MARKET PLACE
The route to precision
Automation is naturally suited to producing health care products with limited variability and the precise construction that is critical to ensure patient safety. There are two basic questions that producers of health care products should ask when considering a partnership with an automation company:
- What are the required basic competences of an automation partner?
- When in the project lifecycle should the automation partner be engaged?
The use of the word “partner” rather than “supplier” is intentional and designed to emphasise that the basis of the relationship must be one of trust. Moreover, the union of the medical device producer with the automation system provider must be highly integrated throughout the project life cycle to exploit the expertise of each. Bilateral partnerships of this type will generate positive results for both companies.
Basic competences
There are a host of automation houses capable of making appealing offers of their products and services. But it is necessary to look past the offers and examine their specific competencies and experience. The ideal automation partner will have global presence, be vertically integrated and have capabilities that can be utilised throughout the project life cycle. These include consulting services, concurrent engineering, bench-top prototyping, production simulation analysis, pilot and high speed automation equipment design and delivery, service and support.
Timing
There are significant differences between developing automation systems for the health care sector and those, for example, for the automotive sector. The automation technology for the automotive sector is mature and the companies have years of experience of designing for high speed manufacturing systems. In the health care sector most companies have a thorough understanding of the product, but less understanding and experience of automation and production systems.
Therefore, it is best to engage an automation company in the concept phase of the product development life cycle. Early partnership can influence the design of the product and take into account not only product functionality, but also its manufacturability in a future high speed production system. Early design concepts can be optimised to reduce nonvalue added assembly processes by incorporating self-locating features, and minimising the need to re-orient the assembly allows for less complex fixturing. Early design analysis can eliminate unnecessarily tight tolerances; reduce the number of parts by using integral attachment methods; harmonise and standardise bonding materials and techniques; limit the number of exotic or unique components that drive up costs; and integrate component features that enhance part feeding and presentation into the manufacturing space.
Design assistance
A potential automation partner should be adept in analysis of Design for Manufacture and Design for Assembly. These analyses, when conducted early in the design cycle, can reduce the product time-to-market, reduce the total cost of programme development and help identify and mitigate risks. Concurrently designing products and manufacturing processes allows teams to utilise past experience and employ similar designs and processes. A reduced number of parts results in fewer fabrication steps and processes to be designed, procured and controlled. Furthermore, incorporating design features in support of future automation while still in the concept phase can streamline the approval process for the product. For example, fewer product and process design changes improves documentation and maintenance of the history file and device master record. Also, fewer design and process changes reduce the number of validation cycles.
Regulation awareness
In addition to these fundamental capabilities, an automation partner must have a thorough understanding of the medical device industry’s regulatory requirements, a mature quality management system, and understanding of good manufacturing practices. Appropriate ISO certifications such as compliance with the quality management systems standards for medical devices ISO 9001 and ISO 13485 may also be useful indicators for identifying the right automation partner.
Satisfying time and cost Uwe Geissinger, Vice President of Operations Europe at Automation Tooling Systems says, “Health care companies are increasing their interest in flexible standard manufacturing systems. This allows them to produce different product types with the same production line. They can skill operations quickly, save money and redeploy reconfigured systems as needs change. Early involvement with an automation company allows the manufacturer to define and implement automation solutions that provide efficiency, throughput, quality and cost-effectiveness, and thereby get the most out of each euro invested.”
Information supplied by Alexander Sedlak, Manager Technical Marketing, ATS Automation Tooling Systems Munich GmbH & Co. KG, Heimstetten, Germany, tel. +49 89 427221 0, email: europe@atsautomation.com, www.atsautomation.com.
