Is Clinical Data Enough to Drive Market Adoption?

Written by Eric Sugalski and Ulrich Herken

“You need to show clinical evidence that your medical device provides a benefit.”

It's a common request that early medical device innovators hear after they gain regulatory clearance. It’s rational, especially for a profession that is deeply rooted in science.

But after this clinical evidence is captured and published, does it initiate customer purchasing and market traction?

Unfortunately, the answer is typically “no.”

There are plenty of new medical devices that have gathered robust evidence through clinical trials but then fall short of expected market adoption. And there are many other medical devices that are successfully adopted with very little scientific evidence at all. 

In this scientifically driven profession, why isn’t clinical data the deciding factor when it comes to purchasing decisions?

It comes down to risk.

Most healthcare customers prefer to be followers – not leaders – when it comes to purchasing and using new medical devices. The "wait and see" adopter approach is far less risky than the "early adopter" approach.

Risks that frequently arise in new product adoption include the following:

• Will the promised benefit really materialize outside of a clinical trial?
• Will there be side-effects that haven’t been discovered yet?
• Will there be new legal liabilities?
• Will extensive training, downtime, and associated costs be required?
• Will the product interrupt clinical workflow and create backlash?

So, how should medical device innovators overcome these adoption risks? Here are few suggestions -- that need to be addressed early, in product development -- to reduce market adoption risk.

1. Identify and engage KOLs

Key Opinion Leaders (KOLs) are typically willing and able to assume more risk in the procedures they conduct and the products they utilize. They have likely risen to this status by conducting pioneering procedures that other medical professionals have been unable or unwilling to do. As a result, these KOLs are recognized as thought leaders within their clinical specialties and may influence the accepted products that are considered and ultimately adopted within their clinical areas.

As a medical device innovator, you should aim to identify and engage the KOLs that relate to your target indication and clinical procedures. Consider adding them to your clinical advisory board. Engage them to trial new product concepts and help steer the product into a direction that fits their clinical preferences. Leverage their skills and expertise in early clinical work that may be completed.

By engaging KOLs early in the development and pre-market process, you will increase your chances of these same KOLs driving future adoption. You are effectively gaining their buy-in early, while also benefitting from their expertise, both of which will pay dividends to your company when you start to market your device.

2. Make the product intuitive

Be aware of how you describe your medical device. You may have developed something new, patented, high-tech, cutting edge. But for the medical community, this novelty may introduce risk. It may trigger questions about the true benefits, reliability, undiscovered side-effects, and increased legal liability.

Instead, aim to make your product intuitive. Are there other applications of your technology (or a similar one) that have already gained market acceptance? If so, can you leverage those examples to help the medical community make the mental leap – from a new and unproven technology to a device powered by technology that has been proven and established through a parallel application?

An Archimedic customer - Tangobelt - uses airbag technology to protect the hips of seniors in the event of a fall. The company leverages a technology that has been proven through the automotive sector for the benefit of patient care. "It's like airbags from your car -- but used to protect your hips." Tangobelt often uses this reference to make the product more intuitive to users and customers.

3. Make the product familiar

Despite what many people would like to think, marketing works. 

It's the reason that television commercials, internet advertisements, and even spam exist. They may not work the first time, but after you have seen that ad twenty times, your subconscious mind begins to accept the product. And when you go to the store to look for a pack of soap, your subconsciousness influences the bar you grab.

The same is true with new medical devices.

Exhibiting at trade shows, conducting demonstrations and clinical seminars, running advertisements – these will all build familiarity with your target audience. They may not work immediately, but drip by drip you will be building a reservoir of familiarity in the subconscious minds of your customers. And when it’s time to close the deal with your customer, less explaining and "selling" will be required -- the familiarity will already be there, and the risk to your customer will be reduced as a result.

Summary

There is a saying in sales and marketing – “People buy emotionally and justify rationally.”

By taking the steps mentioned above to create connections with KOLs, make the product intuitive and create product familiarity, you will be catering to the “emotional” component of purchasing decisions.

Supplementing these emotional triggers with hard data will give customers the “rational” justification to support their emotional purchasing decisions. This is where clinical trial data comes into play. Without this clinical data, there may be proponents of a new product, but it will not gain widespread acceptance until this rational data is published, accessible, and accepted.

The winning combination is where strong product marketing and professional connections are coupled with robust clinical data. Of course, this process takes time and planning – and should be key elements that are woven into your product development and commercialization strategy.

Guest Contributor

Ulrich "Uli" Herken is the founder and principal of Quorad – a consultancy focused on medtech research and strategy. Uli has spent over 30 years in medical device research and development, managing pre-clinical and clinical research activities in several start-ups as well as in a corporate environment. Uli is a physician by training and worked clinically in emergency medicine, intensive/critical care, and internal medicine. He has also held various management positions in medical device companies in the areas of diagnostic and therapeutic ultrasound, and acute critical care (monitors and sensors, defibrillators, ventilators). Uli has worked with US and international researchers on projects ranging from exploratory studies to multi-center clinical trials.

Find more on Uli and Quorad here.