A webapp for creating calendar events with unique links to meet.jit.si for video conferencing. It was an early pandemic project that I haven’t done anything with since putting it up.
We have a few of #2 we got from Amazon. You can still cut yourself but it's more of an abrasion than a laceration. It's great when you can find real tools for your kids to use and explore their ideas independently.
He's got two weeks to provide the detailed information he should already have or a reason why he doesn't have it. He could even provide an estimate (see instruction #4 in the Special Order). The threat of legal consequences is if any information/reason is missing or if the order is completely ignored. Getting your company shut down by the government only comes after a lot of back and forth communication and is usually due to willful negligence on the company's part.
Why do that when you could just get the information directly from the NHTSA [1]? I expect all those companies have been in communication with regulators from the beginning and produced plenty of documentation. Besides, they can't do the same thing the large players did since they aren't in control of developing the entire vehicle.
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
First of all, thank you Shift Labs for putting up their information and helping make confusing regulatory processes clearer.
Secondly, I want to let people know my company[1] works with many start-ups in the medical device space that are developing regulated products, both 510(k) and CE mark. We are engineers that understand the regulatory process not just regulatory consultants.
If Mr. Gustavsson is involved I wonder why there's no mention of the regulations they need to pass before they can sell units in the US. I did a quick search [1] and found a few of the systems he has been involved in and they are all FDA Class II devices which is a long, involved process. They'll need data showing substantial equivalence to a predicate, unless they've come up with a way to get around the FDA. At a minimum they'll have to register as a laser product with CDRH before they can ship anything. [2]
Yeah, BaaS :-), but what CRO would take on those type of jobs when they can't charge what they do for clinical trials or drug discovery.
I'm not sure how much interest there is either and I agree that something is missing. Maybe affordable kits similar to how PCs became more accessible to the masses as IC prices came down. Maybe bringing modern scientific equipment in to school biology classes to expand public knowledge beyond test tubes and bunsen burners.
It's great that the tools and services the article mentions are out there but I think the author misses the wide gulf there is between limits of what can be done in a garage or shared lab and the resources, time and capital to do things like synthetic biology and drug discovery.
It would be interesting to see where the DIY biotech movement could apply the biotech research tools and methods to where people are already doing home "biohacking". Could home brewers and fermenters gain insight into what's going on inside their jars? Maybe small scale farmers would be interested in quantifying the bacteria in their soil. Larger brewers are already using PCR to check for spoilers in their beer, could this be turned in to BaaS (Biology as a Service) and expanded, or trickled down to the home brewer?
Check with your state's cooperative extension [1]. They'll have articles about proper watering and fertilization. They'll also have places where you can send soil samples from your yard and get a report back on its condition.
This is what technical debt looks like on the hardware side, missed deadlines and quality issues. Kudos to Cameron and the Lockitron folks for sharing their experience.
I think bravo22 already covered some of the choices they made up front that got them in to trouble. It appears they didn't have the knowledge or experience to put a good plan together when they suddenly had to scale from 1000 or so units to multiple thousands. Here are a few (more) reasons:
1. Unaware of the environment. bravo22 already touched on the existing deadbolt standard and current products on the shelf. Whether they knew about these or not, it sounds like they chose to go in to production with their prototype (buggy) design instead of sourcing or modifying an existing solution.
2. Lack of specific knowledge. They expressed difficulty meshing the electronic and mechanical parts of their system. There are plenty of engineers that have electro-mechanical design experience that they could have leaned on, either hired on to do the redesign or to guide them in the right direction for things like gear-train torque calcs, material selection and fabrication methods (think redesigning a part for injection molding), power consumption calcs, part count reduction... Much of this may only be a Google search away, but if they don't have enough knowledge to know how to apply it correctly then that leaves them at the mercy of either fate or their suppliers.
3. Documentation. "While there is some truth to this, making hardware at scale is still incredibly difficult — if not for the actual physical manufacturing itself but for the compounding complexity of suppliers, tooling and testing." You need good documentation. Part drawings with realistic tolerances that produce parts that make functional assemblies. Work instructions that spell out things like order of operations, screw torque specifications, inline QC checks, etc. The documentation is often your contract with the supplier and if it's poor or not well thought out then the product quality suffers.
These guys are going through an awesome trial by fire. They have a well funded, very public, product that they are trying to turn out and they should be commended for sticking with it for that last two years, and for being willing to talk about their challenges. Just like any other start-up, succeed or fail, they're going to be a better position when they do it again.
> I tell college students that there is both risk and opportunity in Detroit. If you want the safe choice it's probably not where you want to go. But if you want to skip a few steps in your career rise along with a higher risk of failure then it's one of the best places.
I expressed this exact sentiment at a conference a year ago where the topic was about keeping great talent here (Detroit/Michigan/Midwest) instead of losing it to the coasts. Basically, you could go be a cog in the Google machine, or you could stay here and drive something new to success. Of course you're taking risks; big names missing on your resume, a six figure starting salary, winter. There are benefits though; you get to set the culture, much lower cost of living, and fall here is awesome.
With the bankruptcy in motion I think locals now feel that Detroit has finally hit bottom and can now work its way back to something better. It's not going to be the next Silicon Valley, but with the increased interest from younger generations it's going to be something more than it has been in a while, growing.
A webapp for creating calendar events with unique links to meet.jit.si for video conferencing. It was an early pandemic project that I haven’t done anything with since putting it up.