Working with Surmodics

At every point in the development process, Surmodics is your hands-on collaborator, innovator, and technical advisor. Count on us to identify opportunities, anticipate issues, remove barriers… simply do everything we can to reduce risk and help speed your product to market.

Roll over the boxes below to learn more about each stage of the development process.

  1. Feasibility & Development
  2. Verification & Validation
  3. Technology Transfer
  4. Contract Coating Services
  5. Manufacturing & Commercialization
  6. Ongoing Technical Support

Feasibility & Development

At this phase, we work with you to:

  • Understand your specific device requirements
  • Optimize the best formulations for your unique application
  • Test to confirm the coating’s performance
  • Conduct rapid iteration of coating (if needed)
  • Optimize the coating process parameters to meet your needs

Verification & Validation

Next, we work with you to:

  • Complete coating design requirements for verification and validation builds and testing
  • Develop coating specifications
  • Provide Regulatory and Quality support
  • Validate the coating process
  • Provide coated products for pre-clinical and clinical studies and for particulate testing
  • Provide coated products for sale, upon licensing

Technology Transfer

You may choose to move the coating process to your facility, upon licensing we:

  • Provide training at your facility and ours
  • Provide complete technology transfer documentation
  • Provide details on reagent formulation

Contract Coating Services

We welcome the opportunity to provide the contract coating services you need before and after you are ready to fully commercialize your device. This includes:

  • Coating suites with controlled environments and high throughput coating equipment
  • Products manufactured under our ISO 13485/9001 certified quality management system
  • Assuring the quality and consistency of what we supply our customers
  • Documentation to support the manufacturing process

Manufacturing & Commercialization

As you drive to commercialization, Surmodics helps to get you there as quickly as possible. We also partner with you to develop process improvements and implement cost savings throughout the product life cycle. This includes:

  • Efficient, high-throughput manufacturing process
  • Rapid UV cure times to minimize process cycle time
  • One- or two-coat process to meet a variety of product requirements
  • Coated devices that can be tested or inspected immediately after coating

To support your manufacturing, coating equipment is available from OakRiver Technology.

Ongoing Technical Support

With your manufacturing and commercialization strategy in place, Surmodics continues to provide highly responsive support. This includes:

  • Dedicated technical support team
  • Training for new engineers
  • Trouble shooting to enhance your process efficiency
  • Providing analytical expertise
  • Supporting your regulatory team
  • Providing you with data and rationale that address your technical questions