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The Surface is only the beginning.
A Hydrophilic Coatings Overview for the Medical Device Engineer
The Surface is only the beginning.
Presentation Outline
Coatings Overview • Why coatings are critical • Challenges in hydrophilic
coatings • FDA requirements • Coating thickness • Internal vs external coatings • Testing methods
Working with Medi-Solve • AquaCoat® platform • Lubricious coating
performance • Anti-microbial performance • Basic equipment • Developing a Coated
Product • What to ask? • Why Medi-Solve Coatings?
12/18/12 Medi-Solve Coatings, LLC Confidential 2
The Surface is only the beginning.
Why Coatings Are Critical
• Lubricity – The difference between “getting there easily or not getting there at all”
• Expertise – Need specific expertise to do coatings R&D
• “It’s chemistry, baby!”
• Regulatory – FDA is now coatings savvy….looking for specific performance and tests
such as particulate testing. • Does it come off? • Will it conform to parenteral guidelines (i.e. USP 788, Particulate Matter in
Injections)?
• Tolerances – How thick is it?
• Outsourcing – Most companies today would like to outsource the whole process
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 3
The Surface is only the beginning.
Challenges in Hydrophilic Coatings
Balancing Lubricity, Coating Adhesion & Durability
• What Works – Most coatings will work on Pebax, Nylon, PET – Easy to bond to polar groups on surface (amide, ester, vinyl acetate)
• Coating Watch-outs – Adhesion to Various Materials - metal guide wires, polyimide tubing , PVC
(plasticizer), silicone – Durability - Remain lubricious after tracking, removal and re-use – Particulate - How much is coming off? What shape and size is it? – Drying Out - Stay lubricious for 5+ min after initial wetting – Swelling Off – Stay lubricious after 1-2 hour soak – Geometry - Inside Coatings, Partial coatings for SDS, Balloons – Environmental Concerns
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 4
The Surface is only the beginning.
FDA requirements
Safety and Efficacy are key concerns of FDA on every 510K submission
Coating Safety • Biocompatibility • Particulate testing
Coating Efficacy • Friction data
– COF – Tracking Model
• Adhesion testing – Multiple abrasions – Extended period soak at body temp
• Sterilization Method/Accelerated Aging
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 5
The Surface is only the beginning.
Coating Thickness
• Coatings can range from 1 to 10 microns, dry – Typical coatings are 2 to 5 microns
• Balloon coatings- low end of range (1 to 3 microns), to limit increase to folded balloon profile
• Guide wire coatings – thinner to preserve coil tip flexibility • Thicker coatings – offers more durability (through multi-layer approach)
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 6
The Surface is only the beginning.
Internal vs External Diameter Coatings
• External coatings - offer more versatility and options
Major Concerns – Geometries must be suitable for even application of coating – Need to be able to drain coating solution – no nooks and crannies
• Internal coatings - often desired but can be difficult
Major Concerns – Maintaining an even coating along entire length of ID – Ensuring coating is well bonded through entire length
• UV systems – Is coating too viscous to coat the entire lumen. Will light be able to expose the entire internal length?
• Thermal systems – can you evenly apply, drain and dry the coating?
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The Surface is only the beginning.
Testing Methods
• Coefficient of Friction (COF) – Measure force required to run coated part through some sort of restriction
• Opposing pads • Orifice
– COF is calculated by dividing Measured Force by Applied Normal Force
• Abrasion Resistance – Measure COF through repeated passes in fixture – Typically involves a pre-soak at body temp for some clinically significant
amount of time
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL--
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The Surface is only the beginning.
Working with Medi-Solve – AquaCoat® Platform
AquaCoat® LC Highly lubricious coating Drainage catheters, guide wires, neuro catheter applications, etc
AquaCoat® AM Antimicrobial that kills both gram positive & gram negative bacteria PICC, CVC
AquaCoat® PA Plasma activated surface Diagnostic catheters, Imaging catheters
AquaCoat® DEB Designed for drug delivery systems Cardiology balloon catheters
AquaCoat® Gel Retains water and remains slippery after most coatings dry out Endoscopic sheath, Intermittent catheters
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 9
The Surface is only the beginning.
AquaCoat® LC : Lubricious Coating Performance
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 10
Lower graph is better
The Surface is only the beginning.
12/18/12 Medi-Solve Coatings, LLC --CONFIDENTIAL-- 11
AquaCoat® AM : Anti-microbial Performance
Higher graph is better
The Surface is only the beginning.
Working with Medi-Solve – Basic Equipment
• Vertical Dipper • Coating Tanks • Low Temperature Oven – 120 F • Racks to hold product • Equipment Costs:
– Significantly less than most of our competitor’s
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The Surface is only the beginning.
• Understand problem
• Develop plan
Identify the Need
• Formulate • Coat samples
Customer Evaluation
• Finished devices • Larger sample
size Verification
• Solution Supply Agreement
• Specify process/equipment
Scale-up
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Working with Medi-Solve – Developing a coated product
The Surface is only the beginning.
Working with Medi-Solve – What to Ask?
Some of the questions you should ask your coating supplier are:
• What type of coating system – oven Bake or UV cure • Chemistry solvent based or water based • Will their coating work on ID’s? What are the limitations • What are the capital requirements, especially for low volumes • What’s their business model, technology fee, royalty, minimums,
solution cost
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The Surface is only the beginning.
Working with Medi-Solve – Why Medi-Solve Coatings?
• Great Chemistry – Easy to implement and use – Water based
• Outstanding Hydrogel Expertise • Low Capital Equipment Cost • Fantastic Business Model – You simply buy solution!
– Formulate to your requirements – Manufacturer and Provider of Coating Fluid
• Shipped to your door, Formulated and Pre-measured – Easy to Administer – We Sell Solution to You
• No Complicated Agreements • No Expensive Royalties • No Minimum Coating Requirements • No License Fees
• WE ARE HERE TO WORK WITH YOU!
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The Surface is only the beginning.
Working with Medi-Solve – How to contact us?
• Sales – Art Madenjian
• [email protected] • (781) 366-0927
• Technical – Ron Sahatjian
• [email protected] • (781) 366-0227
– Rick LaPorte • [email protected] • (781) 381-5165
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