Why Clinical Data Is Essential to Value-Based Healthcare

May 1, 2023

Value based healthcare blog (new)

The healthcare industry in many countries is undergoing a transition. We’re moving away from a strict focus on the upfront cost of care to what’s known as “value-based” healthcare (VBH). 

In a nutshell, value in healthcare is patient outcomes divided by the cost of achieving those outcomes. In a value-based healthcare ecosystem, cost is still a factor, but only in the context of whether or not a treatment is improving patient outcomes. 

For MedTech companies, the move toward a VBH approach has a number of implications, including an increased need for clinical data. That’s because clinical data is the only way to demonstrate whether a device is improving patient outcomes, rather than just being the least expensive option. 

In a VBH ecosystem, if the choice is between two similar devices at similar price points, clinical data may offer one device the edge it needs to end up in the hands of physicians around the world. 

Value-based healthcare is here to stay, and it’s intimately connected to regulatory changes that are going on right now, as well. So let’s take a look at value in healthcare and why the need for strong clinical data is only increasing.

The move to value-based procurement in healthcare is making clinical data more important than ever

Value-based healthcare starts with a value-based approach to procurement. Making decisions about purchasing with more than just the upfront cost in mind is fundamental to achieving the goals of VBH.

In fact, to spur value-based procurement, the EU released a new directive on public procurement (Directive 2014/24/EU) that directs procurement groups to assess decisions through both Total Cost Ownership and a price-quality ratio. In other words, public procurement in the EU has to take value into account. 

But in order to make purchasing decisions with more than up-front cost in mind, procurement groups need data on patient outcomes. Remember, clinical data is the other half of the equation in a VBH system. Cost will always be a factor, but it has to be balanced by the effectiveness of the device.

VBH Graphic

One interesting effect of the move toward value-based procurement is the rise of health economic studies in MedTech. These studies attempt to demonstrate not only how a treatment helps an individual patient, but the overall economic benefit of using that treatment and its cost-effectiveness on a macro level. The studies may answer questions related to both costs and outcomes, such as:

  • Are recovery times faster using this device?

  • Are hospital stays shorter?

  • Does this reduce the need for treatment or surgery later on?

  • What is the overall economic benefit of this device—and how does it compare to other options?

As value-based procurement gains steam, any MedTech company that wants their device to be chosen over another device or treatment must be able to speak to both the cost and their device’s ability to improve outcomes above and beyond what is already available.

FREE DEMO: Click here to get access to our 15-in-1 clinical investigations content bundle filled with insights and knowledge to help you collect high-quality clinical data for your medical device studies.

Regulatory bodies also expect more from clinical data

In recent years, regulatory bodies have begun looking for more proof of a device’s safety and effectiveness via clinical data, most notably in the European Union. 

EU MDR is pushing medical device manufacturers to get clinical data on their devices before they get to market, as well as requiring ongoing data collection for many devices via new requirements like the Post-Market Clinical Follow-up (PMCF).

Clinical Data Lifecycle

In the US, the FDA still allows companies to use regulatory pathways such as the 510(k), which don’t necessarily require proof of safety via new clinical data before the device can be marketed. However, that doesn’t mean FDA is ignoring clinical data. For instance, a company may gain 510(k) clearance and still be required by FDA to perform a post-approval study

In other words, if FDA believes there are still ongoing questions to be answered about your device, they will require you to collect the clinical data to answer those questions.

FREE DEMO: Click here to get access to our 15-in-1 clinical investigations content bundle filled with insights and knowledge to help you collect high-quality clinical data for your medical device studies.

MedTech companies need to re-think their clinical data collection strategies in response

So, what does this all mean for MedTech companies, especially those with devices in higher risk classes?

For one thing, companies need to understand that the need for clinical data will only continue to increase. The regulatory and economic forces pushing for more proof via clinical data are enormously powerful, and that means the clinical side of your business is critical to your success in the market.

It also means MedTech companies may need to change the way they look at collecting clinical data. Yes, clinical trials are still an excellent way to get data to prove the safety and efficacy of your device. But enrolling subjects in a clinical trial is time-consuming and expensive. And with the increased demand for clinical data through a device’s lifecycle, manufacturers need to start exploring ongoing, but less intensive, methods of data collection. 

This might include non-interventional activities like:

  • Registries 

  • Surveys

  • Cohort studies

  • Case series

These observational clinical activities still collect valuable clinical data from patients that can be used to make the case for a device in a value-based healthcare ecosystem.

FREE DEMO: Click here to get access to our 15-in-1 clinical investigations content bundle filled with insights and knowledge to help you collect high-quality clinical data for your medical device studies.

Greenlight Guru Clinical is the answer to your clinical data collection needs

The trend toward more and better clinical data is clear. But collecting that data is not necessarily a simple matter. The tools you use to gather and analyze that data can have a profound effect on the quantity and quality you have at hand when it’s time to make the case for your device in a VBH system. 

That’s why we purposefully built Greenlight Guru Clinical for MedTech companies just like yours. Our electronic data capture (EDC) platform lets you collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more. 

Greenlight Guru Clinical also meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020.

So if you’re ready to try a flexible, powerful, and intuitive clinical data solution, then get your free demo of Greenlight Guru Clinical today!

Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.

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