How to achieve better products, greater product quality and increased profitability.
Mitigating risk and uncertainty
As a manufacturer of automated assembly systems, it is often striking that producers of medical devices and pharmaceuticals do not have a comprehensive understanding of what is meant by the terms “assembly automation” or “automation.” Many often use a term such as “packaging” when speaking about the automated production of infusion sets or even when working on changing an existing manual production process, which involves several work steps, to employing automation that is primarily controlled by means of software or machinery. As well as some useful clarification of the terminology used in this area, this article outlines why medical device manufacturers should employ automated assembly and production.
Not only in the medical area, but in almost all cases, automated production and assembly has a good reputation for saving money, but unfortunately this is often at the expense of personnel, because of the economies achieved by the automation effort. However, from the medical perspective, the priority must be product safety and protection; the greater product safety that automation provides not only protects patients’ health, but also manufacturers against the risk of legal infringements.
Assembly brings single parts together to deliver a product with function. Whether it is a cardiac pacemaker that consists of several technical parts or an infusion set that consists of a needle, holder, fittings and hoses and perhaps a liquid bag, all parts are brought together and manufactured into the final product at a certain point in the production process, which is generally called “assembly.” This sounds commonplace, but being aware that the required technical process is nothing more than assembly can ease finding a suitable partner. This will be a company that is capable of manufacturing the necessary equipment and of understanding the processes, the requirements and the product for fully automated or manually supported assembly automation. These are the ingredients in successfully increasing the number of pieces that are produced. Not every automation company will be the ideal partner for all projects and this has been examined in a previous article.1 But it does not require sophisticated science to find the best company for processing even complex projects.
Knowing the known
In terms of automated assembly, one of its most important benefits is that in the factual manufacturing process the biggest uncertainty factor is eliminated, that is, the human being. Where humans exist there will be errors and this is the case even in the development of automation systems. However, with the use of approved measurement systems such as Total Quality Management (TQM) for project management, unrecoverable errors or failures can be dramatically mitigated. In addition, and this is the best message, still existing residual risks can be “moved away” from the most critical processes by rigorously applying the guidelines of product and process quality management. In the same ratio that errors are mitigated, product safety will increase. This means that a thoroughly planned automation system will be able to work with repeated accuracy that is close to 100%, if all the factors that influence the process are identified and carefully considered. The results are reliable processes and systems and ultimately, products manufactured to a consistently high quality.
Improved working conditions
It seems ironic, but in some cases people who are employed in the health care sector are working in unhealthy conditions. They are exposed to the dangers of being contaminated or of acquiring infections when handling, for example, blood samples. Protecting the health of personnel in the working environment could be the best reason to automate an existing production process. Automation can be of help in batch processes, for example, for individual mixing processes. This could best be done with the integration of robotic technology that is suitable for sterile conditions. There are system integrators and robot manufacturers who can supply adequate technical solutions for these special requirements. New proprietary surveys show that solutions are urgently needed that must supply safety; they will also protect companies from risks of litigation by aggrieved employees.
Don’t emigrate, automate
Many products can only be manufactured by means of automated equipment because of the already mentioned risks to which workers would be exposed, the small size of parts, or the precision requirements involved. Also, there are often economic reasons when there is no alternative to automated production, for example, when, because of changed conditions of production and/or increased product complexity, costs have become too great. The motto, “Don’t emigrate, automate!” can be true for many medical devices and other health care products. Automated production can ensure profitability for the producer with lower priced products, and patient safety and health will benefit too. Automated assembled and produced goods are better if automated production is considered in the early development phase of the product lifecycle.
Total automation in production
The manufacture of medical devices is highly regulated. TQM, which is the ideal form of any quality management model, can best be attained with the help of a total automation solution throughout the entire product planning and product lifecycle. Important terms in this context (see Table I) are outlined below.
End-to-end project management. This means that not only the product, but the whole project, including the conditions for manufacturing and all other respective parts of the project, must be under the responsibility of a comprehensive management system to ensure the required high quality.
Product development and automation prototyping. This means that the special requirements for automated manufacture of the end product can strongly influence the development and prototyping phase. This should be considered early in the project and by experienced professionals.
State-of-the-art assembly and test equipment. Modern medical products are often characterised by great complexity in shape and function, which may require complex production processes that can only be adequately met by high-tech production conditions and product testing. These systems will also enable the manufacturer to implement product traceability, which is another way to attain high product quality.
Multiple-build and factory-scale integration. These capabilities relate to company size and factors such as turnover, number of employees or global positioning. They may be the preserve of larger companies and are more to do with selecting an automation partner than a characteristic of the product or the production.
Process information systems and traceability tools. These are other important measures to attain safe, high quality products. The respective systems record relevant data during production and in some cases these systems are part of the legal requirements for production of products.
Service and maintenance. A well established service and maintenance concept is of particular importance to high productivity automation systems.
Automation in assembly and production is important for consistent success in medical production. Even medical devices that are currently produced manually, which may be no longer competitive, can sometimes be automated in a step-by-step process. This can help to protect production from dislocation and can improve quality and safety for all related groups.
1. A. Sedlak, “How to Effectively Partner With an Automation Company,” Medical Device Technology, 18, 7, 52 (2007).
Alexander Sedlak is Manager Technical Marketing, ATS Automation Tooling Systems Munich GmbH & Co. KG, Heimstetten, Germany, tel. +49 89 4272 210, e-mail: firstname.lastname@example.org, www.atsautomation.com