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Technologies and Products

  • We support diagnostic products based on different technologies (e.g. molecular, immunology, artificial intelligence, next generation sequencing, etc.) on various platforms and formats (e.g. rapid diagnostic tests (RDT), point of care (POC), high throughput testing, etc.).

  • We advise on tests and ancillary devices intended for “in house” use, or distributed as research use only (RUO), investigational use (IUO), or in vitro diagnostics (IVDs), either as CLIA or CLIA waived.

Consulting AREAS

Strategic Advisory

  • Provide best practices for diagnostics product development

  • Plan overall product development, delineating key milestones, activities, and timelines

  • Create strategies to accelerate development and commercialization

  • Estimate resources and budgets

Diagnostics Product Development and Manufacturing Processes

  • Technology assessment and its application to product concepts

  • Evaluation of customer needs and their translation into product requirements

  • Feasibility studies and reports

  • Design control documentation

  • Phase review documentation

  • Documentation to support design transfer to manufacturing (stability program and protocols, quality and manufacturing specifications, etc.)

  • Design verification study plans, protocols and reports

Clinical and Regulatory Support

  • Clinical intended use definition

  • Pre-clinical exploratory studies (biomarker selection, algorithm development, etc.)

  • Pivotal clinical trial design, clinical science

  • Regulatory Strategy

  • Documentation supporting regulatory communications and submissions (e.g. FDA 510(k), deNovo, IND, BLA, PMA, WHO-PQ)

  • Presentations to regulatory agencies

Marketing Scientific and Technical Assistance

  • Scientific and Medical Affairs studies supporting clinical utility, reimbursement and product introductions in developed and developing (Global Health) markets

  • Interactions with KOLs

  • Publications

Client Focus

  • Innovators and start-up companies that wish to move technologies and ideas into products

  • Diagnostics companies with work overflow requiring extra hands to meet deadlines, or help in approaching new markets (e.g. Global Health)

  • Pharma and Vaccine organizations lacking diagnostics expertise to support their clinical development efforts

  • Investors and VC doing due diligence in diagnostics

  • Consulting companies in other areas (e.g. marketing, regulatory) requiring overall diagnostics expertise for certain projects

Previous Clients

  • 3D Medicines Biomedical Technologies Inc., Fremont CA

  • Adaptive Biotechnologies Corporation, Seattle WA

  • Atila BioSystems, Inc. Mountain View, CA

  • Bill and Melinda Gates Foundation, Global Development-Integrated Delivery and Global Health-Vaccine Development, Seattle WA

  • Cepheid Inc., Sunnyvale CA (sub-contracted)

  • Dot Laboratories, Inc., San Francisco CA

  • ERBA Molecular, Ely, Cambridgeshire, UK (Scientific Advisory Board Member)

  • Hewlett Packard, Palo Alto CA

  • Intellectual Ventures’ Global Good Fund, Bellevue WA

  • Intus Biosciences LLC, Farmington CT

  • Mann Global Health, LLC, Columbus NC

  • NDA Partners, a ProPharma Company, Washington DC and their clients (FDA-CDRH, MelMont, Rhythm, Caris, etc.)

  • PandiaDx LLC, Frisco TX and their clients (MicroGEM, FluroTech LLC, MSK, TeamedON, etc.)

  • QuantuMDx Group Limited, Newcastle upon Tyne, UK (sub-contracted)

  • The J. David Gladstone Institutes, San Francisco CA

  • The Weinberg Group LLC, a ProPharma Company and their clients (Charite, Excelera Health; Sermonix Pharmaceuticals, LLC; Biosplice Therapeutics;  Aditxt, Inc.; SMi-Drug Discovery; VolitionRx Limited)

  • Watmind USA, Jackson MS