4 ms·

Lots of biotech/medical device companies in this class. Historically this has not been a good category to invest in (unless you like to lose money), nor one tha

Lots of biotech/medical device companies in this class. Historically this has not been a good category to invest in (unless you like to lose money), nor one that is easy to get right. The FDA is a real pain to deal with and trying to "do things that don’t scale" has you end up like Theranos. I do give YC kudos for trying.

StephenSmith 11y ago
The FDA also provides a HUGE barrier to entry. Once a company makes it through the approval processes (if they make it), they will have a monopoly on that corner of the medical market for many years. I agree its difficult, but the rewards are higher.
- danieltillett 11y ago
  You can still fail at the marketing level even if you make it all the way through the approval process (Affezza comes to mind as a good example of this [1]). My background is in biotech and I feel the risk/reward ratio is too great in this area. Still a gutsy move from YC. 1. http://www.fiercepharma.com/story/sanofi-tried-and-failed-afrezza-why-does-mannkind-still-think-it-can-win/2016-02-10 http://www.fiercepharma.com/story/sanofi-tried-and-failed-af...
  - lisper 11y ago
    My very first angel investment was in a medical device company. They had FDA approval, patent protection, all the manufacturing in place, rave reviews from users, clear benefits over the competition... and they still failed because they couldn't get distribution. Ten years later I made another medical device investment. Again, good IP protection, FDA approved, clear data showing life-saving benefits. This one failed because the technical founders decided to go off the ranch and have a turf battle with the CEO. The Murphy factor in this sector seems pretty high to me.
    - danieltillett 11y ago
      Yes the bar in this area is very high as there are so many things that can go wrong. I think the difference is with pure software you are just dealing with human created complexity - with biotech you also have nature’s complexity to deal with too. Mix the two together and spice it up with some unbelievably stringent regulations and you have a recipe for a lot of heartburn.
- neurotech1 11y ago
  For low risk medical devices, startups can use a FDA 510(k) [0] to get approval if the device has a comparable (predicate) device already approved. This is how some startups get devices approved with relatively little red tape from the FDA. This may also work for some healthcare software apps. [0] http://www.emergogroup.com/resources/articles/fda-510k-clearance-process http://www.emergogroup.com/resources/articles/fda-510k-clear...
- patrickk 11y ago
  Perhaps it would be possible to attack this market using a different approach. The classic startup path is approximately --> geeks hammer out MVP product, get some funding and try to grow as quickly as possible, and either go big or fail. I got this idea after watching the Vice interview with Martin Shkreli (obviously not a role model)[1] Shkreli made the leap from hedge funds (betting against pharma companies) into becoming the CEO of a pharma company, which apparently does research in addition jacking up the prices of HIV drugs (Shkreli actually gives out chemistry lessons on youtube[2]). So maybe some geeks could try getting funding, buy up some underappreciated, undervalued but already FDA approved drugs, and using the cashflow to do further research, or develop cool new products or services in the healthcare space instead of the traditional, risky route. (I'm not advocating jacking up the prices of critical lifesaving drugs obviously). [1] https://www.youtube.com/watch?v=2PCb9mnrU1g https://www.youtube.com/watch?v=2PCb9mnrU1g [2] https://www.youtube.com/watch?v=zQljHkKuC2I https://www.youtube.com/watch?v=zQljHkKuC2I
baus 11y ago
I wonder if this has something to do with PG stepping aside. I heard a talk from him years ago and it didn't sound like he was to interested in getting into the health care domain. I can understand his position. It is a bureaucratic nightmare.
- cel1ne 11y ago
  And you have a lot of powerful players that don't like to see you succeed. (read: big pharma)
  - maxerickson 11y ago
    Big pharma buys startups all the time.
    - cel1ne 11y ago
      Big pharma sues startups as well.
bambax 11y ago
I find the proposition of "Spinal Singularity" strange: why would you need a connected urinary catheter?? The things on your body, being on your body, are easily accessible. If I ever need a urinary catheter I'd rather control it with a manual pump than a cell phone. Does everything need to be connected?? Does this thing require you to have your cell phone with you in order to take a piss? And can you go if your phone dies? Also, if your cell phone can control it, it's only a matter of time before it's hacked (fun in the board room!)
- autopov 11y ago
  I agree wholeheartedly. It seems this device just creates more points of failure (e.g. lost/dead phone, urinary tract infections, interference, etc.) for a little convenience. Self-cathing isn't that difficult once you get the hang of it.
  - phrogdriver 11y ago
    I think the founder would disagree. He's working on this specifically because he finds self-cathing difficult and cumbersome.
- adrianhoward 11y ago
  Having family with catheters they would have loved this / love this. The external valves, and associated bags, are all additional causes of infection — and this would cut those out. It's really hard to change those bags without spillage. This cuts that out. The external pipework getting caught on things and causing pain. Solved. You have to adjust the kind of clothing you wear so that you can have space for the catheter bag. This would cut that out. The location of catheter bags means that people with certain kind of mobility problems can't change them themselves - this would cut that out. This one directly affects a friend of mine right now. Four times a day that have to be around somebody who is willing to change a catheter bag with them. They cannot get up at night without somebody to disconnect/reconnect the night bag. The whole issue of not knowing how full the bladder is - this would cut that out. Never being able to go swimming. Never being able to have a bath. Solved. If this can be made to work well, and it's a big if I'm sure, it is a game changer and a major quality of life improver.

