Author: Ian Chan

Ge-Shen Group has FDA registered facilities

The FDA is the perhaps the best-known regulatory body of its kind, responsible for ensuring the safety of medicines, medical devices, and food. When it comes to these critical products, the FDA is synonymous with quality and trust. The FDA requires all imports of these products to be well documented and accountable so that any issues can be traced back. Registration and listing provide the FDA with the locations of medical device establishments and the devices manufactured at those establishments.

Ge-Shen is proud to have FDA registered manufacturing facilities, we understand the regulatory requirements and know how to ensure that your medical or food grade products can be manufactured and delivered without worry. Combined with our ISO 13485 quality systems, we can ensure confidence, trust and accountability for products manufactured by us.

We can work together to register your products whether they are exempt or have:

  • Premarket Notification (510(k)) number
  • De Novo (DEN) number
  • Premarket Application (PMA) number
  • Product Development Protocol (PDP) number
  • Humanitarian Device Exemption (HDE) number

Do get in touch with us to see how we can help, we offer:

Layman’s History of Electronics Assembly

Have you ever wondered how most electronics devices are produced? Or how we can create cost effective disposable electronics? We owe many advances and cost savings to a simple technology called printed circuit boards (PCB) and its various assembly methods.

Early History

Before circuit boards, electronics were a mess of wires and components! Components and wires would be soldered directly to each other. This is known as point-to-point construction.

Motorola Goldenview – Image from Wikipedia

Using the Motorola Goldenview as an example, you can see that manufacturing this would be difficult and would be dependent on skilled people remembering where each point had to be connected to.

Much of this changed with the use of circuit boards, which allowed easier assembly by humans. As time progressed eventually manually assembled circuit boards led to automation of pick and place of components, greatly speeding up the manufacturing process.

Introduction of Circuit Boards

A printed circuit board (PCB) serves to bring together the huge number of resistors, capacitors, logic chips, controllers, etc to function as a single device. Th board helps to support and connect all the components together in a precise repeatable way, forming the circuits needed for the device to function. You can think of it as a road for cars, it serves to connect the points where we want to travel between.

PCBs were first used with manual assembly methods, typically with through hole components and, where human workers would assemble the components by hand onto the PCB and solder the components to create the connection.

Hand etched and soldered circuit board – Image from Wikipedia

The Next Leap

PCB technology hand in hand with Surface Mount Technology (SMT) allowed for large scale mass production to take off. Now you have mass produced circuit boards being assembled with components by a pick and place machine capable of over 100,000 components an hour.

Pick and place machine – Image from Wikipedia

Surface Mount Technology has allowed for quick mass production of circuit boards and electronic devices. Standardised components available from less than 1mmx1mm to more than 1cmx1cm can be quickly assembled.

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Ge-Shen Group’s LSR Demo Product

There is a learning curve in understanding and adopting new technology. There is also no shortcut to experience. We believe that learning through the development of our own demo product is the best way for the team to get hands-on experience and to also demonstrate our readiness to our customers. I’ll walk you through the process of how we designed our LSR product and manufactured it in time for the K Fair.

In earlier posts, we talked about adding this new capability and why people would choose to use silicone rubber. LSR is a versatile material useful for making parts that are suitable for a wide variety of applications in the medical, automotive, industrial or consumer industries. However, it is a little tricky to work with. We started the process of understanding the material properties a year ago leveraging our partnerships with key material suppliers. It is key to have a good network of material suppliers with the knowledge and experience with LSR processing as we work hand in hand in developing solutions for our customers.

Designing the part

Once we had a good understanding of the material properties and how it would affect our design, we started on the project of designing our part. In choosing what to make, we wanted something useful to hand out as a demonstration item. We want our customers to think of us when they use this item. With some consideration, the team decided to design a drinking glass. Kumar – an assistant manager at Ge-Shen Plastic was brought on board to lead the design of it. We picked through 3 designs and chose one that we would go forward with.

Part design and material information in hand, we utilised our CAE flow simulation software Moldex3D to simulate the processing (link here for a brief video on LSR simulation capabilities). CAE is important in our process as it helps to identify any manufacturability issues before we get started on the tool. Any changes after a tool has been fabricated means hefty expenses and a significant delay to the project timeline.

Good tools mean fewer problems in production. Our team has many years of specialist knowledge, successfully managing many projects from diverse industries. Having an in house tool team is also vital to support any repairs, modifications or last-minute changes to tools. We have found that this is invaluable to our customers

Manufacturing the part

From a plastic injection standpoint, typical processing parameters must be reversed. LSR is a thermoset silicone rubber that vulcanises (cures) in heat. This means that instead of heating the material through the barrel and cooling it down in the mould, you must keep the material cool through the machine and heat it up in the mould.

