About Gary w. kuroki, ph.d.

I’ve had the opportunity to learn from some amazing successes and as well as trying disappointments in bringing new clinical diagnostics products to market. I am committed to translating that experience into helping companies plan, execute and navigate a sustainable path to revenue.

I have more than 20 years of IVD marketing expertise working with large, small and startup companies. I have provided marketing leadership for 5 global product launches and managed product portfolios in excess of $300 MM. Product management areas of expertise include fully automated platforms, consumables, reagent kits and software.

I am proficient with all product management and marketing responsibilities from concept through launch including product obsolescence strategies. I am experienced with the design control process, defining voice-of-customer, development of business and marketing plans, product launch planning and implementation, portfolio strategy development, competitive analysis, and OEM partner collaborations

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Career highights

Entrepreneurship

Co-founder, Chief Product Officer, Miraplex Diagnostics.

Miraplex Diagnostics is developing fully automated, rapid ELISA-based technologies. The Miraplex Diagnostic System system will deliver central lab assay performance in a multi-analyte format and is an enabling technology from point of-care to the central lab.
Primary responsibilities include business plan development (market assessment and product positioning, portfolio analysis and product road map, competitive intelligence, milestone planning), market research, investor deck development, PI on SBIR-STTR grant applications.

Founder and Principal Consultant, Kuroki Consulting.

Kuroki Consulting provides comprehensive clinical diagnostics business and marketing services. Specializing in early-phase start-up companies, as well as life-cycle management support for established companies from concept through launch, post-launch and obsolescence. Services include: Customer Requirements, Business Plan Development, Portfolio Assessment and Strategy, Life Cycle Management, Milestone Planning.

Strategic Leadership:

Supported management efforts to transition Singulex from a start-up to mature company through culture change; active role in transitioning from a development driven company to a market driven company.
Provided marketing leadership from product concept through launch for 4 global IVD products.
Identified and quantified key product portfolio gap; lead ad hoc committee to build awareness and drive formal project implementation.
Identified and directed strategic investment decision to ensure consumables quality and quantity.
Championed instrument allocation project that was required due to the inability to fulfill orders. One year allocation period with no lost sales or customers.
Certified Master Mentor for Thermo Fisher Practical Process Improvement program.

Upstream and Downstream Marketing

Represented voice-of-customer to the organization by authoring Customer Requirements for 5 product development projects.
Worked with ad agency to create de novo product positioning, imagery, and define product brand platform.
Out bound marketing responsibilities included sales tools, sales training, webinars, marketing collateral, KOL events, trade shows, competitive intelligence, forecasting, budget planning and management.
Over 2,000 cobas® AmpliPrep/TaqMan® Real Time PCR systems placed during role as product manager.
Achieved 2011 launch revenue stretch goal for CMV IVD reagent sales.

Global Product Launches

Successfully managed five global product launches in IVD (FDA, CE, MHLW) and basic research markets. Products included high sensitivity Singulex Clarity system, Singulex Clarity C. diff. assay, cobas AmpliPrep/TaqMan CMV assay, cobas p630 pre-analytical system, cobas AmpliPrep/TaqMan Real Time PCR system, Solaris 530 automated combinatorial chemistry workstation.

Revenue Responsibilities

Managed $25 million herpes product portfolio.
Managed $300 million cobas Ampliprep/TaqMan instrument portfolio.
Managed $50 million consumables product line.
Full P&L responsibilities for $50 million ABI PRISM® 310 Genetic Analyzer product line.

Teamwork

Experienced leading and working within highly matrixed international teams. Strong communication skills, highly organized, adept at multi-tasking and working in a fast-paced environment. Experienced managing from a position of influence and building collaborative relationships.

Product Life Cycle Management

Identify market opportunities, develop business cases, create customer requirements, engage development teams on critical trade-off decisions, managed product life cycle activities from concept through launch and post-launch support, product line extension, and product obsolescence strategies.