StephenSmith 11y ago

The FDA also provides a HUGE barrier to entry. Once a company makes it through the approval processes (if they make it), they will have a monopoly on that corner of the medical market for many years. I agree its difficult, but the rewards are higher.

danieltillett 11y ago
You can still fail at the marketing level even if you make it all the way through the approval process (Affezza comes to mind as a good example of this [1]). My background is in biotech and I feel the risk/reward ratio is too great in this area. Still a gutsy move from YC. 1. http://www.fiercepharma.com/story/sanofi-tried-and-failed-afrezza-why-does-mannkind-still-think-it-can-win/2016-02-10 http://www.fiercepharma.com/story/sanofi-tried-and-failed-af...
- lisper 11y ago
  My very first angel investment was in a medical device company. They had FDA approval, patent protection, all the manufacturing in place, rave reviews from users, clear benefits over the competition... and they still failed because they couldn't get distribution. Ten years later I made another medical device investment. Again, good IP protection, FDA approved, clear data showing life-saving benefits. This one failed because the technical founders decided to go off the ranch and have a turf battle with the CEO. The Murphy factor in this sector seems pretty high to me.
  - danieltillett 11y ago
    Yes the bar in this area is very high as there are so many things that can go wrong. I think the difference is with pure software you are just dealing with human created complexity - with biotech you also have nature’s complexity to deal with too. Mix the two together and spice it up with some unbelievably stringent regulations and you have a recipe for a lot of heartburn.
neurotech1 11y ago
For low risk medical devices, startups can use a FDA 510(k) [0] to get approval if the device has a comparable (predicate) device already approved. This is how some startups get devices approved with relatively little red tape from the FDA. This may also work for some healthcare software apps. [0] http://www.emergogroup.com/resources/articles/fda-510k-clearance-process http://www.emergogroup.com/resources/articles/fda-510k-clear...
patrickk 11y ago
Perhaps it would be possible to attack this market using a different approach. The classic startup path is approximately --> geeks hammer out MVP product, get some funding and try to grow as quickly as possible, and either go big or fail. I got this idea after watching the Vice interview with Martin Shkreli (obviously not a role model)[1] Shkreli made the leap from hedge funds (betting against pharma companies) into becoming the CEO of a pharma company, which apparently does research in addition jacking up the prices of HIV drugs (Shkreli actually gives out chemistry lessons on youtube[2]). So maybe some geeks could try getting funding, buy up some underappreciated, undervalued but already FDA approved drugs, and using the cashflow to do further research, or develop cool new products or services in the healthcare space instead of the traditional, risky route. (I'm not advocating jacking up the prices of critical lifesaving drugs obviously). [1] https://www.youtube.com/watch?v=2PCb9mnrU1g https://www.youtube.com/watch?v=2PCb9mnrU1g [2] https://www.youtube.com/watch?v=zQljHkKuC2I https://www.youtube.com/watch?v=zQljHkKuC2I

baus 11y ago

I wonder if this has something to do with PG stepping aside. I heard a talk from him years ago and it didn't sound like he was to interested in getting into the health care domain. I can understand his position. It is a bureaucratic nightmare.

cel1ne 11y ago
And you have a lot of powerful players that don't like to see you succeed. (read: big pharma)
- maxerickson 11y ago
  Big pharma buys startups all the time.
  - cel1ne 11y ago
    Big pharma sues startups as well.

bambax 11y ago

I find the proposition of "Spinal Singularity" strange: why would you need a connected urinary catheter?? The things on your body, being on your body, are easily accessible. If I ever need a urinary catheter I'd rather control it with a manual pump than a cell phone. Does everything need to be connected?? Does this thing require you to have your cell phone with you in order to take a piss? And can you go if your phone dies? Also, if your cell phone can control it, it's only a matter of time before it's hacked (fun in the board room!)

autopov 11y ago
I agree wholeheartedly. It seems this device just creates more points of failure (e.g. lost/dead phone, urinary tract infections, interference, etc.) for a little convenience. Self-cathing isn't that difficult once you get the hang of it.
- phrogdriver 11y ago
  I think the founder would disagree. He's working on this specifically because he finds self-cathing difficult and cumbersome.
adrianhoward 11y ago
Having family with catheters they would have loved this / love this. The external valves, and associated bags, are all additional causes of infection — and this would cut those out. It's really hard to change those bags without spillage. This cuts that out. The external pipework getting caught on things and causing pain. Solved. You have to adjust the kind of clothing you wear so that you can have space for the catheter bag. This would cut that out. The location of catheter bags means that people with certain kind of mobility problems can't change them themselves - this would cut that out. This one directly affects a friend of mine right now. Four times a day that have to be around somebody who is willing to change a catheter bag with them. They cannot get up at night without somebody to disconnect/reconnect the night bag. The whole issue of not knowing how full the bladder is - this would cut that out. Never being able to go swimming. Never being able to have a bath. Solved. If this can be made to work well, and it's a big if I'm sure, it is a game changer and a major quality of life improver.