The incubation of French Medtechs in Asia, a key development factor in the face of changing European Regulations
A recent article published in Le Figaro discusses the impact of the new European regulations, which will come into force in 2021.
“It’s a regulatory tsunami!” Stéphane Régnault, vice-president of Snitem, which brings together 480 French manufacturers of medical devices (medtechs), does not mince his words.
This regulation imposes new requirements on manufacturers to put together their certification file. They will have to add a clinical study for the more technical products. In addition, by increasing its requirements, Brussels has reduced the number of certification bodies from 60 to 20. This will undoubtedly create bottlenecks in the process of certification.
Because the bill is heavy for French medtech companies, which have between 800,000 and 2 million references on the market. They will be forced to recertify their entire product portfolio, including old devices that have proven their worth.
Faced with the foreseeable consequences linked to the change in regulations, which are the decrease in workload in France and the additional cost of the certification process, French companies will have to seek international growth.
At OPKO Finance, we help Start Ups, SMEs and technology companies to integrate their structure into the best hubs in Asia and provide outsourcing services at a limited cost through our offshore office based in the Philippines.
The advantages of integrated solutions for our customers are multiple:
- Benefit from the best hubs (Hong Kong, Singapore, Dubai) to penetrate an international market, particularly in Asia, both in terms of ease of installation and the low level of taxation,
- Access to a larger pool of talents and skills at a lower cost,
- accelerate your development by having adequate resources quickly,
- Increase your bilingual staff in English, which constitutes a competitive advantage in your international development,
- Reduce your operational costs thanks to our offshore structure based in the Philippines,
- Free up your internal staff to focus on your main goals and core activities.
In a specific case study, we worked closely with one of our customers specializing in electric vehicle charging solutions. We have thus defined the patterns of activities that can be outsourced, the operating procedures between our client and OPKO Finance, as well as the best ways to integrate our offshore solutions with local teams, from the start-up phase to the development itself. This required a whole strategic reflection on the essential functions that our client wanted to concentrate and keep internally (R&D, sales development, marketing and quality strategy) and the functions that he could outsource (back office of their operations such as administration sales, logistics, IT and accounting). In addition, we provided our client with our expertise and experience on the process of organizing and optimizing the flow of operations to be shared between their headquarters in Europe and their new company based in Hong Kong. Once these different schemes were validated, we proposed with our client all the technological and software tools necessary for the management of outsourced operations.
Since the creation of its structure in Hong Kong, our client has recorded double-digit annual growth with double profitability compared to its historical data.
For more information on how to structure your operations in Asia, please contact our team at email@example.com or by phone + 852 2654 8800 or +63 32 402 0170.