Medical Devices
We support new medical device development, process and workflow optimization, and manufacturing scale-up. With expertise in extracellular matrix-derived and other biological biomaterials, we empower your medical device regulatory data submissions, commercial launch, and production.
Medical Device Design and Manufacturing
We specialize in medical device development projects where the product is composed of extracellular matrix-derived biomaterials, natural or biologic polymers such as chitosan and cellulose, and occasionally may include synthetic polymers.
We follow our D4 process, Define, Discover, Develop, Deliver, to meet or exceed your project requirements, and support scaled up contract manufacturing leveraging our in-house capabilities and partners.
Our customers either seek new product development utilizing one of our existing ECM technology platforms, engage in co-development, or bring us their technology for process optimization and scale-up.
Examples of medical devices we have worked with include wound dressings and skin grafts. Our team has supported new product regulatory approvals, commercial launch, and scaled-up manufacturing, while adhering to our stringent quality policies. Our ISO 13485 certified facilities and capabilities offer flexibility in working with customers from early stages of product development to cleanroom manufacturing, packaging, sterilization, storage, and shipping.
Extracellular Matrix
Biomaterials
Medical
Applications
Design
Services
Contract
Manufacturing