Device Manufacturing

Device Manufacturing

In addition to component and sub-assembly manufacturing at three sites in the United States, your finished device manufacturing needs are provided for by manufacturing sites in California, Germany and Romania. We manufacture a variety of different medical devices such as catheters for coronary, peripheral and cranial indications, dilatation catheters, devices for local drug delivery, stent delivery devices, ENT (ear, nose and throat) devices and several other devices.

Products are manufactured according to our customers’ specifications, but there are also devices available for which we have the CE approval. 
As a pioneer in drug coated balloons, we also offer the drug coating of balloons with your specific coating formulation, if you provide the recipe of your formulation. The drug coating takes place in our dedicated GMP clean rooms.

Devices can be delivered packed, labeled and sterile – ready to go – or non-sterile depending on the customers’ needs.

Customizing Devices

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 Forming 

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

Crimping of Stents 

We can crimp your stents, coated or uncoated, onto balloons. We have multiple in-house crimping technologies and the crimping process will be validated for your specific stent to provide for consistent product performance.

Coating of Balloons 

Many of our dilatation catheters are used as so-called “combination devices”, 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. Coating formulation can be provided by our customers or developed in conjunction with our CDMO team. CDMO work, from coating process validation to batch release testing, can be handled by us.

Packaging, Labeling, Sterilization

In addition to development and manufacturing we also offer development and validation packaging, labeling, external sterilization and shipment of your finished device.

Regulatory Support, Submissions and Product Approvals

We offer all the necessary support that our customers require to gain local product approval with the major relevant regulatory agencies around the world.

Product Transfers

If your strategy is to optimize and reduce cost, or outsource a particular product or product line, our Device Design and Device manufacturing teams can facilitate your efforts with options for lower cost manufacturing environments.