Product Development

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

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

The proposal is signed.Now watch it get built.

Client portal New

Your whole job, live, in one place.

Every client gets a login. Read and accept the proposal there, then follow each phase against what was quoted: no status meetings, no digging through email.

  • Each phase: quoted amount and time, planned and actual dates, percent complete, invoiced to date
  • Clear to proceed: a yes or no for the next phase, with what is outstanding
  • Issues that need an answer, change requests with cost and schedule impact, support tickets
  • Deliverables, client-supplied items and a full event log

1Scope of work

DisciplineWork performedTools and methods
Use case definition, requirements capture, user research, feasibility studies, cost modelling, regulatory pathway mappingField interviews, contextual inquiry, competitive teardown
Concept sketches, appearance models, colour, material and finish specification, surface models for tooling, packagingSketch, foam and printed models
Enclosures, mechanisms, thermal and structural analysis, tolerance analysis, ingress, drop and vibration design, drawingsSolidWorks, Creo, ASME Y14.5
System architecture, schematic capture, PCB layout, power and battery systems, analogue front ends, wireless, EMC pre-complianceAltium, 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 testsBare metal, Zephyr, FreeRTOS, embedded Linux
Task and use-error analysis, formative studies, summative validation, instructions for useIEC 62366-1
Works-like and looks-like prototypes, test fixtures, verification protocols and reports, failure analysisIn 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 packageContract 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

PhasePurposeOutputsTypical duration
Define the use case and requirements.Use case definition, requirements, user research summary, cost model, go or no-go recommendation4 to 8 weeks
Select an architecture and reduce technical risk on the bench.Concept studies, system architecture, bench test results, cost model, program plan8 to 12 weeks
Detailed design, built and tested in iterations.Design files, alpha and beta prototypes, verification reports, design freeze3 to 9 months
Transfer the design to manufacturing.Tooling, pilot builds, line support, transfer package3 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. info@nuproduct.dev