| Consulting
Services for the Medical Device Industry |
| ENGINEERING |
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Does the competition seem to have better ideas than your company? Well, it probably is not the idea mill that may be failing you. Whether ideas come by the basketful or simply trickle in, companies often don't need a better mousetrap ... just a better understanding how to design, develop and build the mousetraps already in the pipeline. If you fail to understand the underlying chemical, mechanical, biological and physiological systems under which a medical device must perform, your devices will come up short. The time to avoid problems is before a product hits the market. We don't have to elaborate on the affect field problems and failures can have on your sales efforts. An FDA recall can devastate a market share! Don't rely on your customers to tell you what's wrong; allow us to let you arrive in style! NOTE: To review our
consulting plans and how we work, please go to the "Consulting" page. |
With 25 years of device world
experience we have learned more than just a few tricks!
| Our specialty areas are | |
 | Antiseptic coatings for catheters and many other devices - including developing new antiseptic systems |
| Hydrophilic and hydrophilic / antiseptic coatings for both slippery and non-slip applications |
| Adhesive systems for assembling a wide variety of materials |
| Ultrahigh purity water systems - specifications, design, construction, startup, validation |
| Engineering design of medical devices from concept through market release, including FDA regulatory approval. The list includes but is certainly not limited to every type of catheter, catheter accessories, syringes of all types, spring wire guides both coated and uncoated, needles, drapes, drug dispensing vehicles, fluid drainage systems, tissue repair both skin and internal organ, stents, artificial valves. |
| Cleaning solutions and systems for metal and plastic parts - for both bulk washing in large machines and cleaning at the assembly station |
| Setting all of the performance and QC specifications for medical devices |
| Developing and instituting manufacturing processes and procedures for devices |
 | A few examples of successes over the years. These accomplishments, of course, include some projects prior to the formation of the consulting services company. Most current projects either have secrecy still in force or cannot be divulged due to the desire of clients to not reveal work done. We treat secrecy as a sacred trust! |
| Developed and introduced the world's first antimicrobial coated catheter: from analysis of the original technology to development and implementation of all research, pilot plant, physical/biocompatibility testing, manufacturing processes, all documentation, personnel training and product market release - in short, the entire project from inception to market, including the FDA. Furthermore, this catheter was the only catheter in the world for 8 years and currently outsells the competition by more than 10 times. By all accounts I am the only one in the entire world to have brought one of these puppies through from start to finish - and by myself! |
| Developed and successfully applied an antiseptic coating to surgical needles in under seven weeks |
| Created and implemented several slippery-when-wet hydrophilic coatings, including one that delivers 90% of the friction reduction in the dry state as it does when fully hydrated and has no perceptible tacky transition stage. This latter coating is currently used on over ten million devices annually |
| Formulated and developed a device coating that held its slippery state for two minutes to allow ample time for positioning and insertion |
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Within four weeks created, developed and implemented a specialty coating for various metals that was both durable and physically appealing. This "one-size-fits-all" coating could be hydrophilically treated to be slippery or treated to carry drugs for varying purposes without changing the base coating |
| Determined and wrote the complete manufacturing processes for applying antimicrobial coatings, heparin coatings and slippery coatings to single-lumen and multi-lumen catheters - many still in operation after 15 years |
| Designed, developed and implemented solvent cleaning systems to remove dirt, grease and ink smudges from medical parts without damaging the device material |
| Within two days, designed, developed and implemented solvent cleaning systems to remove part printing ink from rubber ink pads during operation, without affecting print integrity or printing pad performance - still used across a wide variety of printing operations |
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Designed, specified all components for, supervised construction for and trained all personnel on several ultrahigh purity water systems for parts washing. All systems deliver quality better than Water for Injection (WFI), including one system capable of producing 10,000 gallons/day of bacteria-free water with <0.125 EU of endotoxin and operating unchanged since 1987! |
| Specified and instituted the use of a variety of materials of construction for a wide variety of devices - catheters, point-of-use radioisotope reaction chambers, housings, hubs, spring wire guides |
| Developed and instituted adhesive systems to bond a wide range of materials - PEEK, nylon, polyurethane, ABS, PVC, polyethylene, polypropylene, glass, acrylics |
| Established and wrote the complete specifications packages for literally dozens of devices - including manufacturing, performance and QC specifications |
| Developed and implemented the coating and full manufacturing process for and obtained complete regulatory approval for a unique shrink-tube coated epidural catheter that has been in the marketplace for nearly 20 years |
The
list goes on, but you get the idea! We generated a solid background in advising
on or the direct development of scores of medical devices.
Experience does count, and our record of successes can work for you!
Copyright © 2003 Consulting Services for the Medical Device Industry