Columns
A collection of short posts that give an insight to my philosophy of managing people and business.
Technical debt
Technical debt — a concept borrowed from software development — applies with equal force to medtech product certification, where deferred decisions and cut corners accumulate into a hidden drag on resource and commercial opportunity. Most senior leaders don't see the cost until a crisis forces the issue; the argument here is for making it visible, measurable, and planned for before that point arrives.
Regulatory affairs is more than a support function - and should report directly to your CEO
Why regulatory affairs needs a seat at the board table.
What does the Challenger disaster have to do with medtech?
Why management style sets organisational risk tolerance, and how this impacts patient safety.
Is there enough culture in your compliance strategy?
How leadership influences organisational culture, and why this is a critical part of putting quality first.
One eye on the business
Regulatory affairs quietly generates competitive intelligence that most medtech businesses never use commercially.
Does psychological safety get results?
I argue in favour of Edmonson’s psychological safety framework, in building high performing teams.
Quality, Cost, Delivery
Why medtech occupies a uniquely challenging space in this triangular paradigm.