5 Ways to Earn Serious Consideration for a Medical Device

Getting a new medical device into a health system's formulary can be challenging. Here are five essential milestones medical device companies must share with stakeholders to build trust and credibility and earn serious consideration.

Getting a new medical device into a health system formulary is a rigorous process—to say the least. Changing the status quo is extremely difficult due to the multitude of stakeholders, regulations, and policies.

From the beginning, medical device companies need a professional brand and content that clearly articulates the problems they’re solving, why their device is superior to existing solutions, and the value it adds to each stakeholder.

Understanding the business and personal drivers of the physicians, health system administrators, investors, and patients who decide whether the medical device will be used is the first step to having meaningful conversations that advance the company.

Communicating effectively how a medical device can improve everyone’s experience is the only way to capture attention and create change. Getting into the minds of your target audience and thinking from their perspective will help develop messaging that resonates.

Here are five key details medical device stakeholders must know about a medical device before adding something new to the formulary.

1. Physician Champion: Innovative, recognized physicians or clinicians (nurses, physical therapists) are the driving force for change. They have reviewed the device and are interested in using it. Most health systems require champions to get a new medical device before value analysis committees, so obtaining their support is essential.
2. A well-defined problem: The medical device addresses gaps in care, improves patient outcomes, or streamlines operations. If the device doesn’t address a clear problem, it will be difficult to justify its adoption.
3. Clinical Validation: Health systems must see strong clinical validation from clinical trials or research studies before adopting new devices. High-risk devices typically require more comprehensive clinical data, while lower-risk devices can use prototypes or results from smaller-scale studies. The efficacy and safety of the medical device are paramount.
4. The Reimbursement Landscape: Even if a device is clinically validated, reimbursement challenges can significantly impact its adoption. Health systems are unlikely to adopt devices that don’t have clear reimbursement pathways. Understanding how the device fits into existing billing codes or if new codes need to be created is a critical part of the process.
5. Workflow Integration: A device that disrupts existing workflows or requires excessive training is unlikely to gain traction. Health systems value efficiency and medical devices must integrate seamlessly into clinical or operational processes. Minimizing the level of disruption, reducing costs overall, or optimizing the current processes will help accelerate medical device adoption.

Founders lay the groundwork for success by articulating the problem the medical device solves, demonstrating its superiority over current solutions, and showing its impact on patients, physicians, and healthcare systems.

Technology Tip!

Using a scalable, all-in-one platform like HubSpot from the start gives founding teams the flexibility and efficiency they need to craft a compelling story, showcase value, and build relationships that drive growth.