Preview
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.

Work With Us → Explore Capabilities →
Idea / Prototype
Development
Technical Evidence
Manufacturing Readiness
Transfer / Scale
Our capabilities

End-to-End Co-development for MedTech Innovation

Engineering & DFM / DFA

Design for manufacturability and assembly to optimize performance, risk and cost.

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.

Schedule a Discovery Call →
CRAFT
Need-driven medical device development

Every device starts as a need. We make sure it does not end there.

CRAFT takes validated clinical needs from prototype to a documented, manufacturable product — built in Costa Rica, with cost treated as a design requirement from the beginning.

Tell us about your device
Most development shops start when you hand them a drawing. We start earlier — with whether the need is real — and stay until the device can be made responsibly.
Why CRAFT exists
We exist to turn validated clinical needs into devices that can actually be built — so that where a person is born stops deciding what care they can receive.
We start with the clinical need, not with a specification handed to us.
We treat cost as an engineering constraint, not a procurement conversation at the end.
We prefer evidence, traceability and careful execution over adjectives and promises.
The discipline starts before the drawing
A clear need statement should survive independently of any proposed solution.
PopulationWho is experiencing the problem?
ProblemWhat must become meaningfully better?
OutcomeWhat measurable change would prove that it worked?
How we work

We start at the need.

A finished CAD file is not proof that the right problem is being solved. We pressure-test the need, the user, the cost target and the evidence required before those assumptions become expensive.

  • Start with the need.One problem, one population, one outcome. We ask the question even when the design already exists.
  • Cost is a design requirement.A device that works but cannot be afforded has not finished solving the need.
  • Small teams, deeply invested.We staff for depth of ownership and judgement, not for the appearance of headcount.
  • Evidence over assertion.Build records, test data, traceability and risk decisions carry more weight than marketing language.
  • Unreasonable care.We try to anticipate what the project and the people behind it will need before they have to ask.
What we do

We work alongside your team from the need through to a product that can be manufactured.

CRAFT is deliberately asset-light in this phase. Some work is performed directly; specialized capability is accessed through qualified partners. We describe that distinction plainly.

Co-development & research

Need validation, product definition, DFM/DFA, design iteration and technical programme leadership.

Fabrication

Prototype, pilot, low-volume and medium-volume manufacturing pathways through internal and partner capability.

Testing & documentation

Inspection, traceability, test evidence, build records and the documentation discipline needed for transfer.

Supply chain & transfer

Specialized supplier coordination, process knowledge capture and preparation for qualified CM/CDMO handoff.

Quality roadmap: formal ISO 9001 and ISO 13485 certification implementation is underway. We state that as a roadmap item, not as a certification already held.
Proof before promotion
Until a project can be named publicly, the method itself should be visible enough to inspect.
  • Need statementThe clinical problem and target outcome are explicit before solution choices harden.
  • Design rationaleTradeoffs, cost constraints and risk decisions are recorded rather than reconstructed later.
  • Build & inspection recordsPrototype and pilot work leaves a traceable technical history.
  • Test evidenceClaims are supported by appropriate verification, inspection or development testing.
  • Transfer contextSupplier knowledge, process history and open risks move with the device instead of being lost at handoff.
The people

The credibility engine is the team, not the capability list.

CRAFT is being built by people who have spent their careers inside medical-device development, industrialisation and manufacturing.

CF

César Fuentes-Ortega

Technical & Innovation Lead
26 issued U.S. patents · 85+ total filings · Stanford Biodesign Fellow · senior R&D leadership experience.
Product-development and innovation leadership across major medical-device environments. CRAFT brings that need-driven discipline closer to the teams that usually cannot access it early enough.
FM

Fabián Murillo

Business & Operations Lead
Medical-device engineering · NPI · manufacturing operations · project and business execution.
Experience translating engineering work into controlled execution across manufacturing, transfer and operations. CRAFT joins that industrial discipline with an earlier, need-driven product-development model.
Building in Costa Rica is not a discount story.
Access, by design

It changes the arithmetic of what can be built.

Costa Rica combines a dense medical-device manufacturing corridor, trained technical talent, supplier infrastructure, regulatory literacy and North American time-zone alignment.

That matters because affordability is easier to protect when it is treated as a design constraint from the start — without giving up the engineering and quality discipline the device requires.

Medical-device manufacturing ecosystem
Specialized supplier access
Experienced engineering workforce
Bilingual collaboration
U.S. time-zone alignment
Nearshore logistics
Start a conversation

Tell us about your device.

The first questions are the same ones we would ask in the room: what need are you solving, and where does the project stand today?

