BrightInsight is trying to become a run of the mill SaaS company with a rinse and repeat business model where they can scale fast. There company has pivoted from a SaMD focus to a traditional IT infrastructure focus that is all about deployment and scale. At the outset, this may sound like it makes sense, but then when you consider the initial and entire value proposition of the platform, you realize this makes no sense if you just copy the development, launch, and maintenance models of other IT services (all of whom have failed in SaMD). This is what happens when you get a bunch of B2C SaaS Execs. and Mgmt Consultants to run the company who have ZERO concept of what a medical device takes and the true service, technology, and documentation needs of medtech. A lot of new leadership have all been hired in from teams and organizations with very little hands-on expertise and experience in the medical device world (believe me I can tell just by talking to them). This fact is captured in what they value (smooth talk to assuage customers, business jargon, and acting before thinking about RISK/consequences), all of this is at odds with the PROCESS needed to capture the end result of a safe and efficacious product.
Speaking of process, let me begin. BrightInsight has HUGE process overhead when it comes to the unnecessary and the zero yield discussions. For instance, what to offer for WFH equipment, data for employee satisfaction (zero progress here btw), and how to decide on deciding the best finance tracking software (why can't the execs. input HERE vs. on actual product development and delivery?!). Where process is lacking and it is a giant cluster of future audit risk and free-for-all is in the actual design control processes, DevOps, Testing (VnV), you know, the actual work to make a medical device? Anyways, this rant is long enough. Don't even get me started about the large layoff that just happened right before the Thanksgiving break; good talent is hard enough to find already, let alone medtech SaMD talent, funding should last a while even though ARR has underperformed, there is ZERO reason for layoffs besides to boost Q4 numbers (sound like a bunch of consultants anyone?).
