[HN Gopher] Common pitfalls of digital health startups and how t...
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Common pitfalls of digital health startups and how to avoid them
(2023)
Author : gone35
Score : 72 points
Date : 2024-04-12 20:53 UTC (3 days ago)
(HTM) web link (bettychang.xyz)
(TXT) w3m dump (bettychang.xyz)
| oezi wrote:
| One important thing which isn't mentioned in the article is that
| you need at least 1m EUR/USD to become a company with a medical
| device. So you better have a plan to to raise such money, spend
| and recoup it with revenues.
| Jimmc414 wrote:
| Can you go into a little detail on the expenses that 1m needs
| to cover?
| oezi wrote:
| Quality Management setup and certification
|
| Clinical study
|
| Technical file / DHF creation
|
| FDA Submission (510k/DeNovo) or CE marking (via Notified
| Body)
| WA wrote:
| Depends a lot on your product, your target market(s),
| number of supported languages, number of employees, and
| most of all: the risk class of the product.
|
| QMS can be around 15-20k
|
| Study: not necessarily needed if you do not need new
| evidence. Then you can write a literature review, which is
| A LOT cheaper
|
| TechDoc: yeah, takes time
|
| CE marking: depends a lot on the notified body. Here's a
| slightly outdated list and apparently, you can pay anything
| between 15kEUR to 500kEUR:
| https://openregulatory.com/notified-bodies/
| nradov wrote:
| For most hardware devices that's correct. But software as an
| FDA Class I medical device can be done cheaper than that. Under
| US regulations, pure software with no hardware component can be
| considered a "medical device" depending on functionality.
| pintxo wrote:
| In my past company we looked at EU MDR class 2a
| certification, we established it would cost around 100kEUR/a
| to get and maintain all necessary certifications. Essentially
| hiring a full-time resource to do all documentation, plus
| costs due to slower work cycles, plus certification reviews,
| plus external consulting as needed.
|
| Ultimately we closed shop before we starting going down that
| route, so I cannot tell if that number was correct.
| notamy wrote:
| (2023)
| tokyovigilante wrote:
| They've forgotten the classic error of engaging only with client
| at the management and IT and ignoring clinical requirements until
| UAT, and a clinician revolt ends in project failure, adverse
| media coverage, millions of wasted dollars, and ongoing patient
| harm from unsatisfied requirements and persistent legacy systems.
|
| Also needs an asterisk about not relying on your customer's BAU
| resource to deliver projects, particularly those with large
| integration components, and one about not buying a business for
| its product as a replacement for yours which is EoL, then
| immediately trying to push it on your customers as an "upgrade"
| when you've lost half the acquisition's engineering talent and
| you don't understand the product.
| duffpkg wrote:
| Wrote Hacking Healthcare for O'Reilly, former hospital executive,
| built and operated hundred of hospitals and multi-practice
| groups. Created the open source ClearHealth/HealthCloud EMR and
| WebVista.
|
| I advise a lot of health related startups. I think the list is OK
| but the two most important things I have seen come up over and
| over again are 'have a show pony' and KISS.
|
| "Have a show pony" means you need to have a doctor associated
| with your business, idea, etc that is high profile and a public
| advocate for it. Doesn't necessarily mean as an employee or
| consultant, etc, that can get complex because of corporate
| practice of medicine regulations but advisory boards and research
| partners are often good fits. This lets you be taken seriously by
| what are extremely risk averse institutions in most cases,
| especially when dealing with "two guys and a hard drive"
| startups.
|
| KISS is the old adage, keep it simple stupid, but really in
| healthcare the overwhelming high priority problems are insanely
| simple people issues. Getting people to wash their hands, getting
| patients to show up at the right time and the right place, having
| an organized and non-duplicative flow of operating information. A
| tremendous amount of healthcare is done via spreadsheet, think at
| that level. Complex solutions can be profitable but almost never
| endure and can be extremely hard to sell.
|
| I think a lot can be gleaned about the general dysfuction of
| healthcare as an industry from this previous HN thread:
| https://news.ycombinator.com/item?id=39186252
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