Name: Forme Technologies
Address: 11 Frankston Gardens Drive, Carrum Downs, Victoria, Australia 3201, Carrum Downs, Victoria, 3201, AU
Telephone: +613 9782 3033

+613 9782 3033

GET IN TOUCH

Case Study

FORME MANUFACTURING No-1

Surefl02
Medical Industry

Scope:
Using ISO 13485 guidelines, undertake the design, development and manufacture of a medical oxygen indicator flow device for use in applying oxygen to a patient.

Support processes:
Bio-Clean assembly environment.
In-house Phosphor bronze spring manufacturing.
QA Functionality testing.
Entire end-to-end from design, production through to packaging.
Performed within a clean environment.

THE PROBLEM

Leading Melbourne anaesthetist, Dr Matthew Matusik, identified a potential risk for patients undergoing surgical procedures requiring supplementary oxygen therapy – especially frail or at-risk patients. Dr Matusik had studied the well documented global cases of patients in theatre suffering from hypoxemia (low blood oxygen) due to an oxygen supply blockage. Using his many years of experience at St Vincent’s Hospital, he was aware that this serious issue could be due to many causes. But the main ones were equipment failure (i.e. a kink in the oxygen hose), human error (i.e. accidental disconnection), or an unattended (empty) oxygen bottle. The consequences are severe resulting in brain injury or even death.

Finding a solution was the first problem for Dr Matusik in inventing a safety management valve called the SureFlO2. But finding a suitable manufacturer to produce medical procedure components became an even bigger issue for the doctor.

Enter Forme Technologies. They became the ideal fit due to:

Transforming an idea into a robust working solution for the medical sector
Offering a manufacturing platform and solution suitable for mass production of medically rated equipment
Working within all compliance guidelines and regulatory bodies in order to take it to market.

THE BRIEF

Take Dr Matusik’s idea and turn it into a fully functioning medical device from the design stage, the development stage, right through to manufacturing. This device has to be able to show that the oxygen supply is working when delivering oxygen to the patient’s oxygen mask.

The following issues also had to addressed in the design process:

The device must function to specification regardless of a patient’s position.
The indication of flow should be immediately clear and visible – even from a distance.
The device must be fail-safe.
The device must be MRI transparent.
The device has to be manufactured to ISO 13485 guidelines.
The materials used for its construction must be biocompatible and compliant with applicable 10993 and 18563 standards.
The device must be Australian Regulatory Body compliant and bearer of the CE Mark.

Product Developement

Forme Technologies in conjunction with the SureFlO2 medical team designed a device that met all requirements as to functionality, reliability, safety, and highest manufacturing standards.

1. Performance
Achieving constant gas flow is achieved in the mechanism using a spring loaded ‘bucket’ that uncovers an orange indicator signifying gas flow.
2. Monitoring gas flow
To guarantee a minimal flow of at least 2 ml/min of gas, Forme Technologies calculated the lift force, weight and counter force required on the spring to keep SureFlO2 working within the required flow limits regardless of orientation. The spring dynamics also had to be carefully considered which Forme Technologies designed from scratch and also built in-house. Testing was meticulous to demonstrate the efficacy and safety of the device. SureflO2 was even tested for blockage when exposed to patient emitted reflux and vomit where oxygen could easily be restricted.
3. Safety and Risk
Having covered off safety through a rigid testing regime, a risk analysis was undertaken whereby the device was assessed for accidental dismantling or part dismantling during use. The results showed that disassembly was achieved only through tampering and with the assistance of tools – and neither would happen during a surgical procedure.

Tooling

Forme Technologies worked with its Australian based partner toolmaker to develop the tooling for the manufacturing of SureFlO2. Combined and ongoing testing was performed under Forme Technologies’ meticulous project management.

This included:

Meeting the highly demanding manufacturing guidelines.
Employing the very best plastics to achieve maximum results.
Consistent replication, integrity and build quality of all components.
A stringent quality control along the manufacturing process with 100% testing of the final assembly.

All of this could only be achieved through the use of Forme Technologies vertical CNC milling machine complemented by their EDM equipment. Both machines reduced critical response time, and moved manufacturing straight from the toolroom onto machine assembly.

Manufacturing

Forme Technologies specialises in the use of plastics and polymers. This made the tolerances required in the manufacturing of the moving and fixed parts, much simpler to control. ‘Steel like’ tolerances could be achieved due to the use of state-of-the-art machinery and highly experienced staff.

The manufacturing process includes:

One of the business’s DEMAG INtElect2 50 electrical injection moulding machines with inbuilt statistical process control software.
Setting equipment thresholds for moulding variables to maintain quality of the parts including machine alerts, rejections and auto stop functionality.
The use of a self-encapsulated manufacturing environment holding all machinery for the end-to-end manufacturing of the SureFlO2. This ensures the quality of air purity classifies the enclosure to ISO 7 standards and is regularly measured by an accredited third party.
Powering the manufacturing facility is by 273 solar panels generating 75KW. The effective capacity in our electrical network is optimised by our power factor correction unit.

QUALITY ASSURANCE

Forme Technologies aligned its ISO 9001:2015 system to comply with the requirements of ISO 13485.

This included the ability to accurately provide:

A partnership capability to work with medical expert SureFlO2 in understanding the exacting requirements for a successful final outcome.
Provide full documentation including the delivery of the ‘Device History’ file to take the product to market and as part of the regulatory requirements for the TGA approvals and CE Mark acceptance.
Traceability of all the manufactured and purchased raw materials including packaging.
Design and develop a systematic process of testing protocols in order to verify and validate the device at every phase, demonstrating its full efficacy and safety.
Constant monitoring of the injection moulding process drawing samples for measurements in our CMM over specific time intervals. The CMM has an accuracy within 0.001mm.

Clean room facility for end-to-end manufacturing
Quality Assurance was further enhanced in the assembly of SureFlO2, with Forme Technologies introducing a ‘fit-for-purpose’ Lean Manufacturing cell to encapsulate the entire engineering process of componentry to final assembly right through to packaging.

THE OUTCOME

Not only is SureFlO2 a TGA approved medical device, it also bears the CE mark. It is currently being used in several leading medical institutions in Australia.

Objectives met by:

SureFlO2 providing a fail-safe delivery of oxygen to a patient in the operating theatre.
SureFlO2 signifying to the medical practitioner whether or not oxygen is flowing through the mask.
SureFlO2 mitigating the risk of disease transmission from the patient to medical personnel, as the indicator can be seen from a distance.
SureFlO2 being safe to be used in a MRI machine under designated conditions.
SureFlO2 being an Australian designed and manufactured product.

GET IN TOUCH