Services
Three functional areas, applied together or independently
Engineering execution, market strategy, and corporate development for technology start-ups building physical products in medical device and other regulated industries.
Engineering
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ENG.01
Requirements Definition (clinical endpoints, usability targets)
Design Inputs · 21 CFR 820.30(c)
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ENG.02
Specification Development (material & component through finished goods)
Design Outputs · 21 CFR 820.30(d)
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ENG.03
Risk Management
ISO 14971
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ENG.04
Process Design
Specializing in Medical Implant Delivery Systems
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ENG.05
Design Verification and Validation
ISO 13485 · 21 CFR 820.30
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ENG.06
Design Transfer
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ENG.07
Equipment and Process Qualification
IQ / OQ / PQ
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ENG.08
Standard Operating Procedures (SOP) Implementation
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ENG.09
Process Monitoring and Control
Including Sampling Plans ANSI/ASQ Z1.4
Market Strategy
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MKT.01
Customer Discovery
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MKT.02
Voice of Customer (VOC) Programs
Structured Interviews & Surveys
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MKT.03
Needs Statement and Definition
Unmet Customer Needs · Includes Literature Research as Applicable
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MKT.04
Clinical Research
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MKT.05
Competitive Landscape
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MKT.06
Market Models
Sizing & Segmentation
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MKT.07
Regulatory and Reimbursement Considerations
Pathway and Coding/Payment/Coverage Screening
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MKT.08
Business Model Canvas Development
Early-Stage
Strategy & Corporate Development
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COR.01
Strategy Development
Mission, Vision, Core Focus Areas
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COR.02
Revenue Model
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COR.03
Financial Analysis
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COR.04
Target Sourcing and Screening
Fit & Feasibility Criteria
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COR.05
Investment Memos and Business Plans
Pre- and Post-Diligence Versions
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COR.06
Diligence Synthesis and Risk Framing
Technical, Market & Operational Findings
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COR.07
Valuation Support
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COR.08
Deal Structuring
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COR.09
Exit Strategy
