Services · Phase 2
Ideation and product strategy for medical devices and combination products.
Translate user needs into product concepts, architecture options, and a development path the rest of the program can build on — with regulatory, manufacturing, and lifecycle realities in scope from the start.
When teams call us in
- A promising concept needs to become a feasible product architecture.
- A platform decision is approaching and the team needs structured architecture options before committing.
- Two adjacent programs are diverging when they should be converging — and a platform-consolidation decision is overdue.
- An R&D portfolio has multiple opportunities and a roadmap and tradeoff strategy is needed to allocate limited capacity.
How we approach it
- Anchor on the user need and the decision being made — not on the technology in front of you.
- Generate multiple concepts, then narrow with explicit feasibility, regulatory, and manufacturing tests.
- Architecture before optimization — the right system topology makes the rest of engineering cheap.
- Tie product strategy to commercial reality — manufacturing scale, regulatory burden, sustaining cost — not just the prototype.
Typical deliverables
- Opportunity framing and prioritization memo.
- Concept generation and downselect record.
- Product architecture and trade studies.
- Feasibility and risk plan tied to the development roadmap.
- Capacity and tradeoff strategy across a multi-program portfolio.
- Stage-gate readiness package for early development phase entry.
Frequently asked questions
- Where in the lifecycle does ideation engagement typically start?
- Most often after early user research has surfaced a need and before substantial engineering work has been committed. We engage to translate insight into multiple product concepts, evaluate them against feasibility, regulatory, and manufacturing realities, and converge on a defensible architecture and development path.
- How does product strategy connect to design controls?
- We treat the architecture decision as the entry point into design controls, not separate from it. The product concept and architecture become the seed of the design inputs, the high-level risk analysis, and the verification strategy. That way the development team starts on a defensible footing instead of retrofitting design controls onto a frozen architecture.
- Do you do feasibility prototyping?
- Yes — at the level needed to retire architecture risk. Breadboards, alpha prototypes, and bench rigs that test the specific feasibility questions that would block development if wrong. We do not run large prototype builds at this phase; the goal is to inform the architecture decision, not to skip ahead into engineering.
- Can you support platform consolidation across multiple programs?
- Yes. The principals have led platform consolidation that aligned 100+ contributors on a single next-generation system and avoided ~$80M in duplicate development cost. We bring structured architecture trade studies, capacity and tradeoff strategy across a multi-program portfolio, and the governance to land an actual platform decision.
Moving from concept to architecture?
Engagements typically start with a scoping call to clarify the decision in front of you and the timeline you are working toward.