Ronald Citron
Telephone: 610-916-2949
E-mail: clientservice@devicedesignfda.com

Professional Summary: 
Exceptionally experienced expert with a strong understanding and application of FDA and ISO 10993 biocompatibility requirements, including analysis and evaluation of results and writing accurate reports. Strong understanding of animal and human clinical studies and capable of special and unique test designs. Strong in-depth knowledge and application of cGMPs and GLPs and FDA regulatory requirements. Experience and strong expertise in all aspects of the research, development, manufacture and testing of disposable medical devices. Exceptional knowledge of sterilization processes and material compatibility.
 
Work History:  
Independent Consultant: Medical Devices/OTC Products, Reading, PA June, 1998 – Present
Some of my clients include Cardinal Health, Ansell Healthcare Products Enable Injections, Flowonix, CR Bard, Precision Medical Products, Algorex Pharmaceuticals, NET Recovery Corp, Horizon Medical, Flowonix Medical, US Surgical.

1. Completed six-month consulting contract with Cardinal Health that was extended twice to 11 months doing Biological Evaluation Plans (BEP) and Biocompatibility Risk Assessment (BRA), MDR Section II. Efforts focus on ISO 10993 and FDA biocompatibility, biocompatibility gap remediation and Private Label biocompatibility evaluation. Reports and analyses span across a variety of medical devices including drapes, gowns, enteric feeding, gloves, electrodes, syringes, needles, catheters, lung suction tubes, leg compression devices, etc.
2. Position as part of my consulting: Columbia University, consulting from 2009 to present. Consulting includes developing process for antimicrobial treatment of dialysis catheters; advised on biocompatibility and safety of numerous materials used in medical device development; advised on FDA and EPA regulations for client companies; advised on sterilization of a broad range of products under development for client companies
3. Position as part of my consulting and simultaneous with Columbia: VSP Technologies, Inc., Vice President of Research & Development, 1996 – 2018; developed a large number of OTC antimicrobial soaps, scrubs and gels using my knowledge of chemistry, emulsions and antimicrobial systems; accomplished the packaging and sterilization of anti-irritant and skin protectant products; advised on biocompatibility issues and safety of all ingredients; instituted cGMPs and GLP testing

• Continued determining FDA and ISO 10993 biocompatibility test requirements for clients as a consultant, including requisitioning tests and analyzing the data. Work also includes determining the appropriateness of data acquired from client’s previous personnel
• Continued working on combination devices that have been regulated as drugs – one as an NDA and one as a BLA. My work guided the device component
• Continued advising and testing antimicrobial devices for clients, including catheters, surgical needles, examination/surgical gloves, and other devices
• Worked on development of a large number of OTC antimicrobial soaps, scrubs and gels using my knowledge of chemistry, emulsions and antimicrobial systems
• Wrote more than a dozen scientific technical bulletins in support of new and unique antiseptic and anti-allergy OTC products for presentation before hospital purchasing agents and department head physicians. In addition, designed and wrote numerous PowerPoint presentations covering technical topics on anti-allergy and antiseptic products. The presentations and bulletins successfully sold the products in question
• Sole auditor evaluating four companies for compliance with FDA regulations and capabilities in developing and processing medical devices
• Helped clients sterilize a wide variety of medical devices and OTC products

 
Arrow International, Inc., Reading, PA                                            January, 1983 – June, 1998
Corporate Manager of Materials Test Laboratory/Senior Research Engineer

• New products developed and product improvements accounted for 50% of the company’s gross profit by the time leaving to become a consultant
• Established and solely operated and controlled entire corporate wide FDA and ISO 10993 biocompatibility program, including evaluating the results and writing all reports for the FDA and TUV (Notified Body)
• Totally responsible for every aspect of the design, development, testing, clinical evaluation and 510(K) release of the World's first antimicrobial medical device that represented 50% of company’s total annual profit three years after its release
• Established the standard by which the FDA approves the use of chlorhexidine on antimicrobial combination devices. Acceptance and use of chlorhexidine is based on my work, including animal and human clinical testing and biocompatibility studies
• Ran over 1,500 animal in vivo and in vitro tests. Testing and evaluation included a dozen biocompatibility and safety tests of my special design
• Evaluated and analyzed toxicology testing results on materials and devices and wrote reports on the findings that determined go/no go decisions for management
• Designed, wrote the comprehensive protocol and requisitioned special animal clinical studies to determine the safety and efficacy of novel medical devices and wrote the CER (Clinical Evaluation Report)
• Used animal clinical test data to write an IB (Investigator’s Brochure) presented to the hospital’s HRB in support of the human clinical trial
• Directly obtained five 510(K)s and successfully prevented two other unique one-of-a-kind devices from being regulated as a PMA
• Designed and completely oversaw building corporate world wide analytical test laboratory and determined all dry chemistry and wet chemistry analytical test equipment. Set up the equipment and all maintenance and calibration procedures
• Designed, procured all materials for and installed 5 high purity water systems, including a 10,000 gal/day RO/DI/UF system which supplies water of quality less than 1/2 water-for-injection, while effecting current cost savings of $280,000/year.
• Wrote numerous SOPs and IFUs for invasive medical devices and numerous operations manuals following cGMP regulations for maintenance and manufacturing equipment and processing, including validation SOPs.
• Developed and applied a unique slippery hydrophilic catheter coating currently applied to over 20 million catheter and sheath introducer units/year.  Coating exhibits remarkably low coefficient of friction wet or dry and does not pass through the tacky phase intrinsic to hydrogels

