This is a blog written by Elemed expert guest blogger Christian Weckert. Want to be a guest blogger? Email firstname.lastname@example.org for more info!
“Men get out of countenance with themselves and others because they treat the means as the end, and so, from sheer doing, do nothing, or, perhaps, just what they would have avoided.”
Johann Wolfgang von Goethe, Wilhelm Meister’s Journeyman years
Cyril Northcote Parkinson must have been a man blessed with that typical British humour.
On November 19, 1955 he published an article in The Economist. What he wrote would more than 60 years later still be of relevance to organisations which want to strive in a digital age.
He began describing a letter being posted by “an elderly lady of leisure” (read it with a thick British accent in your mind). This “elderly lady of leisure“ however, he went on, “can spend the entire day in writing and dispatching a post-card to her niece at Bognor Regis. An hour will be spent in finding the postcard, another in hunting for spectacles, half-an-hour in a search for the address, an hour and a quarter in composition, and twenty minutes in deciding whether or not to take an umbrella when going to the pillar-box in the next street. The total effort which would occupy a busy [person] for three minutes.”
The article went on to describe in summary what is known as Parkinson’s Law:
“Work expands so as to fill the time available for its completion.”
Busyness in Business
We have all experienced at some point or another that Parkinson was onto something. The dull feeling after a day full of meetings. When we feel that we haven’t accomplished much while the piles of work on our desks are only getting bigger.
The truth about workflow efficiency for many organisations actually is that it is often only at 10 percent. This means that work items are waiting 90 percent of the time! The reaction to this often is a focus on faster output, making deadlines a higher priority and putting more people on the projects. But there is a common phenomenon published by Fred Brooks in 1975 in the essay The Mythical Man Month: “More manpower on a late project only makes it later.”
It’s like walking through quicksand: Trying to go faster actually makes you slower. What we need instead is to go smarter.
We’re all the same
During my career, I made some important observations. When I asked subject matter experts in my role as risk manager to identify risks I always got an impressive list of possible scenarios. It turns out: When asked how things can go wrong people become incredibly creative. But when we ask them how things are actually supposed to work the answer often is silence.
There is an important cognitive concept that has something to do with avoiding losses but that would go too far here. The matter of fact is: We’re all subject to forms of cognitive biases.
So, my observations led let me to formulate the following principles:
- We (and I am deliberately including myself in here as well) tend to mistake means for ends. Or with other words: we focus on output over outcome. This means that we often work on the answer in absence of the question.
- We have the tendency to take the second step before the first. This jumping to conclusions directly leads to problems becoming overly complicated at a later point in time.
- Although we put the world around us into categories we actually memorize, understand and learn in narratives and pictures. Categorising leads to a loss of context and detachment from the outcome.
It is important to understand that because being busy without being effective is at some point attributed to one of the factors above.
Deterministic vs. emergent
In their recently published book Sooner, Safer, Happier – Antipatterns and Patterns for Business Agility, Jonathan Smart et. al. call for a sense of urgency:
“We are living through a once in a forty- or sixty-year event, the Tipping Point from the Age of Oil and Mass Production to the Age of Digital, with a global pandemic accelerating the demise of organizations who are victims of their past success, doing too little too late to move with the latest technological revolution and associated ways of working.”
In the Life Science and Medical Device Industry, this trend can be seen as well. What used to be an industry focused on the development and manufacturing of mechanical devices is now shifting towards cyber-physical and interconnected systems. It is becoming more and more data-driven and digital. Business models are changing, and so is the domain of problems.
Where in the past work domains have been more deterministic, the problems at hand today are highly emergent. Determinism (from Latin determinate, that means “to set out”, “set limits”, or “to calculate”) is the understanding that all future events are clearly defined by preconditions. So, in general: predictable outcomes and clear cause and effect relationships.
Deterministic thinking is fundamentally engraved into Gantt charts. Henry L. Gantt by the way, who developed this tool, lived more than a century ago at a time when so-called scientific approaches to management have been on the rise. It was the time of Taylorism, and the improvement to production scheduling and fragmentation of manual labour.
