MANUFACTURING
Jabil, St Petersburg, Florida, USA
A fine balancing act
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Image: iStockphoto
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Medical device companies are under ongoing pressure to deliver a range of sophisticated products. They must invest in processes to meet stringent regulatory requirements and bring products to market quickly, and do this while minimising operating costs and maintaining high quality standards.
Manufacturing is a critical compo-nent in this delicate balancing act. Sound manufacturing processes prevent costly errors and create healthy profit margins. Conversely, inefficient manufacturing practices can delay a product and significantly affect the financial well being of a company. In the medical device industry, manufacturing is partic-ularly complex because it requires high-mix, low-volume production, that is, an array of complex products must be made in relatively small quantities.
There are many challenges associated with conducting high-mix, low-volume manufacturing. Smaller quantities and more specialised processes can create more opportunities for error. Lower quantities demand frequent product line changeover, which can lead to the inefficient and costly use of equipment and labour between product runs. To handle these challenges, many medical device companies outsource their production. It helps them gain greater control of their margins and become more profitable by dedicating themselves to their core competencies such as research and development innovation, design and service.
In the medical device arena, there are a few experienced electronics manufacturing services (EMS) companies at the forefront of high-mix, low-volume production that have developed industry specific manufacturing processes and capabilities.
There are some tried and true capabilities and procedures that an EMS company involved in high-mix, low-volume, complex medical device manufacturing should follow. As medical device companies consider the pros and cons of outsourcing, here are some questions to help determine if an EMS company is equipped to handle some of the toughest challenges of this type of manufacturing.
Quality is the first priority for health care products. How can you guarantee that my product quality will remain superior if I outsource to your EMS company?
A strong track record of regulatory compliance is one important quality indicator. It is critical that an EMS company provides documentation to show compliance with the United States Food and Drug Administration regulations and ISO certification. Consistent employee training is at the heart of an EMS company’s commitment to quality. Institute for Printed Circuits electronics industry training is essential, as is a cross-trained workforce to maximise flexibility. Low turnover and high labour retention is also an indicator of a highly skilled labour force. Advanced Quality Planning is essential to success in first time expected quality rates as well as Design for Manufacturability improvements.
What are some of the things EMS companies do to maximise efficiency?
Contract manufacturers equipped for high-mix, low-volume production should have the ability to change over product requirements and convert assembly lines in a matter of minutes and add capacity to accommodate greater volume. In addition, good manufacturers will utilise lean manufacturing concepts such as standardisation, cross-training and the disciplines of 5S, a Japanese philosophy of work place efficiency, to maximise flexibility.
Do you manufacture in lower-cost labour areas such as India or China? How do you monitor quality in those facilities?
Rather than investing more capital in manufacturing facilities overseas, medical device companies can turn to an EMS company with an established and growing global footprint in emerging markets to manufacture in the most advantageous locations. EMS companies should be able to prove their ability to set up and maintain the same rigorous quality protocols for all of their plants, wherever they may be in the world. This can be achieved by showing consistently high customer satisfaction scores from current customers, customer references, the presence of quality initiatives such as advanced and lean manufacturing, high level certifications and robust internal quality plans.
How is supply chain information managed and how will you share it with me?
Choosing an EMS company with large supplier contracts allows for competitive pricing. As an added advantage, EMS companies should perform extensive quarterly reviews of high-tech suppliers around the globe to ensure they meet strict standards and price competitively. By maintaining a single instance of enterprise resource planning, an EMS company should be able to provide transparency and access to manufacturing and supply chain information globally to the customer and to the supply base.
Help with the challenges
As medical technology continues to develop at a rapid pace, medical device companies are standing at a similar juncture as personal computing companies did almost 20 years ago. They must determine if it makes sense for them to continue investing in their own manufacturing capabilities, or if their capital is better spent on innovation and marketing. Every company has its own path to success and outsourcing may not be for everyone, however, it does offer many ways to address the challenges of high-mix, low-volume production.
Tony Allan is Vice President, Instrumentation and Medical at Jabil, St Petersburg, Florida, USA, tel. +1 727 803 7360, www.jabil.com.
