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As originally asked by Tim [LION] Ruffner.
Have you done it? What are the draw backs? Do you use only for trial, prototype or do you actually manufacture the devices there as well? What would entice you to use a China based firm? I am not even sure if Medical is a market for China at the moment, that is why I am wondering.
For the shipping, you should assign a reliable courier.
Select your supplier carefully and plan to be significantly involved to insure your projects stay on track, cost are managed and quality meets you expectations. Listen carefully to understand your Chinese partners’ needs and to understand project status — ongoing communication is essential.
In the past, the choice to produce in China was simply based on large cost savings and in some case the necessity to complete with products made in China. Today China is much more expensive. Carefully analyze the the cost to produce your products in China, include the cost of additional inventory, additional warehouse space, additional lead time, travel, management of your supplier and the cost of quality.
If you do your homework, carefully select your Chinese suppliers and are prepared to be fully engaged, China can be a good place to produce medical products.
One more frustrating was, a non-binding dealer used my product pretending their own samples got all the green lights. They just received their OWN registration last month. Hope you can get my point. It is an unpredictable society. Too many uncertainties. Pales.
Remember, one or two successful cases do not give you the full picture. We need to cherish comment from black sheep so we can include their lessons in our assessment. Relatively speaking, Taiwan is safer.
John Bennett MD
At any rate, I can see when you do a device, you are aware it may be copied, or whatever, and reproduced in India or China, or Mexico.
The reason this thread caught my eye was, as I was looking for things of interest for my website, www.InternetMedicine.com, I came across a Medical device like AliveCor, originally made by a cardiologist from Oklahoma, Dr. Albert, on Amazon.
[http://www.amazon.co.uk/Heal-Force-Handheld-Portable-Software/dp/B00944DL3G|leo://plh/http%3A*3*3www%2Eamazon%2Eco%2Euk*3Heal-Force-Handheld-Portable-Software*3dp*3B00944DL3G/gPvs?_t=tracking_disc] … …
and there are lots of portable EKG devices that seem to be knock offs. Now, I don’t know the law, but it must be OK. Surprised me…….
Cheng Chi Ho Kevin
I think your entire challenge would be expand your market outside your location, China would be a good way for yours looking for. But i think HK is a step for yours before get into China.
To Tim: what made you post the question as you did:
1)Our factory is SFDA approved, compliant with ISO13485. We have parts listed in FDA.
Why not have a trial of Chinese supplier. A real step is more important than just thinking.
Thomas J. Czarnowski h. Lada
The advantage is price, speed, and control.
Tim [LION] Ruffner
Cons: IP Info, Not the best quality, customs, engineering and project management.
Let me tell you what I found from experience just with the current company I work for. I cannot speak for others, however, I did tour some facilities and I agree to what you so. So the thing about it is…you have to pick the right supplier. You cannot just go off one of those damn emails you get in your inbox and hope for the best. Do a strict audit with the company you are working for, you want a long lasting partnership why wouldnt you right? Plus hell, have fun in China while you are there…hit up a KTV or something ;). Just like any company you deal with in the US, you will most likely visit their facility and find out their expertise before working with them, am I correct?
For STAR which is a WOFE and western owned, we are setting a whole new standard for these types of issues. One, IP issue, that can be with any company anywhere…even in the US, they are doing it as we speak. But, to minimize your issues here, why stick with one supplier and why have the company see your full assembly drawings? For us, we deal with companies like Google, Qualcomm, Lexmark, Speck, Bio Rad and many more. They dont give us their whole project, they give us a portion of it.
Quality and materials, well you would have to see ours to believe it, we check every material with an oxford instruments XRF gun, we abide by RoHS testing and everything we do is inspected. You should see these reports and what I get back from my project managers, its crazy amazing.
Engineering and project management, with us, we are western owned so this is where our expertise comes into play. Also each department is ran by a westerner so you know you are receiving western quality. To be frank, we aren’t normal chinese pricing though, we will typically be 20% higher because of all these added benefits.
Now we don’t get into much production, so I couldn’t speak for much of that, we are mainly prototype and pre production samples dealing with some of the largest customers in the world. But when it comes to customs, just be happy you dont live in India or Portugal where its 40-70% import tax. We are like 3% or something right?
The moral here is picking the right supplier, don’t just choose some people fishing to earn your business from an email. Having the right project management is key, find a western owned or western managed chinese facility and you will be amazed by what you receive.
That is my 2 cents. Now still, I don’t know if medical is the right market for us…I really hope so because to be honest, that is all I really know. So if you know anyone who is looking help a brotha out!!
The vendors I have used have a turn around time that is very fast. However, U.S customs creates a huge impact on that turnaround time.
Also, If you have tight tolerances it is rare to get something made to specifications. I find when my product is received re-work is needed.
So all the time saved and money saved is used used on re-work and customs delay’s. I have found that using a SLA 3d printer for plastic parts and local Machine shops are more reliable, accurate and quality is far more superior.
Thomas J. Czarnowski h. Lada
I’ve spent several years working for medical device companies in China and have pushed many new devices through development into production and managed a portfolio of many regular production line devices..
The main reasons for developing in China are:-
Speed. The turn around of tooling, parts, alterations, specialist machining is staggering, no more waiting until next week or month, you can get bits done by tomorrow. The number of companies offering services allows you to avoid queues.
Cost. See speed above, the sooner you get it the sooner you make profit. Getting those specialist bits made can be very cheap as well.
However with 3D printing this is soon going to be overtaken.
Reasons for production in China are:-
Cost. Labour intensive manufacturing methods allied to an in depth supply chain and logistics makes China way ahead of the rest of SE Asia.
China market. Biggest in the world, so get a foothold in asap. As long as you have you global patents in place copies cause little threat to your rest of world markets.
Getting goods into the China market can be frought, SFDA registration is a nightmare unless you use a consultant company, usually an ex-SFDA employee who knows the latest regs changes and the people who to talk to, testing house managers etc. Be very careful of paying back handers as a way of driving your product through registration.
Copies. More of an against point than for. Tooling (moulding) companies will actually call your competitors and offer an exact copy of your tooling. (Get it made elsewhere)Brochure companies (printers) will do the same. Employees will leave and set up their own direct competition making the same products. It happens. If you can’t deal with it, don’t go to China. You can limit the copying by…..
Setting up a company. Best way to avoid a mess is to avoid the JV route. Your partner will always be looking for ways to cut you out/rip you off. Set up your own WOFE.
Staffing. You need to make sure the person/people in charge is not a local. You must have in place people who understand western quality, engineering of products, and can fully understand the communications from head office and can feedback truthful and accurate state of play reports. The world is littered with companies that set up in China, left everything in the hands of locals and lost it all.
P.S. If you are going to CMEF, Canton Fair etc, then watch the number of people with cameras taking pictures of all the products on display. Go to the next show and see the same products being offered by competitors.
In addition, I’d recommend that you focus on outsourcing low-volume products rather than high-volume products. If it’s a one-off, or an every-now-and-then, well, fine, you can live with the long delivery cycle. If it’s an everyday product, the supply chain will kill you, and the temptation to co-opt your intellectual property may be too great to resist.
Just a thought or two . . .
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