MP

Michael Plishka

Available to hire

I am Michael Plishka, founder and President of ZenStorming, a design and innovation consultancy.

About

I am Michael Plishka, founder and President of ZenStorming, a design and innovation consultancy. For 30+ years I have designed, developed and launched products, including medical devices, by staying close to the customer, building relationships, and translating needs into tangible product ideas.
I bring applied creativity to product market differentiation, platform development, and regulatory strategy, with hands-on experience in 510(k) submissions, GMP/GLP, risk assessment, and IP development. From rapid prototyping with 3D printing to teaching teams across hospitals and startups, I help transform insights into disruptively useful products. I have presented at conferences, led multi-site studies, and built enduring relationships entrepreneurs and manufacturers to deliver meaningful healthcare innovations.

  • 34 years' experience
  • Joined March 2026

Languages

  • EnglishFluent

Industry experience

  • Healthcare
  • Life Sciences
  • Manufacturing
  • Professional Services
  • Other

Work experience· 5 roles

Founder and President · ZenStorming Solutions, LLCApr 2008 – Present · 18 yrs 8 mos

Founder and president of a design and innovation consultancy, providing new product concepts, strategy, IP development, clinical training programs, regulatory support, and mobile app story-boarding for medical devices and related technologies.

Engineering Specialist; Access Systems · Baxter HealthcareJun 2006 – Apr 2008 · 1 yr 11 mos

Led development of next-generation vascular access products; authored 510(k) submissions; contributed to design controls and IP portfolios; mentored engineers and trained clinicians; improved prototype manufacturing efficiency.

Engineering Specialist; Special Procedures · Cardinal Health (Allegiance Healthcare Corporation)Apr 1999 – Jun 2006 · 7 yrs 3 mos

Directed product development from concept to launch for drainage catheters, biopsy devices, and vertebral repair; led physician advisory boards; developed platforms and training materials; supported design controls and regulatory submissions.

New Product Development Engineer · Manan Medical ProductsMar 1995 – Apr 1999 · 4 yrs 2 mos
Biomedical Engineer · Hines VA Hospital / Loyola Medical CenterMar 1991 – May 1994 · 3 yrs 3 mos

Education

Bachelor of Science, Mechanical Engineering · University of Illinois at Chicago2030 – 2026
Master of Arts in Ethics and Spirituality · Loyola University Chicago2030 – 2026

Certifications and awards

ISO Registration (Quality Management System)2030 – 2026
FDA 510(k) Submissions Authorship2030 – 2026
Regulatory Compliance & Design Controls2030 – 2026

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