Services
As an industry-leading global health expert, Tom partners with life science and biotech organizations to accelerate innovation, optimize development processes, and ensure successful product commercialization. He focuses on helping companies navigate the intricate journey of diagnostics product development—whether for rapid testing solutions, complex automated instruments, or full end-to-end product portfolios. By providing tailored strategies and actionable insights, Tom empowers organizations to overcome technical, regulatory, and market hurdles with confidence.
Exclusive Services
Strategic Consulting for Diagnostic Product Development and Launch
1
Product Development Management
Tom provides comprehensive guidance for product development from concept to commercialization. This includes:
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Overseeing product development phase/gates to ensure alignment with business objectives.
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Managing design transfer processes to facilitate a seamless transition from prototyping to full-scale manufacturing.
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Assessing manufacturing readiness to mitigate risks, improve efficiency, and meet quality standards.
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Implementing best practices to streamline timelines, reduce costs, and drive innovation at scale.
2
Clinical Strategy
Clinical studies are critical for proving product performance toward regulatory requirements and achieving successful market launch. Tom offers:
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Strategic design of clinical trial protocols to meet regulatory requirements and business objectives.
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Oversight and execution of studies to generate robust, reliable data for regulatory approvals.
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Alignment with global regulatory frameworks (FDA, CE-IVD, PQ approval, etc.) to expedite approvals and market entry.
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Comprehensive support to ensure products meet performance benchmarks and readiness milestones.
3
Go-to-Market Planning
A successful product launch requires a carefully orchestrated strategy. Tom helps organizations:
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Define target markets, user personas, and customer adoption pathways.
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Develop data-driven launch plans integrating marketing, sales, and distribution strategies.
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Identify key differentiators to position products as market leaders.
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Drive revenue generation through clear value propositions for healthcare professionals, payers, and end-users.
4
Project Leadership
Effective diagnostics development relies on seamless collaboration across functional teams. Tom provides:
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Strategic oversight to coordinate R&D, operations, regulatory, and commercial teams toward shared goals.
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Milestone-driven project management to keep timelines and budgets on track.
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Resource alignment to balance investments with business priorities, delivering efficient results.
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Proactive risk identification and resolution to maintain momentum and achieve successful outcomes.
Tom bridges the gap between innovation and commercialization, empowering diagnostic organizations to meet their business goals with confidence and clarity. Let’s collaborate to bring groundbreaking solutions to market—faster and smarter.