Medical Device Devices

908-***-**** (cell) William T Donahue **********@****.***.***

Developing Medical Device Function, Materials and Processes Concept thru Product Introduction

Chemical Engineer active in Polymer Materials, Composite Materials, Coating, Cure & Testing

Hands-on, versatile, experience developing manufacturing processes is available. Prototype builds, polymer processing & device validations show my problem solving. Coating, curing and testing films focus exercised mostly in medical devices. Medical & military composite materials. Rehired at Hydromer, Osteotech and Cordis

● 20 years in Medical Devices ● Solve problems: DMAIC, Six Sigma tools ● Cardiovascular & Disposables projects

● AutoCAD and SolidWorks user ● Originated medical device tests ● Write Validation Protocols & Execution

Contributing to Medical Device development from the earliest concepts to sustaining & revalidating extant devices. Strong in small scale fluid mechanics and delivery tools, prototype building & testing, TM development.

Contract Process Assignments (short term) through IT Minds, Phaidon and Dev-X (2022 & ‘23) on-site: RI, NJ & CT Pharmaceutical, Web Processing & Medical Devices (Vertex Pharmaceuticals, Rogers Corporation, Church & Dwight )

Commercial Development Engineer Explored commercial coating of ePTFE to convert membrane packages from hydrophobic to hydrophilic. Simplified several rate-limiting steps from proto-method. DHF Remediation Engineer (lubricants) Remediation of DHF on a recently acquired line of consumer products and medical devices. Stopped when European manufacturing facility was temporarily closed.

Senior Process Engineer (Foam Rubber Manufacturing) Found PTFE-coated belt permeability tool; belt repair tools; cheaper styles; fixed belt steering, receiving inspection. Released as DuPont merger was terminated.

Time-out after Covid for Health and Oral Surgery (2020 & ‘21) Replaced both knees. Repaired broken bridgework.

Collagen Matrix, Senior R&D Contract Engineer (Regenerative Implants) (’17-‘19)(new operator-Regenity ‘19) Oakland NJ

Developed large-bore Vascular Closure Tool. Designed Nitinol substitute for holding balloon to reduce the number of sizes to stock. Improved marking method on collagen implant; demonstrated that a specific ink jet printer could deliver appropriate guide marks for subcutaneous stapling. Evaluated several metered dispense units for marking the collagen implants. Selected corporate’s 3D printer to mix multiple components for assembly.

St Jude Medical is now Abbott, Contract R&D Coating Engineer (OCT Catheter) (Jun’16-Jan’17) Westford MA

Found and demonstrated issues with extant coating formulation, mix sequence & cure technique. Changing the sequence of ingredients into the coating mix saved hours of batch assembly and avoided an unsafe hot plate heating. The UV cure agent concentration proved too low to provide integrity. Demonstrated that the extant UV cure technique left much of the required surface uncured. Also identified an outsourced coating with robust integrity, demonstrated effective UV cure & found hardware to deliver sufficient capacity.

CareFusion is now BD, Contract Sustaining Engineer (Respiratory therapy disposables) (July’14-Dec’15) Totowa N J

Sustaining engineer for high volume disposables as CareFusion moved to Mexicali. I led a change of oils in a plastisol face mask part for respiratory therapy. With the engineer in Shenzhen manufacturing we discussed steps and sorted through a number of trials before settling on a replacement skin contact compatible oil. We then confirmed the new mix could continue to fill extant molds 50 times before requiring manual cleaning. From NJ I set up the manufacture of box lots (standard shipper containers) to model waits on the waterfront and at sea, followed by accelerated aging and mechanical testing of the 13 different styles in a dozen or so sizes to revalidate the new product. Closed REACH and RoHS labelling issues across all corporate products.

Advanced Defense Solutions Technologies, Senior Project Engineer (Composite Materials)(‘09-‘12) Bloomfield CT

Impregnated knits for new shop with multilayer cast, cure, coat, laminate & paint operations. Tripled capacity in footprint; set plan for 20+fold. Selected both pilot impregnation and production, test gear and controls for upgrade to continuous online coating operation. Eliminated steps taking processes into spec. Upgraded testing to mission precision. Cold peel testing was improperly set-up. Identified that the laminating adhesive film was manufactured in production by a different coating method than was demonstrated to sell into the mission and supplied too thin. Showed that double laminating to the product allowed adhesion to approach the specification. Demonstrated that ceiling fume extract intakes needed to be lowered to remove heavier-than-air solvents.

