Episode 335

#335: Accelerating SaMD Development in a Compliant Agile way


In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.

Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.

Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.

Some of the highlights of this episode include:

  1. An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.
  2. The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.
  3. The need for companies to focus on their core competencies while being adaptable and compliant.
  4. The importance of a positive mindset and a well-defined success metric for any MedTech project.


"Our mission is to make the industry more accessible, more human centric and more productive" - Zach Markin

Reference Links:

*Interested in sponsoring an episode? Use this form and let us know!

About the Podcast

Show artwork for Global Medical Device Podcast powered by Greenlight Guru
Global Medical Device Podcast powered by Greenlight Guru
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 ...

About your host

Profile picture for Etienne Nichols

Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast