Catch up on the latest news

World Class Production Services

The manufacturing capabilities of SE Asian suppliers have evolved to the point that they are able to meet the standards required for the production of medical devices. Porticos Asia has supported medical device production in SE Asia for numerous customers. Often these products are engineered by our partner, the US engineering consultancy Porticos Inc. Our customers range from start-ups, with production runs of several hundred to global companies with quantities in the hundreds of thousands.

SE Asian suppliers not only offer competitive pricing but can match the quality standards of American and European suppliers. In addition, lead times from final engineering prototypes to delivery of first production units are unbeatable. And because we offer a turnkey solution, from engineering design to product launch we can further accelerate development times. For a Spooler for Automated Medicine Dispensation designed by Porticos Inc for Spencer Health Solutions, we were able to make important contributions at the design stage. As a result, the time from the final engineering design to shipment of first production units was just 12 weeks.

When it comes to the supply of components, from off-the-shelf parts such as batteries, LCD displays and cables to custom parts such as injection molded housings, the supply chain in SE Asia is unparalleled in its depth and breadth. Although there is evidence that some production reshoring is occurring it will take a considerable amount of time to build up a supply chain locally that can match that found in SE Asia. 4WRD Innovation is developing a telecommunications device and has engaged us to provide key subassemblies including modules for the LCD display, camera and fingerprint sensor. As Dr Giua, Director of the 4WRD Innovation Milan office, mentioned, there are simply no alternatives to SE Asian suppliers for these components.

Leveraging the Competitive Advantages of SE Asian Suppliers

SE Asian suppliers offer manufacturing solutions combining high-quality, competitive pricing and short lead times. But to fully leverage these advantages a number of criteria need to be taken into consideration. In this short article we will look at ways in which medical device production in SE Asia can be optimized.   

Electronic Component Specification

Electronic component supply has reached a critical juncture. Lead times have increased for some components to over two years. And in other instances, components simply aren’t available. Once a design has been finalized it becomes much more challenging to modify it. Alternative components that can be sourced from SE Asian suppliers that have shorter lead times and lower cost can be specified. But this intervention needs to be made at the development stage, before the design is locked down. With the electronic engineering team at Porticos Inc. we were able to propose alternatives for components for a cardiac monitoring system developed for Medicomp. With these alternatives Medicomp was able to replace components that were not available and proceed with production which was previously at a standstill.

Raw Material Selection

As with electronic components raw materials have recently been subject to increasing lead times. When certain materials such as biocompatible resins are specified, this can exacerbate the problem. And once a material has passed through a certification process making a change can be prohibitive. A legacy biocompatible resin used by one of our customers has a lead time of over 6 months. What’s more, it has a large minimum order quantity of several tonnes, way in excess of what is needed for a single production run. Again, by intervening at the design stage, materials with shorter production lead times and smaller MOQs and that are more readily available in SE Asia can be selected.

Supplier Certification

As a rule of thumb, the tier 1 supplier, that is the supplier carrying out the final assembly and testing, should be certified ISO 13485 for medical device production. This certification assures that manufacturing and quality process control are at the level required. For example, to allow traceability, the final product as well as critical components such as the PCBA need to have a unique ID. With such a system the manufacturing details of a particular unit can be determined. This is important if there is an issue with a product in the field. An ISO 13485 certification ensures that the facility has the system in place to manufacture traceable products.

In addition to ISO 13485 there are more onerous certification requirements such as the certification of a specific supplier for a specific product. One such example is the TÜV SÜD standard requested by Masimo, a medical device manufacturer. For this standard an audit team will visit the chosen facility and certify it for the manufacture of the product in question. This provides additional level manufacturing and quality assurance. The drawback is that if, for whatever reason, a change in supplier is needed then the new supplier will have to be recertified.

Use of Local Parts and Materials 

In general, we do a lot of work sourcing local alternatives to those specified. Finding potential alternatives is not that difficult. The real challenge is finding alternatives that meet the specified standards and that are produced by suppliers that can be trusted in the long term. For one medical device, a blood glucose meter, we found a local and highly reliable battery supplier and developed a custom design thereby offering a significant saving compared to the original off-the-shelf battery. 

