MediConcepts

MediConcepts designs and makes medical devices for other companies. The head office is in Hong Kong and the factory is in Dapeng, on Shenzhen's eastern coast. It started in 2002 when a UK surgeon asked for a laparoscopic specimen retrieval bag, the pouch used to remove tissue during keyhole surgery. The first ones were made by a small team on a borrowed injection molding machine. From there it moved into other minimally invasive surgery instruments, and its motto is still 'Think Medical'.

Founder and managing director Benjamin Chan has an engineering, finance and law background. He was deputy chairman of the Hong Kong Medical and Healthcare Industries Association (HKMHDIA) from 2012 to 2020 and chairs the advisory committee of PolyU's biomedical engineering department. Co-founder Gene Tang, an electrical engineer, set up the quality system.

The factory molds engineering plastics and liquid silicone rubber (LSR) on 30–120 t machines, including two-shot overmolding and insert molding, with tools designed in-house. Every machine is qualified and every molding project goes through operation and performance qualification (OQ/PQ, the validation steps medical customers expect). Assembly happens in an ISO Class 8 cleanroom, with a separate white room for electro-mechanical products, and it can arrange packaging and sterilisation. Its markets are surgical, diagnostic and anesthesia, laboratory, pharmaceutical and electronic devices, such as a wearable health monitor for elderly people in New Zealand and a tracker for herb and supplement intake that works with a smartphone app.

MediConcepts says it is certified to ISO 13485, the quality standard for medical devices, though the certificate itself isn't posted on the site. It lists design verification and process validation work (FMEA, test protocols, tolerance stack-ups), clinical evaluation, and regulatory help for the US, Japan, China and Hong Kong. It takes on high-mix, low-volume pre-production runs, design or production transfers, and full mass production. It exhibited at MD&M West in February 2023.

MediConcepts suits medical-device companies that want design, tooling, cleanroom molding and assembly under one roof, especially for surgical instruments and handheld devices with molded parts.