In the Product Design & Development Brainstorm we talk with industry leaders to get their perspective on issues critical to the design engineering marketplace. In this issue, we ask:

What should medical device OEMs expect from their suppliers?

John Koon, Director of Corporate Communications & Public Relations, Express Manufacturing

Express Manufacturing, Inc. (EMI) has been in the Electronic Manufacturing Services (EMS) business for almost 30 years with headquarters in Santa Ana, CA and factories in both the U.S.A. and China.

Both facilities standardize on the Fuji equipment lines with certification from ISO 9001-2008 and ISO 13485:2003 (medical). With years of experience in the electronic field, EMI has found that medical devices are most demanding of all, due to stringent requirements because its applications are used on human beings.

Therefore, medical device OEMs should expect, at the minimum, the following from their suppliers, whether they are EMS providers or component makers, to ensure quality and safety of their products.

Supplier Knowledge & Experience in the Related Field. An EMS provider should have knowledge and experience in the medical electronic field to support OEMs with design, test and manufacturing of such products.

The major difference between medical electronics and other electronic devices, such as industrial control, is that medical devices directly affect the patient’s well being. The impact of poor product quality ranges from inaccuracy of results to potential bodily harm. An OEM should partner with a knowledgeable and experienced EMS provider to assure quality and safety.

Reliable Process in Place. To produce a quality product, an EMS provider should have the ISO 13485 certification which dictates the EMS provider to have a rigorous procedure in controlling the manufacturing process with detailed documentation to ensure reliable output on a consistent basis.

In case of failure, the process can be used to track the causes of the problems and find fixes to prevent them from happening again. Everything should be documented and can be audited any time.

Dependable Services from the Supplier. These include responsiveness, support and quality product at a reasonable price. An EMS provider should be a partner of an OEM to help the OEM to be successful. This requires the EMS provider to have a strong support team stand behind the OEM.

Finally, an OEM should always expect quality product from the supplier. While product cost is always a factor, product quality is evermore important. Expect the best from your suppliers and work with them to achieve success.

Peter Resca, Director of Engineering, Astrodyne

Medical device OEMs face a difficult environment and require their suppliers to be less passive vendors and more active partners.

The nature of the medical device market is that the manufacturers are subject to regulation from many agencies including the FDA, European Union, safety organizations, etc. This makes it important for their vendor base to support their efforts. The support may come in many forms from initial design and documentation through process controls, lot tracking and material composition.

Further complicating the environment is the fact that the guidelines are constantly changing. For those in the medical electronics space, the International Electrotechnical Commission (IEC) 60601 3rd Edition (the electromedical equipment safety ‘bible’) represents a major shift in the approval process. 

Medical OEMs will need to understand possible faults to ensure the risk analysis is complete. The elimination of the RoHS exemption in medical electronics will also have a significant impact, as OEMs must evaluate and update their products for material composition to guarantee compliance.

A second major change in the environment is the move by many OEMs to market their products internationally. Leaving a specific region may entail a new regulatory body with a different set of rules.

Alternatively, the domestic China market is facing new challenges as they bring their products more in line with the IEC 60601 standards. Many of the domestic vendors have had difficulty supporting the medical device OEMs and thus, the OEMs have turned to partners with a history of supporting international markets.

Experience teaches us that the best foundations are the result of communication and desire to win together.

This is true for the suppliers who partner with medical device OEMs to provide exciting new products in a market space that is pushing forward in a meaningful way.

Keith Hechtel, Director of Business Development, Curbell Plastics, an International Association of Plastics Distributors Member Company

Medical device OEMs manufacture products that are used to care for sick and injured human beings. Product performance is critical since part failure can create hazards for patients and can potentially expose device manufacturers to legal liability. Because of the critical nature of their products, medical device OEMs should expect suppliers to go beyond the basics of good customer service, competitive pricing and quick deliveries.

First, suppliers need to use top quality raw materials to ensure part performance. Metals and plastics of questionable quality can often be obtained at discounted prices, but the potential for part failure increase dramatically when poor raw materials are used for manufacturing.

Suppliers also need to be able to provide full material traceability with lot control numbers documenting each step in the supply chain. It is particularly important for raw materials that require certifications to standards such as USP Class VI or ISO 10993. Inaccurate or late documentation can cause costly manufacturing delays while paperwork is corrected. 

Suppliers should also be prepared to offer design assistance to medical OEM customers. It is essential that the technical associates at suppliers become engaged early in the design process to offer tips on materials, part geometry and manufacturing methods to improve product quality and/or reduce manufacturing costs. Plastic material suppliers can often suggest small design modifications that can be the difference between part performance and failure. 

Finally, suppliers should provide OEMs with information on new materials and subassemblies. From a plastics prospective, new polymers with an improved ability to be sterilized, better mechanical properties, lighter weight and improved wear characteristics can improve medical device performance and keep device OEMs at the forefront of technology.

Lianne Coppinger, Director of Compliance and Regulatory, Cogmedix

Cogmedix is an Food and Drug Administration (FDA) compliant and ISO 13485:2003 certified medical device contract manufacturer that provides contract manufacturing and fulfillment services for class 1 and 2 medical devices. Our customers are medical device OEMs that depend on us to be partners in compliance and quality, and to operate as a seamless extension of their business. Compliance, commitment and communication are three key expectations medical OEMs should have of their suppliers.

Compliance is especially important because the medical device industry is heavily regulated. Adherence to international standards such as ISO 13485:2003 and to the FDA's Quality System Regulation — also known as current Good Manufacturing Practices (cGMP) — are mandatory for manufacturers of medical devices. Medical device OEMs are ultimately responsible for the compliance and quality of all parts and materials used in their medical devices and the FDA will hold them accountable.