Quality Control

Ensuring a SE Asian supplier is qualified to make medical products is important. But this does not guarantee production quality. The first step in quality assurance is to develop detailed working level quality plans for each part, sub-assembly and the final product. second is to ensure the specified quality control process is strictly followed. The only way to ensure quality remotely is with the use of third-party quality control staff, stationed at the factory during production. Porticos Asia has experience with numerous medical products developing detailed quality control documentation and directly ensuring compliance. Reports then are prepared for each production run for the customer’s convenience. For example, for iSirona, a device that aggregates medical data in a hospital, we provide our customer with records of the  automated final functional check which is carried out on every unit. 

Production Management

Beyond quality control there are numerous interventions needed for production to take place without mishaps. These include: the design of the production layout; development of detailed work instructions; worker training and; the coordination of all vendors in the supply chain. Despite such planning issues always occur. And when they do prompt and decisive intervention is needed to minimize any disruption. It is not always possible for the customer to intervene at short notice, especially during the pandemic with travel restrictions in place. This is where it is advantageous to have a regional partner.  

Excellence in Medical Device Production, with Caveats

An Economist Intelligence Unit report concluded that Asia will continued to be a preferred production hub in the medium term because of reliability, convenience and cost-effectiveness. This is especially the case for medical device production in SE Asia. The capabilities of suppliers in this region have continued to advance with the accumulation of experience and capital investment. But these advantages can only be leveraged through careful supplier selection and management. Realizing high quality, cost competitive products requires a focus on detail and meticulous implementation that can only be achieved by directly overseeing the manufacturing and quality processes.

The electronic component shortage has been dragging on for over a year now and shows no sign of abating. In this short article I highlight some of the measures we at Porticos Asia have been taking in managing electronic component shortages.

The Origins of the Electronic Component Crisis

A 2021 article by Attinasi et al. for the European Central Bank noted how demand from the automotive industry collapsed during the  second quarter of 2020 due to the pandemic. This drop was more than offset by an increase in sales of computers, smart phones, video conferencing equipment and gaming consoles. People were forced to work and study from home and so demand for these electronic goods surged.

The car industry eventually bounced back but the production capacity hasn’t been sufficient to meet this return in demand. What’s more, fires and droughts affecting large plants have exacerbated problem.

Factories have responded with plans to increase capacity but this will take time. For example, the expansion of chip maker TSMC won’t come online until the second half of 2022.

When Will Things Return to Normal?

EMS Now recently solicited feedback from industry leaders on the challenges they are facing and expectations moving forward. The issues highlighted varied from the risk of counterfeits to short term spikes in pricing and last minute cancellations of component deliveries. Also, all of the 20 executives agreed shortages would persist for some time. Alfred Birgmann, Vice President Global Procurement at Zollner summed up the gloomy sentiment stating that he thought the shortage of “passive components [would] relax mid- 2022”. He added that in the active component area improvements wouldn’t be seen  “until the end of 2022/start of 2023.”

Dealing with Uncertainty

Strategies for managing the disruptions caused by electronic component shortages fall into three categories: 

1. Designing for disruption. This involves designing or modifying products to minimize exposure to hard-to-buy components.
2. Operations innovation. Using supply chain based solutions such as maintaining inventory or encouraging customers to plan for the longer term.
3. Ecosystem innovation. Simply put, greater supply chain transparency. It could be argued that supply chain transparency is a characteristic of any healthy customer/supplier relationship. Nevertheless, it is especially important in volatile environments. 

With the following case studies we detail how we have managed the adverse impacts at Porticos Asia using one or a combination of these solutions. Customer names have been omitted in line with confidentiality agreements.

Case Studies in Managing Electronic Component Shortages

Telecommunication Products in the Public Safety Sector

This first example involves a telecommunications product for law enforcement, fire, utilities and emergency medical services. We manufacture this product for a Fortune 500 company.

The design was developed by our partner, Porticos Inc. before electronic component shortages were a concern. On sourcing materials for repeat production orders we found some components were out of stock with our regular suppliers. Furthermore, lead times had increased to over 50 weeks. In this instance we have been able to secure components from alternative reliable sources and also avoid disruptions to the production schedule. As we will see from other examples we haven’t always been so lucky.

