Jan Krouwer has over 30 years of experience in the medical diagnostics industry. For most of the time that Jan was at Bayer Diagnostics and its previously acquired companies of Chiron Diagnostics, Ciba Corning, and Corning Medical, he was the Executive Director of the Evaluations and Reliability Department, an internal consulting group that he created and staffed. Before that Jan was at Technicon Instruments. He has a Ph.D. in synthetic organic chemistry from M.I.T. and a postdoc in enzymology from New England Medical Center.
He specializes in solving problems in project delays and in quality. He focuses on modeling, data analysis, reliability, and software tools. His web site is http://KrouwerConsulting.com
Some highlights of Dr. Krouwer’s work in industry
Ranking what’s important – experience using decision analysis based financial modeling (worked with Strategic Decisions Group). Responsible for decision analysis software at Chiron Diagnostics and has trained and facilitated project valuations.
Predicting when it will be done – data driven techniques to estimate project completion (see publication)
Deciding what should be done – developed many of the performance and reliability specifications used in Chiron Diagnostics using his experience in statistics, reliability, and marketing research.
Designing robust products – experience in the following techniques
Design of experiments – cause and effect diagrams, error modeling, flow charting, screening, factorial, and response surface methods
Reliability – started a reliability initiative with key hires and later practiced these techniques himself, which were adapted from the defense industry and include: Fault Tree and FMECAs, FRACAS, reliability growth management.
Knowing how to get it done – took Peter Block’s course on consulting and devoted part of an R&D strategy on implementation techniques.
Evaluating if it’s good enough – developed many of the procedures used to evaluate products and has published widely in this area. Multifactor protocols, based on work by Cuthbert Daniel, is an example that reduces the number of runs needed to evaluate product performance. Four PMAs were submitted and approved under his management as well as numerous 510ks. Recently, approval was granted for a waiver assay for a client, submitted using the FDA draft guidance for waiver applications.
Efficient data analysis using software – data analysis tools using Excel VBA, visual basic.net, and SAS.
Knowledge Transfer – in-houses courses in statistics, reliability, and others such as how to write a report that will be read.