Med-Tech Innovation Surface Treatment
commodities since their early experimental usage before the 1940s. They are usually applied using standard vapour deposition or spray equipment that can coat nearly any surface morphology with materials such as polytetrafluoroethylene or polyxylylene. Like most other commodities, the business model entails placing an order for which the vendor generates a quote. Suppliers can be contacted for quotes on machinery for applying the coating or for contract coating services. In stark contrast, hydrophilic coatings, especially as used in the medical field since the early 1980s, are not a commodity. They are an advanced, specialised, heavily regulated part of the overall good manufacturing practice developed for making medical devices. Although the two industries are at different levels of evolution, there are indeed differences in the learning curve and level of know-how needed to effectively apply the two technologies. With some small amount of training and validation on pre-fabricated coating process equipment, a manufacturer could create usable products with hydrophobic coatings. This is because standard processing equipment for hydrophobic coatings is suitable for multiple projects without too much modification.
In contrast, hydrophilic coatings always require fine- tuning of process parameters and extensive modifications to process equipment. If a hydrophilic coating is sold as a bulk product, the client would run into significant delays when trying to develop and validate a process. Eventually, a usable process may emerge, but without help from a knowledgeable hydrophilic coating vendor, process development will be significantly delayed. Therefore, many idiosyncrasies exist with each hydrophilic coating that is on the market and even a coatings expert would take time to sort through them. Selling bottles of coating solution at near cost is not a particularly viable business model for hydrophilic coatings. The business model that is used for selling hydrophilic coatings employs a closely integrated relationship between client and vendor and is consequently more complex. Initially, before solidifying a sale or relationship with
a hydrophilic coating company, the client will need to work with the vendor to develop the application and determine if the coating is appropriate. That means sending the vendor samples of the medical device to have them coated as a test. It may take several rounds of testing back and forth to see if the coating can work. Not everything works on the first try. Because hydrophilic coating methods include dipping and spraying, as opposed to chemical vapour deposition methods seen with some hydrophobic coatings, they are more sensitive to technique and differences in device configuration. Due to higher technical support and time requirements by hydrophilic coating clients, hydrophilic coating vendors often charge a licence fee and royalty. Some hydrophilic coatings are patented; with others their patents have expired. Either way, a licence fee will cover the patented material and/or the know-how. For this licence fee, the client should get substantial technical support, technology transfer help and a “can-do” customer service attitude.
www.med-techinnovation.com Precision Modules 134 x
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Some differences among the various hydrophilic coating vendors occur in this “courtship” process. Some vendors will charge high fees for “development.” They will require a development contract with a down payment and milestone payments. Other vendors will not do this unless the project is so complex it would require significant time and resources from the coatings vendor to determine how to apply the coating. Another difference will occur with royalty payments. The actual royalty rate that each company charges is usually confidential. The combination of licence fee, reagent costs and royalties is unique to each relationship and often strikes a balance between volume and margins.
Comfortable coexistence Given the differences in functions, applications and business models for hydrophobic and hydrophilic coatings, it is easy to suggest that the two industries will coexist indefinitely. Although some of the clientele overlap, there are definite niches of users that do not. Medical device design engineers should be aware of the advantages, characteristics and functions available in coatings to make the most suitable choice for the final application.
Josh Simon, MBA, PhD, is Senior Product Manager at Biocoat Inc, 211 Witmer Road, Horsham, Pennsylvania 19044, USA, tel. +1 215 734 0888,
e-mail:
jsimon@biocoat.com,
www.biocoat.com
Precision Ultrasonics for
Welding & Joining Telsonic ultrasonic systems deliver the performance, precision and consistency demanded by the Medical Device industry
• Linear or Torsional welding configurations available
• Wide range of modules and systems available to suit every application
• Clean, fast and controllable process
• Process data stored and analysed using “Telsoresult” analytical software
• Backed by over 40 years of innovative development and application expertise
Telsonic ultrasonic welding and joining systems are used to produce a diverse range of Medical Device industry products and components including:
• Filters • Membranes • Drug delivery devices • Diagnostic Devices • Wound Care
Tel: 01202 697340 E:
sales@telsonic.co.uk •
www.telsonic.co.uk
14-15 Birch Copse • Technology Road • Poole • Dorset BH17 7FH
April 2011 ¦ 19 18/03/2011 13:49:20
Ultrasonic
Technology for all Applications
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