By Nadine Broghammer (ERNI Switzerland)
Software development is still a young field in the MedTech sector; however, it is of growing importance. In Switzerland alone, the annual increase in sales (before COVID) was 6% per year. New decision-making processes and workflows must be established and aligned with existing products and processes to keep up with the high pace of innovation. High-quality, secure products and a stable development process are of utmost importance. With this article, we will be looking at the following two questions:
How can this be done? And how can the Agile way be of help?
It is widely agreed that using the benefits of software for improvements in medical and health areas – for example, blood analysis – is the thing to drive towards. Various fields have emerged over the last several years; they range from software-in-product appliances for customers such as hearing aid devices or new software for laser eye surgery equipment to new video game technologies helping children in cognitive behavioural therapy.
All those advancements have the well-being of the patient or user of the technology product as a common focus: To this end, principles and guardrails for technology development must be implemented. In 2019, the German parliament approved the new Digital Healthcare Act, driving the digital transformation of the healthcare system forward for the benefit of patients.
Especially in the medical and MedTech environment, it is crucial to put the patient at the centre of attention. High quality standards have to be reached, especially since the devices are used in medical care, and any imperfections might have an impact on human life. To ensure certain levels of quality, security, standardisation and alignment, regulators such as the FDA, EMA and PMDA Swissmedic help us to find assurance. When it comes to software within a medical device or software as a medical device, and thus to the development process of software, a few clarifying concepts have to be taken into account. Furthermore, fundamental certificates such as ISO 13485, ISO/IEC 27001, ISO 14971 and IEC 62304 have to be considered when developing software products. Complexification is not the goal!
What role does agility play in software development?
Modern software development (including software development in MedTech) follows an evolutionary strategy, acknowledging that the user needs are not fully understood at the beginning. Moreover, these needs may change, and requirements may not be defined upfront. A DevOps mindset brings clarity; this culture and set of technical practices is part of Agile product delivery and enables continuous flow where quality and security are built in at every step and where solutions are architected for change.
The pioneer David Farley describes this effective software development process with two core principles: first, learning and exploration, and second, managing complexity. Contemporary frameworks, methodology and concepts highlighting the above are often referred to by the term agility.
The evolutionary life cycle approach of modern software not only puts the patient in the centre but it also satisfies the previously mentioned regulatory requirements of medical and MedTech environments for qualitative and secure products. The Technical Information Report 45 (AAMI TIR45) bridges the gap and provides written guidance on what has so far been implicitly applied. The TIR was developed to align Agile software development practices and their associated beliefs with the regulated medical world and to foster the focus on human safety, risk management and quality. Even without being directive or referencing beyond the FDA, this pioneering document earns a lot of respect and application.
Through alignment in goals and values between contemporary Agile software development and regulatory perspectives, high-quality software can be developed in medical and MedTech environments.
Also, in the business field of MedTech, we feel the pressure to innovate and speed up in the context of Agile software development. True to the oath of protecting and improving the lives of patients, medical and MedTech companies must choose their life cycle model wisely. The process model described by Agile ways of working can bring the benefits of enhanced delivery and patient focus.
Furthermore, integration activities on various work levels bring much-needed visibility and transparency. Integrating small parts (or stories) into an increment, and releasing dedicated parts on demand provides feedback to the stakeholder and the various people working within the system.
Generally, we aim for an agreed product or outcome of our software development process. In the fields of medical and MedTech, those agreements and characteristics are compiled in a Design Input (DI) Document and a Design Output (DO) Document. Activities have to be mutually defined and understood to have an agreed DO. The valuable insights from the DI Document and DO Document combined with the Definition of Ready and Definition of Done of work (or stories) align with agility and the regulations of medical and MedTech environments. This is also true for releases of document versions; this can be done incrementally with every increment delivered (aligned with the definition used in AAMI TIR45) or per Release Version. Therefore, defining the release cycle is a crucial element for MedTech companies.
Hence, medical and MedTech companies have to define those review and control processes, irrespective of whether they follow Agile methodologies and frameworks. Complexification is not the goal; evolutionary design of products and Agile thinking are.
MedTech is in the lead. How can other industries learn from them?
This transformation process of medical and Med-Tech companies towards an evolutionary design within given regulatory boundaries brings excellent insights into the regulated business world. Other business areas such as FinTech, energy and telecommunication have already started their transformations into more tech-related aspects and digitalisation. Of particular interest could be the product aspect of the transformation; transformations are complex per se, but the production aspect, based on the evolutionary design of physical products, brings yet another layer of complexity. Therefore, it can be concluded that MedTech is leading the way.
What role does ERNI play?
We are pioneers of Software Engineering. We have great respect for performing a transformation within regulatory boundaries and help you embrace the challenge. We are convinced that alignment in all we do, and a shared mindset on why we do it, are vital. As your trusted advisor, we help your business to achieve precisely that.