Duane Yamasaki Email & Phone Number

Santa Clara, California, Us

Early stage development of product requirements, for an electro-chemical immuno assay detection platform for the point of care market. Development of reader instrument and disposable test cartridge product and manufacturing process development.

Developing new bacterial moldecular diagnostic platform for the over the counter at home use. Developed and launched two NPI for Covid-19 FLU A and B over-the-counter at home molecular diagnostic platforms in 6 and 3 month time frames for Health Canada and under EUA for US. Developed and scaled up reagent, lyophilized pellet manufacturing process. Constantly developing and improving internal pilot device assembly manufacturing capabilities for multiple development assay platforms. Delivered a second set, quantity of 7, 16-cavity injection mold tooling doubling daily capacity. Additional responsibilities also included managing two sets of Automation programs; Semi-automation to supplement manual contract manufacturing processes and a full turnkey high volume internal program.

NPI for a Covid-19 POC molecular diagnostic platform. Developed the manufacturing process for the disposable cartridge during the design transfer process from the product design contractor to the outsourced high volume (1MM + /mo.) manufacturing contractor. Built a team of engineers to transfer design, develop and scale manufacturing process for the outsourced cartridge and reagent manufacturing. Regulatory strategy is an EUA submission. Also responsible for nstrument design transfer and manufacturing development to a high volume instrument manufacturing supplier.

Developed high through-put bench top DNA/RNA synthesizer. Responsible for all aspects of engineering and development of a bench top instrument. Proof of concept through prototype design development and working feasibility models. Identified contract development firms to construct working demo units. Responsible for software/firmware development. Participated with fundraising activities.

Develop integrated Lab on a chip bio-sensor. Utilizing CMOS technology for an immuno based diagnostic testing platform. Lead all engineering, product process development from research base inception at UC Berkeley's QB3 incubator through product/ manufacturing process development and acquisition .

Executive leader - formed engineering and operations teams leading Coagusense from start-up through successful clinical trials, FDA approval 2010, and commercial operations. .Scaling up manufacturing for commercialization from ground up.Hired and mentored all operations staff.Building high performance relationships with suppliers and CMOs.Direct responsibility for P and L

San Jose, Ca, Us

Lead Product development efforts of Ventus' (OTC Anti-Snoring Device). Sourced clinical CM through high Volume OEM CM. Reduced COGs by 71% from initial design to meet corporate margin target. Independently selected the prototype and contract manufacturing suppliers to support Venuts’ virtual company business model.

Developed manufacturing process for an implantable cervical disc replacement device and surgical tooling system. Product development included device DFM and proof of principle testing for assembly and fixturing for pilot and clinical manufacturing of devices. This included the development of a laser welding process and specifying and procuring a laser system for welding Titanium implant parts. Lead surgical instrument contract manufacturing development and packaging efforts. Assisted in defining new facility design requirements and build out.

Joined a nine person early stage start-up to develop Farallon Medical’s Immedia Prothrombin Time Monitoring system and disposable test strips. Refined and improved meter operation and efficiency of clot detection system and software algorithms. Manage contract engineering resources for meter Industrial Design and PCB design. Identified coordinated contract manufacturer for meter PCB fabrication. Managed outsourced injection molding of plastic meter components. Designed, developed and built strip reagent dispensing platform for manufacturing disposable strip.

Fremont, California, Us

Managed Production of Toxicology Materials for Combinational Pharma/Device delivery systems. Developed toxicology proof of concept models for 4 inhalable drug platforms. This includes active pharmaceutical ingredient (API) coating development, characterization, and equipment development. Prepare manufacturing section for IND submission. Commercial Product Development, responsibilities include product design for manufacturability and development of scalable manufacturing processes, for coating (API) and product assembly of energetic materials in a disposable inhalation drug delivery system. Contributed to the development of a multi-dose, disposable, inhalable drug delivery platform. Elements included process development for API coating, assembly, and packaging of the device.

Responsible for designing and developing a scaleable manufacturing process for TheraSense’s implantable continuous glucose sensor. Propelled project forward from lab models to working in-vivo clinical devices. Manage a group of process engineers and technicians. Setup and validated pilot manufacturing controlled environment room for preparing clinical materials on schedule. Designed, built and debugged proof of principal pilot equipment. Plan and execute capital budgets for program. Develop supplier’s capabilities in return for quality low cost components employing existing proven technologies. Wrote documents for the Manufacturing Module PMA submission.FreeStyle® Manufacturing- Developed and implemented second generation automated strip packaging line (Tripling capacity) up to 120 parts per minute. Managed contract machine builders (both domestically and in Europe) for labeling, cartoning, and case packing machinery. Machines delivered in 7 months from purchase order to floor.

Successfully delivered two assays for a partnership access program by implementing robust scalable technologies in the development of disposable plastic and film substrates for high-throughput screening assays. Designed and installed a controlled environment pilot manufacturing line for producing disposable plastic “lab on a chip” technology. Technical team development contributor for micro-fluidic dispense applications. Responsible for developing quality control testing, documentation and material control system.

Product and Manufacturing Process Development for Medical Devices and In-vitro Diagnostics. Developed manufacturing for 4 immunoassays Helping Start-ups finish.

Hercules, Ca, Us

Responsibilities include product/process feasibility studies, justification, development, design, and fabrication of automated production equipment for manufacturing, low cost Capillary Electrophoresis cartridge systems, HPLC columns and diagnostic reagents. Successfully scaled a five fold capacity increase in HPLC column manufacturing for 5 product lines of lab diagnostic instruments. Design, specify and commission injection mold tooling for low cost plastic assay preparation components. Automated bulk processes and QC assays and inspections. Implemented SPC to evaluate Clinical manufacturing processes. Support efforts for ISO 9001 Certification. Spearheaded quality improvements both internally and externally(suppliers) while reducing direct labor and material costs on existing manufacturing, bottling and packaging lines. Improved product quality and lowered cost by implementing SPC at supplier facilities.

Responsible for designing, developing, and building aseptic PLC controlled automated production equipment for manufacturing aseptically filled and packaged protein products. Responsibilities include design justification, procuring quotes, and overseeing the fabrication, installation qualification and validation of bioreactors, process vessels and automated filling and packaging machinery. Developed, scaled and optimized a protein lyophilization process for a gamma irradiated bone graft product. Developed a custom automated aseptic syringe filling machine for two product lines with multiple product configurations (12 fold increases in capacity over existing line). Developed a Collagen protein Homogenizer increasing capacity from 600K to 1.2 Million ccs/year. Wrote documentation supporting PMA and 510 applications.