This lesson had a big impact on me. I read it years ago in David Maister's book, "Managing the Professional Service Firm":
QUALITY WORK doesn't mean QUALITY SERVICE
Put another way:
FDA CLEARANCE doesn't mean QUALITY SERVICE
FUNCTIONING SOFTWARE doesn't mean QUALITY SERVICE
As regulatory consultants and engineers, it's natural for us to focus on technical excellence. While crucial, it's actually a smaller part of our clients' overall experience. Most clients can't directly evaluate our technical quality—much like most people can't judge the intricacies of a car repair, a legal contract, or a tax return.
Then what is quality service?
- How stressful was working together?
- Did you make the client feel like the submission was organized and in control?
- Did you provide frequent progress and budget updates?
- Did you respond quickly to emails and slack messages?
- Did you speak down to the client?
- Do you wear professional-looking clothes and have a clean zoom background?
- Did you praise their good work, or highlight their deficiencies?
- Were you positive and encouraging?
- Did you highlight and explain the quality of your work?
All of this can be captured in Maister's "First Law of Service":
SATISFACTION = PERCEPTION - EXPECTATIONS
Here's an example from the last point above: Clients won't automatically see your good work unless you explicitly highlight and explain it. While a technician might view this as self-promotion, it's actually ensuring clients fully perceive the value you're providing.
Quality work is foundational—necessary but insufficient on its own.
Over the past decade of helping clients develop and FDA-clear their medical device software, I've consistently observed how vital this lesson is. That's why all our new hires read this chapter from Maister's book.
Have you had service providers do quality work while not doing quality service? What are common ways FDA regulatory consultants or software engineers could provide better service? I'd love to hear in the comments!
#professionalservices #medicaldevices #FDA #customersatisfaction #regulatoryaffairs #10x
