The Secret of Entering The Automated Assembly Trend

The Secret of Entering The Automated Assembly Trend

Obamacare and Europe’s economic situation are exerting significant cost pressures on Medical Devices. Leading manufacturers are meeting these pressures with semi and full automation, even at their low-cost locations. The benefits are clear, cutting the total process length and training costs can massively affect costs. Executing manual processes automatically reduces risks and is more robust. Yet for businesses who wish to jump on this wagon, and automate their assembly line or part of it, a few considerations should be taken into account.

Successfully automating assembly processes, either in products or in Custom Integrated Components (CIC), requires a knowledgeable and professional design, preferably as part of the product design stage and by a partner with experience in the area. Thorough process design includes characterizing and choosing the right method of automation. The automation should be considered through all processes with value and can include electromechanical assembly, coiling and micro assembly, packaging, raw material cutting and stripping, laser soldering and welding,  and the like, combining the right portion of automation to human elements in the process.  With an efficient design of the process, a medical device business can harvest the power of automation and robotics, maximizing cost effective benefits.

Quasar group, with 3 decades of experience in medical device manufacturing, has implemented the most advanced automation methods already in its core assembly capabilities. We already run production lines combining human and automatic processes, whether in manufacturing, in AOI (Automatic Optical Inspection) or in the packaging stages. We now do micro assembly under 10 micron and have automated the adhesive placement process, both amount and location. We further implemented an automated vision and measurement process in product qualification process. We support these new operational skills with professional process design services, and minimize the uncertainty in the planning stage.

Our customers benefit hugely from these capabilities. As partners in the design process, we plan for and execute production with fixed duration and high consistency.  The 10,000th product that  emerges is identical to and  the same quality as the first product, allowing us to provide the highest levels of performance to our clients, saving on months of training and operating at the highest efficiency.

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Medical Device Manufacturing Risk Assessment

Assessing Risk: 5 Tips for Medical Device Risk Management

What is Risk Management Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike. Risk Management Standards for the Medical Device Industry Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as [...]

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medical device design and development

Medical Device Product Development: Make the Process Work for Your Product

Medical Device Product Development: How to Make The Process Work For Your Product The medical device design and development process consists of four main phases from start to finish of a medical device’s product lifecycle: conception, design & development, technology transfer, and mass manufacturing. The following is a simple step-by -step approach on how to make the medical device design and development process work for your product, pertaining to every medical device design and development process phase respectively. These factors are key to quick and successful time to market. Conception From as early as the product conception phase, care should be taken to [...]

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ISO 13485 Manufacturing

Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process

ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]

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Design Control Medical Device

A Simplified Introduction to Medical Device Design Control

Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]

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