Similar portable medical electronic devices are being favored by the market, which is clearly a growing market, but so far, traditional Chinese electronic OEMs and EMSs have received little attention. Databeans, the market research company, predicted in 2004 that semiconductors have a capacity of $59 billion in the entire medical device market; another report pointed out that sales of wireless medical electronic devices in Europe will increase from $98 million in 2003 to 2008. $445.8 million. “This represents a small part of a larger market,†said Keith Robinson, industry manager at Frost & Sullivan. “But it is clearly a growing market.â€
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There are two factors that can also indirectly prove the above argument. First, countries around the world, especially the US government, are asking the health care industry to control costs. Second, some countries are ageing, while middle-aged and older people care about health care and demand affordable health care reforms that could not have been possible 10 years ago.
Robinson also believes that traditional medical devices are merging with digital consumer electronics and wireless products that are shrinking in size, lighter in weight, adding more features and connecting to wireless networks. This marks the consumerization of medical electronic devices, which are moving out of hospitals and doctors' offices to other channels. This seems to be somewhat similar to the trend in wireless devices.
For example, the automatic electronic defibrillator was first put on the counter in 2004. Greg Love, CEO of Micro Power Electronics Inc., said the typical cost of a defibrillator has dropped from $5,000 to $2,000. The company supplies battery systems to the 70% defibrillator market. He said: "Mobility and portability are becoming the key to the medical electronics industry."
The trend toward miniaturization of medical electronics begins with blood glucose monitors and extends to other devices such as wearable heart monitors and infusion pumps.
30% of Plexus' annual sales revenue comes from the manufacture of medical products, amounting to 300 million US dollars. Brad Goskowicz, vice president of the company's EMS provider Plexus Technology Group's medical division, found that the market for home monitoring equipment using RF technology is on the rise, such as communication equipment used to monitor heart patients. Goskowicz also mentioned that there are more and more types of medical electronics that can be implanted into the human body, such as pacemakers.
At the same time, large OEMs such as GE Medical Systems and Philips Medical Systems realize that they need to reduce equipment costs and develop products faster in order to remain competitive in the portable world. In the process, these manufacturers are breaking the tradition and asking EMS vendors for help.
"EMS vendors can bring their technology in multi-layer board design, imaging and image processing, wireless and multi-chip modules to the medical field, enabling medical OEMs to further improve their products from a technical perspective," Robinson said. The electronics industry is behind some other markets in some respects."
US market access rules
Manufacturing a defibrillator is clearly different from making a 3G phone. It must meet the health care regulations and regulations. Let's take a look at the US rules. In the United States, although the production of electronic products is handled by EMS, the final assembly work is tightly held by the medical OEMs because they must ensure the overall performance, intellectual property and compliance with the US Food and Drug Administration. (FDA) regulations.
First, the manufacturer must be an FDA-registered or FDA-approved company. FDA-registered companies refer to companies that have been verified to have a quality system that meets the Federal Good Manufacturing Practices (GMP); FDA-approved companies are those that provide products to end customers and must meet further requirements. For example, an EMS company called SMC is an FDA-registered company, but it is not an FDA-approved company, and its OEM customers are responsible for the final testing of the product.
There are several steps to be taken to meet FDA requirements. The main step is to document the medical product, starting with the concept, in many cases until the end of the product's life. According to industry insiders, the FDA's requirements are not cumbersome, but compared with consumer products, it is more important to pay attention to details because it involves legal issues. “If the product is not well documented, you will have trouble applying for government approval after the end of manufacturing,†said Dan Marinsik, vice president of quality assurance and regulatory affairs at the company.
At present, medical electronic products account for about 6% of the total sales revenue of the four seas. Marinsik said that in the past two years, the ratio has increased by 5% per quarter and is expected to rise to double digits by 2008.
In addition, care must be taken to prevent materials and components in the gray market from being mixed into medical products, and suppliers must pass FDA approval. "The FDA should be involved and review the supplier's qualifications," Marinsik said. Four Seas also regularly reviews its suppliers and uses a global ERP system to ensure that raw materials cannot be sourced from sources outside the AVS list. He said: "In any matter related to medical care, you must always guarantee legality."
