Adaptive Change Management in highly regulated industries focuses on the interdependency

The quality or condition of creating interdependency in regulated industries is firstly a question of the enterprise’s value-system

The leading principle in medical companies or other safety-critical highly regulated industries should be enacting adaptive change management differently in different divisions and different situations. Its main principle is not focusing only on “team performance” but rather on the interdependence between regulatory, standard development process, units, and management. More and more home-used devices and the need for hardware platforms as well digital control of some technical processes have spurred enterprises to somehow continuous delivery. Why?

These industries have to follow the so-called sequence of events as well as standardized product development processes. Behind the sequence of events lies the great chance for structures in the opportunity to look for competitive advantages in new ways of working, like the disciplines of product management, that can bring advantages into the company structures. If one reads between the lines of the sequence of events, there is clear evidence that there are often complex self-grown but not exactly required by authorities.

The approach how to achieving the sequence of events is relatively free as long it can be logically explained why an approach was chosen and why it was reasonable for special product development and the traceability can be proven. For example, FMEA, and EMEA in medical device developments must be for example done during the software and hardware development process and not afterwards. Other examples are risk management as a standard operating procedure or that a technical module must be self-contained for verification tests. Sadly, many modern med tech companies don’t go that way – it starts already with requirement processes.

Regulatory rules don’t regulate by law that there has to be the one and only development process (software, hardware, bio components, mechanical parts, etc.). One misleading concept is the so-called AAMI TIR45 which is soled as the golden gate bridge for agile software development practices for those industries. After years in the med tech development, we got the observational learning that they can’t be aligned with quality and safety standards. All of this is not novel but hyper-underestimated for organizational interdependency. The confusion and on top complexity start with new roles, unclear accountability, decision latency and no way to scale.

The good news is that there is plenty of room within regulations to adopt adaptive change systems to reduce complexity and yet accelerate. One valid reason is that adaptive change systems do not insist on creating some mistakable mindset or an expensive dual operating system structure by releasing a method war in your Enterprise.

The adaptive change management view on enterprises reveals the real adaption zones to daylight. One supporting pillar is the idea of interdependency. Interdependence is, for example, a connection between individuals, organizational parts, or technologies where one subject’s needs can be fulfilled by the other subject’s resources. In other words, the buzzword “wisdom of the crowd leads to mediocrity which we can call the concept of copycats.

Interdependency is deeply correlated to the reciprocity mechanism if person x does a service for person y that person y will then feel grateful and seek to reciprocate in some manner. Why does it work? The answer is easy – instead of following arbitrary rules of some frameworks focus first on one of your company’s strongest assets: the value system of the enterprise. And avoid following outdated frameworks in the New Normal.

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