In case you missed seeing this recent article of mine, as guest writer for Naveen Agarwal, where I encourage QA/RA functions to lean into driving innovation and revenue growth for their organisations, and not simply focus on compliance. Enjoy!
According to some close observers of the medical device industry, Quality/Regulatory functions have become increasingly focused on compliance. But only compliance.
Don’t get me wrong, being compliant is important, in particular in the medical device industry given the potential impact on patient safety. However, a compliance only attitude leads to a tick and flick mentality.
The problem with a tick and flick mentality, is that the outcomes may not result in the risk a device poses being addressed. Why? Because no one sat down long enough to truly think about why the regulations are in place, the potential risks the device may pose and what can be done about those risks now, when – in almost every circumstance – it will be much cheaper to remedy a problem before the device is on the market.
What could be the holy grail for these departments? An approach to Quality/Regulatory functions that turns the approach to compliance into a sustainable competitive advantage that drives revenue growth! One where their work is seen as a leadership imperative, where advancement in the organisation requires a proactive mindset on quality and regulatory compliance.
What is the advantage you can gain from a shift in mindset about these functions? Plenty. First, it costs to comply and to do quality well. Get good at it by getting it right the first time and avoid the inevitable instances of re-work. Applying some quality management principles will go a long way!
Next, get very good at it. Create a challenge for your leaders to find the most cost-effective way to run your quality and regulatory compliance programs. Explain to them that if they find a way to deliver quality and comply with regulations better and faster than the competition, they gain a sustainable competitive advantage.
Now, get great at it. Turn your quality and regulatory compliance programs into a haven of innovation and revenue generation. How? Set your leaders the goal to not only identify actions ensuring device standards meet stakeholder expectations but to also seek opportunities within each action. It could be an opportunity in component design, material selection or additional functionality just to name a few. More importantly, work with leaders to develop marketing strategies that demonstrate the safe pair of hands your customers will be in if they choose your product.. The emphasis on working with suppliers that government agencies and corporates can rely on in is growing exponentially. Often driven by regulators. Just different ones to yours!
“But I’ve tried to do most, or all of that, but they didn’t listen” I hear you say. Maybe what you said, and what they heard are very different? Maybe you weren’t speaking their language. Or what you told them did not spell out the benefits to THEM personally.
Take a moment and have a think about what you said and how you said it. What was the value proposition you presented to them? What problems did you articulate would be solved? What opportunities did you spell out FOR THEM. And did you use their language? The language they use when speaking about risk and opportunity. And did you bring in the corporate values? Did you explain how a leadership approach to quality and regulatory compliance is inherently demonstrative of some or all of those values?
Affecting change at executive level from your position in an enabling function is never easy. Execs are constantly trying to save money at the back end. And, according to many surveys, most senior executives think enabling functions cost too much and underperform.
Assuming your execs are similar, you must plan your approach, bring all your persuasive powers together and convince them you can turn red tape into blue ribbon! A subject I just happened to write a book on. Check out my LinkedIn profile and see for yourself.