by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Birthing Your Medical Device Idea: Ensuring a Healthy Delivery

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.


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by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Guidance: Is Partnering with a Third-Party Developer Worth It?

Great ideas are a dime a dozen, as the saying goes. It’s the execution of ideas that determines their long-term success. The same is true for medical device development and medical device guidance, particularly in markets where buyers have plenty of options competing for their dollars.

Reasonably, a medical device that’s steered by a developer with rich market expertise will yield better results than a device whose development is rooted in limited know-how and experience. But is an external development partner worth the investment?

In this post, we explore four considerations for your medical device development, or ways that partnering with a seasoned, impartial developer can pay off in big ways.

Medical Device Guidance

Refining Ideas, Boosting Your Value Proposition

Like any industry, the medical device market is full of hopeful, self-proclaimed innovations that fail to compel users to whip out their credit cards. Creating a device that users will buy, recommend to their patients and peers requires a deep understanding of the user mindset, how they experience the product, and the problems you’re solving for them.

An expert medical device developer helps ensure you’re asking the right questions and considering psychological and physiological principles in your design, for starters. Put another way, they help you think through how humans make buying decisions and use products to create a more compelling offer and experience than your competitors.

(More on product ideation.)

Countering Blind Spots

It’s tough to spot flaws when you’re too close (or personally invested) in your medical device idea. In fact, your expertise can actually hurt you, cautions the Harvard Business Review, citing a decade-long research into top executives.

Two reasons for that: “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 author explains.

Put bluntly, blind spots are inevitable when your development team lacks objective insight and real-world experience to overcome market challenges. A reputable development partner can illuminate areas you haven’t considered and pinpoint blind spots before they sink your investment or slow your progress.

Reducing Risks & Uncovering Opportunities

While a zero-risk scenario doesn’t exist, the success of your medical device hinges largely on the level of risk it poses to users.

De-risking considerations include the likelihood and severity of potential hazards, the environment where the device will be used, potential for human error or misuse, supply chain risks, and more. Reasonably, that requires careful testing, risk tracing and mitigation, starting with your prototype.

In looking for ways to reduce risks, your expert device developer can also uncover opportunities to make your device more competitive.

(More on medical device risk reduction.)

Meeting Regulatory Demands

It’s important to know how the FDA classifies your medical device, and what it demands from you. Other regulatory bodies (ISO, ANSI, ASTM) may have additional performance standards you must adhere to.

Your medical device developer can help you assess regulatory considerations so you’re not hit with a costly violation down the road (or worse — hurt a patient). That know-how can also help you discern your acceptable risk level, how much money to invest, and long it will take before you start seeing revenue.

Medical Device Guidance: Expertise as Loss Prevention

All things considered, a reputable medical device development partner is akin to loss prevention, helping you avoid financial, opportunity and reputation hits that could derail your entire investment.

Before attempting to win over your market, ensure you have a winning product. Getting the development of your device right is considerably more economical than launching a flawed product or correcting an oversight post-launch.

>> Related Resource: How to Choose the Right Medical Device Design and Development Partner

>> Follow Us on LinkedIn for Additional Timely Shares on Medical Device Guidance