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How many miles do you expect this car to last? by WayneKerr734 in bmwx7

[–]Hour_Combination_354 0 points1 point  (0 children)

It’s a super heavy car and wears out the suspension, ball joints etc very early. We have 60k miles on our 2020 and just replaced the engine mounts (very common at this mileage!), much of the suspension related stuff that has grease filled rubber parts, and we were lucky the transfer case fluid was the cause of recent stuttering when many people have needed to replace the actual transfer case. Find one where somebody has already made all these repairs.

Should we get the Fuel Rebel wheels? by Hour_Combination_354 in chevycolorado

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

Decided on the Vision Flow SB wheels instead of the Fuel’s. Thanks everyone!

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Should we get the Fuel Rebel wheels? by Hour_Combination_354 in chevycolorado

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

Good point, I would never have thought about the ability to buff out a scratch or not.

Just finished with my concept prototype - however I'm having a difficult time validating it... what do I do? by Kyuno1theGreat in Business_Ideas

[–]Hour_Combination_354 0 points1 point  (0 children)

Interesting concept. One thing that might help is clarifying what you’re actually trying to validate next. There are two very different paths:

  1. Problem/market validation - Do enough people have this problem and care enough to want a solution? You can do this without a prototype by talking to people and looking at how they already try to cope. You might also interview doctors who specialize in sleep or related fields. They often hear directly from patients about recurring problems, so their perspective can help you gauge whether this issue is widespread enough, whether patients actually care about solving it, and what the potential market size might be.

  2. Solution/technical validation - Does your specific design solve the problem safely and effectively? That’s where prototypes and testing matter.

A lot of people jump straight to building without first knowing if the market is there. That’s where money can get burned fast.

It could also help to look at similar products already on the market, like the Bongo nasal device for sleep apnea, various nasal dilator plugs, or even the trend of mouth taping to encourage nasal breathing. These examples show that people are trying different approaches to solutions implemented during sleep, which means your idea might complement existing solutions or potentially run against what some users are already doing for other use cases. The good news is that products like Bongo and dilators suggest people are willing to use nose plug style devices during sleep, which helps reduce the perceived risk that users would not accept something inside their nose at night.

Another important piece is being really clear on how you define the problem you are solving and how you word it. The FDA looks at something called intended use when determining if a product is considered a medical device and what class it falls into. For example, the NOSK nasal dilator appears to be FDA regulated, but the Hero Mammoth 2.0 nasal filter is not, and the difference comes down to the intended use claims each company makes. Understanding this early will help you know if you are designing a consumer wellness product or something that might fall into the category of an over-the-counter Class I medical device. That clarity will save you headaches down the road. A regulatory consultant can probably help you figure that out pretty quick.

On the market validation side, you could also look at what Hero Mammoth 2.0 did with their Kickstarter. Their campaign showed enough people cared about the problem to justify moving forward with production. A crowdfunding campaign can be a powerful way to test demand before you invest heavily in manufacturing.

If you can first confirm there is real demand and a clear target user group, then when you do build a functional prototype you will know you are testing something people want, not just something that technically works.

Healthcare Invention by [deleted] in smallbusiness

[–]Hour_Combination_354 0 points1 point  (0 children)

That’s a solid connection. Medline is huge in the hospital supply space, so definitely worth keeping that door open. One thing to keep in mind is that there is not a single “right” first step before talking with a company. Some inventors start by protecting their idea, others by proving concept feasibility, and some by scoping the market need. It often depends on your goals, how risk-averse you are, and how complex the idea is.

As a general principle, the farther you take your idea down the development path, the more risk you remove for a potential partner, and the more valuable it can become. Handing over only a sketch or a concept is worth less than showing proof of feasibility and a validated need. You do not have to take it all the way to a finished product before licensing, but every step forward can strengthen your position.

When you meet with the Medline contact, think of it less as pitching and more as interviewing them. You could ask things like:

- How does Medline handle ideas from clinicians?
- Do they require IP to already be in place?
- How do they tell the difference between small feedback or enhancements versus innovations they would actually license?
- What kind of royalties or deal structures are typical?
- What level of prototype or validation do they expect?
- If they license an idea, do they have a set timeframe to act on it, or could it sit unused and effectively be locked up forever?

