Medical device & combination product consulting
End-to-end product development for medical devices and combination products.
Hitmaker Engineering helps regulated-product teams move from early user needs and product concepts through engineering, design controls, manufacturing transfer, launch, and sustaining support.
We help teams clarify what to build, prove it can work, develop it rigorously, transfer it effectively, and sustain it after launch.
Support across the product lifecycle
Support Across the Product Lifecycle
We engage across the full path from research and ideation through launch and post-market — and at any single phase along the way.
Phase 1
User Research & Discovery
Identify user needs, workflows, pain points, and product opportunities.
Phase 2
Ideation & Concept Strategy
Translate needs into product concepts, architecture options, and development paths.
Phase 3
Design & Engineering
Develop mechanisms, systems, requirements, prototypes, and technical solutions.
Phase 4
Design Controls & Risk Management
Connect requirements, risks, verification, validation, usability, and regulatory evidence.
Phase 5
Manufacturing Transfer & Launch
Support DFM, process readiness, supplier alignment, launch planning, and commercialization.
Phase 6
Sustaining & Lifecycle Support
Address post-launch issues, design changes, complaints, cost reduction, and product improvements.
Track record
Product Development Experience Across Complex Regulated Programs
Representative outcomes from prior regulated-product leadership include:
- $60M+
- R&D budget responsibility on a Fortune 500 medical-device portfolio
- 100+
- cross-functional contributors aligned on a single combination-product platform
- $80M
- duplicate development cost avoided through platform consolidation
- $10M
- per-product savings through FDA combination-product strategy
- 150+
- user and system requirements structured for development execution
When teams call us
When Teams Call Hitmaker Engineering
We engage at the points in the lifecycle where product decisions cross functional boundaries — where user needs, engineering feasibility, regulatory expectations, manufacturing realities, and business goals all need to be reconciled.
- Early user research needs to become a clear product direction.
- A promising concept needs to become a feasible architecture.
- Requirements, risks, usability, and design controls need to connect.
- Engineering decisions are starting to affect regulatory, manufacturing, or launch risk.
- A product is approaching design freeze but the evidence package is not ready.
- Manufacturing transfer is exposing gaps in design, process, suppliers, or documentation.
- A launched product needs sustaining support, cost reduction, or post-market improvement.
Working on a medical device or combination product?
Engagements typically 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.