Development and Manufacturing

Here at Summit Medical we are practical, goal-oriented product developers. Our strategy is to work closely with medical personnel to identify and understand unmet needs and then rapidly develop unique and technically superior products. Our ultimate goal is to develop products that improve patient care and simplify the practice of medicine.

Summit Medical is a complete turn-key source, that takes products from the concept stage all the way through design, premarket approval, manufacturing and into the marketplace. To accomplish this, Summit Medical has a full, in-house staff of experienced professionals in various technical disciplines such as medical materials, device engineering, drafting and documentation, product testing, regulatory compliance, manufacturing, risk analysis, and quality assurance.

Facility & Capabilities

Summit Medical is located in St. Paul, Minnesota. Our state-of-the-art medical manufacturing facility includes an office, warehouse, manufacturing floor, inspection room, machine shop, engineering lab, clean molding facility and packaging clean room. Manufacturing capabilities include clean room silicone molding, plastic injection molding, bench assembly, inspection, testing and clean room packaging.

Quality & Regulatory

Our product development program and manufacturing systems comply with US FDA cGMP requirements and European and Canadian ISO13485 requirements. Our products are CE marked for international distribution with sales in 35 countries outside the USA.


Summit Medical markets through a worldwide network of independent specialty sales representatives and stocking distributors. Our sales force is supported through a complete communications program including electronic and printed media. Products are promoted through attendance at medical trade shows, meetings, conferences and seminars as well as through websites, direct mail, fax and e-marketing along with direct communication with our sales team.

Outsource Development and Manufacturing

Summit Medical offers a full range of product development, custom design and manufacturing capabilities to other companies on an OEM or private label basis.