Contract Process Assignments thru Quintiles, Engineering Resource, et al. On-site: FL(2), CA, CT, NH, NJ(4) Medical Devices: Coronary, Circulatory, & Orthopedic: Boston Scientific Electrophysiology,2 rehires (Cordis is now Terumo Aortic; Osteotech is now Medtronic)

Revalidating the manufacturing processes on production electrophysiology catheters. Moved R&D composite implantable ortho scaffold into production. Modified and validated the multistep manufacturing process: IQ, OQ, PQ, Process Validation. 2nd contract expanded capacity more than 4X. Tuned a process to cure a catheter section coating; designed tooling & validated coat durability; 2nd contract was team effort: conceived test method to demonstrate integrity of drug coating on stents. Identified flow classical engineering and well understood.

Hydromer, Inc (rehired) Process Development Engineer (medical coating manufacturer) Branchburg NJ

Hydromer, a polymer R&D company, sells permanent lubricious medical and anti-fog coatings and hydrogels.

Developed process to meter-coat hydrogels into sponges for client’s new wound dressing product line. Selected meter-mix-dispense unit for a client’s application. Revived coating facility for meter-mix-dispense of hydrogel onto release liner for therapeutic delivery. Examined paper coatings for possible improvements to a cheaper but brighter ink jet paper.

Bolton Medical (facility moved to Florida Jan 2003 now Terumo Aortic) Senior Project Engineer Fair Lawn NJ

Bolton makes coronary and peripheral stents and catheters to deliver them. Bolton moved to FL

Developed techniques to coat polymers onto stents for drug-elution. Ultrasonic coating technique deposited polymer solution over silane treated surfaces. Evaluated coating coverage and quality into 1st clinical screening.

Cardio Technologies Inc. (start-up, closed April 2001) Senior Project Engineer Pine Brook NJ

Cardio Technologies was developing a less invasive temporary therapeutic device to support cardiac function. Start-up Cardio Tech closed

Developed elastomeric material for reliability test stations to match wear of cardiac tissue on the implanted device. Redesigned electrode to synchronizing cardiac rhythm. Relieved fatigue failures of elastomer cuff to hold electrode against pericardium.

Meadox/Boston Scientific/Maquet (medical devices) Process Development Engineer Wayne NJ

Released after product introduction

Processed ePTFE & PTFE to timely introduce EXXCEL vascular grafts. Identified signature artifacts in SEM micrographs of competition revealing process. Developed 3 processes to make step-shaped grafts from expanded tubes, took strongest into production. Built production gear. Borrowed routines from composites to eliminate non-uniformity in yarn-wrapped product.

Patents 6,364,903; 6,733,524 and 7,285,132 – Powder coat stents with PTFE to attach ePTFE covers for stent grafts

Hydromer, Inc (medical coating manufacturer) Process Development Engineer Whitehouse NJ Designed and built a continuous coater with a 14ft vertical drying oven for spools of tubing, operated it 3 weeks later. Set up a clean room and coated guidewires for clinicals. Designed flammable liquid storage and dispensing facilities. Prototyped 2-part hydrogel for wound care and transdermal drug delivery: introduced it at MDM both as film on scrim & cast from dual-cartridge.

Fiberite Composite Materials is now Solvay Process Development Engineer Winona MN & Tempe AZ

Fiberite is a leading supplier of prepreg (fiber impregnated with polymer in tape, fabric or tow form) ICI sold off Advanced Materials Division

Focus was on mixing, quenching, and coating processes, the upstream technology end of the Fiberite prepreg operation.

First assignment turned out to be a pre-LEAN “single minute exchange of die” event. Biggest scrap producing line changed rollers 2X-4X weekly. Change time usually ran 2-4 hours but many failed after 16 hours. Problem presumed instrumentation. But a change to split-pillow-block bearing housing eliminated realignment issues and cut roller changes to near 30 minutes.

Conceived and built prototype resin melter with three controls to replace thermostatted production units and resolve nagging control issue. Payoff was in safety, product uniformity, production rate, and control.

University of Minnesota Minneapolis MN (incomplete thesis) PhD Chemical Engineering

PhD Thesis: Wave Formation at the High-Speed Limit of Dip Coating Advisor: LE Scriven

Designed and built a 14in wide pilot coating line to service ongoing group research into several coating methods. Examined waves on a rising web at the high-speed limit of dip coating. Waves emerge from a smooth zone which shrinks in length with increasing web speed. Adapted novel methods to use on the moving web: capacitance micrometer for film gauge; shadow graphy for gross patterns; and laser beam deflection for wave shape & growth. Showed waves are classical, well-understood, falling liquid films.

Massachusetts Institute of Technology Cambridge MA BS Chemical Engineering

BS Thesis: Heat Transfer from a Cylinder in Crossflow to Dilute Polymer Solutions Advisor: PS Virk

Hot wire anemometry to probe aqueous drag-reducing solutions. Compared heat transfer reduction to drag reduction.

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