Great demands were put on usability and ergonomically correct use. Therefore, users and other stakeholders were involved in the development. Adapting the design to the current process competencies in Ambu’s plant in China was also an important issue, as the items are disposable meaning that low unit costs was an important focus area.
Since early 2004, MGS Design & Development has worked with Ambu on the development of training and resuscitation equipment to hospitals and rescue services. We have been responsible for the entire project, from definition of concept, design, usability studies, construction, materials, documentation and manufacturing of tools and validation of the production line.
Solutions
We worked according to Ambu’s development manual and contributed with our skills to develop medical articles for regulatory requirements, including the CE marking for the Medical Device Directive and FDA approval 510 (k). The production took place at Ambu’s plant in China where we have visited on a regular basis to participate in the production start-up and to undertake all approvals of the prototype, O-series etc.
A unique product family was created counting a total of 15 variants in 7 different sizes covering premature babies and upwards.
The design is revolutionary as complies with the following:
- Transparency – doctors can observe the patient through the mask
- The cuff is ergonomically designed to fit the face
- The pressure in the cuff can be adjusted individually
- The mask itself was to be produced combining several types of plastic (2K)
- Easy to use for anaesthetists and nurses
Testimonials
What People Say?
MGS Design & Development has been a key player in creating a product optimized for uses and production processes.”
The overall goal was achieved by continuous focus on optimization of material, construction and production processes.”
Insights you might also be interested in:
Why you Should Apply Virtual DoE to the Design Process
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
Regulating Medical Devices in the European Union: Legislation vs. Driving Business Outcomes
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.
How Early-Stage Drop Test Simulations Can Uncover Hidden Design Optimization Insights
Learn from ALK’s success with MGS Design & Development experts, gaining crucial insights for smoother testing and reduced project risks.