LSR material comes in two parts, an “A” part and a “B” part. The first step is to mix them together. This happens in our specialist 2KM dosing unit. Each pail is loaded on their respective sides and careful setting of the machine ensures that they are mixed in an exact 1:1 ratio.

Whilst the material is being loaded, the team simultaneously sets up the tools and connects the heaters and thermocouples to our Arburg 520 A injection moulding machine. With the set up of the tool complete, the next step is to trial the production parameters. Based on the material specification and the simulation results. We start by establishing the processing window. The lower and upper limits should be established through calculating the theoretical processing parameters and then lowering or increasing a single parameter until failure.

The tool trial often results in some interesting events such as below where the ejector pin goes straight through the part!

After production, we laser mark to demonstrate how we can mark clear transparent LSR parts and get a bit of marketing in.

The end result

It takes a lot of work to get even a simple part designed and manufactured. Much work and effort goes into making sure that each project is a success. Thank you for following me through the manufacturing process. Hopefully you will agree with me that the result is a beautiful part with some tasteful marketing thrown in!

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What are Tariffs – How Do They Work?

Most modern economists suggest that tariffs are harmful for all nations involved and in the last 60 years many countries have been trying to minimise any friction to trade by removing tariffs. However, in recent news, not a day goes without mention of tariffs! So what are tariffs, why is everyone talking about them and how do they affect your day to day business?

A Background into Tariffs

A tariff is essentially a tax on imports and/or exports between sovereign states. Historically, governments have used tariffs to raise funds from traders. It is important to note that tariffs don’t cause a rise in the seller’s price, but instead cause an increase of the purchaser’s cost, affecting importers and consumers. They are often collected by Customs agents at entry points such as seaports, airports or border crossings. The revenue from these collections then goes to the government.

Interestingly the US Federal government was primarily funded through customs revenue from independence until 1913 when the Revenue Act was passed, leading to the introduction of income tax. During this period, customs revenue routinely accounted for 80-90% of total federal revenue. As of 2017 customs revenue makes up roughly 5% of revenue.

Other than revenue generation, tariffs have also been used to provide protection for domestic industries or to attempt to influence global trade. In theory, through tariffs goods imported from overseas end up costing due to the additional taxes placed on these imports. The additional costs end up being borne by consumers. Supporters of tariffs say that they help protect domestic industries that are less competitive. Opponents of tariffs argue that tariffs are an unfair tax on consumers and results in domestic manufacturers less competitive with little incentive to improve production processes.

How tariffs work

Modern Tariffs

The World Trade Organisation (WTO) is where nations negotiate and set the rules on international trade. The WTO deals with diverse matters from the harmonisation of product classifications to the administration of trade rules. Generally no WTO member may discriminate against another member when trading. This is known as most-favoured-nation (MFN) treatment, all WTO members should be given the same tariffs. There are exemptions to this.

The WTO state: “countries can set up a free trade agreement that applies only to goods traded within the group —   discriminating against goods from outside. Or they can give developing countries special access to their markets. Or a country can raise barriers against products that are considered to be traded unfairly from specific countries. And in services, countries are allowed, in limited circumstances, to discriminate. But the agreements only permit these exceptions under strict conditions. In general, MFN means that every time a country lowers a trade barrier or opens up a market, it has to do so for the same goods or services from all its trading partners — whether rich or poor, weak or strong.”

Despite these rules, the WTO do not have any enforcement powers. They can investigate claims brought against sovereign nations for unfair tariff targeting and these findings are then published. If there is no remedial action undertaken, the WTO then allows retaliatory tariffs.  

The WTO are currently investigating the tariffs from the US & China

Issues with Tariffs

The US has increasingly attempted to influence global trade by placed placing tariffs related to the country of origin of a product. Through the Trade Act 1974, the US imposed 25 per cent additional tariffs on approximately $34bn of Chinese imports in June 2018. These have slowly ramped up and almost all goods from China imported to the US now attract a 25% tariff. This has created a large headache for product owners, it isn’t easy to build a new supply chain in less than a year. I wrote about this earlier in a previous post.

Ge-Shen is based in Malaysia where we maintain normal WTO trading tariffs with the US and have extensive experience with localising supply chains. Do get in touch with us to see if we can help you overcome problems associated with new or potential tariffs

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Trade uncertainty – Options for Manufacturers

For today’s global companies, geopolitical uncertainty has affected more than just price, but also investment, consumption, inventory and even the way companies must do business. With changing tariffs, free trade agreements, bans and retaliatory actions, how do you stay lean and cost competitive.