Medical device OEMs should be able to trust their suppliers’ commitment to compliance and product quality. Cogmedix understands that poor quality can result in product recalls, customer dissatisfaction, regulatory ramifications and costly rework; therefore, we operate with the highest degree of transparency.

We support our customers by assisting them with facility inspections and quality audits. We consistently verify conformity to specifications through test and inspection, and we insure product quality by monitoring and sharing quality data. Training and certification are standard operating procedures for our employees. 

We also strongly encourage accurate and timely communication with our customers, starting from the beginning of the partnership by clearly defining and communicating respective roles and responsibilities in a written agreement, and continuing the communication on an on-going basis so that customers are kept informed and can manage their business. 

Larry Walck, Director, Business Development, Mack Molding

From a contract manufacturing perspective, the answer to this question falls into two main categories: skills and services (the more absolute) and long-term partnership capabilities (the more abstract).

To tackle the first, the supplier should have a solid team of personnel with the appropriate skill sets related specifically to the manufacture of medical devices.

Broadly speaking, these skills should support several key areas of proficiency, including product design and development, materials expertise, program management, manufacturing engineering, quality engineering and production services.

The supplier’s quality systems should support the rigor of medical manufacturing, and a regulatory compliance group should be in place to ensure conformity to the FDA’s current good manufacturing practices.

Purchasing controls should be in place to manage supply-base risks, as should a robust document control system with a formal change control process. The supplier must have the financial wherewithal to support the engineering-rich and quality oriented approach necessary for medical device manufacturing, as well as the lengthy product development and regulatory approval cycle that typically accompanies it.

Modern, well-maintained equipment and facilities are also important and can reflect a company’s financial strength.

Beyond the more obvious list of skills and services, however, the OEM should expect their supplier to become part of the OEM’s team – one team working toward common goals. As part of one team, each party should expect full transparency, honesty, integrity and mutual trust.

The supplier should not only serve as a sounding board, but as a lens through which the OEM can view its product from different perspectives. The supplier should come to the team prepared with a progressive, innovative approach to business, technology, finance and services.

The OEM and supplier must be culturally compatible and share common goals — and the supplier must be willing and able to go the distance until those goals are attained.

Paul Cain, General Manger, Piher North America

In the case of position sensor suppliers who serve the medical market, there are some very consistent expectations that cross over many medical applications. The first is product performance; for position sensors that means being able to achieve the OEM’s requested accuracy (typically -linearity) over the life of the device.

This might not be an issue with a disposable device, but in the case of durable hardware (capital equipment), these devices can frequently stay in service long past its intended design life.  This is where a sensor’s accuracy and durability can make a real difference in the overall system performance.

Next on the list of expectations should be a supplier’s ability to deliver known, documented materials in their device. Medical approval processes require extensive documentation (material certifications) on every single material used in the device to ensure its compatibility with all types of contact with the human body.  

Closely related to this is process control and traceability. OEM’s should expect that a supplier will have a thorough system of lot traceability for their raw materials and component lot numbers.

Additionally, suppliers that serve the Medical OEM’s must have extremely robust control over contamination and process control measures to ensure the required cleanliness level of every part.

OEM’s should also be able to expect that their sensor supplier should have the engineering resources to custom engineer solutions specific to their needs. In today’s environment of medical cost control, extracting out unnecessary cost(s) while still achieving high performance frequently involves designing in a custom solution.

The supplier should be capable of designing and testing unique solutions that fit the increasing list of specifications –that is key to remaining competitive.

Peter Ranalli, Vice President Sales and Marketing, Selco Products Company

OEMs in the medical equipment industry should expect high quality, responsiveness, on-time delivery and cost-competitive pricing for the product they are buying. Because of the risk/benefit nature of medical devices, OEMs in this industry are extremely concerned with optimum safety, precision accuracy and high reliability.

These are critical requirements for every step of the OEM’s design and manufacturing process.  Stiff government regulations for medical devices are another element added to the mix of product requirements.

Suppliers that not only deliver on these requirements, but also help solve some of the OEM’s design headaches, are a huge asset. We accomplish this by providing design assistance to OEMs in the product development cycle.

Simple and complex product modifications of a standard component, be it a temperature control, thermistor or electronic device, can make a big difference in solving a design challenge and in savings at the production end.

With today’s competitive economy and strict product regulations, OEMs can afford to work with suppliers that provide only the best at every level to meet the safety and performance standards of the medical equipment industry.

David Crafoord, Partner & Design Consultant, ergonomidesign

Our clients are often large companies such as Johnson & Johnson, DePuy, Mitek, 3M and Novartis, and as an industrial design consultancy, our clients expects us to help them succeed in new markets, increase sales and build strong brands through attractive, user-friendly and innovative products.

I believe a product is one of the most important carriers of a brand. A great product design has the ability to strengthen a brand and build customer loyalty. The combination of our multi-disciplinary teams has helped our clients all the way from revealing user insights and concept development, to prototyping and implementation. For example, when Ergonomidesign worked with Siemens to create the ventilator, Servo-i, we achieved global market success. A ventilator is a complex and demanding system and through our design research, we uncovered the needs and demands of nurses, doctors and patients. We translated this knowledge and insights into a user-friendly and attractive solution – the Servo-i. The Servo-i system fulfilled several unmet needs in the marketplace, which in turn exceeded the expectations of its sales representatives, users and buyers.

Our people-driven design has the potential to enhance the quality of life, build businesses, and transform entire industries. Our proven track record and 300 patents illustrates that we have delivered life-changing and paradigm-shifting solutions for the last 40 years.

To keep delivering, we never stop asking questions. We believe in involving all types of stakeholders in the design process, and we believe it is crucial to have a close collaboration with our clients.