Birthing Your Medical Device
Creating a new product is a lot like giving birth: You naturally fall in love with your idea and feel no one knows your “baby” better than you. You also tend to overlook flaws as you marvel at your creation and dream of its potential. But even the healthiest of babies can struggle to thrive without expert input, guidance and monitoring. The same goes for your product.
Want a healthy delivery? Just as important: Want your product to thrive past its infancy to live a long, productive (and profitable) life? Then partner with people who’ve produced those outcomes before: specialists who’ve built successful devices, navigated through FDA requirements, and taken medical devices to market.
Your expertise can severely hurt your device’s performance
A few months ago, we posted about a decades-long research that revealed heavy reliance on your own expertise can severely hurt your performance. There are two reasons for this, as the Harvard Business Review reports:
“The first is overconfidence: believing that brilliance in one area leads to competence in another. The second is when deep knowledge and experience leave leaders incurious, blinkered, and vulnerable — even in their own fields.”The antidote is to approach new challenges with a beginner’s mind, knowing that blind spots are inevitable when your team lacks objective insight or real-world experience to overcome market challenges.
Shielding your product from failure
We won’t repeat the advice we’ve covered about how to discern if you’re at risk of being blindsided and what to do about it. (You can read that here.)
On the flip side, partnering with a reputable, seasoned medical device development firm enables you to identify gaps and opportunities that might have escaped you otherwise.
Consider, for example, the impact that a single mishap or new discovery in any of these areas could have on your product performance:
- Market research
- User experience
- Product design and key functions
- Potential hazards, potential for human error or misuse, supply chain risks
- Prototype testing and de-risking
- Regulatory/FDA demands
- Patient safety considerations
- Materials selection (is there a safer, better, cheaper way to meet product requirements?)
… and more
The process of bringing a product to life is a complex one, with each phase requiring distinct expertise and mastery. We’ll be blunt: No astute startup trusts their own hunches and limited know-how to navigate this process. Too much is at stake.
Protect your investment by having the right partner bring your “baby” to life.
- Medical Device Guidance: Is Partnering With a Third-Party Developer Worth It?
- Product Ideation: Building a Device Users Will Crave
- Medical Device Pitfalls: Beware of Perfectionism, Excessive Bells & Whistles
- Medical Device Development De-Risking
- How to Choose the Right Medical Device and Development Partner