Clinical Trials Medical Device Guidelines: What Sponsors Should Know

---

Contributing Experts at Medrio: Tina Caruana, Director of eClinical Solutions, and Rod McGlashing, Data Science Subject Matter Expert

Sponsors work through clinical trial medical device guidelines while dealing with new complexities.

They’re wrestling new rigors in high-quality data collection. They’re identifying new inclusion opportunities. And they’re dealing with a tightening funding environment.

With new market trends, regulatory guidance, real-world evidence, and artificial intelligence, the industry is evolving. Meanwhile, the stakes are high. It costs more than $500 million to bring a complex class III device to market. 

What you’ll learn in this blog:

• Select regulatory trends affecting medical device studies 
• Typical study phases of a medical device trial
• Protocol development best practices based on trial specifics
• Trial design tips that include a data management plan
• Must-have tools to incorporate in your medical device clinical trial

Meeting Clinical Trial Requirements for Medical Devices​

Sponsors need to understand the regulatory environment they’re about to enter. That context will guide protocol design, data collection, and trial execution. Plus, it will provide insights for other milestones from proof-of-concept to commercialization.

More than anything, submissions need to show that a device is safe and effective. But sponsors need to back up those claims with traceability and transparency. 

To meet guidance and regulations, sponsors should:

• Understand regulations that impact the trial
• Create a firm recordkeeping and data management plan
• Disclose any financial relationships or conflicts of interest
• Review relevant regulatory agency guides and resources
• Prepare a diversity action plan, if applicable

Along with that foundational reading, consider regulations governing data management and electronic processes. 

Global resources include:

• ISO 13485 | 2016, Global Standard
• ISO 14155 | Global Standard
• CDISC | Global Standard
• EU MDR | European Commission Regulation

FDA medical device clinical trial guidance and regulations​

Medical devices generate a lot of data. Sponsors need a good knowledge of data frameworks ahead of time to set studies up for success. If you are running trials in the US, familiarize yourself with resources provided by the U.S. Food and Drug Administration (FDA). 

FDA resources include:

• How to Study and Market Your Device | 2023, Article
• 21 CFR Part 11 | 2003, Guidance
• Content of Premarket Submissions for Device Software Functions | 2023, Guidance
• Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies | 2024, Draft Guidance
• Cybersecurity in Medical Devices | 2023, Guidance

Phases of Medical Device Clinical Trials

Medical device trials follow a distinct pathway compared to other trials. This change is mainly due to differences in regulatory requirements, risk assessment, and study design. 

Pharmaceutical trials typically progress through Phase I to IV. However, medical device trials are typically categorized into pilot, pivotal, and post-market studies.

The phases of medical device clinical trials include:

• Pilot/first in humans
• Feasibility
• Pivotal
• Post-market/observational

Writing Your Protocol: Resources and Considerations

Every study starts with a protocol outlining the trial design. Be intentional with a protocol and its language. Amendments are common and costly, but they are often avoidable with a well-planned document.

When writing a protocol, sponsors should:

• Complete a market assessment for predicate devices
• Refer to a protocol template 
• Consider ethical questions and associated risks
• Assess federal and other accelerator programs
• Monitor new developments in technology to aid protocol writing

Look into federal and other accelerator programs. Programs can span resources to initiatives that provide novice sponsors with more education and support.

Programs to investigate include: 

• FDA’s Total Product Life Cycle Advisory Program
• MedTech Innovator
• MedTech Accelerator
• mHUB MedTech Accelerator
• Biodesign Innovation Fellowship

Interested in learning more about protocol? Check out Medrio’s medical device clinical trial guide.

What’s an example of a medical device clinical trial protocol?

When writing a protocol, sponsors can look for “predicate” examples. Predicates are similar devices that already exist in the market. They won’t always apply, but if they do, they can impact your protocol and regulatory approach. 

Sponsors should look at what else has been approved up to that point. This information might affect how you’re classified from a regulatory standpoint. Start with a market assessment to understand the space and what it might be missing.

Clinical Trial Design for Medical Devices

You need high-quality, compliant, and clean data as you prepare for clinical trial submission. 

As you create a data management plan, you should:

• Consider the implications and nuances in your specific device type
• Identify experts with direct, relevant experience
• Understand CDISC standards
• Obtain informed consent for applicable technology
• Build a data integration strategy

Different clinical trial requirements for medical devices

Different medical devices need different study designs. For example, blood pressure monitors will have different data needs and requirements than something that is surgically implanted.

Sponsors should consider several questions about their device, including:

• Does the medical device have electronic recording? 
• How is that data transmitted to the appropriate collection agent? 
• Does the medical device include Bluetooth? 

With these questions in mind, look for partners with direct, relevant experience. An experienced clinical trial data services team can be very helpful. 

Other medical device clinical trial design considerations

When it comes to clinical trial design for medical devices, sponsors have many things to consider.

Data standards

Medical device sponsors should be familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. These data standards simplify data processing, from patient-reported instruments to clinical information.

Patient privacy

Sponsors should be mindful of informed consent considerations across protected health information (PHI) and personally identifiable information (PII). Patient privacy considerations are especially important when it comes to digital therapeutics.

Data transfer and signoff

Sponsors may need to account for data transfer and signoff. Plan how data will move from the device to the data repository. Build workflows to review, verify, and sign off on that data by the site team. 

Must-Have Tools for Your Clinical Trial

Clinical trial technology includes various tools sponsors and CROs can use to plan and execute a medical device trial. Some of these tools help to implement eSource in clinical trials.

When selecting clinical trial technology, sponsors should:

• Consider CDMS/EDC solutions for data collection and management
• Explore ePRO and eConsent for patient-centric benefits
• Work with data management, biostatistics, and clinical teams with therapeutic experience
• Collaborate with technology experts experienced with your platforms

CDMS/EDC

In terms of data management, a clinical data management system (CDMS) or electronic data capture (EDC) system should be high on your list. A CDMS/EDC operationalizes the collection and management of high-volume clinical trial data. 

ePRO and eConsent

Patient-facing solutions include electronic patient-reported outcomes (ePRO) and electronic consent (eConsent). These technologies facilitate workflows for hybrid and decentralized trials while supporting patient engagement and retention.

Expert service providers

Sponsors need to find data management, biostatistics, and clinical teams with therapeutic experience. Partnering with the right clinical trial project management team is key to a successful medical device trial. The underlying service is what helps make the software most effective.

Learn more about how to select the right medical device software solution.

Get Your Medical Device Past the Finish Line

As wearables, apps, and other modern medical devices become a fixture in healthcare, many sponsors are embarking on medical device trials. Just know that trial complexities are part of the equation.

You can overcome those challenges with a strong head start: 

• Know your regulatory environment
• Be intentional with protocol development
• Build a lasting data management foundation 

Most importantly, surround yourself not just with the right software, but also the right partners. 

Purpose-built technology coupled with strategic planning helps reduce costs and delays. You can create order from the chaos of trial complexity to generate high-quality, submission-ready data.