NU Product Development

Product Development

Contract design and engineering for hardware products, from requirements through transfer to manufacturing.

At a glance

Disciplines: Industrial design, mechanical engineering, electrical engineering, embedded software, human factors
Sectors: Medical and life science, industrial, consumer
Engagements: Whole program, team augmentation, program recovery
Structure: Four phases, each quoted separately
Ownership: Client owns design files, source code, test data and tooling
Contact: [email protected]

1Scope of work

Discipline	Work performed	Tools and methods
	Use case definition, requirements capture, user research, feasibility studies, cost modelling, regulatory pathway mapping	Field interviews, contextual inquiry, competitive teardown
	Concept sketches, appearance models, colour, material and finish specification, surface models for tooling, packaging	Sketch, foam and printed models
	Enclosures, mechanisms, thermal and structural analysis, tolerance analysis, ingress, drop and vibration design, drawings	SolidWorks, Creo, ASME Y14.5
	System architecture, schematic capture, PCB layout, power and battery systems, analogue front ends, wireless, EMC pre-compliance	Altium, KiCad, BLE, Wi-Fi, LTE-M, LoRa
	Drivers and board support, control and signal processing, connectivity, secure boot, over-the-air update, hardware-in-the-loop tests	Bare metal, Zephyr, FreeRTOS, embedded Linux
	Task and use-error analysis, formative studies, summative validation, instructions for use	IEC 62366-1
	Works-like and looks-like prototypes, test fixtures, verification protocols and reports, failure analysis	In house: 3D printing, bench-made PCBs, manual machine shop, electronics bench. Partners: cast urethane, soft tooling, short-run PCBA
	Vendor selection, design for manufacture and assembly, tooling review, pilot builds, work instructions, test procedures, transfer package	Contract manufacturer on-site support

2Engagement types

: Requirements through production transfer. One point of contact.
: One or more disciplines working within the client's team.
: Assessment and completion of a stalled design or a failed test.

3Process

Phase	Purpose	Outputs	Typical duration
	Define the use case and requirements.	Use case definition, requirements, user research summary, cost model, go or no-go recommendation	4 to 8 weeks
	Select an architecture and reduce technical risk on the bench.	Concept studies, system architecture, bench test results, cost model, program plan	8 to 12 weeks
	Detailed design, built and tested in iterations.	Design files, alpha and beta prototypes, verification reports, design freeze	3 to 9 months
	Transfer the design to manufacturing.	Tooling, pilot builds, line support, transfer package	3 to 6 months

Each phase is quoted separately, with stated deliverables and price.
The client decides whether to proceed at the end of each phase.
Durations are typical and depend on scope.

Design controls: 21 CFR 820, ISO 13485
Risk management: ISO 14971
Usability engineering: IEC 62366-1
Electrical safety and EMC: IEC 60601, IEC 61010, CE, FCC
Quality system: The client's, or NU procedures
Records kept: Requirements, design reviews, test reports with raw data, bill of materials with second sources, change log

The client owns design files, source code, test data, tooling and vendor relationships.
A non-disclosure agreement is signed on request before information is shared.
Work samples are available on request.
Enquiries are answered within two working days.

6Contact

State what is being built and its current status. A few sentences is sufficient. [email protected]