The cooperation between Innokas Medical and Monidor Ltd. has developed to the next level during this year. The first steps of the cooperation were took already in 2015 when Innokas was offering QA and RA consulting services to Monidor, and now the companies have signed a manufacturing agreement, which covers the manufacturing of Monidor’s Monidrop Infusion Therapy device. The production started at Kempele factory with 0-series validation in May, and the actual mass manufacturing begun in autumn.

Monidor Ltd. is a Finnish healthtech company specialized in solutions for wireless monitoring and eHealth. Monidor’s objective is to offer safe and secure solutions with the best quality and reliability. Their first innovation, Monidrop Infusion Therapy device, has now passed the pilot phase and the mass manufacturing of the product has started at Innokas Kempele factory. The first observations from the end users have been encouraging.

“Our innovation is very potential from the viewpoint of streamlining the daily work at hospitals while reducing human errors. The first letter of intent related to the pilot versions were signed with the hospitals in the spring, and according to test uses the users were very happy with our product and its features. The device has been warmly welcomed at the hospital field as clear and straight cost as well as time savings are possible”, tells Mikko Savola, CEO at Monidor.

Monidrop is an accurate, small and lightweight device, which is designed to improve the quality of care in intravenous therapy. Today, nurses and doctors evaluate the amount of medicine and/or liquids given to patient by counting the drops and time through the liquid tube. With Monidrop Infusion Therapy device this operation is automated, as the device is able to calculate the optical density as well as the liquid and medicine dosage automatically. By comparing the count the device has given with the order the doctor has prescribed, the nurses can manage the hydration and medication of the patient easily.

“The device has also a wireless connection, which allows the real-time monitoring of all the Monidrops remotely. This reduces the number of nurses’ inspection rounds and the need for evaluation of the medicines and liquids given to patients”, Savola continues.

From QA&RA consulting to manufacturing agreement

The cooperation between Innokas Medical and Monidor began already in 2015 when Innokas was offering them consulting services for implementing company’s ISO 13485 quality system for medical device design and manufacturing. The QA&RA consultation continued also in 2016 and based on the consultation and development actions, Monidor reached their ISO 13485 certifications during the summer 2017.

“Innokas Medical guided our company in defining our ISO 13485 quality system, and trained our personnel and quality director. As a global player, Innokas is a great co-operation company for our kind of start-up company also in the longer term”, Savola tells.

As Monidor has been satisfied and has gained a great customer experience from Innokas already from the very beginning, the cooperation was developed to the next level first time in the end of last year. Innokas’ NPI and engineering teams started to work with Monidor to finalize the manufacturability of the product by prototype production and developing the mechanics and testing of the device. Finally, in the beginning of this year, Monidor decided to outsource the manufacturing of the Monidrop Infusion Therapy device to Innokas and the parties signed the manufacturing agreement during the first quarter of this year.

“We’ve been very satisfied with the cooperation with Innokas, so it was quite easy for us to choose Innokas to be our contract manufacturer. The production was started at Kempele factory by 0-series validation already in May, and the actual mass manufacturing started after that during autumn. The agile and high-quality production line was tailored specifically according to our device needs. In addition, Innokas’ production were perfectly suitable for NPI phase and for lower volumes that is faced during the starting point of manufacturing”, Savola comments.

Innokas Medical’s Business Development Director Mikko Kangas also sees that Monidor’s product is very potential one for future healthcare and daily patient care. He also sees that Innokas has been able to create a concrete and valuable benefits to Monidor concerning the cost-efficiency and the product launching schedule when the company has all the needed competencies in house to support Monidor’s project. The actual demand of the device is evaluated to be even thousands of devices already during 2018.

“Monidrop concept is very interesting and will definitely have a positive effect in the future on both  accuracy and rapidity of patient care, and of course on the cost point of the hospitals. It is great that Monidor chose Innokas to be their contract manufacturer”, Kangas says and continues:

”In addition to being a strategic partner with many leading global medtech brands, Innokas works also with new, smaller companies in helping them to enter the market and to grow into successful companies. Monidor is one of these companies.”