You are casting too wide of a net, when specifying 'Medical Device Companies' the failure rate is 75%
<<<<<<<< 19 of 20 biotechs fail. >>>>>>>>
"In the US, 75% of medical device start-ups fail, and 98% of digital health startups fail. Moreover, 75% of venture-backed companies never return cash to their investors, and in 30-40% of cases, investors lose their entire initial investment. Oct 25, 2023
When looking at failure rates of all Startup businesses combined the rate is 90%.
"The average cost to bring a 510(k) product from concept to market exceeds $31 million, with greater than 77% of the cost—approximately $24 million— spent on regulatory and FDA-related activities. The cost of a PMA averages $94 million, with $75 million spent on FDA-linked stages. That is nearly 80% of the total amount."
BIEL does not have just 1 FDA 510k Indication but 5 :
Blepharoplasty (eyelid surgery) K022404
Postoperative Pain K190251
Plantar Fasciitis K152432 (OTC)
Knee Osteoarthritis K152432 (OTC)
Musculoskeletal Pain K192234 (OTC)