CR Bard, Inc., Murray Hill, NJ                                                    October, 1981 – January, 1983
Research Engineer

• Developed special antimicrobial system to reduce infections from urine collection bags
• Solved sterilization problem in urinary catheter packs
• Determined over $2 million savings by cleaning and chemically recovering liquid Freon

 
Hydromer, Inc., Whitehouse, NJ                                                   October, 1978 – October, 1981
Research Scientist                                      

• Designed and built enteric feeding tube coating and curing manufacturing process
• Solved numerous internal company coating problems associated with flagship product
• Designed and completely oversaw building corporate analytical test laboratory including setup and installation of wet chemistry testing equipment

 
Over-The-Counter (OTC) and Personal Care Product Development:
Columbia University and VSP Technologies

• My own company was an OTC registered company from 2003 through 2012 during which time the company had five registered OTC products it developed including skin protectant, antimicrobial skin creams and special performance ointments

• Developed a unique special performance ointment base that allows the release of a drug while maintaining primary hydrophobic behavior.

This ointment has the unique property where it thickens with sweat instead of being displaced and is easily washed off using a mild soap.

• Developed a therapeutic, true wound-healing skin cream; market application would require an NDA. Field testing has shown healing effectiveness nearly twice that of polysporin and mupirocin products.

This cream fits the OTC Monograph as a skin protectant and was sold using skin protectant claims, but performs as a true therapeutic skin care cream – softening and immediately soothing irritated and compromised skin, reducing redness, eliminating flaking.

• Co-developed an anti-allergy cream and gel that prevents latex allergies. Was being sold as Allergy Guard® Skin Protectant cream.
• Developed a unique skin cream base that is fully compatible with a broad range of cationic and non-ionic antiseptic ingredients.
• Developed three all-natural (Ecocert approved ingredients) skin treatment products: skin lightening, skin eruption treatment, full body skin softening lotion. All-natural and botanical are now the main focus of product development across the world, especially Asiam Europe and North America, and I am ahead of the R&D curve.

The focus of the all natural space is the use of only ingredients that have approval of Ecocert, IONC and ICEA approval bodies. These products meet the requirements spreading across Europe and North America for all natural personal care products from renewable sources.
 
Patents:     
U.S Patent 8,932,624; Co-inventor; Bio-film resistant surfaces
Patent Application 20090029961; Bio-Film resistant Surfaces
Patent Application 20140178447; Reduction of Biofilms on Medical devices
Patent Application 20150118275; Bio-Film Resistant Surfaces
Patent Application 20170368234; Bio-Film Resistant Surfaces
 
Education: 
MS, Chemical Engineering, University of Iowa, Iowa City, Iowa
BS, Chemical Engineering, University of Massachusetts Lowell, Lowell, MA
 
Qualifications:

• Exceptional knowledge of FDA and ISO 10993 biocompatibility testing, material safety testing and infection control
• Fully capable of full analyses of biocompatibility testing and understanding how test data applies to acceptance/rejection criteria for medical devices under test
• Full understanding of biocompatibility Biological Evaluation Reports and biocompatibility gap remediation
• Fully capable of running of both Animal Clinical Testing and Human Clinical Testing of medical devices, including establishing HRB review, setting protocols, establishing data collection and evaluation and writing comprehensive IBs and CERs
• Comprehensive and practical understanding and application of cGMPs, GLPs and FDA regulations and requirements
• Strong and comprehensive knowledge of the development, processing and application of nearly all polymers currently in use. Knowledge includes molding, extrusion, solvent effects, bonding techniques, surface preparations, surface alterations
• Strong and comprehensive knowledge of materials of construction, including metals and a broad range of plastics and rubbers
• Exceptional knowledge in materials/solvents interactions, including environmental impact on materials
• Exceptionally capable of technical writing and its application to developing clear, concise and understandable documentation