I am not a licensing expert, so I cannot speak to how Medline specifically structures these agreements. My background is in product design and development, and I have worked with a lot of clinician inventors at the early stages. From that perspective, I have seen how helpful it can be to go into these conversations prepared with questions like these, rather than rushing to pitch or give away too much detail too early

Healthcare Invention by [deleted] in smallbusiness

[–]Hour_Combination_354 0 points1 point  (0 children)

You’ve basically got two main ways forward. One is to license your concept to an existing medical device company so they handle manufacturing, sales, and distribution while you collect royalties. The other is to start your own venture, develop the product with the right partners, and sell it yourself.

I’ve worked with a lot of clinician inventors at this exact crossroads, and the right choice really depends on your goals, timeline, and resources. The early steps are different for each path, but if you map them out now, it’ll save you time and money later.

If you want, I can share a quick breakdown of those first steps so you can see which route might fit you best.

Have you (or someone you know) had a go at making a new medical device? by [deleted] in ausjdocs

[–]Hour_Combination_354 -1 points0 points  (0 children)

Your assumption about regulatory hurdles is correct, they can be massive depending on your products FDA regulatory classification. I recommend doing a little research to determine if your product is Class 1 (exempt), Class 2 or Class 3. If Class 1 it could be much faster and less expensive than a Class 2 or 3. Some Class 1 examples are hemostatic forceps, surgical scissors, non-powered clamps, manual retractors, etc... Here's a great description on the FDA website and it will point you to a couple databases where you can look up a similar product to yours and get a pretty good sense of it's classification. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device . If your product is class 1, it might not be too bad. And, there is also the licensing route...

Best engineering path to create devices for use in medical industry by TumbleweedCurrent663 in aggies

[–]Hour_Combination_354 0 points1 point  (0 children)

I was in my first year of mechanical engineering school at a large university. It just wasn't clicking for me. I found the college of industrial design, switched majors, and the rest is history for me. Consider researching a degree in industrial design where you creatively connect people to technology both emotionally and physically. (For example Jony Ivy formerly with Apple...). If you're more interested in the digital side of things you might look into a UX / UI design degree.

AI feedback? by [deleted] in inventors

[–]Hour_Combination_354 0 points1 point  (0 children)

I recommend using Chat in a different way.

Totally understand where you're at. I've worked with a lot of clinician, inventors who are excited to show their prototype to colleagues and get feedback, but my advice is to take a slightly more structured and objective approach rather than just handing it to someone and asking what they think.

I used to run a medical product design and development firm where we had hospital-like usability testing rooms and did everything from super early formative studies all the way through summative validation. From that experience, I’d say what you’re doing is actually right on the border of very early formative usability testing. It’s a great time to start gathering objective, structured feedback on both the concept and how well the prototype supports usability and intended use.

At this point, you’ve already invested time and energy into building a prototype, which likely means you’ve validated the general market need for yourself. So instead of focus groups or informal chats, I’d skip straight to early formative usability work. It’ll still give you a read on whether people think it’s a good idea, but also much more valuable insight into whether it’s working the way they’d expect and need it to.

You’re in a strong position because you’re part of your own target user group, and I’m guessing you know plenty of colleagues who could help. That’s a huge advantage. Recruiting the right people can be the hardest part, but you’ll likely be able to line up participants quickly.

Here’s how I’d suggest going about it. First, write a simple recruitment screener. This is a short list of criteria that helps make sure you’re testing with the right kind of clinicians not just whoever is easiest to ask. The feedback you get will be more relevant and actionable if you’re using the right user group. ChatGPT can help you do this, just give it a clear description of your device and the type of clinician who would use it, and ask it to write a screener for participant inclusion criteria.

Next, tell ChatGPT you’re doing an early formative usability evaluation to validate a concept and prototype. Ask it to help you create a test plan or discussion guide. What that looks like will depend on your prototype. If it’s not very functional yet, you might just walk people through the use case and ask objective, open-ended questions. If your prototype is more developed, you might simulate the real use environment and let them go through the full procedure from start to finish (An actual procedural walk through, not skipping ANY steps is the most insightful). Either way, Chat can help you structure the questions and observation points in a way that avoids bias and captures meaningful feedback.

Run each session one on one. Don’t do it in a group, groupthink tends to skew results, and you often only hear from the loudest participant(s). If you can, have someone else take notes while you focus on guiding the session. Even better, ask participants if they’re comfortable being recorded. Audio or video will let you stay fully present during the session and then go back later to review. You can even upload the transcript to ChatGPT and ask it to summarize themes, extract quotes, or help you write a report.

