Baylis 100% Oxygen Accessory for the V4C-560 Ventilator

Baylis’s 100% oxygen accessory is a ventilator add-on designed to extend the oxygen delivery capability of the V4C-560, enabling clinicians to support more severe respiratory cases through an integrated enclosure, flow regulation, plenum, tubing, and manufacturing-transfer architecture built around an existing ventilator platform.

The Challenge:

Baylis engaged Inertia to help develop an accessory that could expand the oxygen delivery capability of an existing ventilator platform during a period of urgent clinical need. The goal was not to create a new ventilator from scratch, but to design and launch a physically coherent add-on system that could work with the V4C-560 and support delivery of up to 100% oxygen.

What made the challenge complex was that the accessory was not a single part. It was a system of interdependent components – including a flow regulator, plenum, manifold, tubing, mounting strategy, and enclosure – that had to integrate around an existing device without compromising usability or manufacturability.

Early work focused on how the accessory should be packaged, mounted, and organized around the ventilator. As the program moved forward, the challenge expanded into manufacturing transfer: design-for-manufacture refinement, tooling coordination, production validation, documentation, and change management all had to be carried through launch without losing the original product intent.

The Approach:

Inertia supported Baylis across both concept development and manufacturing launch. On the front end, the team worked from Baylis’s supplied specifications, BOM, and CAD data to refine the accessory architecture and develop enclosure concepts around the core oxygen-delivery components. Multiple concept directions were explored to resolve packaging, portability, mounting, and tubing-management questions and to define a more coherent physical relationship between the accessory and the base ventilator.

As the project progressed, Inertia’s role extended into project and technical leadership for manufacturing transfer and launch. This included DFM and DFA review with manufacturing partners, management of tool build and tool trials, oversight of engineering changes, and development of launch-phase quality documentation.

Inertia also supported component approval through IQ/OQ/PQ, FMEA, and FAI documentation, while coordinating fixture-related work, schedule management, and weekly reporting to keep technical, manufacturing, and quality streams aligned through build and launch.

The Outcome:

The result was a more complete path from urgent functional requirement to production-oriented accessory program. Baylis moved from early architectural and enclosure exploration into a more structured launch process that addressed not only how the oxygen accessory should function and integrate, but how it would be transferred into manufacturing and controlled through validation.

The system achieved:

A defined accessory architecture for integrating oxygen-delivery components around the existing ventilator platform
Concept directions exploring enclosure, mounting, portability, and tubing-management strategies
DFM/DFA refinement with manufacturing partners before and during tooling

Technical oversight through tool build, tool trials, and launch activities
Structured change management and launch documentation, including PFMEA, FAI, and IQ/OQ/PQ support
Alignment of design, manufacturing, and quality activities through production preparation

By extending the work beyond concept development into manufacturing transfer and launch leadership, Inertia helped Baylis turn an urgent oxygen-delivery requirement into a more credible, buildable accessory program organized for production reality.

Services Provided

Concept Development & Validation

Requirements Definition

Technology Feasibility

User Needs Development

System Architecture

Assumption Validation

Concept Prototyping

R&D

Industrial Design

Mechanical Design

User Interface Design

Quality Management

Requirements & Risk Management

Verification & Validation

Design For Manufacturing

Low Volume Manufacturing & Pilot Builds

Manufacturing Transfer & Launch

Supply Chain Management

Precision Fabrication & Assembly

Value Engineering

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