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A professional partner that the best rely on

Innokas Medical has been designing and manufacturing advanced systems for some of the leading names in the medical device industry for close to two decades. Its expertise in health care technology, regulatory requirements, and life cycle thinking has made Innokas a highly valued partner.

Finland’s health technology manufacturing sector has been steadily growing for a number of years, and exports now exceed imports by a wide and growing margin. Health care technology is Finland’s second largest exporter of high technology after telecommunications today – and products developed in Finland are renowned for offering excellent performance and durability, as well as for being extremely safe.

One of the companies driving this development has been Innokas Medical, a contract designer and manufacturer of complex medical systems and solutions. Certified to ISO 13485/ISO 9001 and registered with the FDA in the US as a contract manufacturer of medical devices ranging from individual PCBs to MEG (magnetoencephalography) systems, Innokas now counts a number of global medical technology companies among its customers. Devices designed and manufactured by Innokas Medical can be found in hospitals, doctor’s offices, and physiotherapy suites around the world.

Proven track record

Innokas Medical’s first project was to develop a body warmer for burn patients. This was designed from the ground up from little more than a wish list of features, rather than an actual specification. The first 50 units were delivered in the spring of 1995 to a large hospital in Moscow and are still giving excellent service to this day.

Innokas can handle everything from the initial concept of a new device through development to manufacturing and delivery.
Since then, the company’s product range has grown considerably and currently includes a digital imaging device, a six-channel EMG unit, a specially produced non-magnetic EEG cap used in MEG examinations, a MEG control unit, and various diagnostic devices. Innokas has designed most of these products itself and manufactures all of them in-house, at its facilities in Finland and Estonia.

Innokas designs devices all the way from the initial concept through development to manufacturing and delivery – drawing on its extensive expertise in areas such as mechanical and electrical engineering, embedded and client software development, user interface and usability design, prototyping, verification, and validation.

Innokas’ design process covers the entire chain, including comprehensive risk management and Device Master Record (DMR) documentation in accordance with FDA 510(k), MDD (CE), and other regulatory requirements. The company’s NPI (New Product Introduction) teams work closely with customers to select the most efficient production process for a product, the optimum place to manufacture it, together with the best suppliers and most efficient logistics to use.

Innokas’ manufacturing process – covering the manufacturing and testing of PCBs, modules, devices, and systems – is fully certified to ISO9001:2008 and ISO13485:2003 standards and complies with FDA regulations. The process is tailored to customer-specific needs and requirements for each and every product, and makes use of various electronic systems designed to streamline both Innokas’ internal processes and how it interfaces with its suppliers and customers.

By turning to Innokas and tapping into its know-how, customers benefit from shorter timeto- market, lower unit costs, and extended product lives. The latter strength is based on Innokas’ commitment to keeping products up-to-date throughout their service lives, expertise in maintenance and end-of-life engineering, and flexible spare parts and repair service.

Partnering with Innokas Medical ensures that customers can launch their products quicker, that products are always fully compliant with the relevant regulatory requirements – and are competitive.

Elekta and Nexstim have both chosen Innokas

Two customers that have turned to Innokas Medical for the multiple benefits that it offers are Elekta of Sweden, a provider of clinical solutions for treating cancer and brain disorders, and Nexstim, a Finnish pioneer in Navigated Brain Stimulation (NBS).

Elekta and Innokas Medical have worked together since 2007; under a recent multiyear agreement, Innokas is now responsible for manufacturing Elekta’s latest generation of magnetoencephalography (MEG) devices.

Innokas is responsible for manufacturing Elekta’s latest generation of MEG devices...
Used to determine the exact location of brain functions, such as sight or hearing, in the cerebral cortex and capable of establishing the timing of various events there to the nearest millisecond, these devices use low-temperature superconductors and are marketed globally, in Japan, the US, and Europe.

Featuring improved overall design, usability, and signal processing, the new MEG devices were developed with valuable input from Innokas Medical’s R&D experts. Following manufacture of the electronics and control systems at Innokas’ Kempele plant, final assembly and testing are carried out at the company’s Helsinki plant, which now includes a dedicated testing environment for MEG devices.

Under a new long-term contract with Nexstim, Innokas is also now responsible for sourcing, manufacturing, assembling, testing, and delivering Nexstim’s NBS System 4, as well as its new NexSpeech® module and TMS II stimulator coils.

NBS System 4 is Nexstim’s latest generation of non-invasive direct cortical mapping technology for clinical neurosurgery and clinical research. Fully selfcontained and mobile, the new system is very compact, with a footprint of less than 0.6 m2; while NexSpeech® extends its capabilities into presurgical speech mapping and offers a more intuitive and less costly method than fMRI.

The switch to Innokas forms part of Nexstim’s increasing focus on new therapy products and will bring improved production control, while maintaining high quality standards.

> Jouni Ihme
(Published in HighTech Finland 2013)