Meet Michele R. Gardill, PE, MBA

Ms. Michele R. Gardill, PE, MBA, has worked in medical device commercialization at companies large and small--for J&J, Abbott Laboratories, Bristol-Meyers Squibb, Noven Pharmaceuticals, and even smaller companies that grew from just 1 or 2 people.  She bridges Marketing ideas with Manufacturing practicality.  

A licensed Professional Engineer since 1994, Ms. Gardill owned her own engineering consulting firm for 5 years, from 1994-1999.  She maintained Project Management Professional (PMP) certification for over a decade.  She holds a B.S. in Chemical Engineering from the University of Dayton, and an MBA in International Business from Xavier University.  She serves Medical Device Pros, LLC and its sister company MD Pros, LLC as both a Professional Engineering Consultant, and as Director of Global Business Development.

Ms. Gardill has also patented a few of her own inventions.  She is the sole inventor on a device that received a U.S. Utility Patent in 2021.  She was also sole inventor on a different invention that received a U.S. Utility Patent in 2022.  In 2023 she attained a U.S. Continuation Patent allowance.

Since 2021 Michele has been part of the ANSI Z80 Accredited Standards Committee for Ophthalmic Optics.  Michele also owns a separate company which deals with these and other developments.

Language Interests: Spanish, Mandarin, German, Portuguese. 

"Since Medical Device Pros, LLC provides personalized support to people developing various medical devices, it requires us to have diverse technical expertise and business abilities.  As Engineering Department Manager at Johnson & Johnson’s medical device subsidiary, I led engineers and technicians to efficiently develop dozens of new devices.  These included: nitinol and other alloy stents, guiding catheters, guidewires, and more.  We applied proven methodologies to help make the development as safe, complete and swift as possible--such as Competitive Analysis, Experimental Design ("DoE"), and Failure Mode Analysis. So I am glad to be able to bring this diverse medical device experience to Medical Device Pros, LLC."  
 

"At other companies, I held either technical or business leadership roles such as Plant Manager or Director of Project Management.  Since I was responsible for talent acquisition in many of these roles, I understand what it takes to create and support a great team of people—and I am happy to serve Medical Device Pros, LLC, and our key Clients as a Professional Engineering Consultant."  

"To me, the most successful projects are often the result of a collaboration among many people." 

"Often today, those people happen to live in different countries. A couple of my favorite examples:
 

--a speedy and cost-effective development of a new transdermal patch when the smaller U.S. company partnered with a much larger U.K. company.
 

--the development of a new cosmetic for commercialization in Brazil, China, and the U.S., utilizing new silicone technology from an outstanding German company.
 

Medical Device Pros, LLC offers services worldwide, so my comfort with working across cultures, languages, and time zones is a benefit for us all, especially for our global customers.."

"At Medical Device Pros, LLC we have 'been there/done that!'  That is, our engineering team has been through the entire product commercialization cycle from Feasibility to successful Launch many times, with many different products, in different parts of the world. This allows us to put the right resources in place, and get things going smoothly toward success for our Clients."