The Market Adoption Landscape Has Shifted. Here’s Who to Consider When Creating Your Medical Device Design Strategy.

As a leader in the medtech space, you have two primary concerns on the road to medical device commercialization:

1. Time to market — how quickly the product can realize ROI

2. Market adoption — how to ensure the market accepts your product and realize ROI

Time to market, from a design and development standpoint, comes down to process. It’s a straightforward concept to articulate (although less so to accomplish): Go faster.

It’s much more difficult to encapsulate market adoption in a directive. The factors that influence it are ever-evolving and often trend-based. As a result, there’s a plethora of design advice to speed up time to market but not as much about how to secure market adoption.

To even out this imbalance of information, you must understand the current market adoption landscape. Only after doing that will you be able to create a medical device that improves patient outcomes while catering to its stakeholders, therefore reducing your investment risk.

The Elusiveness of Market Adoption for Modern Medical Devices

As mentioned, it is more difficult to identify how to design a medical device for successful market adoption than it is to identify how to design one for efficient time to market. As it stands today, the formula for how to achieve high rates of market adoption is also harder to understand.

That’s because it’s no longer enough to produce a safe, effective, and delightful medical device for end users. Although that is obviously still critical. Key opinion leaders (KOLs), such as high-ranking physicians, used to take note of an innovative new product, request and test it, and then, if warranted, recommend it. But this model is part of the reason healthcare has become so expensive. In general, there wasn’t a stopgap ensuring that health systems and hospitals didn’t over-purchase these recommended, yet duplicative, costly devices.

While value analysis committees (VACs), or some variation of the concept, have been around for a while, they’re even more central given today’s value-based healthcare system. VACs are multidisciplinary groups that manage medical equipment evaluation and purchasing for large healthcare systems, including hospitals. VACs are meant to serve as that stopgap to inefficient spending. In fact, their main objectives are to:

• Curb overspending,

• Create efficiencies (like purchasing one product multiple departments can use),

• Improve patient outcomes, and

• Bring greater value to patient care.

Today’s focus on VACs means that the modern market is made up of more medical device adopters — stakeholders serving as gatekeepers to market acceptance of your medical device — than ever before. So your product must be designed to galvanize more people than ever before as well.

You Conducted Usability Evaluations With Representative End Users

To meet the requirements of the various stakeholder groups impacting the market adoption of your medical devices, you have to first understand who makes up these groups. And what they’re looking for in a commercially viable product.

Each group has its own criteria for adoption and uses their awareness of the healthcare industry’s current competitive landscape to benchmark your product.

1. Key Opinion Leaders in the Healthcare Industry

KOLs are essentially influencers of the medical world. They’re generally physicians who have earned a certain status and clout. Consequently, they vouch for technologies and others heed their opinions.

This group often acquires products to test because they work for particularly innovative, cutting-edge healthcare organizations interested in piloting advanced technologies. KOLs assess these products with the following questions in mind:

• Does this medical device ameliorate patient outcomes in a novel, valuable way? Or,

• Does this medical device build upon my trust in the current, comparable device by improving it?

If the answers to these questions are yes, KOLs tend to evangelize about the product, influencing others to evaluate its worth for their own applications.

2. Value Analysis Committees for Healthcare Systems

VACs exist to make healthcare systems more cost-effective, efficient, and positive for patients. To understand who is on these committees and what their priorities are when analyzing medical devices, we have to break the group down further:

Clinical VAC Members

This VAC subgroup is composed of lead clinicians within a healthcare system. The clinical stakeholders on a VAC evaluate products with the following questions in mind:

• Does the medical device improve patient outcomes? More so than the competition’s product and/or the product currently in use?

• Does the medical device reduce use error? In other words, is it more efficacious?

• Does it improve user safety for both the patient, device operator, and general treatment audience?

• Will purchasing this product improve the clinical reputation of the healthcare system and help attract and retain top talent?

Administrative VAC Members

Leaders in hospital or healthcare system administration also sit on VACs. The people in this VAC subgroup ask themselves the following questions when considering medical devices:

• What will training look like for this product? How long will training take? Does the device employ effective information design?

• What is the potential utility within our healthcare system? Are there multiple indications for use? Is the design flexible? Can it be used by clinicians with variable levels of certification and acuity?

• How will this product impact user safety in a peripheral, non-treatment sense? What’s its environmental risk?

• Will acquiring the medical device boost trust, confidence, and perceived value in the patient and public’s eyes?

Finance VAC Members

The final VAC subgroup is related to the administrative subgroup above. But healthcare system administrators with a background in finance also ask:

• What’s the total cost of ownership (TCO) for this medical device? Will it reduce costs and increase revenue? What is the potential utilization rate within our healthcare system?

• Can we streamline purchasing operations if this product can be acquired along with a holistic system of products through a single supplier?

• Is the supply chain predictable for this product and its components? Is production scalable to meet fluctuating demand? How insulated is it from component availability risk?

Each of these health system’s subgroups (clinical, administrative, and finance) come together to champion — and adopt — the medical devices that best meet the system’s needs in their estimation.

3. Medical Device End Users

End users are the people who will ultimately interact with and operate your medical device. Of course there’s overlap between this group, the people on the VAC, and even KOLs. That’s because end users are often clinicians who happen to sit on a VAC or be a KOL.

But there are also end users who do not sit on a VAC and are not KOLs. They make up the rest of the medical professionals dedicated to helping improve people’s lives, day in and day out. And they have their own considerations when it comes to a medical device’s adoptability:

• How will this product allow me to provide the best possible care?

• How will it reduce unnecessary complexity and improve my work experience?

End users don’t necessarily have decision-making power. But remember, they’re the people who will interact with your product the most. And word of mouth is a powerful referral source for your company. It will influence market adoption. Be sure to design with end users in mind so your product is practical for the people who will actually use it.

4. Hospital and Healthcare Center Patients

Patients have even less power than certain end users in the medical devices used to treat them. They might select a specific healthcare system because of the technology it offers, but only if their resources allow for that level of choice. Even if they don’t have a choice in the matter, patients want to know:

• Will I be better off thanks to treatment from this product?

• How much will it cost to receive treatment with this device?

• Is it worth the value delivered?

Despite their typical lack of decision-making power, it’s imperative that you design with patients in mind. After all, the treatment they receive from your product will change the trajectory of their lives — or not. Back to the basics, it’s your duty and responsibility to create a medical device that is safe and effective for all parties involved, especially the patients who need it most.

Medical Product Commercialization Is One Step Closer

An effective medical device design and development plan is one that considers each stakeholder group’s adoption criteria relative to your company’s positioning and portfolio strategy. You now have the lay of the market adoption land so you can start your plan.

Just remember: You can never go wrong when you keep the health and wellbeing of the patients and clinicians who will benefit from your products at the forefront.