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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.…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.

Michael Plishka

Designer, Product Designer, Brand Designer, +6

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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.…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.

Available to hire

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.

Skills

3D Model

3D Design

Product Design

Experience Level

3D Model

Expert

3D Design

Expert

Product Design

Expert

Language

English

Fluent

Work Experience

Founder and President at ZenStorming Solutions, LLC

April 1, 2008 - Present

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 at Baxter Healthcare

June 1, 2006 - April 1, 2008

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 at Cardinal Health (Allegiance Healthcare Corporation)

April 1, 1999 - June 1, 2006

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 at Manan Medical Products

March 1, 1995 - April 1, 1999

Worked with clinicians to develop drainage catheters and biopsy products; managed manufacturing scale-up; authored 510(k) submissions; led validation testing and procedures.

Biomedical Engineer at Hines VA Hospital / Loyola Medical Center

March 1, 1991 - May 1, 1994

Developed bi-polar surface electrodes and implantable meshes; co-designed catheters for bladder studies; contributed to computer simulations and clinical research.