Engineering & DFM / DFA
Design for manufacturability and assembly to optimize performance, risk and cost.
MedTech development & manufacturing
From Prototype to Technical Evidence, Manufacturing Readiness and Scale
We help early-stage MedTech teams bridge the gap between prototype and a manufacturable, documented product — so they can move forward with confidence.
Our capabilities
End-to-End Co-development for MedTech Innovation
Prototype / Low- & Medium-Volume Manufacturing
Prototype, pilot and repeatable low- to medium-volume production through internal and partner capabilities.
Testing & Quality Documentation
Inspection, test planning, traceability, build records and evidence that supports technical readiness.
Supply Chain & Specialized Partners
Curated access to specialized suppliers, tooling, materials, electronics and technical services.
Program Management
Cross-functional coordination of requirements, risks, milestones, suppliers and technical execution.
Technology Transfer Preparation
Prepare technical knowledge, process history and documentation for transition to qualified manufacturing partners.
Quality & readiness
Built for Quality. Ready for What’s Next.
We are building a disciplined quality foundation from day one so projects can progress with stronger traceability, control and confidence.
✓
ISO 9001Certification pathway — In Progress
✓
ISO 13485Certification pathway — In Progress
- Traceability from development through delivery
- Disciplined builds, inspection and test records
- Low- and medium-volume manufacturing pathways
- Supplier quality and technical coordination
- Risk-based decision making
- Continuous-improvement culture
Our process
A Proven 5-Step Journey
1
Discover & Define
Align on goals, requirements, risks and success metrics.
2
Design & Develop
Iterate through engineering, prototyping and manufacturability.
3
Validate & Document
Generate technical evidence, inspection results and project records.
4
Prepare & Produce
Build with quality systems for pilot, low- and medium-volume manufacturing.
5
Transfer & Scale
Prepare a smooth handoff into the right long-term manufacturing environment.
Representative work
Example Program Types
Illustrative, anonymized examples based on the types of MedTech programs CRAFT supports.
Patient-facing device
Therapeutic / Supportive-Care Device
Prototype refinement, supplier coordination, materials processing, inspection, functional testing and documented pilot builds.
Surgical technology
Precision Surgical Instrument
Manufacturing strategy, cost optimization, packaging and sterilization planning, and readiness for clinical use.
Portable medical system
Low-Cost Clinical Equipment
Validation-partner coordination, design-history support, quality documentation and regional manufacturing assessment.
Industrialization
Medical Device Manufacturing Transfer
Process knowledge capture, supplier development, build documentation and transfer preparation for qualified CM/CDMO partners.
Client identities, institutions, clinical partners and confidential project details are intentionally omitted.
Our ecosystem
Why Costa Rica for MedTech Innovation
Strategic Location
Nearshore to the U.S. with strong logistics and connectivity.
Engineering Talent
Experienced technical talent with strong medical-device exposure.
Bilingual Workforce
English-Spanish collaboration for international programs.
Time-Zone Alignment
Real-time collaboration with North American teams.
Supplier Access
Established manufacturing and specialized supplier ecosystem.
Leadership
Experienced Leaders. Hands-On. Results Driven.
BO
Business & Operations Leadership
Experience across medical-device engineering, NPI, manufacturing operations, project leadership and business execution.
TI
Technical & Innovation Leadership
Experience across medical-device innovation, R&D, product development, clinical innovation and manufacturing readiness.
Let’s Build What’s Next in MedTech.
Partner with CRAFT to move your innovation forward — faster, with less fragmentation, and built for scale.