[HN Gopher] Common pitfalls of digital health startups and advic...
       ___________________________________________________________________
        
       Common pitfalls of digital health startups and advice on how to
       avoid them
        
       Author : gone35
       Score  : 33 points
       Date   : 2024-04-12 20:53 UTC (1 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)
        
         | 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.
        
       | 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.
        
       ___________________________________________________________________
       (page generated 2024-04-13 23:01 UTC)