We are pleased to welcome a new member to our team – Mike Heald.  Several of the team have worked with Mike on a number of projects over the years, so it’s great to be able to work with him again.

Equipped with an aerospace engineering background and a degree in Medical Engineering, Mike started leading the development of medical devices and combination products more than 12 years ago.  Over that time, he has worked principally in the development of drug delivery devices of varying complexity for the pharmaceutical industry.  Mike blends Engineering with real-world experience, Project Management, Quality and Regulatory knowledge to deliver effective and pragmatic medical device development.

“Medical Device development is never a handle turning exercise.  There are three major protagonists to be looked after; Engineering, Regulation and Stakeholders, and they can all spring surprises at any time.  The stakeholders lean on you all the way, the engineering is always visible but has a sense of mischief, and then the Regulations jump up to bite you near the end.  In my experience the attention this trio receives is often unbalanced with Regulations taking a back seat and Engineering detail trusted to do the right thing.  I see it as my job to restore this balance and help to keep those stakeholders happy all the way to delivery.”