About SBE Medical
Your commercialization partner from prototype to patient
SBE Medical is a veteran-owned small business based in Comstock Park, Michigan. We help medical device inventors, startups, and clinicians navigate the path from a working prototype to commercial product.
We aren't a contract manufacturer. We're the commercialization partner who gets you ready for manufacturing — and connects you with the right partners to build at scale.
Our Mission
To improve patient outcomes by helping great ideas reach the patients who need them. We believe in fast, disciplined commercialization — removing the regulatory, clinical, and operational friction that stops innovations from reaching the market.
Quality Management System
Our team brings over 30 years in the medical device industry and operates under ISO 13485:2016 standards. Your device is developed and validated under the same rigor you'll need for FDA submission and commercial launch.
What Makes Us Different
We've walked this path
Our own product, the Tibbe™ EUD, went from concept to commercial product using the same playbook we apply for clients. Clinical validation, reimbursement coding, regulatory, distribution — we've done it.
No manufacturing conflict
We're not trying to sell you contract manufacturing. We introduce you to the right manufacturers based on your device, your volume, and your cost targets — so you can pick what works for you.
Sourcing expertise
Through our partner network, we bring decades of global sourcing experience — domestic and offshore — to help you find the right manufacturing fit for prototype to production.
Reimbursement focused
A device that isn't reimbursable doesn't get adopted. We build reimbursement strategy (HCPCS, CMS coverage) into the product plan from day one, not as an afterthought.