< 1 min reading time

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.

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Ms.Erica Pang
Medical Device Contract Manufacturing
For Robert Houghland ‘s Cases, the only issue is you & your supplier has not so good communication. They should inform you before action, not after the fact. In our factory, we report to customer in advance for any changes.

For the shipping, you should assign a reliable courier.

Robert Houghland
CEO at Hanover Pen Corp., Hanover, PA
I would like to share two events that happened recently with products we ordered from China.
Case 1: We re-ordered 100,000 items from our reliable supplier in China, an item not available in the USA. Normal production time is 3 to 4 weeks plus 4 to 6 weeks on the ocean for a total lead time of 8 to 10 weeks. The product was manufactured and placed on a ship as scheduled. However, as the ship was in transit Super Storm Sandy hit. Instead of docking in New York as anticipated the ship was re-routed to Baltimore. The Baltimore customs people were so inundated that the product sat in Baltimore for another 6 weeks. The lesson here is that no matter how good your relationship is with your Chinese supplier things can happen to interrupt the supply chain.
Case 2: We ordered 300,000 products consisting of 3 parts from a supplier in China that was new for us. We needed some of the product for our customer to launch their new line in February. We placed the order in early January and were told that the factory could not start until after Chinese New Year. We were lucky that they had 10,000 in stock and had them air freighted in to meet the customer’s launch date. The ocean shipment was scheduled for early April for delivery the first week of May. The factory took an extra week to produce the items. They placed all of components 1 and two but only 6000 of the 290,000 of component 3 in a container and shipped it via ocean for delivery the second week in May. The balance of component 3 they placed in another container for shipment the end of April for delivery the first of June. They did not tell about the split shipment until after the fact. Now we have lost face with our customer, missed some of their key product deliveries, and won’t be able to ship them finished goods until the middle of June. For an order placed in January this is unacceptable both to us and our customer.
Robert Houghland

Russ Pizzuto
Lead Design Quality Consultant at Menarini Silicon Biosystems
I successfully manufactured and sourced medical products in China for nine years. I also led an Chinese engineering team that designed two products. While medical products can be successfully produced in China, business is approached differently, standards are not what your accustomed to and contracts may be arbitrarily ignored.

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.

Shivan Ramdhiansing
Research & Development Leader
I see a lot of valuable comments. Hope to add or emphasize with my experience:
Pros: Quick FOT due to 24/7 mentality. Proto/Pilot moulds of e.g. 12 small high precision (tolerances +-0.30-0.03mms) plastic parts withing 6-10 weeks depending on complexity. This opens possibilities to use parts for first Assembly runs, Marketing promo’s, Quality checks and gaining knowledge in an early phase within NPD.
Cons: Quality, communication and out of the box thinking is something the Chinese (not negative generalizing, but just my exp with culture/dynamics of one company) are different in. Usually they just do what is directed, which is ok in some cases. I suggest to have a moulding engineer and quality man in China at milestone points in the New Product Development who know the product (requirements) at the project kick off and before first part production and start of multi cavity moulds.

Ted Wolkomir
CEO at Exegen IP Alliances LLC
Yes. We do Class I or II devices.

Mark Workman
President Return2Fitness
Why not produce in the USA – better service, quality and lead times. I can beat China pricing with quality ISO13485 manufacturing at my facility in Indiana.

Teeming Tsao
Sales and Marketing, Coreleader Biotech. Co. LTD.
Although I am in the wound dressing business, well, for electronic related medical devices or more advanced disposables items, you should come to Taiwan to find yourself a toller. Three reason:
1) The IP protection is better
2) The island is the MFG hub for high tech parts for every electronic things
3) it is better regulated island that you can foresee the result and expect to be treated fairly. I can’t put it in black and white. Just giving you an example, I have filed for my product registration for 2 years. While Chinese companies can get such approval at provincial level, foreigner has to go to BeiJing. The sample review conducted by SFDA has failed for three times although two labs and my own lab proved OK.

