Our Backgrounds, and how we help you “take advantage of us”
Our job is to put the best in a field to work for you. That entails an engagement manager who understands your field and your strengths and needs, who can tutor the rest of our staff and coordinate with you.
A “Chief Operating Officer” keeps a lot of essential interrelated “balls in the air” so that your entire organization can move toward customer discovery followed by commercial “shipments”. We work with, or act in that role to make you more effective.
Guiding medical imaging startups through product development through seed, finance rounds, and exit.
World-wide Project Manager of an X-Ray Product Line.
Guiding quality and regulatory actions to national and international standards.
Helping commercialize academic research innovations.
Offering the most advanced cloud-based medical device quality system.
A premier product development firm, used by Google, Steinway, etc.
An award winning strategic turnkey, FDA and ISO compliant product development consulting firm with over 45 years experience
The Komm Crew
Our in-house team concentrates on the BioTech and Medical Device field. Although we have “Boots on the Ground” experience creating some of the products you now trust in many areas, we love helping our patients and medical professionals.
It became obvious that many of our great medical ideas took too long to serve the patients and missed some of the targets of “Safe and Effective”. Worse, many lacked the management “assists” that lean use of a great Quality Management System can bring to speed commercial release.
We speak cloud-based ISO 13485, ISO 14971, IEC 60601, 21 CRF Part 11, and SAMD, etc., and apply them to get a better safer product quicker!
Intelligent Product Solutions
Delivering product design excellence to diverse markets with precision, transparency and enthusiasm.
When you’re serious about a market changing product design.
They have done designs for Google, Steinway, and a “Smart Pill Bottle”.
SBIR / STTR
America’s Seed Fund
12 Agencies of the US Government who offer non-dilutive grants for research and commercialization.
Preparing the submission for the proper agency can help company planning. We can help.