5 Tips: How to Scale Up for Medical Device Manufacturing


How To Get Your Product Ready For Manufacturing

E Komo Mai and Aloha. Welcome to another episode of Imua on TV, the place to be to take your medical invention to market. So I’m glad you’re here with me today. I had Bill write in with a question. So Bill’s looking for some, just guidance with how to get ready for manufacturing. So he’s got his product working, he’s ready to scale it up. So Bill, I have 4 1/2 points for you. I know 4 1/2 sounds kind of funny, but we’ll get to that.

#1 Design For Scale

So the first one. Now you want to design your product for manufacturing. You wanna design it so it scales. So what do I mean by that? Well maybe you have this great product, it’s working, you’ve proved it out, you built it in your garage. Awesome. Now how do we get it from one product working, how do we get it to five products, to 10 products, to 100, 100,000, a million. So we wanna make all of those things, the materials, the processes, even who’s putting it together, you don’t wanna put together a million of those by hand. So a lot of thought goes into this scaling process. You need to hook up with a product development company, if you haven’t already. So Imua Service is a great service for that. So stay in touch with us, we’ll get you set for that. So to summarize, number one, you need to create a scalable design so you can go to manufacturing first of all.


#2 Engage Manufacturing Partners Early

Okay, tip number two. You need to engage with these manufacturing partners early. So as soon as you have that product scalable, built for manufacturing, once you’re proving that the process is working, that’s a good time to engage with one of these manufacturing partners. So each partner is gonna be different, they’re gonna have their own processes that they go through in their particular facility, and you wanna be sure that your product matches up with their process. And it’s just so much easier, rather than developing it all the way through, getting to the end, and then having to change a bunch of things because it doesn’t fit with their system. So number two, engage with these companies early.


#3 Careful With Funding

Number three, you gotta be careful with funding. So I see a lot of companies struggle with this. They get through product development, and then they totally underestimate the cost of the manufacturing setup and what it’s gonna cost to manufacture. So you wanna be careful with that, whether you’re self-funded, whether you’re angel-funded, VC-funded. Again, it goes back to point number two, just engage with these companies early, get a really, really good handle on the cost so you don’t run out of money and your not dead in the water. That would be horrible.


#4 Manufacturing Logistics & The Right Fit

So number four is my two-part answer, which is why I say 2 1/2. So the first part of number four, you want to be able, you wanna make sure that you find the right fit as a partner. So there’s lot of manufacturing companies out there for you to go to all over the world. And what makes sense for you? Maybe year one and year two, you’ve looked at your forecasted annual volume that you’re gonna sell for the years, and it’s relatively low compared to, say, year 10. Well maybe you wanna stick closer to home because you wanna have more control over that manufacturing process or it just doesn’t make logistical sense to have it manufactured overseas and then shipped back over here. For that low of a volume, we can get it done here. Or maybe your product is going gang busters. You anticipate a half a million in your first year, and you really wanna get that cost of goods down, then overseas manufacturing is for you. So weigh your options, kind of see what’s your best play with that. So again, you wanna choose a manufacturing company that’s the right fit for you.


#5 Evaluate Manufacturing Skillset

Along those lines actually, I’m gonna give you a bonus, so I’m turning it into five right here, so along those lines, not only where is the company located, you need to look at their specific skill set. What type of manufacturing do they do? How much experience do they have with your particular product? You don’t wanna go to one that is specialists in, say, form fill sealing and you have an orthopedic device. That doesn’t really make sense. So make sure they’re a good fit for you in terms of that too.


Bonus: Buffer For Product Launch

Okay, the second part of four, which has turned into five is you need to be realistic with your time. So it’s going to take time from working with the product-development company through that transition time to manufacturing. So if you’ve got sales department breathing down your neck and saying, “Hey, I need this product out the door “by quarter two of next year,” and I’m gonna point back exactly what I said in tip number two which is to engage with these companies early. Everything you can do as early as possible is gonna save you time in that transition. So you wanna allow for that. It’s kind like a construction project. Very rarely to they actually end on time. Just be aware of that. Give yourself a buffer. Maybe it you’re, maybe its the VC is actually breathing down your neck, so to the VCs you can say, “Hey, we are expected to be on the market in quarter three,” and then really thinking that maybe you’ll have it done by quarter two. And they hey, maybe you’ll even be done early, and that’s great.


So if you enjoyed this video, I have more, so stay on my channel and watch more. You can check out, it’s imua-services.com, that’s imua-services.com. And hey, I’ve got a bonus for you today. So not only did you get a bonus tip, but I’m giving you a bonus. So if you text the word wipeout, that’s all one word, to the number 44222, I’ll send you the biggest wipeouts that startups make in med device development. So enjoy that. If you have anything at all that you’re curious about, get in touch with me, you can email me, you can send me a voicemail on the website. You can get in touch with me on social media. So I’m on Facebook, LinkedIn, Twitter and Snapchat these days, I have some pretty cool stuff on Snapchat. So I’d love to talk with you. Have a great day, and until the next episode, IMUA!


About the Author

Meghan M. Alonso
Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for equipping medtech & IVD companies with the knowledge, resources, and connections they need to bring innovative products to market. She’s the IVD Product Marketing Manager for NAMSA and founder of Imua Services. She’s a contributing author for best selling book “Put a Shark in Your Tank” with Shark Tank’s Kevin Harrington, and the prestigious “Molecular Profiling – Methods and Protocols”(a must read in molecular diagnostics). Her podcast, MedTech Inspired, in which she interviews the hottest startups, experts, and investors, won iTunes “New and Noteworthy”. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD companies through development and manufacturing. When she isn’t helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable husky Abby, crossfitting, enjoying great restaurants and fine wine with her husband, soaking up the sun the nearest beach, and promoting the adoption of shelter dogs.

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