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f you have been experiencing difficulties with sales in Russia recently, it is for a reason. You might think about currency rate issues or recession influencing clients’ activity. However, buying less and less imported medical equipment is a state policy in Russia, and it won’t get better.

What is the situation in the medical device market now?

• It is a 4 billion EUR market, where 80% in value or around 3 billion EUR is imported.
• In Russia locally produced medical devices are highly recommended for purchasing, especially within government contracts. The legislation frames are provided by the document called the Government Strategy 2030 and many other regulations.
• Working with local distributors does not guarantee winning the government contracts. It’s quite hard to compete when your winning company gets 15% less of the contract price or is expelled from the government contest altogether when 2 local participants are present. Unfortunately, these are real terms for the imported certified medical devices.

However long and tricky the registration and sales process of medical equipment may seem now, it has two big advantages compared to the EEU rules that will be activated in 2026:

• Current RU certificates for medical equipment (analogue of CE certificates) have no expiration time as for now. It means, having received a registration certificate by 2021, your company still will be able to sell in Russia without receiving an EEU certificate.
• Clinical trials for most of medical devices now can be passed in the form of analysis, without actually repeating them in Russian clinics. After the EEU regulations will be put into action, a medical device producer will have to pass on-site clinical trials in 2 clinics. For sure, it will make the process of registration much more prolonged and expensive.

Considering these facts, the best way for small and medium medical equipment manufacturers to place a foot in the Russian market is to begin the registration process and make certain steps towards localization of their devices. Then by 2026, when more stringent EEU rules will be applied, one could have a local product with a certificate “made in Russia”.

From our experience with Luneau Technology, a French manufacturer of ophthalmological equipment, it is possible to pass all the way from starting registration to launching sales of the partially localized devices in 2-3 years. Yet the correct roadmap for registration and localization is critical in the process. Medica LLC can help both with the roadmap design, the registration itself, as well as assembly, small series production, packaging, labeling and after sales services.

If you email us to the address below and refer to this article, we can schedule for you a 30 minutes free Q&A session on your problems and opportunities in the Russian market of medical equipment.

Medica LLC is a subsidiary company of a private venture building company TechnoSpark.

Medica provides localization and registration services for medical device manufacturers.

What do we suggest?

• Localization scheme
• Contract manufacturing
• Selecting and managing local suppliers
• Obtaining all necessary certificates from Russian authorities
• Providing maintenance of the produced equipment

Parts of Visionix VX130 device by LTO, France, localized in Russia by Medica LLC

TechnoSpark Group is a private venture building company that specializes in creating, developing, and selling high-tech startups in hardware industries, from energy storage systems to medical devices.

TechnoSpark cooperates particularly closely with leading international research centers and has years of experience as an industrial partner in the affiliation programs of IMEC and KU Leuven (Belgium), Solliance, Holst, TNO and ECN (Netherlands), Flex Enable (UK), etc. It has two international HQs: at High-Tech Campus Eindhoven, in the Netherlands, and in Tsinghua Science Park, Beijing, China.

Precision metal working / Optical and industrial coatings / Genomics / Microbiology / Integrated electronics/ Flexible electronics / Metal and plastic 3D printers / Composite braiding / Integrated photovoltaics / Synthetic diamonds/ Industrial design

From new green-field near Moscow in 2014 to 7500m² of the technological facilities in 2016

Medica LLC

Website: www.contractmedic.ru

Email: info@contractmedic.ru

Performance is crucial in space technology, every successful generation in design represents a new state-of-the-art. Advancements proven in space may return to earth in unexpected places. Well-known examples are: satellite TV, water purifiers, freeze-dried food, and artificial limbs.

Caeleste is a Belgian fabless SME specialized in custom designed CMOS image sensors. The focus of its projects is very wide, yet in each project specs are “beyond state-of-the-art”. The company partners with world recognized institutions as the European Organization for Astronomical Research and the European Space Agency.

In this note we show how Caeleste re-used space mission results in sensors for the medical domain.

Space, although “empty” or effectively a deep vacuum, is not a benign environment. It is permeated with high-energy electromagnetic and particle radiation. This radiation is not only harmful to humans, it also destroys electronic devices. Caeleste has mastered to design its electronics resilient to the effects of radiation, or “radhard”. The damaging effect is seen as “total dose” and “single event” effects. Through many years of innovation, its image sensors and ROICs designs are successful in space missions.

X-Rays are used in the most common forms of medical imaging. Our partnership with Trophy, part of Carestream Dental, is an example where Caeleste adds value in a domain where resilience against high energy radiation is required. We partnered in developing a new generation X-ray sensor for 3D reconstruction in dental imaging.

Unlike regular cameras, no lenses are used in X-ray imaging. Consequently, the size of an image sensor must match the size of the target area. This sensor measures 12 x 14 cm, or “wafer scale”. Caeleste’s IP made it possible to produce wafer scale devices with a high production yield.

This achievement for a medial application can be traced back to know-how acquired in space, and vice-versa. This systematic synergy of seemingly distance domains is unique for Caeleste. The technology that survives the space environment is applicable to many other forms of radiation; the high yield methods acquired in X-ray images apply on their turn to many other distant domains.

The expertise on low noise charge sensing circuits, originally acquired in deep cryogenic readout ICs (ROICs) for long wavelength infrared imaging, eventually led to the collaboration with the Californian med-tech startup Paradromics. Caeleste was part of a fundamental paradigm shift in the field of brain computer interfaces by developing a sensor for our customer that allows electrodes to be implanted into the brain at higher density than previously possible without causing thermal damage to the neural tissue. In addition, the sensor has an extremely challenging noise requirement to be able to read the neuron potentials. This is where craftmanship and passion for finding technological solutions were crucial for the success.

Solutions of this category cannot be purchased off-the-shelf and need to be developed by a team that has the expertise and the confidence to realize goals beyond what is available.

Caeleste complements the sensor design with the driving system and the capability to do the full characterization. How the image sensor is used most effectively depends on the external system, and a sensor design is often a total system optimization. This impacts the presence, position and resolution of the ADC. It impacts on the amount and nature of image processing, on-chip, in-system, downstream. It involves design choices aiming to low noise operation, low power or high speed, high temperature or cryogenic temperature operation. The collection of know-how and IP enables us to design sensors for a variety of clinical applications such as ophthalmology, dental and mammographic imaging.

For the development of a custom sensor Caeleste offers dedicated support after the design and testing process. To optimize the integration, Caeleste acts as a one-stop-shop for :

• Interacting with the Silicon fdounry and related suppliers for post-processing
• Package design and manufacturing, glass lids, filters
• Optical Simulations
• Dedicated Coatings
• Driving electronics and boards

Caeleste’s partners are leaders in their respective fields such as: foundries, medical qualification specialists, testing houses, dicing and packaging experts.

If the needs of the customer change over time, we offer a collaborative approach and remain open to new possibilities. This describes our flexibility as a company but always with solid high-quality solutions in mind.

Caeleste

Hendrik Consciencestraat, 1B