Nowadays, companies producing medical devices must take into account many very strict regulations in this field. In addition to being competitive, medical device manufacturers must therefore be able to manage the risks of non-compliance. With the progress of science and new technologies, they must be at the forefront to guarantee products adapted to demand.
CHALLENGES: New technologies for healthcare
Innovation is a fundamental challenge in the Medical Devices and Equipment industry. It needs to be anticipated and/or monitored in order to anticipate the arrival of new, more efficient products on the market while remaining competitive.
The players in this industry, forced to innovate to keep pace with market developments, must ensure that they are economically profitable.
Risks of non-compliance
Manufacturers of medical devices must ensure the quality of their products by adapting to current regulations, including protocols and technical standards. Medical equipment is constantly evolving, which means keeping up with changes despite increasingly complex systems.
Meeting patients demands
One of the key challenges for the sector is to put the patient at the heart of the process, to adapt to their requests and therefore to offer them a personalised experience to optimise their care.
The service offered and the quality of care are important factors of differentiation, they offer a considerable competitive advantage since they reflect patients’ expectations.
In order for everyone to have access to the same information at the same time, it is essential for the Medical Devices and Equipment industries to improve communication and data exchange between the different sectors. This will allow companies to save time, productivity and generate higher margins.
Improvement of the manufacturing process
The challenge is to accelerate innovation, produce high quality products and optimse their marketability.
This industry must be able to manage partially or totally outsourced production, while being able to master detailed specifications and product definition and preserve its expertise.
SOLUTIONS : A PLM approach to meet the challenges
A PLM approach is a major lever to meet the challenges through an optimisation of the entire life cycle from understanding needs to after-sales service of the medical equipment used.
The use of Dassault Systèmes’ 3DEXPERIENCE® platform optimises the manufacture of medical devices. Thanks to the different solutions, manufacturers will be able to:
- Better manage quality issues: improve traceability, compliance, prevent risks of regulatory non-compliance
- Delivering unparalleled experiences: connecting data that reflects patient expectations
- Synchronize manufacturing networks: increase visibility and improve real-time process control for employees and suppliers.
License to Cure for Medical Device and Smart & Synchronized for Medical Device are two Dassault Systèmes solutions specialised for the Medical Devices and Equipment industry.
The first one focuses mainly on product design, and the second on collaboration and data exchange within sectors.
License to Cure for Medical Device
This License allows the Medical Devices and Equipment industries to accelerate the manufacture of products, while improving their quality, complying with regulatory standards and ensuring an improved patient experience.
This solution includes implementations:
- On regulation
- Compliance with environmental standards
- Modification of the design history file (DHF)
- Modification of the main device data (DMR)
- Document control
Smart & Synchronized for Medical Device
The Smart & Synchronizes for Medical Device solution, available in the cloud or on premise, emphasizes collaboration and therefore allows real-time information sharing and optimization of medical device manufacturing. It facilitates interactions between the different sectors involved in product design, validates concepts and tests performance.
This collaborative environment gives engineers the opportunity to have an overview of the entire project and therefore to anticipate the next steps.
Thanks to this system, it is possible to trace all the design steps, which will limit possible errors. It also provides the opportunity to perform simulations downstream of production in order to seek to innovate and continuously improve its products.
To manage production as efficiently as possible, the Smart &Synchronizes for MedicalDevice solution integrates control systems that will make it possible to validate the steps before the product is placed in production and marketed. This will ensure quality but also patient satisfaction.
This solution includes:
- Synchronisation of system engineering
- Synchronised electrical design
- Synchronised hydraulic design
- Synchronised multidisciplinary behaviour