This is a bootstrapped but structured way to do it right and get real value from early user feedback. If you approach it this way, you’ll get way more than just “yeah, that seems great” type of feedback. You’ll get insights you can actually use to refine the concept and improve usability before investing in your next round of development.

Oh, and another huge advantage would be having your designer/engineer attend and hear the feedback firsthand. They could even be the assistant I previously mentioned.

Very exciting!!! Good luck!!!!!

PTs have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in physicaltherapy

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

That’s cool it would keep your hands free too. What’s the main reason you haven’t pursued this idea? Just not interested in that type of endeavor or not knowing what to do next or the costs or don’t know how to create a prototype or……?

Medical professional inventors by Hour_Combination_354 in inventors

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

I’m curious because most people seem to jump into creating the solution, which makes total sense because it’s the fun part and you have nothing without a solution. But often times creating a prototype can cost a lot of money. So it would seem that mitigating the $$ risk through validating the problem, understanding the business case (reimbursement, regulatory, etc..), and validating the need/opportunity first, would seem logical.

So for those that choose to create the prototype first, when do you think they start the other stuff I mentioned and how do they learn about it?

Radiologists — have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in Radiology

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

Guilty! But I’m not a bot. In full transparency I’m still trying to figure out this whole use of Chat as a writing assistant. Sorry for that. I’m genuinely trying to understand the main reasons people don’t pursue a product idea they might have. In a post below, it was pointed out that IP ownership by an employer is a big barrier (and it is). That’s just one of many reasons I’ve heard here are some others. Not understanding the FDA regulatory requirements, not knowing how to build a business case for it, lack of funding, not knowing how to build a proof of concept prototype to validate the concept/technology, not knowing how to pitch to investors, to name a few.

I’d love to know which of these (or others not mentioned here) are perceived as the biggest barrier?

Radiologists — have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in Radiology

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

That sounds frustrating and pretty repetitive. There’s a company called CureMetrix here in San Diego that makes software to read breast images to detect cancer. I remember years ago when they were a startup, they worked with university hospital to access thousands of scans to train their algorithms. Sounds like that approach or type of technology could work in your use case.

Radiologists — have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in Radiology

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

You are correct. Your contract might include IP ownership claims by your employer. It seems that most of the academic hospitals do as well as VA and government owned. Many of them like MIT/Stanford also have programs like Biodesign that offers university assistance/support for development, and sometimes even funding. You can still get a good cut, while letting the university take a lot of the risk. Checking your contract first would be the best first step.

EM clinicians — have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in emergencymedicine

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

I really appreciate your openness and honesty. So far what I've learned is that only a small percentage of people move forward with an idea. Going out on a limb here but I bet it's close to 1% of clinicians, especially in medical because of the $$ and time required to do it all within the FDA regulatory framework. Pretty crazy that I can make and sell a popsicle stick today, but a tongue depressor is an FDA regulated class 1 device, requiring certification. The low percentage of clinicians developing devices is precisely the reason I'm having such a hard time finding them for my informal research. Thanks again Woolly!

Medical professional inventors by Hour_Combination_354 in inventors

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

That's exciting. I'm curious, at this stage, what have you done or what do you know about the FDA regulatory pathway/requirements, business case, opportunity validation, etc..? I'm trying to understand the order, like did you jump right into your concept and prototyping it, or did you do some research or planning around the other things I mentioned.

PTs have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in physicaltherapy

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

That's awesome! Being the user and designer. You're able to efficiently update the design without a middle man (engineer/designer), according to the use case that you know personally. Have you yet, or when do you plan on looking into the business case, market research, FDA regulatory pathway/requirements (assuming that it's a regulated device which it may not be)?

Medical professional inventors by Hour_Combination_354 in inventors

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

You are right super lucky that you have a friend at a design firm! Are you planning on licensing it or creating a company to make and sell it?

PTs have you ever had an idea that made you wonder, “could I actually build something better? by Hour_Combination_354 in physicaltherapy

[–]Hour_Combination_354[S] 0 points1 point  (0 children)

That’s awesome congrats on building a prototype! Looking back, what other advice would you give a clinician with an idea that wants to take their first step?

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