Dr Shruti U Bhat, Director Strategic Innovations, Continuous improvement and Training; Shifting Paradigms BC Canada elaborates on how companies can stay healthy and grow despite rapid changes such as regulatory or poor economy undermining them
My column ‘Transforming Businesses from Good to Great!’ is a multiple article series which gives a backdrop of sectors such as pharmaceuticals, medical devices and healthcare. It focuses on creating ‘organisational excellence’, ‘design thinking led innovation’ and ‘strategic continuous improvement’ for start-ups and mid-sized expanding businesses. Further, it aims to recommend ways on how companies can stay healthy and grow despite rapid changes such as regulatory or poor economy undermining them.
Over the past 70 odd years, the pharma industry globally, has evolved grossly and developed processes to ensure that patients receive high-quality products. Yet, we have witnessed a rising number of 483s issued to pharma companies by the US FDA. Severe adverse effects and even deaths reported with drug products undergoing clinical studies or at times after commercialisation, is extremely alarming! This is more so when drug-delivery platforms and their pharmaco-dynamics get more complex. Now more than ever before, there is a dire need to overhaul ‘pharma business operation processes’.
Another quandary is to shift mindsets across this industry that has focused predominantly on compliance, rather than on truly knowing the root causes (and effects) of quality/ business process issues. Very often, we notice failures easily tagged to individuals, rather than being objectively investigated and/or tracked to process or systems issues. Clearly, something more is needed, but, what?
In my view, pharma industry executives should ask themselves some key questions, such as:
- Does my company have at least one process that is world-class?
- What would 10X better performance look like in a process that is part of my business operations today?
- Which fundamental design choice do I need to set right?
- What can pharma companies learn from other industries?
- Is my organisation connected to the best-in-class management thinkers and operations experts?
Because, operational excellence is a hard-won skill and a primer for creating ‘organisational excellence’.
A logical question is how do we achieve this operational excellence?
A standard response I often hear is- “By everyone doing their best” … that, by the way is a wrong answer!
Just doing your best won’t work. In fact, we should be thankful that not everybody is doing his or her best. Imagine the chaos it could create at your work site, everyone bumping into each other trying to be ‘best’ and working with cross-purposes.
The correct answer is that you have got to know what to do, then do your best.
Everybody works together with a common goal about how to achieve it. Not just with what seems to be brilliant ideas, but, with a robust ‘process improvement technique’ targeted to create the desired operational excellence and acknowledging that, it is ‘people’ that create this value.
When people become fully engaged in the process improvement campaign, understand ‘the why’ behind ‘the how’; they become empowered to act independently and to take initiatives. One successful improvement followed by another and then yet another, unleashes an enthusiastic commitment and continuous flow to the ‘operational excellence’ wave.
For starters, a helpful checklist with following questions can facilitate to understand processes:
- How does our company’s value stream (map) look like?
- How do we manage innovations?
- How does our company reduce waste?
- How do we do our jobs?
- How is our (business) process undertaken?
As obvious as these questions seem, it is amazing to see, how many companies forge ahead without answers!
Secondly, one needs to have the existing business operation landscape, the vision of what the business ought to be and the methodology to get there and make it happen!
Like any other transformation, you need to create the core team and its leader. Then, initiate an intensive training programme or ‘boot camp’ to rapidly build the team’s capabilities. Once this preparation phase is completed, use the five-step approach of define, measure, analyse, improve, control (DMAIC) to get the most from your company’s value chain.
The ‘define’ stage of process improvement, usually germinates from one or more of following four streams –
- Innovation in products and services
- Innovation in the process that creates products and services
- Improvement of existing products and services
- Improvement of the existing (business) processes
A point to remember is that, despite the strict vigil for compliance, no pharma manufacturer has succeeded in claiming the industry equivalent of Toyota’s ‘quality crown’. I hope that the global pharma industry can indeed shift its paradigm to achieve a performance that is close to flawless.
There are over 25 different time-tested process improvement methodologies that pharma/ medical devices and healthcare organisations can choose from, in order to achieve increased efficiency with their business operations and derive exponential profits.