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
Developer of Neurosurgical.tv, Neurocirugia.tv, InternetMedicine.com, and Affiliate Internet TV Websites
The Internet shows its power as shown by the crowd sourcing of the internet; collect thoughts of many from the convenience of your computer, to add to the greater good.

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…….

Victor Yu
Director, Program Project Management
I think the answers will depend on what kind medical device you will produced,in general I think the best practies of GE,Philips and JNJ are showing a clear trend that the China market are major driving factors of their business growth.

Cheng Chi Ho Kevin
Project Management in consumer electronic
Tim, thanks for your sharing.
As an experienced project manager in HK/China, i am totally agree with your point:
“”Do a strict audit with the company you are working for, you want a long lasting partnership why wouldnt you right””

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.

Nic Hoefsloot
Available for a new challenge: Customer Support-, Operations- Project Manager in the Medical Devices Industry
Great addition Erica. Almost all large Medical Companies have established development, research and manufacturing facilities in China / Hong Kong.

To Tim: what made you post the question as you did:
“Can you prototype or manufacture Medical Devices in China?”
Did you know anything about China before you posted the question?

Ms.Erica Pang
Medical Device Contract Manufacturing
We are a Chinese Medicial Devices Manufacturer. We accept OEM parts making.

1)Our factory is SFDA approved, compliant with ISO13485. We have parts listed in FDA.
2)Most of our equipment are CNC ones, supplied by HAAS, DMG, etc.
3)We have completed quality system, 2 times audited by TUV each year.
4) We use 17-4ph/Ti6Al4V ELI materials from Carpenter,Bonston Centerless, etc.
5) All our engineers could read and understand english drawings. They are experienced on the process and manufacturing based on designed prints. Could understand the basic function of the parts. Could offer suggestions of improving your process based on manufacturing point.
6) We could do the AQL inspection based on your requirement.
7) Our devices is same good quality as you did in other USA or European suppliers
8) Most important is our price is very low, maybe 1/4 of your local made products.
9) With well established process, you do not need to travel a lot, 2 or 3 months a trip is enough. We can communicate through daily mails or call.
10) China would be the largest market in short few years. Now several most largest medical devices companies have entered into China.

Why not have a trial of Chinese supplier. A real step is more important than just thinking.

Thomas J. Czarnowski h. Lada
Auri Advector Ltd CEO
If you are seriously considering entering China with medical product, I can give you a medical knowledgeable contact there and we can discuss options available to you. tjczarnowski@gmail.com

Greg Good
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We have had molds made in China. We use a U.S. engineer to design the products
and then have an SLA made in the U.S. Once we are satisfied with the design, we release the mold data to China. All products are produced in the U.S.

The advantage is price, speed, and control.

Tim [LION] Ruffner
I am a solutions provider who will educate and sell a 3D Printer that fits best with your application.
So gathering some of the Con’s and some of the Pro’s…

Cons: IP Info, Not the best quality, customs, engineering and project management.
Pros: Fast, inexpensive and willing to give up their kid to earn business lol.

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!!

Tim

Steven Trejo
Sr. Manufacturing Engineer at TE Connectivity
I have used cast/machine companies in China and I have found that it has more cons than pros in my opinion.

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.

Bob Adams
Trading Company
If anyone is seriously thinking about setting up a production facility in China, I can give you several pointers. Need to take this off line though.

Thomas J. Czarnowski h. Lada
Auri Advector Ltd CEO
If you don’t care about patent protection, go ahead.

Bob Adams
Trading Company
I do enjoy reading these types of threads. Seeing how other people view the same things is fascinating. Makes these forums worthwhile.

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.
SFDA Internal audits may well catch it and it will be revoked and you blacklisted.

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.

Jamie Weiss
Senior Consultant – The Task Group • Boston
All excellent comments. I would just add that, in my experience, engineers in China are somewhat lacking in ‘application engineering’ expertise. That is, they’re fine at developing a product to fit a specific specification, but they often lack a broader context around how / when / where the product may be used.

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 . . .