Under the skin: in conversation with Surmodics
Vascular device developers must focus on three critical areas of performance: delivery systems, mechanism of action or treatment, and surface technology. MTI spoke to Surmodics, a company which, through recent acquisitions, is determined to offer whole vascular device products that excel in all three areas.
Surmodics is best known as a developer of coatings for vascular devices. Since 2003, when the group developed the surface technology for the first drug-eluting stent, it has developed lubricious, haemocompatible, and drug-delivery coatings for over 150 devices in all major intravascular categories. The recent introduction of its Serene hydrophilic coating marked another milestone: a highly lubricious yet durable coating that displays both low friction and low particulates.
The group is now aiming to offer highly differentiated, complete vascular devices. Two recent strategic acquisitions are helping Surmodics realise this vision.
In 2015, Surmodics acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ballinasloe, Ireland. With its subsequent acquisition of US-based Normedix, Surmodics attained comprehensive design, development and pilot manufacturing capabilities for custom catheter solutions.
With the Ireland-based design, development and high-volume manufacturing facility, significant investment has already been made to combine all of Surmodics’ capabilities under one roof. The facility controls all critical aspects of product lifecycle design, development and manufacturing.
Dedicated R&D teams design, engineer, and performance-test a wide range of vascular devices. Rapid prototyping, leveraging multiple processes and technologies minimise cost and accelerate development.
From concept through production, Surmodics says it maintains strict design controls, development traceability, and a strong linkage between design and manufacturing for efficient validation testing and predictable scale-up to manufacturing.
Thomas Greaney, executive vice president for medical devices at Surmodics (pictured), told MTI: “Our Ireland facility is much more than a manufacturing site. As our customers drive to commercialisation, we also support them with an experienced regulatory team adept at anticipating and removing potential barriers to timely regulatory approval in global markets. Products manufactured in our Irish facility have FDA clearance, CE mark and Japan approvals, in addition to many other country registrations.”
Surmodics’ manufacturing process begins with multi-layer micro-extrusion of thermoplastic catheter components and balloon tubing to the tightest of tolerances. The group claims to have perfected multiple balloon forming processes to achieve demanding performance expectations. The complete catheter top-assembly uses high output machinery, and Surmodics’ customised packaging and labelling allows customers to brand their products for market differentiation.
“Our customers range from start-ups to global strategic corporations. To satisfy their needs, we have expanded our facility for large-scale, lean manufacturing, with four class-eight rooms Over the past year, we have more than doubled cleanroom and tripled semi-controlled space to enable product development and high capacity manufacturing of all Surmodics technologies.
“Surmodics’ expertise includes a proprietary ultra-high pressure braided balloon technology, as well as conventional low-profile, non-compliant, semi-compliant and compliant capability. By combining this capability with our specialty ultra-thin-wall braided catheter technology, we’re able to offer customers a broad range of highly differentiated total product solutions from one manufacturing location,” said Greaney.
Regarding catheter technology, Greaney said: “Our proprietary coiled/braided shaft technology is truly unique: ultra-thin walled, yet with unsurpassed performance in kink-resistance, torque-control and radial strength. We also offer precision-engineered hemostasis valve technology with exceptionally low insertion and withdrawal force for medical devices ranging from .035” to 34 Fr”.
Greaney continued: “Our Ireland facility uses Surmodics’ industry-leading surface technology, including our patented Serene hydrophilic coatings that leverage advanced UV curing processes to facilitate rapid covalent bonding to a wide variety of catheter substrates. Specific to drug-delivery capabilities, the facility is certified to handle small molecule compounds such as paclitaxel and sirolimus. Surmodics’ research and development teams are advancing a pipeline of drug coated balloons targeting a range of peripheral indications, including SFA, BTK and AV Access.”
While Surmodics’ headquarters in Eden Prairie, Minnesota, remains a center of excellence for surface technology development, to serve customers with European manufacturing, the full range of coating products, performance testing, surface characterisation and chemistry analysis performed at its headquarters is also offered at its Ireland facility.
“Our Irish facility has a history of close partnership with customers, collaborating at all stages of product design cycle to insure market needs are met. That’s very much in keeping with the Surmodics corporate culture, and it’s why Surmodics has invested to make Ireland its global manufacturing centre of excellence,” said Greaney.”