Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

November 18, 2020


Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device.In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices.



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Some highlights of this episode include:

  • Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both.
  • A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices.
  • A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process.
  • Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process.
  • Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals.
  • Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements. 
  • Mantra: Invest time and money in usability/engineering models to get it right the first time to prove indications and meet proper requirements.



Devin Mack on LinkedIn

Devin Mack’s Email


FDA - Design Control Guidance for Medical Device Manufacturers

ISO 13485 - Medical Devices

Six Sigma Black Belt Certification

Greenlight Guru Partner Program

2021 State of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru


Memorable Quotes from this episode:

“Enqual: Engineer and quality because from my perspective, I provide a good balance between both.” Devin Mack

“A big challenge is the establishment of proper requirements, making sure that customer requirements are well-defined in order to establish those technical requirements as you go through the development process.” Devin Mack

“When there’s a lot of chaos, it’s typically because the time wasn’t taken to properly define the requirements of the product that they are hoping to launch within the deadline that they’ve set.” Devin Mack

“A lot of companies almost assume that engineering is synonymous with product development. My particular view is, product development is an enterprise-wide, cross-functional discipline.” Jon Speer



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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