Patients are often connected, via tubes or catheters, to several delivery systems to receive ventilation, medication, nutrients or fluids in a hospital care setting. Misconnections occur when a tube from the medical device for one delivery system is connected to a system that serves a completely different function. These misconnections have led to a number of patient deaths worldwide. Today, a new industry wide standard, defined as ISO80369, is under development to eliminate the incidents that occur from misconnections. The ISO committee are developing several standards for specific healthcare applications and markets. Among these are standards for respiratory breathing systems and driving gases applications (oxygen and ventilators) known as ISO80369-21.


The global respiratory care devices market is expected to grow from USD $15.4 billion in 2016 to USD $24.07 billion by 20212. Growth drivers of this market include a higher occurrence of respiratory diseases and an aging global population. Planned changes in industry standards for respiratory delivery will likely lead to significant changes in the market in the coming years.

Companies competing in the respiratory market, or planning on entering the market, need to prepare for changes likely to take effect in the next few years. Small bore connectors for respiratory applications have been identified by the ISO80369-2 standard as areas for change; one for use on low-flow equipment such as sample ports and anaesthetic and ventilator breathing systems; and other for use on high-flow equipment such as flowmetres, nebuliser therapy face masks, and nasal cannulae.

According to the ISO committee, respiratory standard changes are expected to be fully processed in three to four years. If companies do not react or are too slow to adopt the ISO80369-2 standard changes, they may be at risk of losing market share. Through early adoption, companies can capitalise on these changes and increase market penetration in the respiratory market as has been the case in the enteral market following recent standard changes.

The race is on for medical device companies to prepare for compliance with these new ISO standards. If companies fail to innovate, one or more of their product lines may become obsolete, which in turn may dramatically impact their market position.


SYNECCO and ISO80369-2

Synecco is perfectly poised to assist companies not only to achieve regulatory approval and market launch in light of the development of ISO 80369-2, but transform this market disruption into an opportunity for growth.


  • Design and Engineering
  • Process Development and Tooling
  • Quality and Regulatory Support
  • Rapid and cost effective processes
  • Experience in ISO80369 production, assembly and supply
  • Experience managing the technical, regulatory and inventory challenges of the standard change

  • Volume Manufacturing
  • Packaging and Sterilisation
  • Supply Chain Management
  • Regulatory compliance for ISO 80369
  • FDA and TUV ISO13485 compliance
  • Generating IP around products related to ISO80369 standard change
  • User centred design on ISO80369 products
  • Developing and manufacturing respiratory products


Synecco, founded in 2004 and located in Galway, Ireland is a global supplier of world-leading contract manufacture and design solutions for the medical device market. Synecco have proven to be the partner of choice for many medical device companies seeking design and engineering, component manufacture and assembly, as well as supply chain management solutions.

Synecco is fully compliant to industry standard ISO 13485 and is focussed on developing and supplying innovative medical device solutions for our partners. Synecco has a diverse commercial client portfolio, from large MNC’s to well-funded start-ups.


If you would like to talk to Synecco about our capabilities and experience applying the ISO80369 standard to your portfolio, including design and manufacturing please get in touch with us via info@synecco.com.

For further information on our range and depth of medtech services, click on: www.synecco.com


1. International Organisation for Standardisation , 2010. ISO 80369-1:2010. [Online]  Available at: https://www.iso.org/standard/45976.html [Accessed 03 March 2017].

2. Market Watch, 2017. Market Watch – Respiratory Care Devices Market Worth 24.07 Billion USD by 2021. [Online] Available at: http://www.marketwatch.com/story/respiratory-care-devices-market-worth-2407-billion-usd-by-2021-2017-02-07-92033111 [Accessed 03 March 2017].