How Software Engineering Expertise Fits Into the Development of Digital Therapeutics?

Engineering comes very early in the development of a DTx, even before the beginning of the project! For each customer, it is very important to give a clear and precise vision of our engineering activities and capabilities. Thanks to the work of the team, we have succeeded in developing a secure, compliant, and efficient platform called Theraxium, on which we build our DTx. The objective is using this asset to the maximum.

Once the project is launched, we start to develop the solution in 3 stages:

• The invisible part: The implementation of the DTx architecture and medical algorithms
• The visible part: The design of the solution to make a user-friendly and easy-to-use DTx
• The performance, security, and risk analysis of the DTx

While building the architecture and the algorithms of the DTx, we must anticipate other technical aspects such as its performance, security, and risk analysis. All experts work very closely. It allows us to move forward at a good pace and to validate each development sprint so that we don’t have to go backwards. Thus, all mitigations, pen tests, risk resolution, and data privacy analysis are fully integrated into our development phase. This helps us to have a global vision, to consider all the angles of view on the product, and thus to develop compliant digital therapeutics regulated as Software as a Medical Device (SaMD).

Then, comes the regulatory side. For our product to become a Medical Device cleared by notified bodies, we must keep track of every action we implement. So, the engineering side gives a lot of material to create our submission and regulatory files.

When you co-develop a DTx, one of the biggest challenges is to accept that a change of scope is the norm and that a project that does not evolve as it goes along is a rather naive vision of our business.

Our job is to analyze needs and find solutions that are increasingly effective and fast. With a regulatory framework that is constantly evolving, and that differs according to the territory, we work in a progressive environment and our mission is to adapt at every moment. Hence the importance of having an agile approach in the development of digital therapeutics.

Another challenge is to optimize, reuse and automate our existing regulated platform, Theraxium, as much as possible. We continuously improve the performance of Theraxium. How can we develop new products on a unique platform without a spill-over effect? The more products and features that are available on the platform, the more difficult it gets to maintain, automate, and evolve them over time.  It’s quite simple to manage when there are only two products, but the manipulations become more complex as soon as there are 10 or more products.

A third challenge is the regulations that govern SaMD. A strong regulatory framework means that we must have the ability to follow new regulations, the daily maintenance of products to comply with regulatory requirements, cybersecurity, data privacy, the implementation of processes to trace any executed action, and so on. This is an important challenge – but with the creation and implementation of robust processes, the challenge can be easily met.

When co-developing a DTx, one key element that will drive the whole project is the number and the quality of interactions with the client. The more stable and fixed the project, the better it works. The more you have scope changes and modifications going on, the more complicated and time consuming it is.

Thanks to our experience developing DTx, we are now able to respond favorably to scope evolutions and anticipate blocking points. Our Product Line Engineering approach has proven its worth and allows us to adapt easily to changes. Moreover, our internal processes have been designed so that we are able to move forward quickly.

The platform approach allows us to start from a common base for all our solutions. What we are really changing in our solutions are the medical cases. The real-time recommendations that our applications provide to patients change based on the patient’s treatment and care plan. Our approach allows us to easily integrate new algorithms without altering the substance of our products.

We have implemented three components within Theraxium, our regulated platform, which can be reused regardless of the therapeutic area:

• The creation of new algorithms.
• The translation of these algorithms (which are lines of code) into a decision tree or table, allowing our Clinical Advisors Board and our internal physicians to read and approve the algorithms.
• The full simulation of the medical algorithms to prove that they give the right medical recommendations and that our products are safe.

The unique proprietary technology behind Theraxium is protected by a patent. To consult the patent, click here.

One key criterion is the interaction and decision-making capacity of the client on all the streams of expertise. We make sure that development goes well by leveraging an experienced team of Project Managers and Services and Solutions Managers. In addition, our proven methodologies ensure that we know where we are going. We focus on the deliverables from start to finish, which means that we can control the entire development life cycle of the project and assure that our clients achieve their desired outcomes.