Now in a brand new 30,000 sq. ft. facility. Same trusted service, greater capacity to support your next breakthrough.
Medical Device Design Transfer & DFM
Translate design intent into controlled, repeatable manufacturing.
Sonele reviews your design package, identifies and resolves manufacturability risks, and establishes the documentation, methods and controls required for production.
Let’s move your design forward.
Design transfer is one of the most critical and most mismanaged steps in the medical device development process. When development and manufacturing happen in separate places, engineering intent gets lost, timelines slip, and costly rework becomes the norm. During this handoff, the context, decisions, and engineering knowledge built up over months of development don’t always make it to the other side.
At Sonele, the design transfer process is handled by the same team that will manufacture your device, under one roof and within one quality system. That continuity means fewer surprises, faster process validation, and a cleaner path to production.
A better design transfer partner
Design transfer and design for manufacturability (DFM) are managed as one coordinated process, connecting the available design information with the requirements of controlled production.
Design package review
Sonele reviews product requirements, specifications, drawings, CAD files, BOMs, risk management documentation, verification and validation records, supplier information, and existing assembly, inspection, and test documentation.
DFM assessment and recommendations
Materials, components, tolerances, assembly methods, tooling, inspection, testing and sourcing are assessed for manufacturability, repeatability and production suitability. Sonele recommends changes to simplify production, reduce process variability and address scale-up risks.
Collaborative issue resolution
Our engineers work with your team or design partner to resolve incomplete information and identified manufacturing risks. Approved recommendations are incorporated through controlled design and change processes.
Manufacturing process development
Sonele develops the assembly methods, tooling, fixtures, inspection and test procedures, work instructions and process controls required for consistent production.
Validation and production readiness
Suppliers, equipment, tooling, capacity and process controls are evaluated before production. Initial builds and validation activities confirm that the process can meet established requirements. Sonele develops and executes IQ, OQ and PQ when required.
Design transfer for complex medical devices
Some devices require more than converting drawings into work instructions. Sonele supports regulated products where design intent, precision requirements, assembly, inspection, testing and process control must remain closely aligned.
Engineering continuity
When Sonele develops your device, the engineers involved remain engaged through design transfer and manufacturing setup, preserving the technical knowledge behind key decisions.
Transfer of externally developed devices
Sonele also supports devices developed by customer teams and outside design firms. We identify missing or unresolved information and lead the work required to prepare the device for manufacturing.
Custom tooling and test development
Our team develops the fixtures, assembly aids, inspection methods and test systems required to support controlled, repeatable production.
Complex device experience
Sonele supports ultrasound systems, electromechanical assemblies, diagnostic devices, wearables and other technically demanding medical devices requiring close coordination across engineering, quality and manufacturing.
A direct path into pilot and commercial production
In a well-executed transition, design transfer leads directly into production. Sonele carries the approved design and manufacturing processes into initial builds, validation, scale-up, and ongoing production.
Our manufacturing support includes:
- Engineering, pilot, and validation builds
- Process validation and production controls
- Supply chain and supplier management
- Controlled assembly, inspection, and testing
- Commercial ramp-up and repeat manufacturing
Frequently asked questions
Medical device design transfer is the final phase of the design and development process, where approved design outputs are correctly translated into production specifications, manufacturing specifications, assembly drawings, test methods, and controlled production processes.
Medical device companies should start planning for design transfer before the design phase is complete. Early planning helps the manufacturing team identify gaps in design documentation, manufacturing equipment, supply chain readiness, and production processes before they create delays.
ISO 13485 requires medical device manufacturers to maintain procedures for design and development transfer, helping ensure design outputs are verified, documented, and translated into production processes that meet regulatory standards and quality management system requirements.
Yes, when required. Sonele supports process validation activities such as IQ, OQ, and PQ to help confirm that manufacturing processes are repeatable, controlled, and aligned with regulatory requirements.
A successful design transfer is really a reflection of how well the design process was managed. When your design history file, risk management documentation, and development outputs are accurate and complete from the start, the transfer to manufacturing is faster, cleaner, and far less likely to require rework.
Contact Us
Ready to get your device production-ready?
A seamless design transfer starts here.
Fill out the form, and we will contact you within 3-5 days to get started on bringing your breakthrough technology to life.
