Medical Parts

Medical Parts

ABIS got into medical parts in 2009. Before that we were doing automotive and consumer electronics mostly. A German customer asked if we could make endoscope housings for them. We said we'd give it a shot. Back then not many factories in Shenzhen were doing medical injection molding. Our facility was basic, no cleanroom, material control wasn't strict. First batch of samples shipped out, customer said dimensions were fine but there were particles on the surface. That's when we learned medical parts have completely different cleanliness requirements than automotive.

That project didn't work out. But after that we started taking medical seriously. Got ISO 13485 in 2012. Built our first cleanroom on the third floor, Class 8, about 80 square meters. Looking back we made some wrong equipment choices. Positive pressure system was too loud, HEPA filters needed replacing too often, operating costs ended up higher than expected.

Medical is about 15% of our business now. Not huge, but margins are better than automotive.Let me explain what we actually do.

 

Injection molding

We run PC, PPSU, PEEK regularly. Machines from 80T to 1600T, small parts and large parts both OK. Most common medical applications we see:

Diagnostic device housings. Glucometers, blood pressure monitors, that kind of thing. High volume, medium precision requirements, mostly cosmetic parts. We've been making glucometer top covers for a Japanese brand for six years. About 500K pieces annually. 16-cavity hot runner mold, 22 second cycle time. Not technically difficult but consistency matters. Six years running with Cpk above 1.5.

Consumables. Blood collection tube caps, reagent card housings, pipette tips. The Class 8 cleanroom on third floor runs these mostly. We do a lot of pipette tips for a domestic IVD company. 1000ul size, 64-cavity mold, PP material. The hard part is concentricity. If the tip's off-center by more than 0.05mm, aspiration volume becomes inaccurate. Reject rate was 8% when we started. Changed the mold guidance from four guide pins to precision locating blocks. Got it down to 0.3%.

Implant-related parts we don't take on much. Not because we can't, but validation cycles are too long. One customer came to us for PEEK spinal cages. From first inquiry to production took three and a half years. Material validation, biocompatibility testing, clinical trials in between. Not much we could help with during that phase. Project got cancelled anyway because customer ran out of funding. Lost money on one mold.

MIM is where we're strong

Metal injection molding. Good for small, complex, high-volume metal parts. Lots of MIM shops in Shenzhen now. We've been doing it since the factory opened in 1996, one of the earlier ones.

Medical MIM applications we see most:

Laparoscopic instrument jaws and scissor heads. Complex geometry, internal cavities, traditional machining either can't do it or costs too much. MIM does it in one shot, just polish afterwards. We supply several domestic endoscope manufacturers on an ongoing basis. Can't name them specifically. Material is mainly 17-4PH stainless steel, hardness after sintering is HRC 28-32. Jaw mating surface clearance held within 0.03mm.

Orthodontic brackets. High volume, but we only did one project, didn't continue. Customer built their own line. Brackets are like that. Only a few big global brands, once they figure out the process they bring it in-house. Don't outsource long-term.

Orthopedic screws. 17-4PH or 316L. We've done samples, no production orders. Main issue is we can't do surface treatment and sterilization in-house, would need to subcontract. Customer felt supply chain was too long.

MIM for medical has a material certification issue. FDA has requirements for implant-grade metal powders, not all powder suppliers have the documentation. We currently use powder from BASF and one domestic supplier connected to the Chinese Academy of Sciences. Both have biocompatibility data. But theoretically every time you change powder lot you need to re-validate. Customers don't always want to pay for that.

Secondary processing and assembly

Medical parts often need secondary processing. Laser marking is the most common. UDI codes, LOT numbers, expiration dates. We have two fiber laser markers, can mark metal and plastic. Speed isn't the problem, positioning is. One customer's blood collection tubes required marking position tolerance within ±0.2mm. Had to make a dedicated fixture to get it right.

Ultrasonic welding we do a fair amount of. Plastic part assembly often uses ultrasonic, like test card upper and lower covers. Parameters need tuning. Amplitude, weld time, hold time, different for each material. PC to PC welds easily. PC to ABS you have to be careful, too much energy and you get flash.

Assembly we take on some projects, not all. Depends on complexity. Simple press-fit, dispensing we can do. Anything involving electronic component mounting we don't have equipment for. One customer wanted us to assemble a handheld diagnostic device with a battery. We quoted it, customer ended up doing it themselves. Probably for the best. That project had a recall later. Battery-related.

About the cleanrooms

We have two cleanrooms currently. Third floor is Class 8, built in 2012, runs plastic parts. Fifth floor has a Class 7, added in 2019, smaller footprint, mainly for MIM post-processing and inspection.

Class 7 costs noticeably more to maintain than Class 8. Personnel have to change gowns twice going in and out, production efficiency takes a hit. Our Class 7 utilization isn't actually that high, maybe 60-70% annually. When we built it we thought lots of high-end medical projects would come in. Reality is most projects are fine with Class 8.

Cleanroom particle monitoring we outsource to SGS, tested quarterly. Temperature and humidity we monitor ourselves, continuous recording. This data has to be archived, customers check it during audits.

What we don't do

Some things are outside our scope. Better to be upfront about it.

Sterilization. EO sterilization, gamma sterilization, we don't do either one. Need to subcontract. There are a few specialists around Shenzhen, we can help coordinate but cost is separate.

Long-term implants. Artificial joints, cardiac stents, that kind of thing. We don't have the qualifications or experience. Even if someone asks we won't take it.

Sterile packaging. Medical-grade blister packaging, Tyvek sealing, we don't have the equipment. Regular PE bag packaging we can do but that's not a sterile barrier.

Clinical trial documentation support. We can provide material certificates, dimensional reports, in-process inspection records. But clinical protocols, ethics approvals, that's not our scope.

How working with us typically goes

Inquiry stage needs drawings, 3D preferred. No drawings just a physical sample, we can reverse-scan it but there's a charge. If product design isn't finalized, we can do prototypes first for validation. We have CNC and SLA.

Quote usually comes back in 2-3 business days. Tooling cost quoted separately, part unit price depends on material, cavity count, cycle time, secondary processing. Medical parts we typically add 15-20% on top of standard pricing. Documentation, traceability, cleanroom operations all cost money.

Mold development timeline depends on complexity. Simple plastic parts 6-8 weeks. Complex with slides and lifters 10-12 weeks. MIM molds are faster because parts are generally smaller.

After first article approval we sign a production contract. For medical parts we usually ask customers to sign an annual purchase framework agreement. We don't take one-off small batches except during sample development. Reason is medical parts have fixed costs for parameter lockdown and document management. Too small and we can't make it work.

Questions, contact sales directly. Send drawings to the inquiry email, note that it's a medical project, we'll assign the right project engineer to follow up.

ABIS Mold Technology Co., Ltd. is one of the most famous medical parts manufacturers and suppliers in Shenzhen, China. Welcome to wholesale high quality medical parts from our factory.