SECTOR

Medical

Our medical work spans Class I, Class II, and Class III device programmes, and diagnostic hardware for clinical settings and home use.

The DESIGN CHALLENGE

Sharper thinking. Better devices.

Safety, manufacturability and time to market can all stop medical devices reaching the patients who need them, whose margin for error is often smaller than most.

Medical devices rarely fail because of one bad design decision. They fail because a material chosen for biocompatibility turns out to affect a tolerance under sterilisation, or a manufacturing shortcut quietly reopens a risk control signed off under ISO 14971 months earlier. Every decision touches another, so your design team needs to be across the full picture.

SDW works as the engineering and design function within your programme, structured around your regulatory framework and quality management system, and feeding directly into your technical file. We bring strategic thinking, technical rigour and creativity to every programme to solve problems and get your product to market faster

Clients in this sector include:

application areas

Proven delivery across three areas of medical devices & hardware.

Our team delivers industrial design, mechanical engineering, electronics and embedded firmware across every stage, with full traceability and no gaps in accountability across the development record. We’re ISO 9001 certified, and have delivered within MDR-governed programmes, working alongside clients who own regulatory and quality management responsibility. Every medical engagement is structured this way, from initial opportunity exploration through to transfer to manufacture.

Patient-worn and implantable devices

Active and passive devices where weight budget, sealing strategy, material selection and fatigue performance sit within a single risk management file that governs every design decision. We define validation and verification protocols at requirements capture, not retrofit them later.

Medical devices

Class I, Class II and Class III hardware for clinical settings and home use, built on a single programme structure spanning mechanical, electronics and firmware. We generate HFE evidence as part of the design process, not as a downstream activity.

Healthcare-adjacent hardware

Precision instrumentation that sits at the boundary of clinical and scientific excellence, held to the same engineering discipline applied across regulated device programmes. We resolve measurement integrity, form factor and environmental specification as a single set of connected decisions.

A snapshot of our work

Blatchford

Avior, a microprocessor-controlled prosthetic knee housed in a lightweight, IP65-rated enclosure with sealed controls and magnetic charging.

SkinSafe

A handheld, non-intrusive scanning device allowing users to monitor their skin for the early warning signs of melanoma.

RELEVANT CAPABILITIES

The disciplines behind smarter medical product design.

Industrial design and human factors

Form, ergonomics and usability engineering developed to IEC 62366 standards. We generate human factors evidence as part of the design programme, structured for your technical file.

Mechanical engineering

Structural and mechanism design, tolerancing, materials selection, sealing, human factors and verification testing, each carried out with the technical rigour that your regulated products demand.

Electronics and embedded firmware

Full-stack electronics and embedded firmware for diagnostic, monitoring and connected medical hardware. We develop it within the same team as the mechanical engineering programme.

Transfer to Manufacture

Design for Manufacture and Design for Assembly addressed from the scoping stage. We resolve production cost, assembly complexity and supplier risk before design freeze, and plan transfer to manufacture from the outset.