The medical market includes all companies involved in research, development, production and marketing in the healthcare sector: pharmaceutical laboratories, medical devices, in vitro diagnostics and digital companies.
This market includes:
- 260 pharmaceutical companies
- 1,343 medical device manufacturers, 92% of which are SMEs
- 100 in vitro diagnostics companies, 90% of which are SMEs
- Numerous start-ups that innovate and drive the sector upwards
- 450 very small biotech and medtech companies, most often stemming from French research
Market challenges and perspectives
The current context of this sector is marked by a global growth in demand. Companies must continually innovate to remain competitive. What is more, foreign competition is so strong that it requires adapting to increasingly personalized medicine and increased regulatory and health requirements.
As this field is highly regulated, most prices are set by the state. The position of companies on the global market therefore depends on maintaining a high level of technological expertise and on strengthening the competitiveness of national players.
Tomorrow's major challenges and perspectives for this economic sector are related to multiple medical technologies, diagnostics and therapies that are more innovative and easier to extract data from, notably thanks to artificial and connected objects.
Tame-Test's expertise
TRONICO is the key reference in this field for all life phases of highly critical medical devices in Europe, and Tame-Test is a key part of this strategy.
Tame-Test assists you in the manufacturing process of your class IIa, IIb, III and AIMD medical devices.
Certifications and accreditations
Tame-Test designs and manufactures test benches for the medical sector which, in addition to compliance with ISO standards, require guarantees related to confidentiality.
For all its equipment, Tame-Test ensures:
- Compliance with low voltage directives
- CE marking
- UL marking
- The machinery directive
In addition, if the equipment is a medical device accessory, Tame-Test ensures compliance with regulatory requirements (class A, B or C).
ISO13485
ISO 13485 is an international quality management standard that facilitates the implementation of regulatory requirements applicable to medical devices and associated services (DIR 93/42/EEC, DIR 98/79/EC, DIR 2007/47/EC and DIR 90/385/EEC).
Use case
Stéphane, founder of a medical startup, is the inventor of a medical device for heart failure. He is approaching the production phase of his medical device and wants his product to be flawless. His product integrates 3 different types of electronic cards.
After agreeing with Stéphane on the test strategy, Tame-Test offers him a Check Versatile tester capable of accommodating 4 interfaces, one per electronic card and one for the assembled product. After a few weeks and after his feedback from the first clinical trials, Stéphane asked to implement a tilt test in order to calibrate the accelerometers. Tame-Test, not changing anything on the original Versatile tester, develops a 5th interface equipped with precise mechanical movements to meet Stephane's needs. This test is performed by the existing tester with this new interface.