Features

The ideal contract manufacturer is more than a transactional supplier; rather, it is a partner that improves the product and process. Printed circuit boards (PCBs) and electronic box build assemblies are critically important in the medical field. Today, most medical devices used in healthcare settings to diagnose, test, or treat patients, as well as devices critical to laboratory research, rely on PCBs in one way or another.

High-speed surface-mount and through-hole assembled circuit boards and/or subassemblies should be among the EMS's capabilities.

Examples of devices that would not function without sophisticated electronics include pacemakers, defibrillators, heart monitors, medical imaging systems, magnetic resonance imaging (MRI) scanning systems, x-ray computed tomography (CT) scanning systems, gas analyzers, blood sugar and blood pressure monitors — and the list goes on.

As a result, it is relatively standard throughout the industry for medical device OEMs to turn to electronics contract manufacturers (ECMs) that can deliver the required high-quality PCBs in the required turnaround time.

ECMs are companies that design, manufacture, test, distribute, and provide repair services for electronic components and assemblies. This allows a medical device OEM to concentrate on its core competencies without having to invest in the cleanrooms, personnel, and equipment required for electronics manufacturing.

In addition, ECMs can ensure that the required components are extremely reliable and long-lasting. In the medical arena, if a machine is down due to failure of the internal electronics, a patient may not get properly diagnosed or treated. If the machine is a life-saving implant, a PCB failure could create a significant health risk.

Outsourcing

When medical OEMs outsource PCBs or electronic box build assemblies, the primary criteria when selecting a contract manufacturer typically boils down to cost, quality, and delivery. However, with so many companies claiming to deliver these three key elements, it can be difficult to assess whether a current or future contract manufacturer is truly reaching what should be a very high bar.

Ultimately, differentiating between the available options requires contemplating the question from two points of view: supply chain management and engineering. Although there is commonality between the two, both have unique perspectives in what they require, and expect, from an electronics contract manufacturer.

Where they converge, however, is a desire to work with electronics contract manufacturers that function more as partners than transactional suppliers. By doing so, the OEM benefits from additional design and manufacturing expertise that can serve to improve the product and logistics and even reduce manufacturing costs.

With so many electronics contract manufacturers throughout the United States, there are far too many that work with a simple customer-supplier mentality, which only makes the task more difficult.

The Supply Chain Perspective

Supply chain professionals focus on the “triangle” of quality, cost, and delivery when considering whether to work with a contract manufacturer. As such, rigorous vetting of each supply chain supplier in terms of its capabilities, quality management systems, and ERP systems is typically required. But a simple customer-supplier relationship often is not sufficient. Because business conditions are constantly evolving and changing, working with a partner that is continuously looking to improve production techniques and logistics can provide a competitive edge.

A partner should deliver high-speed surface-mount and through-hole assembled circuit boards and/or subassemblies and should be capable of doing electromechanical box-builds, design engineering/board layout, and functional test design, and should also be able to manage customer repairs.

An electronics contract manufacturer should increase the medical OEM's competitiveness by buying smarter and faster and working more efficiently. The contract manufacturer should consistently call and visit, and even audit its own processes to provide more value to the OEM. The two companies can even hold bi-weekly meetings, for example, to review production yields, any field test data, customer requirements authorizations, and any concerns.

Potential contract manufacturers should possess the production and testing equipment, capable of the necessary throughput for the contracted product.

At Aesynt, a manufacturer of medication and supply handling equipment for healthcare providers and pharmacies, James Norwood, was seeking more in an electronics contract manufacturer than cost, quality, and delivery. As director, manufacturing supply chain at Aesynt, Norwood sought exceptional technical skills and equipment, as well as flexibility. Although Aesynt designs all of its PCBs and provides the specifications, the contract manufacturer purchases all the parts, and then assembles, tests, and ships the completed products.

According to Norwood, Aesynt looked for a contract manufacturer whose employees demonstrated a strong technical background. It was also important that the company was ISO 13485 medical device certified, an international standard that sets out requirements for quality management systems specific to the medical device industry.

“The ECM has helped us to improve quality with their input on design manufacturability,” says Norwood. “On the delivery side, we have a complete Kanban system with our contract manufacturer. They keep a supply of printed circuit boards for us and ship it to us as soon as we release product so it's virtually a JIT process.”

Optimizing Engineering Design

Another vital perspective for any manufacturer considering working with a contract manufacturer is that of engineering. In that regard, quality is often the focus, with cost and delivery still important concerns.

To achieve this, the contract manufacturer's engineering capability must be superior, which often can require various testing procedures to ensure product quality. In addition, for the best results, the contractor must also have the ability to collaborate to improve design and manufacturability.

As such, choosing a contract manufacturer involves an important process of initial evaluation, followed by ongoing evaluation and collaboration over time. Any potential contract manufacturers should also be ISO 9001 certified and should have in place all production and testing equipment capable of the necessary throughput for the contracted product.

Included in a contractor manufacturer's expertise should be a combination of manual testing, automated testing, and functional testing capabilities. The functional testing should involve evaluating voltage, temperature calibration, and other functional measures of finished product.

By doing engineering up front, hand-in-hand with the contract manufacturer, medical device OEMs can reduce the amount of time and cost required to produce each product, sometimes significantly. While manufacturers all have their own criteria in deciding which contract manufacturer is best for their application, choosing one that is ready and willing to collaborate can only improve the product and process.

This article was written by David Spehar, Jr., Vice President of Operations at Pennatronics Corp., California, PA. For more information, visit here.