MEDICAL EQUIPMENT AND INSTRUMENTS

The medical equipment and instruments industry is today facing four major challenges: innovation, adapting to regulations, managing production and meeting patients' demands.

Innovation

Innovation is this industry's main challenge. It can be broken down into four different areas:

• Product miniaturisation
• Cutting-edge technologies that increase the complexity of products, because they draw on new disciplines – on-board software, telecommunications/the Internet, information systems
• Integration of all these systems, which requires the expertise of a product architect
• Connections or links to solutions in the pharmaceutical sector.

Adapting to regulations

Medical equipment regulations are constantly changing. This requires companies to adapt their new product introduction processes (NPI):

• By compelling them to perform accurate engineering iterations
• As the pressure on cycle times increases.

Managing production

The third challenge this industry must face involves being able to manage partially or totally outsourced production in low-cost countries to reduce manufacturing and assembly costs, whilst controlling detailed specifications, product definition and preserving its know-how.

Meeting patients' demands

Patients' demands introduce a key challenge for the sector and become an important differentiation factor. Online access to information and medical monitoring are parameters to be integrated technologically and into product-related services.

PLM: solutions to meet the challenges of the medical equipment and instruments industry

A global PLM approach is a major mechanism for taking up the challenges by optimising the entire life cycle, from understanding needs to the after-sales service of the medical equipment used.

Two vital contributions should be considered:

• a single global collaboration platform to address the challenges and support the entire product design cycle from the initial stage through to engineering, manufacturing, sub-contracting and service
• resources to support and standardise key operational business processes.
  

	Single global collaboration platform
	A platform that includes a modern centralised upgradeable infrastructure with the appropriate level of control, traceability and monitoring. A platform built around the product portfolio to equip organisations that need to be increasingly flexible and agile with the required tools: To involve all the stakeholders as early as possible, in order to devise and validate new service or product concepts, deploy new technologies and reduce the TTM To compile, validate and share information in a structured engineering document repository and thereby increase its reuse To encourage an industry approach to standardising the processes to be equipped with tools and the infrastructures to be deployed To encourage an industry approach to standardising the assemblies to be produced.
	Operational business processes

	Management of the product portfolio and technological platforms to better react to the demands of the market and control the variability of the product portfolio: Management of needs, specifications and functions Management of the portfolio and different types of products Management of product conformity (and non conformity) to the current rules and standards. Management of modifications (ECR/ECO), CAPAs and quality procedures.	Engineering and collaborative validation Systems engineering and mechatronics to control the development of pluridisciplinary systems (electronics, software, mechanics) Definition of the digital mock-up as a master product to control and manage the changes made throughout the life cycle Product simulation to perform reliability and performance target specifications.
	Management of sub-contractors: Linking the design and sourcing processes is becoming more and more critical with the increase in the proportion of subcontracting involved in the final product RFx process Qualification of subcontractors and components Virtual plateau and engineering package exchange to integrate the partners into the co-design process.	Design-to-manufacturing engineering practices used to optimise concurrently the design and manufacture of the assemblies that make up the final product From style to design and manufacture of boxes produced end-to-end. Manufacturing and maintenance schedule Digital planning of assembly operations.

The V6 PLM platform makes it possible to create, implement and manage a global method of introducing new, innovative products into the marketplace.

It enables you to:

• Improve the definition quality of your product portfolio
• Ensure that products conform to functional, technical and regulatory requirements
• Increase the flexibility, modularity and portability of the product solutions and engineering studies and production equipment to be deployed
• Provide an important mechanism for improving the effectiveness of the NPI (New Product Introduction) and NPD (New Product Development) processes
• Reduce the times, costs and engineering risks inherent in accelerating the TTM (Time to Market)
• Control the risks related to service and warranty packages.

Our PLM package consists of PLM solutions and a range of services, from consultancy to operational support.

It aims to improve your processes by leveraging your existing system and the good practices provided by our PLM tools.

• Definition of a PLM strategy and roadmap
• Specification of solutions based on various business processes and adapted to your practices and objectives
• Implementation, deployment and development of these solutions and methods of use in association with our business consultants and service partners
• Support in the use of PLM tools
• Creation of pilot projects or demonstrations
• Business services centres with our service partners.