By Javier Hernández Braña (ERNI Spain) and Cristian Sances Ibáñez (ERNI Spain)
Revolutionary ideas have a way of spreading in all directions, and Agile is no exception. What started in software development in the late 1990s can now be found in the business world everywhere. Even highly regulated industries like medical technology can no longer escape this trend – and that’s a good thing.
A highly regulated environment
Medical technology industries are even more sensitive to their final product than other industries because the final result is people’s health. For this reason, all kinds of different regulations are in place to ensure safety and quality in all the processes involved, and any medical technology industry needs to follow them.
Traditionally, in order to ensure compliance with regulations, companies have approached this challenge by using highly strict control frameworks, commonly based on old waterfall models, where a few people try to control every aspect of product development and compliance.
This comes with a price: first a false sense of security; medical devices are highly complex products, and a small group of people cannot control everything. In addition, if all the decisions come from this group, companies are not flexible enough to find solutions to the challenges that arise. As a result, it also becomes challenging for them to innovate. In a world where customer requirements and their environment change constantly, companies need to be able to adapt virtually every day.
Does it mean we should stop working with a “waterfall” approach? No, it does not; it means that we need to adapt our way of working by adding new techniques and approaches. For example, we always need a final validation. Why? Not only because, as we said, our final product is people’s health, but also because when validating these products, we need resources such as laboratories and operating rooms. And those are finite and not always available.
While both approaches require a final validation, using an Agile approach, any medical technology project will get more frequent feedback about the verification processes. Moreover, in shorter iterations (3–4 weeks), we can ensure that we deliver value along with the needed quality because verification is part of the iterations themselves.
Even though working in MedTech means working under strict regulations, an Agile framework enables rapid changes and fast development while complying with these regulations and policies. As a result, teams are capable of inspecting and adapting every day, iteration over iteration.
Working in an Agile environment
This transition may be a challenge, but it is worth it, especially in a “VUCA world” (volatility, uncertainty, complexity and ambiguity) where the context may change at any time.
When working Agile, we are able to produce small functional parts of a product after each iteration – so-called increments. We are also capable of generating MVPs (Minimal Value Products), and with each
new iteration, needs and requirements can be introduced flexibly. This procedure makes it possible to complete a product more flexibly and to obtain feedback faster, which in the end leads to significant savings and top-design products.
As we said before, another highly relevant advantage is that it is easier to ensure that every increment of functionality has the expected quality, and that it does exactly what is needed. On the other hand, if we waited until the final product as old waterfall models do, we would have to check all the functionality, small piece after small piece built months before, in an endless and overwhelming effort – an almost impossible and very expensive task.
Verifying each increment on its own brings yet another advantage: additional security. Instead of just checking the new parts, we are incidentally rechecking all the previous ones – which is an essential part of the Agile way of working. This additional safety aspect combined with the higher flexibility is one reason why more and more companies are adapting their current way of working, especially in medical technology, where new scientific findings need to be easily integrated.
Customers and their expectations
Having more frequent and verified product increments and the possibility of building MVPs helps companies to reduce the time to market for new updates and products from years to months – a huge step in such a regulated environment. We also become capable of detecting bugs earlier, being able to fix them much faster and to have new updates 100% verified and ready for the validation phase.
This strategy has been tested and proved in several other areas, most conspicuously with our smartphones, where apps are constantly updated week after week, and nowadays, medical technology companies are able to benefit themselves as well, having only a single constraint on the availability of their resources, such as laboratories, as we mentioned previously.
Imagine this in the near future: instead of releasing a major update of your software every year, releasing smaller updates with bug fixes, closed security gaps and smaller new features on a quasi-weekly basis. And normally, bug fixes for the features implemented last time come with the next one. No one wants to wait a year for new features, and certainly not for bug fixes or closing security gaps.
With this strategy, for example, medical technology companies could release five big new features over a year instead of all at once. This way, each feature will be validated separately – reducing risks and ensuring product stability – and if one of them needs any adaptation/correction, we are able to plan and deliver on the next date available, not needing to wait for a whole year.
Whether it’s new findings, bugs or simply changing product requirements, things change all the time, and you can react better to all of them in smaller iterations and adjust the plan accordingly. This is important in all industries, but in medical technology, it ensures companies’ survival and patients’ welfare.