Tracing is accompanied by documentation. When medical electronics leave the health care institutions and doctors' offices, component traceability becomes a critical and challenging task.
Service records are also very strict. For example, if an X-ray tube needs to be replaced, the OEM's installed product database must also reflect the serial number of the new X-ray tube after the technician has replaced it for the customer.
Service and repair are key aspects. If a medical electronic device is returned to the OEM for maintenance, the entire process must be documented. "If you find a trend or a potential problem and can cause harm, you must notify the FDA," Marinsik said.
Medical OEMs typically bear product liability, but this situation can change as more and more products are outsourced. Some EMS vendors are discussing product liability issues with OEMs, and such discussions are deeper than in the past. "The law is clearly a problem that everyone should pay close attention to." Robinson said.
Industry insiders say that despite the layers of regulation for the manufacture of medical electronics, electronics manufacturers should not be intimidated. Meeting the FDA's requirements is not as difficult as it seems on the surface. “Once joined in and become part of this culture, the FDA-compliant manufacturing business is part of the overall process and is not particularly troublesome,†said Plexus' Goskowicz. “It's regulated does not limit or slow business growth. speed."
But when it comes to documentation and traceability requirements, smaller electronics manufacturing companies may face some challenges. John Zurborg, vice president of sales at SMC, said that the development of a corresponding traceability management system could lead to a significant increase in costs.
Notice if the business model matches
Strong engineering capabilities are also one of the potential difficulties. Marinsik of the Four Seas pointed out that medical electronic devices have a longer life cycle than consumer electronics, and small home medical electronic devices typically last 3-5 years. Although the life cycle is long, medical electronics require more attention to design than consumer electronics in terms of accuracy and ease of use.
The biggest trouble is that medical electronic products are usually produced in multiple varieties and small batches. Equipped with Chinese electronics manufacturers for high-volume manufacturing lines, it may not be suitable for the multi-species demanded by medical OEMs.
In fact, when evaluating EMS providers, whether the business model matches is the most important one. For example, a top EMS received a $20 million contract, but after half a year it found that the costs incurred to meet FDA requirements and the rapidly changing technology were significantly different from the company's usual manufacturing methods.
Whether or not you have a factory around the world is not a decisive factor in attracting medical OEM customers. In general, OEMs want final assembly in North America so they can easily send engineers to the EMS factory on a regular basis. For example, all of Sonosite's ultrasonic equipment is finalized in North America, 50% of which is sent worldwide.
Robinson also believes that production in Asia involves intellectual property security issues. In the medical market, counterfeit goods can endanger users. But some people do not fully agree with this view. Plexus' Goskowicz said: "Our customers demand a more global layout where products need to be produced close to their sales market." For example, circuit boards for medical products are produced in Asia and shipped to Europe for final assembly. And sold to the EU region.
In some respects, the production of medical electronics is following the pattern of other electronics. Large OEMs want flexibility when developing products, while small OEMs don't want to invest in factories. Goskowicz said: "Smaller companies often have a termination strategy, that is, waiting to be acquired, and the factory will become their burden."
SMC's Zurborg pointed out that in a recent contract tender, a large medical OEM specifically required EMS partners to have a global manufacturing presence. He said: "This is the best example of OEMs trying to reduce costs." China and India are clearly the preferred low-cost supplier market.
In addition, the portable trend of medical products will also prompt OEMs to hand over product manufacturing to low-cost electronics manufacturers. “Typically, OEMs will look for EMSs that focus on producing medical products,†he said. “With the consumerization of medical electronics, they must take a low-cost path to remain competitive, which will allow a large number of medium-sized EMSs to enter the market.â€
Analysts generally believe that the medical electronics market will not be as easy to form a bubble as other industries. But if Chinese electronics manufacturers decide to invest in the medical electronics market, then take a cautious approach, because the return will not be immediate. But over time, the portable medical electronics market may offer more stable and lasting returns than other business areas.
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