How should you deal with trade uncertainty? What can product owners do to diversify their risk in such circumstances? Here are 5 suggestions we have.

1. Have a backup country / location

Start exploring other countries as a second location to manufacture your products, whist another location might not be the most convenient or most cost economical, any supply shocks from trade uncertainty can be better weathered when you have a backup plan. If the country where your main manufacturing base were to come under unexpected tariffs, you could easily increase the load on a second location.

It often takes more than half a year to develop a manufacturing site or a vendor in a new country, so it pays off in the long term to start sooner. A lot of the work is done up front with qualification and testing being set out, so to increase volume later shouldn’t be difficult as long as you work with your suppliers.

2. Develop your supply chain

With the supply chain in China having grown to such breadth, it may be too easy to rely on a single location. You can work with an established contract manufacturer or supply chain consultants to tap into their existing vendors as they will have a pre-built network. This saves a significant amount of time in searching for vendors as finding a suitable fit between price, quality and delivery is a challenging approach.

Having a new location also doesn’t mean that you need to redevelop the entire supply chain. Countries in South East Asia can easily draw upon your existing supply chain to reduce the burden of sourcing and improve the speed at which you can establish a presence.

3. Understand trade rules

What HS code do your products come under, what is the percentage required for a change in country of origin? Which countries have free trade agreements which each other? How to deal with trade uncertainty? These are all important questions to ask before making inroads into a new location. Global companies often have multiple manufacturing sites to take advantage of different tariffs or free trade agreements. Having a CM with multiple sites can look to reap the rewards of multiple geographic locations without much of the legwork. Vietnam ( is a signatory in a free trade agreement with the EU, so goods manufactured in Vietnam will have a significant cost advantage for European markets.

You might also be able to benefit from assembly in a different country as CKD/SKD can often change the HS codes. Experienced partners can help you navigate and also suggest opportunities for greater efficiencies.

4. Understand the differences

A period of change means the rules will be different, existing strategies may not work, old strategies may be worth revisiting and new ideas have a chance of taking off. Taking South-East Asia as an example, each country has its own language and culture to deal with. Malaysia is multicultural with some of the more widely spoken languages include English, Mandarin, Cantonese and Malay. Malaysia also has a good legal system based off British common law. Vietnam on the other hand is more homogenous with a legal system based off French Civil law and Communist ideology.

5. Don’t delay

Trade uncertainty is the key word, waiting for a clear sign is often too late. It pays to have the infrastructure set up so that you can seamlessly switch should the worse happen. When the worse does happen, you will be caught off-guard and have customs, regulatory and approval delays.

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Manufacturing in Malaysia

When someone says global manufacturing, most people would immediately think of China, maybe you might even think of Vietnam. Most people haven’t considered Malaysia as a manufacturing location despite how Malaysia is well positioned to take advantage of global supply chain. Let me give you 5 quick points on why you should consider manufacturing in Malaysia.

Manufacturing in Malaysia - we have a Southeast Asia manufacturing base
Ge-Shen has manufacturing facilities in Penang and Johor.

1. Malaysia has an established supply chain network

Malaysia has an established supply chain with global companies and strong local players. In fact companies such as Intel, opened their first manufacturing facilities in Malaysia in the 70s. The list has grown to include Robert Bosch, Clarion, Amphenol, B.Braun, Broadcom, Toshiba, Sony, Motorola, etc. The presence of these companies require material and resources which means the 2nd tier and 3rd tier vendors are well developed as a result this makes it easy to manufacture your product in Malaysia

2. LMW – Licensed Manufacturing Warehouse

We at Ge-Shen are a LMW – licenced manufacturing warehouse. This means that there are no tariffs placed on goods by the Malaysian government for goods related to manufacturing, in effect each of our factories are outside of Malaysia for custom purposes. Customs duty exemption is given to all raw materials and components used directly in the manufacturing process from the initial stage of manufacturing until the finished product is packed ready for export, easy!

3. Geography

Malaysia is well placed geographically. The straits of Malacca is one of the main global shipping routes. We are served by well established ports in Penang, Klang, Johor and we can even ship through Singapore. The proximity of Malaysia to China, Japan, South Korea and the rest of Asia also helps with sourcing and exporting finished goods.

4. English Speaking

Malaysia is a diverse country with many ethnic groups and languages, one of the upsides is that English is widely spoken as a business language. This means that we can communicate easily with you to get any issues resolved. Cutting out a layer of translation increases the ease of doing business.

5. Ease of doing business 

Malaysia ranks highly on the ease of doing business rankings as published by the World Bank. Malaysia currently ranks at 15 across all economies in the world. Less red tape means it is easier to get things done, helping you with time to market.

Need help manufacturing in Malaysia?

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