Dave Hasegawa, Vice President of Product Development
Contact Information:
- Phone:
- (831) 459-6476
- Email:
- d.hasegawa@bctech.com
“Sure, we can build products that meet specs and requirements. But to build an extraordinary product… you need immersion. So we take the time to learn how our client works, learn their business objectives, long term plans, and corporate culture… only then can we create a working relationship, and ultimately a product, that exceeds all of their expectations.”
—Dave Hasegawa
Dave Hasegawa
Dave’s goal at BC Tech is simple: to guarantee successful project outcomes. As our client liaison and advocate, Dave provides BC Tech Directors and Project Managers with the resources, expertise and direction they need to meet deadlines and create superior products.
Dave is an accomplished professional with more than 25 years experience leading engineering departments and managing R&D projects in the Biotech, Life Sciences and Medical markets. His experience with medical device development under design controls and implementation of Systems Engineering Process – development methodologies driven by continuous re-evaluation of product requirements and specifications – delivers products that are not only clinically successful, but maximally profitable.
- Companies:
- Novo Nordisk
- Aradigm Corporation
- Arcturus Engineering
- Behring Diagnostics, Inc.
- Syva
- Products:
- Automated Microtiter Systems
- Laboratory Automation and Robotics
- Liquid Handling Systems
- Clinical Diagnostic Systems
- Optical Detection
- Aerosol Drug Delivery Device
- Years of Experience:
- 25+ years in Development, Operations, and Management, with 20 years in Life Sciences, Biotech, and Medical
- Skills and Achievements:
- Experience in leadership and management of the development of systems involving the integration of industrial design, electronics, software, chemistry, biology, disposables, optics and mechanical subsystems.
- Expertise in medical device development in accordance with FDA QSR’s and ISO 13485.
- Experience in taking products from concept into feasibility, through development, into manufacturing and subsequent support; all in context of structured staged development process compliant with regulatory requirements.
- Experience in identification, evaluation, and assessment of new technologies with respect to the commercialization potential, and establishment of technology and development partnerships.
- Direct design experience for a variety systems, technologies, and markets; including robotic laboratory automation, optical detection systems, Biotech, Life Sciences and medical devices.
- Education:
- MS Mechanical Engineering w/ concentration in physiological fluid mechanics, UC Berkeley
- BS Engineering Science w/ concentration in bio-engineering, UC Berkeley, CA
- Company:
- Novo Nordisk / Aradigm
- Product:
- AERx®
No pain, no sharps – aerosolized insulin thought to be future of diabetic care
Since first announced in 2002, health care providers and investors eagerly anticipated Novo Nordisk’s groundbreaking aerosol insulin device – the AERx®. Dave was in the hot seat. As the Director of Device Development, Dave led a team of more than 65 in device design, system development, quality engineering and validation, aerosol technology and device manufacturing & operations. Dave launched a pilot manufacturing line to support Novo Nordisk’s large-scale clinical trials while simultaneously developing a second-generation device to improve drug delivery, manufacturability, size, cost and ease-of-use. The AERx® performed spectacularly in Class III trials.
- Company:
- Syva
- Product:
- MicroTrak™
The foundation of modern communicable-disease detection technology
Immunofuorescence technology, the marking and detection of antigens or antibodies with dyes, has been used since the 1960s to detect communicable diseases in fluid samples. Unfortunately, these tests were often expensive, sparsely available and of dubious quality. Dave and his team developed one of the first purpose built immunofluorescence stations – the Syva Microtrak™ - used for the detection of Chlamydia with a fluorescein-conjugated and a species specific monoclonal antibody.
- Company:
- Syva
- Product:
- ETS
A compact, fast and reliable drugs-of-abuse analyzer
The ETS measures drugs and other impurities in the urine and blood. With an ambitious schedule and modest budget, Syva trusted Dave and his team to initiate the development of a second generation system with features including full paneling, random access, batch capacity, real time results, and 50-80 tests per hour.
