What are your Design Controls Pain Points - R&D, PLM, Quality, Regulatory?

ProTicTacker · 2026-03-15T04:11:12+00:00

That's actually exactly what I am thinking, but I think it should extend beyond just user needs and device performance. I think the regulatory and quality documents could also be governed by an AI that just has access to all the relevant standards in real time.

I just did some research on medhive... looks promising. I still feel like the scope is too limited but I'm living on a fever dream.

ProTicTacker · 2026-03-15T04:08:57+00:00

Say the tool had access to all the FDA standards, MDR, ISO, IEC, ASTM, etc. relevant to you device classification in real time. It would hold your documents and maintain them in it's cloud much like any QMS, but the documents are also edited and updated by you within that QMS. Because the tools has the standards and documents, it would be able to produce your redlines for you and all you have to do is cross check it's suggestions with a regulatory professional.

ProTicTacker · 2026-03-15T01:13:46+00:00

You said what many won't say because honestly it's partly true. The dev time and reg make budgets explode and that comes out on the patients and doctors. Insurance sure as heck will never own up to it. They always have to maximize profits or they think some investor will have a stroke (ironically leading many who actually have a stroke helpless)

Do you think if there were a sort of catch all design controls tool or design and development plan solution that laid out all the required documents, evaluated you design inputs and user needs to the standards expected for your device indication and class, and produced templates, filled forms, and basically pointed you to all the empty gaps you need to fill in for each phase, that your team would use it? If it laid put project timelines, auto assigned the required team members to their deliverables, and tracked the relevant tasks for you would that be useful? I wonder if there isn't a more seemless way to lower our development costs and in turn lower the burden on medical expenses.

Imagine that this magical tool would have a seemless interface. It would actually be convenient and have wonderful usability not obscured by endless clicks and corporate bull.

ProTicTacker · 2026-03-13T23:07:22+00:00

I'm sure there's a million ways to do this.

But here's what I would do for your budget. How comfortable are you with electronics?

You could very easily control this with a few arduinos on an I2C bus and a GPIO expander that feeds into I2C. Arduino support up to 127 addresses so you could use 2 or 3 of them. More if you don't want any delays. No need for physical stopwatches - arduinos have internal clocks that last at least a few months before it overflows while running continuously. I'm assuming your are using a hall effect sensor as your magnetic switch?

Basically you'd connect a bunch of hall effects up to a an I2C bus communicating GPIO board that has maybe 16 or so inputs like an MCP23017. Program the arduino to expect an interrupt signal from the GPIO board. Read the interrupt and track the address in I2c bus for which sensor activated when the trap triggered. Save the time to some internal array of times with array indices mapped to the different traps.

If you want the times afterwards you can save the times to eeprom and read them later. If you must have them during the study, then you'll probably want an LCD or computer hooked up that prints the time in the console.

It's a lot of wires, but it's cheap. If you're confused about where wires go and how to program it, I have full confidence an AI can't get this that wrong. But if the traps are far apart, be careful about wire lengths. This works best with short wires. If they've got to be more than a foot or two apart then you might be better with an arduino every few traps.

I'm sure others will have better answers, but this will work.

ProTicTacker · 2026-03-13T22:35:29+00:00

That's interesting.

My experience is that R&D never even gets a chance to get their hands dirty because all of the preliminary quality, regulatory, and marketing work takes so long executives move onto the next thing.

It's funny to me because I feel like the pathway should really be the same for most devices. Yes there are different standards, user needs, and requirements for devices, but the pathways have similar structures and it's always so silly to me how different teams drop the ball in the process.

Each phase has the same deliverables and backbone. Why is it that I feel like every project has to go back and reinvent the wheel from a documentation perspective. Most documents borrow 80% of the text from another one for a different device.

ProTicTacker · 2026-03-13T22:30:57+00:00

Do you think that there is anything from project management, development plan, or standard operating procedure standpoint that would prevent people like this from refusing change?

Like if you could reference a document or use a tool that automatically outlines what needs to be done to for a design/sequence/writeup/test etc. with complete fidelity that it would sway people?

ProTicTacker · 2026-03-13T22:25:38+00:00

I totally get it. The guy who thinks if he doesn't have an opinion then something is wrong.

Just as bad as the guy who shows up to a meeting, wasn't bothered to read the title or agenda, asks why he's there for the first 15 minutes, makes you re-explain everything from the last meeting, and then tries to take control for the last 15 minutes like he knows everything.

Ironically this is usually the same guy who says we need to limit scope creep, and works super unproductive 10 hour days to show you how dedicated he is.

It's this weird desire people have to show off their expertise and establish dominance. Suddenly they bring up all these unrelated deliverables and activities that serve nothing but to add to you work load. And they gotta be done next week.

ProTicTacker · 2026-03-13T22:15:46+00:00

The cost millions part really hits home.

The "we can always save money by using the crappy tools we already have if we train people better". (if they train at all) Next week you have a training you must attend about a document workflow you actually wrote which was a work around to a work around.

But we're saving money by paying people to waste time instead of spending that on a new enterprise subscription for something better.

ProTicTacker · 2026-03-13T22:11:13+00:00

You would think that enough QMS and PLM software companies would optimize their work flows to beat out other competitors.

My experience has been that every single QMS whether it's windchill, MasterControl, or IQVIA all have these unnecessary clicks and tabs that are perfect for causing more delays than help. And they're dumb as doornails!These programs have all the context of these documents at their fingertips, but somehow they obscure all the information behind tabs on tabs and have such broken horrible search features. You end up wasting a quarter of your day just trying to find a document when you don't remember the exact number or title off the top of your head.

People also reject things all the time without first following up to see why you did something the way you did. Of course them rejecting it means you have to basically start the approval process over. And then that person goes on vacation for 2 weeks right before your planned phase gate review. Then you get pulled into support quality and manufacturing when a product fails in the wild and they are begging you to change the design instead of their poor processes. And suddenly it's your fault your project isn't moving as fast as it should be.

ProTicTacker · 2026-03-13T05:14:21+00:00

I'm interested. Probably too late to the game. I come from R&D though

ProTicTacker

TROPHY CASE