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March 07, 2018 3 min read

How can we justify it? The last time I checked, manufacturing pretty much stopped in the UK ages ago. But somehow, we still manage to justify something as being made here. How, and what value does our geographical location bring?  

Advancements in technology have bought more people together and laid many misconceptions to rest. Language barriers are no longer an issue due to better education and technology. As a result, more companies have started to offer surgical instruments at cheaper rates, which sounds like great news - but if price is the most important thing, what is the trade-off?

We as consumers expect manufacturers to keep up to date with industry best practise, ad-hear to established patterns, be aware of market demand, and benefit from the knowledge trickles down from the end user, however this is not always the case. The "virtual manufacturer" is a key entity in this sector if price is of key concern. Outsourcing the abrasive tasks of the manufacturing process is they easy part, empowering the original equipment manufacturer (OEM) in areas such as regulatory compliance is a must for business sustainability. 

Virtual manufacturers invest a substantial amount of time and effort in vetting OEMs. Approving them is determined by a common theme - how well established they are. Just because something is cheaper, does not mean they have holistic knowledge of our sector, nor that they have the resources or a well established manufacturing process in place. In a "battle for the cheapest", a fully finished product become too expensive for the reusable medical device market place.

In the past, buying was done between a procurement manager and a sales rep. Some companies used to manipulate this relationship to influence buying, however with anti-bribery policies in place, the sales rep uses other tactics such as "training holidays", disinformation and manipulation of the buyers ignorance. Knowledge is power, and can also be a power over you if you are not well informed.

The media are quick to provide and arsenal for sales reps to use when a particular countries manufacturing process is scrutinised, which leads to a knee jerk reaction of demonizing an entire region's manufacturing capability. Some reps may use opportunities like this to dupe buyers with a false sense of security, and convince them that their particular product must be superior based on their geographical manufactured location. Stamps and markings such as: “Made in USA”, “Made in Germany”, “Made in UK”, “American Made Instruments”, “German Made Instruments”, “British Made Instruments”, “Manufactured in the USA”, “Manufactured in Germany”, “Manufactured in the UK” have been and are still used to give a buyer this false sense of security, where as there needs to be full clarity as to what being "made" in a particular country really really means.

As a layman, common sense tells us that a someone who makes a medical devices is the one who is responsible for sourcing the correct material, fabricating the item, and assembling it, requiring high amounts of resources and labour - but this is not unanimously agreed on. Regulations and legislation allow companies to perform the bare minimum in order to inherit the right to be called a "manufacturer" as will be explained.

The medical device directive MDD 93 42 EEC, says that Class I Surgical Instruments are low risk, and that companies wishing to mark CE on instruments can do so themselves as long as they fulfil all the CE's requirements. Once a company chooses to mark CE on an instrument, they are essentially liable for the device and if accredited are classed as a “Own Brand Labeller (OBL) / Virtual Manufacturer”. They are required to have knowledge of the product, from its birth to its performance in the field. [see MDD 93 42 EEC - Article 1: 2(f)]

When an instrument is marked with the said logo and CE etc., the surgical instrument would need to treatment in order to protect it from rust. The passivation process involves submersing the surgical instrument into a chemical - and that's it!

You are entitled to a certificate of origin, allowing the “virtual manufacturer” to claim that the product was “Made in USA/UK/Germany” (see Trade Descriptions Act 1968:36).

Many companies practise this and actively promote their products as being manufactured in an aforesaid country. In some instances the level of work a company takes to ensure the medical device is up to standard requires time and effort. In some cases one "could" justify that this gives a company the right to claim that their surgical instrument were "Made in the UK". If someone in procurement choses to ask the question of, where the device was made - it is upon the company who is offering their products and services to be as transparent and informative as possible so the customer is entirely satisfied with the product, and not deceived by the person. 


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