MEDICAL DEVICE PRODUCTION IN SE ASIA
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.
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.
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.
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.