This is our Chief of Staff ...

No friend to the Chief of Staph!

Who are we? The "we" is a me ... Ronald Citron ... the head of this company along with a few very technically strong friends in high places --- namely, they live upstairs.. Experience has taught me that a problem is defined by the company it keeps. Far too many people believe that yesterday's solution should work today. Why not? The two problems seem to be the same ... so why wouldn't they be solved the same way?

I've worked for big companies and little companies ... in R&D and in manufacturing. I've brought products all the way from conception through the final product ... through the regulatory process and into the doctor's hands. Problems may be similar, but in my 32 years of experience I've never met a problem and its identical twin - maybe its doppelganger, but never it's twin! In the assault on infections, the old solutions simply do not work.

Experienced in Problem Solving:

After years and years of experience with poor consulting, two guiding principles were forged into my personality: (1) when doing a job make sure that I do everything possible to get the correct answer, never losing sight that my client is the most important person in my professional life and (2) charge a fair price for the work done but never - and I repeat, never - charge for mistakes that I make. These guiding principles have given me satisfaction and success and I see no reason to change this late in my life.

My years and years of experience have also allowed me to develop a choice list of associates who can help in critical areas, should my personal resources be unduly challenged.

The problems I have solved have included designing special tests for both device biocompatibility and even material/device performance ... developing unique coatings applications including slippery hydrophilic and antiseptic coatings (both types currently on the market) ... new materials development ... reducing ethylene oxide residuals ... identifying the sources of and eliminating pyrogens ... designing large-scale ultrahigh purity water systems (outputting over 4,000 gallons per day) ... developing specially tailored cleaning processes for sensitive materials ... developing a number of antiseptic device systems ... obtaining rapid FDA 510(K) approval for one-of-a-kind devices, avoiding PMA designation ... correcting static electricity conditions in clean room production areas.

No problem has ever proved too knotty for me! I even obtained the 510(K) approval for the world’s first marketed antiseptically coated invasive catheter. No one else got one approved, but I did! Furthermore, I prevented classification as a drug.

Formed My Own Company:

With over 32 years experience in industry and over 26 of those in medical devices, I charged out of industry - out from under the protective umbrella of a boss - and immediately set up a company that had absolutely nothing to do with medical devices! But, read on!

This company, Therasoft® Luxury Products, thrust me into the world of Over-The-Counter (OTC) and personal care products. In fact, Therasoft® Luxury Products is formally registered with the FDA as an OTC product manufacturer.

I happily developed a therapeutic skin cream and five OTC products registered with the FDA and listed in the Red Book. Separately, I developed a line of nonionic industrial cleaning products that both with and without antiseptic properties.

My OTC efforts have also included wound care, hospital infection abatement and the prevention of skin allergies caused by latex proteins and a variety of other irritants. These and related efforts have derived from my working relationship with researchers at Columbia University. I am currently under contract with Columbia University as a consultant.

Making it All Work in Device Consulting:

So what does all of the above have to do with my medical device consulting service? Absolutely everything!

Having tasted the free life of the entrepreneur - unencumbered by everything, except that there are only 24 hours in a day! - I refuse to go back to life on the inside. First, some old associates came to me to solve their problems. So I set up shop on the Internet and others have come a-calling! I love the challenges and have enthusiastically returned to the world of medical devices.

The challenges and rewards working with medical devices are many and the work is satisfying. Most of all, since going off on my own these past five years, I have discovered the joy of solving a wide variety of problems for clients giant and small, having worked on basic and specialty coatings development, process development, regulatory approval, device design.

Therasoft® Luxury Products will continue with its separate operation, but there is no turning back.

I love it out here ... and medical devices and I have an inextricable future until death do us part. If I have my way that death will not be due to a faulty device!

Copyright © 2004 Consulting Services for the Medical Device Industry

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