Medical Device Contract Manufacturing Innovations

Concept to Commercialization

The innovative Lubrizol Medical Device Design group consists of a highly experienced and fast-working team of project managers, design engineers and specialized technicians. 

Our team will support you in generating new ideas and technical solutions and will help you turn your idea into a real product. Whether starting with and existing design requiring new features and optimization, or starting from a napkin-sketch, we can help you realize an innovative and efficient solution.

The team will efficiently manage your project, provide for a schedule of team calls and interactions to provide updates and achievements to set milestones, and help you shorten the important time and expense to launch your device to the market. 

We will guide you through all the different "device phases", from feasibility, design reviews, design freeze, design verification and design validation to an approved and ready for sale product; 

Your Device Design needs will be further supported by our unique capabilities and resources such as:

  • GMP environment for Drug Coating 
  • Design Centers and full device manufacturing facilities on two continents, three countries US, Germany, Romania.
  • New Device Design and Manufacturing group located in Southern CA
  • Platform designs for PTA, PTCA, (Neurovascular), (ENT)
  • Nearly 30-year history of success with first device development in 1992
  • Relationships with well known institutions and KOL’s
  • Material expertise and Polymer Chemistry from Lubrizol Medical Polymers
  • Support for combination devices with Drug Development capabilities with Lubrizol CDMO  

Therapies and Expertise

The Lubrizol Device Design team experience covers a broad range of therapies and clinical expertise, including but not limited to:

  • Cardiology - (Angioplasty catheters, aspiration, perfusion, stent delivery, local drug delivery, etc.)
  • Radiology - (Angioplasty catheters for above and below the knee applications, local drug delivery, etc.)
  • Cryotherapy - (Incorporated sensors and thermocouples in dilatation catheters)
  • Neuroradiology - (Angioplasty catheters, stent delivery, local drug delivery, etc.)
  • Structural Heart - (Delivery Devices/Access devices for TAVI/TAVR)
  • Ear, Nose and Throat therapies - (Dilatation catheters, local drug delivery, etc.)

Product design

If you have an idea about a clinical need, a specific indication or a special device, we can help you decide on the best catheter design. Our design engineers work closely together with you and your medical advisors in order to satisfy your individual needs.

Device Customization

If existing devices are a good baseline, but they do not completely fulfill your needs and requirements, we are able to customize these catheters according to your individual specifications.

Balloon Design and Forming

We have various in-house balloon forming technologies and can provide a huge range of different balloon sizes, balloon characteristics and balloon materials.

Stent Crimping

We can crimp your stents, coated or uncoated, onto our balloons. We have different in-house crimping technologies and the crimping process will be validated for your specific stent in order that you can rely on constant product performance.

Drug Coating of Balloons

Many of our dilatation catheters are used for “combination devices”, i.e., a combination of an active drug and a medical device. We offer the coating of balloons in our dedicated GMP clean rooms as part of our services. Drug coating formulation can be provided by the customer or developed in conjunction with the Lubrizol CDMO team. We also provide for Coating process validation to batch release testing.

Packaging, Labeling, Sterilization

If our customers do not want to engage in the production process at all, we also offer ready-to-go products including packaging, labeling, external sterilization and shipment.

Regulatory Support and Product Approvals

We offer all the necessary support with regional regulatory agencies required to gain product approval in most parts of the world.