Operate a highly successful Independent consulting organization offering services in technical, regulatory and marketing disciplines in the medical devices industry and specializing in hematology and urinalysis. Human and veterinary diagnostic/device applications.

• Established a formal in-house Clinical Evaluations Laboratory that is Good Laboratory Practices (GLP) compliant. The success of the laboratory, using actual clinical samples, has proved vital in testing concepts, component designs and data gathering for regulatory submissions such as FDA 510(k) documents. The result has been a significant reduction in timelines and associated costs by performing hematology, microscopic, chemistry, and microbiology analyses versus engineering protocols.• Developed and presented various internal training sessions for technical and non-technical employees to provide physiologic, pathologic pathways and their significance for understanding the features and benefits of the company’s products for the end-users and patients. For the technical staff these sessions permitted more appropriate and effective component and product designs and user interfaces. Identified by senior management as having a unique talent for bridging technical, non-technical and clinical teams together.• Developed and executed detailed protocols for data gathering and reduction for internal studies and external medical center sites, resulting in successful completion of the studies within agreed upon timelines and budgets.• Wrote the clinical sections for successful FDA 510(k) submissions and timely clearances resulting in the elimination of additional costs and time associated with clearance delays. • The Clinical Evaluations Laboratory successfully participates in the College of American Pathologists (CAP) laboratory proficiency peer comparison program.

• Collaborated with the Vice President of Marketing to establish effective strategic and tactical global marketing plans resulting in best in class recognition by our distributors and senior management. • Organized interactive meetings with the sales force and international distributors to identify and prioritize their respective market needs leading to new product opportunities and provide solutions ascertained to be barriers to their success.• Developed and delivered influential clinical and product specific presentations to current and potential customers at domestic and international venues leading to increased product interest and sales.• Developed effective collateral pieces, internal and external communications to support the effectiveness and efficiencies of the company’s product line. Collateral pieces identified by the sales force as invaluable in the sales process and shortening successful closure time. The key here was listening to and responding to the needs of the sales force and eliminating their barriers to success.

• Organized and led the ISO implementation team representing all disciplines of the company to develop the necessary procedures, processes and documentation resulting in EN ISO 9001:1994, EN 46001:1996 and EN ISO 13485:2000 certifications allowing the company’s expansion into the international marketplace. • Oversaw the implementation of newly developed procedures, processes and documentation and conducted multiple internal audits to ensure compliance. This was vital for successful ISO certification.• Directed the company’s first FDA two-day, on-site facilities inspection to occur in seven years. Under my direction the company’s quality system was determined to be world-class by the FDA inspector on the first day and inspection was completed in one day. The inspection resulted in no observations and no 483 issued.• Provided support to the R&D effort by identifying over four million urine sediment digital images for the development of automated particle recognition (APR) algorithms which is used in our flagship product, the iQ200 Automated Urine Microscopy Analyzer.• Developed the protocols and managed the clinical studies leading to two successful FDA 510(k) submissions and clearances.

• Successfully formulated effective marketing plan resulting in substantial increase in system sales for the company’s legacy products. Designed sales presentation booklets providing illustrated product technical information and features & benefits.• Developed data reduction/summary templates for computer use by the Technical Specialists to present summary information to evaluators and new users following competitive studies and installation validation for new users.• Collaborated with Research & Development to bring a 10-year development project to market.

• Created and managed the implementation of a new image campaign resulting in increased awareness of the company’s products. Marketing success was instrumental in achieving sales revenues in excess of 300% over the previous two years.• Analyzed historic and current lead generation media and implemented successful new lead generation tactics increasing the number and quality of leads. This included organizing an in-house group of telemarketers to make cold calls, calls for lead follow-up and scheduling appointments for sales force. The sales force considered this service to be invaluable by pin-pointing qualified potential customers in which to direct their efforts.

• Demonstrated ability to manage P&L by overachieving sales and profit goals while controlling expenses below budget. Improved profits over 128% for the combined business units.• Each business unit required a complete understanding of its unique distribution channels. I developed distinctive sales plans and promotions to take advantage of product synergies – across business units - as well as successful, structured bonus plans for direct sales and distributors’ sales forces.• Provided strategies to meet customers’ needs as well as creating and managing the implementation of a new image campaign to raise awareness of the product brands through advertising, promotional pieces and convention properties. Identified a highly profitable niche market resulting in increased sales revenue and profits.

• Created and built the United States subsidiary for a foreign healthcare company, Société A.B.X. (France). • Worked closely with various local, State and Federal agencies to establish the fully operational U.S. subsidiary in less than six months, in cost-sensible facilities.• Constructed, organized and managed clinical investigations generating data to support FDA 510(k) submissions resulting in FDA clearance of the products.• Developed and implemented business policies, business and marketing plans.• Hired all employees, including the sales force.• Trained the sales force and worked closely with individual sales representatives to ensure early placement of products to establish key reference sites.• Instituted effective sales strategy sessions to guarantee appropriate accounts were identified, key decision makers recognized and called upon, the point-in-purchase cycle determined, availability of funds, and customers’ foremost needs were met.• Created and executed successful sales promotion and incentive programs and worked intensively in the field with sales representatives to ensure placement, revenue and profit goals were achieved.

Initially worked part-time covering emergency night-call and weekends covering the entire clinical laboratory. In subsequent years I reduced the time, while working fulltime in organizations listed above, to Saturday mornings and an occasional emergency night call. I maintained a professional association with this institution until my relocation to New York, in order to remain current with my laboratory skills and the trends and technology in clinical laboratory medicine.

Part-time position

Part-time position