Automotive manufacturing is vastly different from many other types of manufacturing. While switches and sensors can be produced by just about any facility, the automotive industry demands an entirely different and higher set of standards. While these ideals support efficiency, they primarily support safety, so they can be applied with great benefit to the medical industry and medical manufacturing, as well.
There are many similarities between these two industries with respect to manufacturing electronics. First, there is an emphasis on safety. Lives depend on the products of these two industries perhaps more than any others. Any entity creating devices for medical or automotive markets must put safety and reliability ahead of all other priorities. Functionality is a secondary key. Every device must function effectively and efficiently – exactly as it is designed and expected to, each and every time a vehicle is used. These industries are also highly competitive, so an efficient manufacturing process that brings quality products to market quickly is also critical. There is no room for failure or waste.
With this in mind, standards applied to automotive manufacturers – which as stated, go above and beyond other industries – can serve medical OEMs. These include Lean Manufacturing processes and TS certification.
Many facilities, even beyond the automotive space today operate under some form of Lean Manufacturing. This system, adapted from Toyota’s production process – hence its popularity in the automotive sector – eliminates waste by focusing on Kaizen, or continuous improvement. Companies like Etratech implement a 5S system to standardize Lean processes and maintain a clean, well-organized and safe workplace. Lean operates on these 5 principles:
- Understand the value in the eyes of the customer – what creates value for them?
- Understand the value stream – every step in your processes
- Make the value stream flow
- Create pull – by producing only what customers request
- Continuously improve
This is as important for medical manufacturing as it is for any other industry because it reduces waste and improves efficiency, which will clearly drive value. It also improves speed, resulting in faster times to market. But most importantly, Lean improves quality. As noted in in April 2015, “Lean is about improving quality as well as delivery/lead-time and cost. By creating a problem-solving mentality within an organization and developing strategies for improving product quality, an organization can produce high-quality products without the cost of added inspection. Instead of increasing the number of inspection stations, a lean medical device manufacturer would utilize true root cause analysis problem-solving to eliminate the causes of defects.”
Similar to Lean Manufacturing process, the ISO/TS16949 is a technical specification that “focuses on development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain,” according to Wikipedia. While based on the ISO 9001 standard, the TS certification was developed specifically by the International Automotive Task Force (IATF) for their industry. IATF members include BMW Group, FCA US LLC, Daimler AG, FCA Italy Spa, Ford Motor Company, General Motors Company, PSA Group, Renault, Volkswagen AG and the vehicle manufacturers respective trade associations – AIAG (U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.) and VDA (Germany).
The TS certification is among the most stringent manufacturing standards. As we’ve noted in previous blog posts, automotive components are built with the understanding that people’s lives are at stake every time they take to the highways. As Etratech’s Director of Engineering, Steve Sanders, has stated, “There’s a definite sense of urgency when designing automotive parts that reflects the fact that these technologies are potentially life-impacting – and that we respect and honor that significance. Its focus that’s as important in automotive as it is in medical.”
The TS automotive quality system is concerned with safety in a way that is comparable to the medical market and other industries that deal with health and safety. Anyone who has worked in the automotive industry understands the importance of design that puts safety and reliability at the forefront, without compromising function and usability.
With Lean Manufacturing and TS certification in place, medical OEMs can feel confident that their chosen EMS partners will deliver products of the highest quality, in the most efficient manner possible. Etratech is proud to be one the very few electronics companies in Canada to hold both an ISO 13485 certification for designing and manufacturing medical devices, as well as TS 16949 certification for automotive. In fact, we’ve been nominated for awards for our efficient processes – and we’ve won one in our unparallelled China facility.
If you’re a medical device OEM, contact us today about how we work together to achieve your business goals in medical manufacturing.