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
Documentation supporting regulatory communications and submissions (e.g. FDA 510K, 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
Adaptive Biotechnologies Corporation, Seattle WA, USA
AI Analysis, Inc., Seattle WA, USA (as Washington Innovation Network Mentor)
Bill and Melinda Gates Foundation, Global Development- Integrated Delivery, Seattle WA, USA
Bill and Melinda Gates Foundation, Global Health-Vaccine Development, Seattle WA, USA
Cepheid Inc., Sunnyvale CA, USA (sub-contracted)
Dot Laboratories, Inc., San Francisco CA, USA
ERBA Molecular, Ely, Cambridgeshire, UK (Scientific Advisory Board Member)
Hewlett Packard, Palo Alto CA, USA
Intellectual Ventures’ Global Good Fund, Bellevue WA, USA
Omic, Inc. Seattle WA, USA (as Washington Innovation Network Mentor)
QuantuMDx Group Limited, Newcastle upon Tyne, UK (sub-contracted)
The J. David Gladstone Institutes, San Francisco CA, USA