How to Plan and Budget for MedTech Clinical Activities

For years, medical device manufacturers have treated clinical data as a regulatory burden—a low-priority obligation that doesn’t garner much attention. Why? It’s primarily because the regulatory framework hasn't enforced stringent requirements for clinical evidence or clinical studies.

But many of the most successful MedTech companies worldwide have shown that a scientific-driven strategy always wins. Clinical data is essential in nearly every aspect of the medical device business, including buyer evaluations, reimbursement strategies, and gaining market approval.

And, with more focus on clinical evidence under the EU MDR and value-based procurement of medical technology, the need to prioritize your clinical data has never been higher. That’s why I want to break down how to stop putting clinical data collection on the back burner, and explore how to plan and budget your clinical activities.

Start considering important factors to consider for your clinical activities

Want to know a universal truth about medical devices? It is never too early to start planning your clinical activities. Clinical data—and the insights gleaned from it— cannot be generated on-demand, as needed. Designing and optimizing clinical studies can take significant time, but the ROI can be incredible.  

There are numerous factors to consider that impact a study’s design and budget. And while no two MedTech companies are alike, here are a few common factors to consider when planning your clinical activities.

• Regulatory compliance such as ISO 14155 in Europe, or the FDA's Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) guidelines in the United States, all of which are critical to ensure that the device is safe and effective for its intended use.
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• Clinical study design affects the quality and reliability of the data collected during the study. The study design should be carefully planned to ensure that it meets the study objectives and provides the necessary evidence to support regulatory approval.
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• Patient recruitment and retention are also crucial factors in clinical activity planning. The success of a clinical study relies on the ability to recruit and retain patients who meet the study criteria.
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• Site selection and management are also important factors in ensuring that the study is conducted at appropriate sites and that site performance is monitored effectively.
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• Data collection and analysis must be accurate, complete, and reliable to ensure that the results of the study are valid. The use of a centralized clinical data collection tool can ensure data accuracy and completeness and streamline data analysis.

FREE RESOURCE: Click here to download our free checklist to help you budget for clinical activities.

Developing your budget for clinical activities

Developing a well-structured and realistic budget is crucial for effectively managing your MedTech clinical activities. A carefully planned budget helps you allocate resources efficiently and ensures that you have the necessary funds to conduct your clinical trials.

But, much like planning for the design of a clinical study, securing an optimal budget requires plenty of knowhow and forethought.

• Identify cost components associated with your clinical activities. These may include personnel costs, site fees, patient-related expenses, CRO fees, data management costs, regulatory fees, and any other relevant expenses. Take into account both direct and indirect costs to ensure comprehensive budget coverage.
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• Estimate personnel costs: Personnel costs are often a significant portion of the budget. Consider the number of staff members needed for your clinical trials, including clinical research associates, project managers, data managers, and biostatisticians. Estimate their salaries, benefits, and any additional costs associated with their roles.
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• Estimate site fees, which encompass expenses related to engaging and managing clinical trial sites. These may include initiation fees, monitoring fees, and close-out fees. Evaluate the number of sites you plan to engage and negotiate fees accordingly. It's also essential to factor in site-specific costs, such as facilities, equipment, and supplies.
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• Estimate legal fees, this includes cost of contracts with Sites, generation of informed consents, agreements and other legal documents that include subjects. Request proposal for other legal documents that might be required along the submission pathway with the ethics committee, IRBs, or competent authorities.
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• Review and optimize the budget, looking for areas where you can optimize expenses without compromising the quality or integrity of your clinical activities. Consider potential cost-saving measures, such as leveraging economies of scale, negotiating vendor contracts, or exploring partnerships with academic institutions.
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• Use a centralized clinical data collection tool as a Single Source of Truth for data collection and expense tracking. The tool allows all stakeholders to access the same data in real-time, reducing the risk of discrepancies and errors.

With a centralized tool, study sponsors can ensure data accuracy and completeness and streamline data analysis. It also allows sponsors to track and manage expenses in real-time, reducing the risk of budget overruns and ensuring that the study stays within budget.
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FREE RESOURCE: Click here to download our free checklist to help you budget for clinical activities.

Essential steps for any MedTech clinical study

It has always amazed me how common it is for MedTech executives and investors to put so many resources into R&D and sales, but at the same time, almost disregard the need for clinical operations efficiency or originally sourced clinical data.

When this happens, it’s usually compounded by a misunderstanding of or poorly defined clinical data collection process. But don’t despair—the good news is that developing a plan for your clinical activities doesn’t need to be painful. These four steps can be used as a template for any successful medical device study.

1. Define your clinical objectives and endpoints

The first step in planning clinical activities is defining your clinical objectives and endpoints. This involves determining the purpose of the study, the patient population, and the primary and secondary endpoints.

       2. Identify the required resources

Once you have defined your clinical objectives and endpoints, you need to identify the resources required for the study. This includes personnel, equipment, facilities, and supplies.

       3. Develop a study protocol and data management plan

The study protocol and data management plan outline the procedures and processes for conducting the study and managing the data. This includes the study design, subject selection criteria, data collection methods, data analysis plan, and data security measures.

      4. Track and manage study progress and data

Tracking and managing study progress and data is critical for ensuring the success of your clinical activities. This includes monitoring subject enrollment, data completeness and quality, and study timelines.

SMART-TRIAL by Greenlight Guru is the ultimate single source of truth for clinical activities in MedTech

Implementing these clinical activity planning and budgeting tips can be a time and labor intensive process, especially if you’re starting square one. And if you’re not centralizing your electronic data collection with a single source of truth,  you could be making life even harder on yourself.

SMART-TRIAL by Greenlight Guru is the complete data collection toolbox for Post-Market Clinical Follow-Up (PMCF), Post-Market Performance Follow-Up (PMPF), Clinical Investigations and Clinical Performance Studies. Not only that, but it comes pre-validated per ISO 14155 to ensure easy implementation.

Avoid wasting unnecessary time and resources on your eCRF setup and validation. If you’re ready to try a flexible, powerful, and intuitive clinical data solution, then get your free demo of SMART-TRIAL by Greenlight Guru today!