5 ms·

Cost of entry is immense. As with anything medical or food and drug related, there are large (and expensive) obstacles to hurdle before any product can enter th

Cost of entry is immense. As with anything medical or food and drug related, there are large (and expensive) obstacles to hurdle before any product can enter the market. It's a rather difficult market to get into without a large amount of capital at your disposal.

echelon 3y ago
> Cost of entry is immense. As with anything medical or food and drug related, there are large (and expensive) obstacles to hurdle before any product can enter the market. What about not using the US as the launch market?
- methodical 3y ago
  The US is probably the worst launch market. The FDA regulates hearing aids so any new product would have to go through the FDA validation process, which is expensive. Edit: I may have misread your comment, my apologies! I'm only loosely familiar with the US regulation on this matter and completely unfamiliar with other countries' regulations but I'd find it hard to believe there's any country more expensive to launch in for a medical device than the US, so for the OP I'd agree with you that the US should probably be a later market to target.
  - thfuran 3y ago
    On the other hand, there's probably no country with as large a population as ready to spend as much money on medical devices.
  - ksherlock 3y ago
    In 2017, congress ordered the FDA to allow over-the-counter hearing aids. In late 2022, they finally got around to it, so it should be easier now than it was. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans https://www.fda.gov/news-events/press-announcements/fda-fina... https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids https://www.federalregister.gov/documents/2022/08/17/2022-17...
    - methodical 3y ago
      Does OTC status affect the process by which a product gets approved by the FDA, or only dictate the means by which it can be distributed? I'm unfamiliar with the distinction, but if it means these types of products are easier for consumers to get access to then it's certainly great news. Certainly, non-implant hearing aids shouldn't have to jump through the same number of hoops as more conventional medical devices.
- bsder 3y ago
  Any market that doesn't have the equivalent of the FDA probably has very little money in it.
  - methodical 3y ago
    Not that I'm particularly knowledgable on the subject but I find this a little hard to believe. I'd expect any first-world country around the world to have a reasonable demand and means to afford a product of this nature. The US obviously isn't the only country with access to 21st century medical devices of this sort?
    - thfuran 3y ago
      And they have regulatory agencies.
- fragmede 3y ago
  Mexico and Australia are the two markets I've heard to start with for healthcare devices. The US market shouldn't be your first for that.
abdullahkhalids 3y ago
You can presumably now sell OTC hearing aids in the US. Also, I see quite a few kickstarters/indigostarters in this space [1]. So it isn't that difficult. [1] https://www.indiegogo.com/explore/tech-innovation?project_timing=all&product_stage=all&sort=trending&q=hearing%20aid https://www.indiegogo.com/explore/tech-innovation?project_ti...

echelon 3y ago

> Cost of entry is immense. As with anything medical or food and drug related, there are large (and expensive) obstacles to hurdle before any product can enter the market. What about not using the US as the launch market?

methodical 3y ago
The US is probably the worst launch market. The FDA regulates hearing aids so any new product would have to go through the FDA validation process, which is expensive. Edit: I may have misread your comment, my apologies! I'm only loosely familiar with the US regulation on this matter and completely unfamiliar with other countries' regulations but I'd find it hard to believe there's any country more expensive to launch in for a medical device than the US, so for the OP I'd agree with you that the US should probably be a later market to target.
- thfuran 3y ago
  On the other hand, there's probably no country with as large a population as ready to spend as much money on medical devices.
- ksherlock 3y ago
  In 2017, congress ordered the FDA to allow over-the-counter hearing aids. In late 2022, they finally got around to it, so it should be easier now than it was. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans https://www.fda.gov/news-events/press-announcements/fda-fina... https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids https://www.federalregister.gov/documents/2022/08/17/2022-17...
  - methodical 3y ago
    Does OTC status affect the process by which a product gets approved by the FDA, or only dictate the means by which it can be distributed? I'm unfamiliar with the distinction, but if it means these types of products are easier for consumers to get access to then it's certainly great news. Certainly, non-implant hearing aids shouldn't have to jump through the same number of hoops as more conventional medical devices.
bsder 3y ago
Any market that doesn't have the equivalent of the FDA probably has very little money in it.
- methodical 3y ago
  Not that I'm particularly knowledgable on the subject but I find this a little hard to believe. I'd expect any first-world country around the world to have a reasonable demand and means to afford a product of this nature. The US obviously isn't the only country with access to 21st century medical devices of this sort?
  - thfuran 3y ago
    And they have regulatory agencies.
fragmede 3y ago
Mexico and Australia are the two markets I've heard to start with for healthcare devices. The US market shouldn't be your first for that.

abdullahkhalids 3y ago

You can presumably now sell OTC hearing aids in the US. Also, I see quite a few kickstarters/indigostarters in this space [1]. So it isn't that difficult. [1] https://www.indiegogo.com/explore/tech-innovation?project_timing=all&product_stage=all&sort=trending&q=hearing%20aid https://www.indiegogo.com/explore/tech-innovation?project_ti...