What clinical or user need are you trying to solve?One problem. One population. One outcome.
Where is the project today?Concept, prototype, verification, pilot, transfer — or somewhere in between.
What is currently blocking the next milestone?Engineering, evidence, suppliers, cost, manufacturing, documentation or something else.
Preview only: the live intake form will be connected once the corporate email/contact workflow is active.
CRAFT
Need-driven medical device development

Every device starts as a need. We make sure it does not end there.

CRAFT takes validated clinical needs from prototype to a documented, manufacturable product — built in Costa Rica, with cost treated as a design requirement from the beginning.

Tell us about your device
Most development shops start when you hand them a drawing. We start earlier — with whether the need is real — and stay until the device can be made responsibly.
Why CRAFT exists
We exist to turn validated clinical needs into devices that can actually be built — so that where a person is born stops deciding what care they can receive.
We start with the clinical need, not with a specification handed to us.
We treat cost as an engineering constraint, not a procurement conversation at the end.
We prefer evidence, traceability and careful execution over adjectives and promises.
The discipline starts before the drawing
A clear need statement should survive independently of any proposed solution.
PopulationWho is experiencing the problem?
ProblemWhat must become meaningfully better?
OutcomeWhat measurable change would prove that it worked?
How we work

We start at the need.

A finished CAD file is not proof that the right problem is being solved. We pressure-test the need, the user, the cost target and the evidence required before those assumptions become expensive.

  • Start with the need.One problem, one population, one outcome. We ask the question even when the design already exists.
  • Cost is a design requirement.A device that works but cannot be afforded has not finished solving the need.
  • Small teams, deeply invested.We staff for depth of ownership and judgement, not for the appearance of headcount.
  • Evidence over assertion.Build records, test data, traceability and risk decisions carry more weight than marketing language.
  • Unreasonable care.We try to anticipate what the project and the people behind it will need before they have to ask.
What we do

We work alongside your team from the need through to a product that can be manufactured.

CRAFT is deliberately asset-light in this phase. Some work is performed directly; specialized capability is accessed through qualified partners. We describe that distinction plainly.

Co-development & research

Need validation, product definition, DFM/DFA, design iteration and technical programme leadership.

Fabrication

Prototype, pilot, low-volume and medium-volume manufacturing pathways through internal and partner capability.

Testing & documentation

Inspection, traceability, test evidence, build records and the documentation discipline needed for transfer.

Supply chain & transfer

Specialized supplier coordination, process knowledge capture and preparation for qualified CM/CDMO handoff.

Quality roadmap: formal ISO 9001 and ISO 13485 certification implementation is underway. We state that as a roadmap item, not as a certification already held.
Proof before promotion
Until a project can be named publicly, the method itself should be visible enough to inspect.
  • Need statementThe clinical problem and target outcome are explicit before solution choices harden.
  • Design rationaleTradeoffs, cost constraints and risk decisions are recorded rather than reconstructed later.
  • Build & inspection recordsPrototype and pilot work leaves a traceable technical history.
  • Test evidenceClaims are supported by appropriate verification, inspection or development testing.
  • Transfer contextSupplier knowledge, process history and open risks move with the device instead of being lost at handoff.
The people

The credibility engine is the team, not the capability list.

CRAFT is being built by people who have spent their careers inside medical-device development, industrialisation and manufacturing.

CF

César Fuentes-Ortega

Technical & Innovation Lead
26 issued U.S. patents · 85+ total filings · Stanford Biodesign Fellow · senior R&D leadership experience.
Product-development and innovation leadership across major medical-device environments. CRAFT brings that need-driven discipline closer to the teams that usually cannot access it early enough.
FM

Fabián Murillo

Business & Operations Lead
Medical-device engineering · NPI · manufacturing operations · project and business execution.
Experience translating engineering work into controlled execution across manufacturing, transfer and operations. CRAFT joins that industrial discipline with an earlier, need-driven product-development model.
Building in Costa Rica is not a discount story.
Access, by design

It changes the arithmetic of what can be built.

Costa Rica combines a dense medical-device manufacturing corridor, trained technical talent, supplier infrastructure, regulatory literacy and North American time-zone alignment.

That matters because affordability is easier to protect when it is treated as a design constraint from the start — without giving up the engineering and quality discipline the device requires.

Medical-device manufacturing ecosystem
Specialized supplier access
Experienced engineering workforce
Bilingual collaboration
U.S. time-zone alignment
Nearshore logistics
Start a conversation

Tell us about your device.

The first questions are the same ones we would ask in the room: what need are you solving, and where does the project stand today?

What clinical or user need are you trying to solve?One problem. One population. One outcome.
Where is the project today?Concept, prototype, verification, pilot, transfer — or somewhere in between.
What is currently blocking the next milestone?Engineering, evidence, suppliers, cost, manufacturing, documentation or something else.
Preview only: the live intake form will be connected once the corporate email/contact workflow is active.