Low-Cost 3D-Printed Prosthetic Hand To Be Tested On Amputees In Ecuador

Zothecula writes A PhD candidate and six undergraduate students at the University of Illinois at Urbana-Champaign (UCIC) have created a low-cost, programmable, 3D-printed prosthetic hand that may soon change the lives of amputees in Ecuador. The hand costs just $270 to manufacture, making it a small fraction of the cost of a typical prosthetic of this type.

Comments

Manufacutring isn't the problem in the US.

[trout007]

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Re:Manufacutring isn't the problem in the US.

[TubeSteak]

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

Re:Manufacutring isn't the problem in the US.

[trout007]

You refute your own argument. If you don't want to go to jail you need to hire a team of lawyers that are experts in FDA regulations to determine if what you want to create is exempt and which regulations you do need to comply with. Then you need an auditing team to make sure that you are properly complying with the regulations you do need to meet.

That is the problem with these types of regulations. You need an expert to even know if you need to follow them.