The Brutal Truth About Bringing a Medical Device to Market
This article is adapted from my recent interview with Business Talks Weekly's Power Talk Show. Read the full conversation here.
Let me be honest with you about what it really takes to bring a medical innovation to market. When people hear I invented MetaFlex® while studying mechanical engineering, they often romanticize the journey. Here's the reality:
"Mostly it's money. The great barrier to innovation is money."
The Real Costs Nobody Talks About
Here's what they don't tell you: "The FDA fee this year for medical device establishment is $9,000, which is a fee every year and it's gone up every year. So the year before it was like 7,000 something and then six and then five."
And that's just to be an established medical device seller in the US. Then there's:
"The cost of all the patents... the money to buy my first lot of inventory... the money to spend in marketing. Money has been, it has been the great limiter in bringing MetaFlex to market."
I couldn't afford consultants, so "I did my own research, which is fine with me. I have a background in engineering. I like digging into things and figuring out what are really the requirements."
But here's the tragedy: "I think it's what is stopping a lot of people from bringing their innovations to market. And it's really a tragedy for the world that we have all of these people creating all of these amazing things that could change people's lives. And they're having so much trouble getting it to market." How many people looking for solutions to arthritis pain, haven't gotten new devices to help because of this red tape?
I planned to launch in 2022, but "we didn't get it on market until 23, cause the manufacturer I was working with didn't have all the FDA registrations I needed. And it took me months of research."
The Personal Transformation
"Being an entrepreneur has changed my life. It's a journey of self discovery and learning all of the things that I'm not good at and learning some things that I am good at."
Let me tell you about my background: "High school was very easy for me. College was engineering school, but it wasn't that bad... And then when I worked as an engineer, it was easy because it was just process engineering."
But entrepreneurship? That was different.
The Sales Struggle
"Things I wasn't good at that I've had to learn? Sales. Talking to people because I feel like I know, I can read people really well, but it felt like manipulation to sell things to people, even though I know this is helping them."
This was a huge barrier for me: "I had this internal thing where I didn't want to ask people for money, which really limited me when it came to raising money, which I had to do because everything's so expensive."
The Marketing Block
"Marketing again, it felt like manipulation, but that's like a mindset switch that I've just had to make for myself."
I had to completely reframe how I thought about these activities. "I'm sure everybody has some different part that's more difficult for them just based on their culture and the way they were raised and the life experiences they've had. But that's been the most difficult part for me."
Embracing Failure as Education
This is what I wish someone had told me earlier:
"When you're failing, you're learning and it's a lesson and don't shy away from it or feel like you're a failure because you did something wrong. You're not going to do every single thing right. It's life and you're learning and failure is just a part of the process."
I've had my share of failures. "There was a time where I approved samples too soon and I ended up having some defect inventory because there was a miscommunication." But you know what? "I worked it out with my manufacturer and we have a really strong relationship."
My perspective now: "Getting through those difficulties is just part of the process."
Think about it this way: "If Edison took like over a hundred tries, right? To make the light bulb. If he would have given up at any of those and thought himself a failure, then we wouldn't have, we wouldn't be as advanced as we are."
"Failure is part of the process and I've learned to embrace it and shift my mindset from, I failed to I learned this. I've got this in my back pocket now and I know how to navigate the situation going forward."
Learning to Be Resilient
Entrepreneurship forces you to grow: "You fail over and over again. And I've learned to be more resilient and choosing to have a positive outlook on life."
It's about developing strengths you didn't know you needed and working through weaknesses you didn't know you had.
The Most Important Person in Your Business
Here's something critical I learned:
"It came from talking to the customer who's obviously the most important person in the business. The person who's using the gloves and figuring out what they needed and what they wanted and what they were struggling with."
When I listened to my customers, I discovered things I never expected. My product had more applications than I'd designed it for, and customers told me about features they needed that I hadn't considered.
That customer feedback is driving our new product development: "We've got two new versions coming out this year... it came from talking to the customer."
A Word of Caution About AI
Everyone asks how we're using AI. Here's my take:
"I want to caution people of using it too much for things that you should do with your own brain and rather just using it as a time-saving tool and as a way to streamline your operations."
We use it strategically: "One of my team members is going to take this podcast and put it into some AI, which can then make a transcript and write out everything. So that's just a time-saving."
But here's the key: "Try to use AI as a time saving tool and not as like a supplement to your brain, because then you're not using those muscles or those pathways. And so they're not getting stronger and growing in themselves."
What I'd Change (And Why I Wouldn't)
"I wish I would have known my first manufacturer wasn't, didn't have all the registrations I needed, but we got through it."
The truth is: "There's so many hurdles where I have fallen on my face, but I got through it. And I don't really know if I would, like, I'd like to change it and streamline it and make everything faster."
But those struggles taught me everything I know now.
My Message to You
"I'd say to anyone when you're failing, you're learning and it's a lesson and don't shy away from it or feel like you're a failure because you did something wrong."
The innovation the world needs might be sitting in your head right now, waiting for you to push through the barriers.
Building ATS Innovations and bringing MetaFlex to market has been the hardest thing I've ever done. But knowing it's improving lives makes every struggle worth it.
Learn more about my journey or read the full interview here.
What's been your biggest challenge as an entrepreneur? Share in the comments—I'd love to hear your story.
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