Consulting Services

Concept and DesignFinding solutions and giving them form
PrototypingTesting and refining designs
Contract Manufacturer SelectionIdentifying, qualifying, and contracting your best partner
Design and Development Plan (DDP)Defining delivereables and responsibilities
Product Requirements and SpecificationDefining the observable traits required for product success
Risk AnalysesIdentifying and mitigating risk of product harm
Manufacturing Process DevelopmentBuilding reliability for building your product
Quality Management SystemQMS and SOPs customized to company size and compliance goals
Design Verification and Test MethodsMeasuring how well your product meets its requirements
Laboratory and Inventory Management SystemsSetting up your research team for success
In Vivo Test ProgrammingIdentifying animal models and sample sizes with the least harm and least expense
Design ReviewsGuiding the development process at critical junctures
Usability TestingProving the product works in a real-life setting
PackagingProtecting your product, in style
Anatomical Test ModelsRepresenting the intended use
FDA PresubmissionsRepresenting the intended use
Pre-Clinical
Trial DesignOutlining robust, but pragmatic study conditions
Feasibility StudiesEarly human use assessments to inform device iteration
Methodology DevelopmentDialing in instructions and assessments
Statistical PlanningBalancing study power and sub-groups with economy
User Training ProceduresSetting up investigators for standardized success
User Training ModelsSimulating product use before first-in-patient
CRO SelectionIdentifying, negotiating, and contracting our best partner
Site SelectionIdentifying excited investigators and qualiifying their facilities
CRF DesignBuilding CRFs that are informative, but not cumbersome
GCP ComplianceEnsuring patient protection and data quality control
Informed Consent Form DesignCommunicating the risks and benefits with simplicity
Investigator's BrochureCommunicating the science and risk mitigation
IRB ManagementGetting and maintaining ethics board approvals
IDE, IND, and BLA ApplicationsGetting the FDA on board
Product WorkflowsIdentifying best practices
Part 11 Electronic System ComplianceProtecting your data
Scientific WritingPreparing research publications and grant applications
Clinical
Market ResearchQuantifying your TAM, SAM, and SOM
Market SurveysCollecting data to back your market capture claims
Competitive AnalysesRevealing strengths and weaknesses of similar products
Portfolio StrategyIdentifying the new products and adaptations most likely to grow your success
510(k) ApplicationGetting the FDA on board
KOL AdboardsCollecting expert feedback and support
Supply Chain and Cold ChainProtecting your data
Manufacturing Scale-UpOptimizing costs
P&LProjecting sales growth against expenses over time
Revenue ModelingFinding the best strategies for generating capital
Clinical MarketingCommunicating the research to drive adoption
KOL Outreach and EngagementFinding your champions
Promotional MaterialsCommunicating accurately and beautifully
Claims and LabelingCommunicating accurately and legally
Intellectual PropertyWriting and prosecuting patents to protect your tech
Reimbursement StrategyCommunicating your plans for coverage and adoption
Commercial
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