Innovation and DTx: how to combine Agility and software as a medical device

The omnipresence of mobile and AI in the daily landscape creates great opportunities to diagnose, engage and educate patients in the treatment of their diseases.

Digital Therapeutics (DTx) are among the promising solutions to solve the problem of chronic diseases that are currently poorly addressed by our health system. This great potential is struggling to see the light of day because of the myth: “build it and they will come”.

From molecules to features, agility is the clinical test that validates the effectiveness of features

User expectations are at their highest regardless of the application used. DTxs must be even higher than the best references on the market to create the contract of trust necessary for any medical intervention. The application must immediately give a feeling of security and benevolence.

This trust must be established through joint work on user experience, product strategy and engineering to offer relevant solutions in the daily lives of patients and practitioners, all in a package that mixes the codes of medical applications and large applications. successful audience.

Even if the first stages of the product's life can be envisaged without certification, it is essential to prepare a framework that facilitates the administrative procedures thereafter.

Between SaMD and agility, an alignment on the issues

Agile methods and SaMD regulations are aligned with the same objective

Produce high quality software

• The values of the agile manifesto are compatible with the “medical device” regulations, in particular for class A:

• A team empowered with regard to its practices increases the efficiency of regulatory processes and tools.

• The documentation produced must bring value to the team and to the regulators without replacing a continuous deployment of functional software and a solid “definition of done”.

• Define schedules with feedback mechanisms that demonstrate effective change management that leave room for emerging needs definition.

An agile approach to ensure the necessary foundations for IEC62304 SaMD certification

Our approach is based on the best practices of agile engineering: validation between peers and automation of tasks.

By implementing the following activities, you ensure the fundamentals of SaMD certification while giving your teams the opportunity to adapt the product strategy to signals from the market.

• Continuous and automated deployment (with automated unit tests) from day one as the basis of an effective integration strategy

• Using the definition of done as the basis for the verification plan

• Use of pair programming as a continuous output verification activity (with validation documentation in the form of accepting merge requests)

• Traceability of the story in GIT to be able to associate lines of code with stories and documentation

• Stories documented and exportable as a corpus of documentation associable to the code

• Ability to log the validations of each version in the integration flow with tag mechanisms (software VERIFICATION and VALIDATION)

• Continuous documentation of the software architecture integrated into the stories with presentation at the end of the sprint (high level software system design, documentation interface, SOUP list)

• Documentation automation: SOUP list derived from software dependencies, interface documentation based on code

• Definition and documentation of a quality management system

• Documentation and monitoring of patient risks coupled with user testing phases (scenarios, mitigation, risk assessment procedure)

To change the world, DTx must combine the best of digital and medical

Thanks to the method presented, teams developing DTx can benefit from the best of both worlds. Both quickly and regularly test the market appeal of their product without compromising on future SaMD certification.

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