Medical Technology Case Study ‘Sleep-Screening Device ResMed ApneaLink Air™“
ResMed offers reliable therapeutic equipment and modern data management solutions designed to simplify the diagnosis and treatment of sleep-related breathing disorders, chronic obstructive pulmonary diseases and other chronic illnesses. ResMed has a team of more than 5,000 employees and supplies more than 2 million patients. The mission? To improve patients’ quality of life, to alleviate the effects of chronic diseases and to reduce health spending in more than 100 countries.
To manufacture prototype tools made of steel for the lower and upper shells of the housing and the battery cover. The surface of the visible sides had to have a grain in compliance with VDI3400 Ref 31 – and the order also included the production of a total of 1,000 assemblies of series material, including 3-colour printing with a logo. The challenge? To produce the components in near-series quality for comprehensive preseries tests, within the very short production timeframe of only eight weeks.
Even with the tight production timeframes, the specialists at Hofmann – Ihr Möglichmacher succeeded in realising the tasks set them by the medical technology customer – and they delivered products with a uniquely high level of quality. The key advantage when you opt for Hofmann is that we have many different manufacturing processes and widely diversified expertise available in-house, so the complete measurement of assemblies, for example, can be performed after the series has been drawn, saving a considerable amount of time.
The agreed timeframe was of course adhered to. The delivery of the finished assemblies meant that selected doctors, hospitals and partners worldwide had prototypes available for important preseries testing. Certification processes are very important in medical technology and, thanks to the prototypes, these could also be initiated at an early stage, so the application for certification could also be accepted much sooner than usual for the CE approval ID in the EU and FDA approval in the US. The provision of parts from series material also provides valuable insights for design optimisations before the series tools are actually manufactured. The sleep-screening device has meanwhile gone into successful series production.