Visible Genetics (VGI) was a mid-sized biotech company that developed novel diagnostic instruments supporting HIV, HepC, and HepB treatments. VGI’s flagship product utilized DNA sequencing techniques to identify resistance of the HIV virus to treatment regimens, allowing physicians to fine-tune management of the disease. Bayer Diagnostics is a major player in the biotech and chemical sectors with a worldwide presence. Bayer Diagnostics acquired Visible Genetics in 2002.
Based on my reputation for excellence in software management, my mandate at VGI was to improve the organization of the software development team and raise standards so that VGI could successfully pass FDA scrutiny as part of VGI’s 510(k) submission. At the time, the software team was missing certain essential functions and process disciplines. I was also the key representative for the department during the FDA audit, which we passed.
With VGI approvals allowing worldwide sales of these pharmacogenomic products, Bayer Diagnostics became interested in acquiring VGI to enhance its molecular diagnostics skills and to extend its product offering. I represented VGI during the due diligence negotiations with Bayer Diagnostics.
My role as VP/General Manager at Bayer was expanded to include all of their molecular diagnostic activities in North America. The challenges of the new role included maintenance of the standards required by the FDA, integrating Bayer and VGI teams and processes, and managing regular meetings with the FDA when our products were upgraded every six months.
VGI: Senior Software Director/General Manager/VP of Engineering
I was originally brought on to help a generalist software team become competent in mastering the software development lifecycle. I was promoted to General Manager/VP of Engineering, where additional responsibilities included mechanical engineering, software, optical systems, quality project management, sales and marketing and two manufacturing plants.
Bayer Diagnostics: General Manager/VP Engineering
Bayer acquired VGI and I was one of the key leaders responsible for integrating the VGI and Bayer organizations post-acquisition. My management scope expanded to include responsibility for Bayer’s existing molecular diagnostics products and their development teams in San Francisco.
My work at VGI was not only key to achieving FDA approvals but contributed significantly to increased productivity and effectiveness of the entire organization, which paid off in the successful acquisition by Bayer Diagnostics.
Bayer recognized my contributions by expanding my responsibilities as a senior executive in their organization. Overall, my management responsibilities during this period grew from six software developers to over two hundred staff that provided business analysis, software and hardware development (both Toronto and San Francisco), QA, manufacturing at three sites, and sales/marketing.
The final structure of the functions under my management was comparable to any of the first-class engineering organizations worldwide, all governed by well-organized documentation such as policies, procedures, work-flow processes, and technical manuals.