Price ranges of prototype design companies - Page 1
Forum section: electronics / general

author: orealm
author_rank: Newbie
timestamp: May 28, 2016, 11:18:54 pm
content: I am in the process of designing a medical device and, although I have been doing some rudimentary prototyping, I have realized that it would be years until I can get the device to an FDA (based in the USA) approved level at the rate I am going (my main background is computer programing and business). Therefore I am looking for some advice on working with a prototype design company and what the price ranges of these services are (i.e., thousands, 10s of thousands, 100s of thousands?). Obviously it depends a lot on the complexity of the device. Basically there are three parts: a central unit with processing with USB and Bluetooth connectivity, an accelerometer and a muscle stimulation unit. The muscle stimulation unit needs to convert 1.2-1.5v (AA battery) power to 50-120v power with ?200 mA peak @500 Ohm load/?120 mA peak @1000 Ohm load and a programmable waveform (or at lease asymmetrical biphasic waveform with an adjustable frequency of ?15-35 pulses per second and a pulse duration of 25-300 microseconds). Has anyone had experience working with a circuit development company in the health care industry? Thanks?

author: uncle_bob
author_rank: Unknown
timestamp: May 29, 2016, 12:52:58 am
content: HiThis stuff typically goes through a couple of steps:1) Come up with a real legit device and see that it works. Best guess, that is in the $40K to $100K range.2) Do some basic testing to demonstrate that it does what is intended and is useful. That is a very open ended thing. Figure at least $100K. Without this sort of checkout, you should not go forward. It also covers the basic testing you should do before you ever consider going through the approval process.3) You then need to go through agency approval. That may involve more than the FDA. Figure it's going to be $100K to $200K for the approvals per agency. If stuff like clinical trials are involved .... you will spend *lots* more.Could those numbers be 2X to high? Sure, if the device likely sells for under $5 they might be. They also could be 2X to 5X to low if the device is fairly complex.Fun and games.Bob

author: coppice
author_rank: Super Contributor
timestamp: May 29, 2016, 04:37:20 am
content: Which FDA approval level will your device require? The requirements for category 3 and above devices are making a number of people walk away from any health care developments at the moment, so you may need to find a specialist developer.

author: John_ITIC
author_rank: Frequent Contributor
timestamp: May 29, 2016, 05:50:46 am
content: I sent you a PM.

author: ar__systems
author_rank: Frequent Contributor
timestamp: May 30, 2016, 02:49:38 pm
content: Sent PM.Specification is nowhere near to be complete, all I can say for now - it will be 20K minimum, probably more. Maybe a lot more.I recommend quoting the project in stages and expect having to go through at least 2 revisions, first being a prototype.

author: IconicPCB
author_rank: Super Contributor
timestamp: May 31, 2016, 05:58:49 am
content: Keep in mind the assembly/manufacturing facility ALSO needs to be approved.Better approach is to make zero claims ( minimal claims ) in your sales approacha nd see it will slide beneath FDA radar.