DAYSY is an intelligent ovulation calculator with app support that records individual menstruation cycles and evaluates these for birth control or pregnancy planning.
INITIAL SITUATION
With regard to the newly developed class 1 medical device, all plastic components were to be optimised for the customer in terms of the production
process and responsibility taken for the planning and realisation of series
production.
DEVELOPMENT
Together with the engineering company responsible for development, the
plastic parts were appropriately designed and adapted to suit further processing
steps. A total of five moulds were manufactured in China at the facilities of competent local partners and sampled as well as optimised onsite by Mythentec. Mythentec selected the material to suit biocompatibility requirements (USP class VI and EN ISO 10993).
INJECTION MOULDING
A 1+1 mould for the casing components ensures that superior quality is produced at low initial costs. The upper casing component, which is the
core part of the device, is produced by means of two-component injection
(ABS-PC/TPE). The associated light conductor was designed to convey the
light as desired and, following insertion, not to fall out during further processing
steps.
The master computer system ensures batch traceability of raw material and continually archives actual injection moulding cycle parameters on the server.
FURTHER PROCESSING
Under enhanced hygienic conditions, Mythentec employs ultrasonic welding
to weld the two cap halves together.
All parts are ordered according to framework agreements. As a consequence,
Mythentec can ensure that continuous stocks are available when costumer orders are placed at short notice.
KEY FACTORS
• Component design suitable for plastic
• Low initial costs through mould procurement in China
• Assessment and optimising of moulds in China
• Ultrasonic welding under enhanced hygienic conditions
• Complete batch traceability of raw materials
