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Medical Device Development: From Concept to Commercialization

Our development process starts with you. Whether you need a partner for one phase of development, or all phases from design through manufacturing, our team of experts can guide you every step of the way.

UFP MedTech is a full-service contract development and manufacturing organization (CDMO) for single-use and single-patient medical devices, sterile barrier packaging, infection-control solutions, and robotic drapes. From initial concept and feasibility through prototyping, design freeze, process validation, and high-volume commercial manufacturing, UFP MedTech supports the development lifecycle through ISO 13485 certified and FDA registered facilities. OEM partners get a single accountable partner – one team, one quality system, no handoffs – from first sketch to first commercial shipment.

We are Your Destination For:

Design Through Manufacturing

Design Expertise
Skilled Engineering
Material Selection
Rapid Prototyping
Full-Scale Production
Global & Nearshore Manufacturing

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Medical Devices & Components

Minimally Invasive Surgery
Infection Control
Surfaces & Support
Therapeutics
Wearables
Diagnostics

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Equipment
Drapes

Robotic-Assisted Surgical Systems
C-Arms
Microscopes
Probes
Cameras
Fluid Collection Pouches

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Sterile Barrier Packaging

Flexshield® TPU
EZ Card® HDPE Backer Cards
Dispenser Coils
Foams
Rigid Plastics
Protective Cases

Our Medical Device Development Process

UFP MedTech’s development process follows a structured stage-gate methodology: each phase has defined inputs, outputs, and control documentation aligned to ISO 13485 and FDA requirements. Whether a project begins at concept or joins the process at a later stage, UFP MedTech‘s engineering and quality teams engage where you are and scale their involvement to match your program’s needs.

Click the sections below to learn more about the different stages of our process.

: When a project begins with early-stage concept development, UFP MedTech starts with a structured feasibility assessment, to align device requirements, intended use, material options, and manufacturing considerations from the beginning. For OEMs that already have defined design inputs or validated concepts, our team can enter later in the process and focus development support where it is needed most.

Deliverables at this stage include: design inputs, preliminary material recommendations, and a feasibility report that aligns development expectations before resources are committed.

Outcome: A substantiated concept, material shortlist, and a clear development roadmap before a single prototype is cut.
: UFP MedTech’s prototyping capability spans the full range of single-use device constructions from barrier film assemblies and infection prevention to fluid management components and robotic drape systems.

Design for manufacture (DFM) input is built into every iteration so the design that reaches design freeze is already optimized for each business case need, both in capacity and cost, not retrofitted after the fact. Multiple design iterations are evaluated against defined design inputs, with traceability maintained throughout.

Outcome: A manufacturable, performance-validated design built for scale, not just for proof of concept.
: Design freeze marks the point at which the device design is formally controlled.

For OEM partners, this means entering validation with a complete, traceable documentation package, not scrambling to reconstruct design rationale under audit pressure.

Outcome: An audit-ready design history file (DHF) and a frozen design baseline ready for validation with no open design actions.
: Process validation at UFP MedTech begins with a risk-based master validation plan designed to support a robust, long-term production process. This plan guides IQ/OQ/PQ activities to confirm that equipment, processes, and production methods can consistently meet defined requirements.

Validation scope is defined at project outset and may include process risk assessment activities such as Process Failure Mode and Effects Analysis (PFMEA), process validation, material validation, device performance testing, sterilization validation, and package integrity testing, as applicable. When specialized testing is required, such as ISO 10993 biocompatibility testing, EtO, gamma, or e-beam sterilization validation, or package integrity testing, UFP works with qualified outside suppliers while maintaining responsibility for validating the materials, processes, and manufacturing approach used for the customer’s product.

Validation outputs are documented and incorporated into the appropriate project records, including the DHF as applicable.

Outcome: Validated manufacturing processes that satisfy FDA and ISO requirements with documentation ready for technical file submission.
: Commercial manufacturing at UFP MedTech follows a scale-up plan defined at project launch, helping ensure the move from validation to production is managed through the same quality system and development framework.

Scale-up is supported by a formal production readiness process with defined milestones, required qualification activities, first article inspection, and production readiness review before first shipment. OEM partners retain full traceability from design freeze through every production batch.

Outcome: First commercial shipment on a validated, fully traceable production line with no re-qualification and no supplier change.

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Why OEMs Choose UFP MedTech for Medical Device Development

• Single-Source Accountability: One ISO 13485-certified partner from concept through commercial production. No handoffs. No re-qualification. No quality system gaps between development and manufacturing.

• Engineering Depth at the Front End: UFP MedTech’s engineering team works alongside OEM product leads from feasibility, providing DFM input, material recommendations, and design control documentation throughout each phase of the process.

• Specialist in Single-Use & Sterile Barrier Devices: Deep expertise in single-use assemblies, single-patient devices, sterile barrier packaging, and robotic drapes, the specific constructions where barrier performance, biocompatibility, and sterilization validation matter most.

• Design Controls Built In: Design history files, design inputs and outputs, verification and validation protocols are built in from day one.

• Scalable from Prototype to High Volume: Proven manufacturing capability across our manufacturing facilities with the process validation and production controls to support up to a Class III device programs at commercial scale.

Resources

Employees collaborating over a design in a development lab

Article

The Competitive Advantage of Development Labs in Prototyping Before Manufacturing at Scale

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Article

Maximizing The Relationship With Your Contract Development and Manufacturing Organization

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Capabilities

Discover UFP's wide range of medical device manufacturing capabilities.

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Frequently Asked Questions

: UFP MedTech supports the full medical device development lifecycle: concept and feasibility, prototyping and design iteration, design freeze and documentation, validation and testing, and scale-up to commercial manufacturing. All stages are managed under a single ISO 13485-certified quality system with no supplier handoffs.
: Yes. UFP MedTech operates under an ISO 13485-certified quality management system covering the full development and manufacturing lifecycle including design controls aligned to FDA 21 CFR Part 820. Documentation, validation protocols, and traceability recordds are maintained from project initiation through commercial production.
: Yes. UFP MedTech’s design-through-manufacturing model is structured for full-lifecycle engagement from initial feasibility and prototyping through design freeze, process validation, and commercial-scale production. There are no supplier handoffs, no re-qualification stages, and no quality system transitions between development and manufacturing.
: UFP MedTech helps compile and support the maintenance of the customer’s design history file (DHF) throughout development[LS8.1], covering design inputs and outputs, design reviews, verification and validation records, risk management documentation, and change control records all aligned to ISO 13485 and FDA 21 CFR Part 820, design control requirements.
: UFP MedTech specializes in single-use medical devices, single-patient devices, sterile barrier packaging, and robotic drapes. We support Class I–III device programs across infection control, surgical, and procedural markets, from early-stage prototyping through validated, high-volume contract manufacturing.

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Whether you need a partner for one phase of development, or all phases from concept through manufacturing, our team of experts can guide you every step of the way.

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