Domains of work
The Cynefin framework (it’s Welsh and pronounced ku-nev-in) has been created in 1999 by Dave Snowden and explains domains in decision making more in detail.
- Simple domain: Cause and effect are obvious. It’s repetitive and best practices work best.
- Complicated domain: More uncertainty in the relation between cause and effect. It’s the domain of subject matter experts.
- Complex domain: Nothing is certain. Cause and effects are only visible in hindsight. Best practices are not working anymore.
- Chaotic domain: There is a complete absence of rules or they change regularly. Best practices are useless.
- Disorder: It’s not a domain itself but rather the result of applying the wrong practices.
The Stacy Matrix (by Ralph D. Stacey, a British organisational theorist and Professor of Management) even goes one step further. It’s a mapping of the domains of work against the level of uncertainty: uncertainty in requirements, e.g. customer expectation, or new unfamiliar regulation and unacquainted technologies and methods. Known-knowns -> Known-Unknowns -> Unknown-unknowns.
Transforming hard work into smart work
If you can’t tell in which domain you’re in, you’ve found yourself in disorder. Disorder is like a door wide open for disruption. It can happen in a project or the whole organisation. Instead of blindly following Parkinson’s Law and being busy over effective, try applying the following steps:
- Focus on Why: Zoom out and put the desired outcome into focus. Visualise that outcome and align everyone towards it. This is key to customer and patient-centric approaches, good quality and safe products.
- Empower the How: Next, focus on simplicity in your decision-making process and select the appropriate means. Always come from the outcome – the customer and patient-centric context – and get down into the details later. Starting from details and going ‘up’ into the context makes matters (overly) complicated and (unnecessarily) complex. Also, it invites error.
- Facilitate informed decision making: Loss of context is often due to categorisation which in an organisation is: Silos. However, every decision (e.g. in a device’s architecture) has to be made in an informed way as it can (and will) have an impact on safety and quality. Risk/QA/RA subject matter experts can act as facilitators instead – actually becoming business enablers rather than policemen and women (watch the interview between Elena and Guenther Weisshaar). Most importantly, this leads to narratives being implemented into the documentation rather than compliance documents created. The technical documentation and the device’s architecture can be reviewed easily, reiterated if necessary, adapted and scaled.
As Mark Schwartz puts it in his book The Delicate Art of Bureaucracy: “Make bureaucracy Lean, learning and enabling.” In the end, legislation is always concerned with outcomes.
Become agile rather than fragile
In essence, this leads to a risk-based approach instead of a one-fits-all. It’s the difference between being a feature factory or the implementation of long-lasting value streams that are robust, adaptable and scalable. It invites (over inflicts) the integration of clinical and post-market data.
It’s a prerequisite to agile, instead of fragile. Rather than focusing on the wrong priorities that tend to lead to under-compliance in some areas and even over-compliance in others – you are carefully and mindfully selecting the appropriate means and achieve good quality, safe products and early compliance.
Because you’re having minimal impediments, you’re having minimal head-wind to change. It starts with a mindset, not a management method.
- Don’t mistake being busy for being effective. Work expands so as to fill the time available for its completion. Organisational entropy creates ineffective (formal and informal) bureaucracy. Instead, make it Lean, learning and enabling.
- Domains of work are defined by uncertainty of future events. If you’re a knowledge worker, you’re working in an emergent domain. Adjust your mindset and invite others to do so.
- If you don’t know which domain you’re in, you are in disorder. Zoom out again to put the outcome – the patient and the user – in the focus. Invest in simplicity and streamline from the outcome into the detail. Risk/QA/RA-professionals can facilitate informed decision making, acting like business enablers rather than policemen and women.
About the author
Regulatory Affairs Manager at Ypsomed AG
Christian Weckert is responsible for regulatory compliance at the Swiss medical technology company Ypsomed. He has worked with partners from the pharmaceutical industry on risk management of combination products and infusion systems, as well as digitally connected devices and Software.
Christian is very passionate about the digital transformation in the medical device industry. In particular, how regulatory and quality compliance, as well as associated ways of working can be combined when developing such digital devices.
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