Services
End-to-end product development, organized around the lifecycle.
Engage at any phase — from early user research through sustaining support after launch — or bring us in to connect the seams between phases where regulated-product programs typically stall.
Phase 1
User Research & Human-Centered Design
Workflow research, user needs, usability strategy, use-related risk, HFE planning and evidence — IEC 62366 integrated with the ISO 14971 risk file.
Phase 2
Ideation & Product Strategy
Opportunity framing, concept generation, product architecture, feasibility planning, and roadmap and tradeoff strategy across multi-program portfolios.
Phase 3
Design Engineering & Development
System architecture, mechanical/fluidic/optical design, requirements development, prototyping, and verification strategy — design controls integrated from day one.
Phase 4
Regulatory, Quality & Design Controls
Design-control planning, ISO 14971 risk management, DHF readiness, traceability, and submission-support strategy — across 21 CFR 820, Part 4, ISO 13485, and IEC 62366.
Phase 5
Manufacturing Transfer & Commercialization
DFM/DFA, supplier and process readiness, manufacturing handoff, launch-risk reduction, and scale-up support — in parallel with design controls.
Phase 6
Sustaining Engineering & Lifecycle Management
Complaint-driven investigations, design changes, CAPA support, cost reduction, and post-market product improvements — without regressing on regulatory posture.
Productized engagements
Common Ways We Engage
Most engagements start as one of these focused, productized scopes — short enough to deliver a defensible answer, long enough to do real work. Custom and longer-running engagements follow from the same starting point.
Product Discovery Sprint
For teams that need to clarify user needs, workflows, product opportunities, and concept direction.
Concept-to-Architecture Sprint
For teams moving from idea to feasible product architecture, requirements, and development roadmap.
Design Controls Readiness Review
For teams approaching design freeze, verification, validation, or submission preparation.
HFE & Use-Related Risk Review
For teams needing stronger alignment between user research, usability evidence, risk management, and product design.
Manufacturing Transfer Readiness Review
For teams preparing to move from development into production, suppliers, assembly, test, or launch.
Sustaining Product Improvement Sprint
For launched products facing complaints, field issues, cost pressures, usability concerns, or design-change needs.
Not sure which phase fits?
Most first conversations start with a scoping call to map where the product is in the lifecycle, the decision in front of you, and the timeline you are working toward.