a service we provide using the health risk calculators. Furthermore, we analyze steps for prevention via our screening recommendations. We focused heavily on user experience and user input: the medical, technical, and design aspects are all extremely important.
So what’s next?
Mouhamad: We are only at the start of our CE journey. We have a growing family of products at Medicus, some of which have more serious medical use-cases and this carry higher risks, which we will be working on CE compliance for. We are just dipping our toes into the CE water, but it’s still a huge milestone. The next step? CE for everything, CE for everyone!
Nisreen: We’ll be covering all our products, from Smart Assist to our pregnancy program, and everything in between. CE is not the only relevant certification: we will also work on clinical investigations for the Medical Device Regulation and Class II CE. The CE marks work with each other, which is great. Once we identify a body to work with, we’ll be able to begin work on more extensive product compliance for Medicus, such as ISO. The future is bright.
