Over our nearly three decades of contract manufacturing, we have received initial design concept sketches on everything from cocktail napkins to sticky pad notes and everything in between. Truly you never know when inspiration for innovation will strike!
This week one of our valued internship partners Rose-Hulman Institute for Technology put out a great read through their Rose-Hulman Ventures newsletter. The article discusses the important questions to ponder before you set out to obtain a prototype of any new product design.
Some of the very same questions the Genesis Plastics Welding engineering and sales team asks of prospective clients during initial prototyping and validation conversations are noted. New product concepts can be invigorating, but if designers want to make it to market eventually as well, taking a step back to address key pathway questions and define end goals can help ensure the initial concept can become a reality.
1. Do you have a development strategy?
It’s extremely rare for a prototype to achieve all goals on the first shot. Do you need the entire device at once, or should you do it in stages? Think about your most important goals and meet them first.
2. What are your post-prototype costs?
Making a prototype can cost anywhere from a few thousand dollars to hundreds of thousands. Do you know how expensive the next steps will be? You want to avoid being deep into a project before you learn later steps will be shockingly more expensive than you imagined.
3. If this is a business idea, does it add up economically?
Will the final sale price cover all of the costs of bringing your idea to market? Other than parts and assembly, there are legal, regulatory, overhead, and initial front-end costs that you’ll need to spread over the number of units sold.
4. What is the FDA pathway?
We’re not FDA experts, but we can help you stay within the FDA path you know you need to follow. Among other things, you’ll want to know if your device is a Class I, II, or III. If you’re not familiar with the FDA’s pathways to approval, get help before committing your resources. One starting point might be here, but, remember, no online resource is a substitute for expert guidance.
5. What about Intellectual Property?
Most medical devices require an IP strategy. Have you hired an IP attorney? Should you complete a patent application before developing a prototype or after?
6. Do you need a team?
Remember, this is going to take time. Whether you develop this in-house or outsource heavily, you may need others, possibly a team, to make things happen. Think about your life. If you have a day job, it’s hard to make progress on a startup after business hours or on weekends.
7. Why doesn’t your idea already exist?
No matter how brilliant your idea is, it’s worth considering why others, perhaps well-established others, haven’t done this yet. There might be stumbling blocks – regulatory, legal, or cultural – that have derailed previous efforts.
8. What’s your ultimate goal?
Is this an exercise in curiosity, the root of a full-fledged business, or something in-between? Does your idea result in a single product or does it lend itself to a product line? Is your best business strategy acquisition, IP licensing, or growing a new business from the ground up?
Have a proven medical device product or product line that you need to take to production? Is your business plan outlined, funding in place and you’re just ready to hit GO? Let Genesis’ controlled manufacturing space, class 7 clean rooms, heat sealing expertise and knowledgeable engineering staff help you take it to the next step. Reach out today.