For follow up telecommunications product for which the design development has recently kicked off an alternative strategy was used. We knew in advance that there is a general shortage of chips that will persist. As a solution, the customer identified a chip set to be used not only based on its suitability but also on its availability. Furthermore, the decision was taken to advance buy sufficient quantities for the first few years of sales. Naturally, in instances where products are being developed for which there is no accurate forecast then it might not be feasible to advance-buy. The downside is of this solution is customers are forced to tie capital up in materials well ahead of generating sales revenue.

Medical Devices

For a medical device that aggregates hospital data for a leader in the B2B medical hardware sector the longest lead time for components has doubled to over 90 weeks. Furthermore, component suppliers have implemented more onerous terms such as the non-cancellation of orders once placed. In this instance components are available on the spot buy market. However, because the additional cost is over US$40K per order of 5K units the customer has decided to forego this option and instead place the order well in advance. This solution is feasible because the customer has an accurate, long term forecast.

An additional challenge that we have had to be overcome is the unavailability of one component. This was due to a fire in the only facility producing this part. The solution in this instance was a design change implemented by our partner Porticos Inc. A straight component swap wasn’t possible. There were no alternative components with the same specifications and footprint. Therefore, the only choice was a redesign of the PCBA to accommodate a substitute. 

In a separate case, in a different B2B medical sector, that of cardiac monitoring systems, a hybrid approach was taken. Having determined that standard lead times for some components had increased to unacceptable lengths of over 100 weeks, we purchased these components on the spot buy market at a greatly increased cost. For example, an IC with a regular price of around $4 approximately was purchased for approximately $12. This was a painful decision for the customer to take. But having confirmed the authenticity of the component and recognizing its extremely limited availability we took the decision to pay the large additional cost. At the same time the PCBA was redesigned so that alternative components that were available could be used.

It should be stressed that it was not possible to establish a buying strategy in advance and implement it. The electronic component market is highly unstable. Components become available or unavailable on a daily basis and prices changing equally quickly. Thus, an iterative process is necessary, adjusting the strategy as new information becomes available.

Transparency and Communication are Critical

The current environment is highly disruptive. It’s simply impossible to devise and implement buying plans as we have been accustomed to. Unwelcome decision involving design changes and increased costs have to be taken quickly. On the other hand it is sometimes possible to avoid changes and higher prices with the use of alternative suppliers and parts. But in these instances extra care needs to be taken to ensure component quality. We have heard stories buyers relaxing normal quality procedures in desperation and finding that the components they have bought are fakes.

The key to managing this extremely difficult environment is transparency across the supply chain. Open communication channels may not soften impact of long lead times and increased costs. But they allow for faster reaction times and build trust.

The world is a more volatile place. No sooner has the manufacturing industry adjusted to the impact of one disruption than it is faced with another one.

The latest calamity to hit our industry are the power cuts in multiple cities across China. Various reasons have been given for this rationing including: a rapid post-pandemic recovery leading to booming exports and so excess demand for electricity; a shortage of coal coupled with a desire to limit imports and; a drive to decarbonize energy production combined with unstable renewable energy supplies.

At Porticos Asia we were first aware of this problem a few weeks ago. Several of our suppliers in Guangdong province, China notified us at very short notice that deliveries would be potentially impacted by power rationing measures. To be fair, our suppliers in turn were given very little advanced notice.    

Because of this reduction in power supply factories have been forced to operate on a part-time basis. Partners have told us they have been forced to cut all but the minimum of power consumption. Some have even been working without lighting and air-conditioning.

To make matters worse the situation is highly unstable. Factories are being told on a week-by-week basis what disruptions to expect. One of our partners was advised on Monday that they would only have power for one day that week. To offset this impact many facilities can generate their own power using an in-house generator. A generator can typically supply enough electricity for lighting and light equipment to allow final product assembly. But it cannot support the use of heavy equipment such as injection molding equipment.

In such circumstances it is vital to be transparent with customers. We have been informing them immediately about possible delays and keeping them updated on the latest developments. Apart from this, in the short term, not much can be done. However, luckily, our partners have so far been able to minimise adverse impact by working overtime once electricity supply has been restored and before the next cut is announced. Also, assembly at our own facility in Hong Kong has not been affected as Hong Kong has been spared mandatory power-rationing.