Platforms that suit medical device companies best handle signed investigator agreements before sites start, budget at procedure level for implant and follow-up visits, separate what the sponsor pays from what is billed to insurance, manage device-specific costs such as training and imaging, and forecast long follow-up periods. Cloudbyz CTFM is a Salesforce-native clinical trial financial management system that device sponsors can use for this, on the same platform as Cloudbyz CTMS, EDC and eTMF.
Why device trials are different
- Signed investigator agreements are required. Under the FDA investigational device exemption rules, a sponsor must obtain a signed agreement from each investigator before they take part, including financial disclosure information (21 CFR 812.43). Sites should not be activated until that agreement is in place.
- EU device investigations have their own regulation. In the EU, clinical investigations of medical devices fall under the Medical Device Regulation (Regulation (EU) 2017/745), which also requires damage compensation arrangements, such as insurance, for participants.
- Some costs may be billed to insurance. In the US, Medicare may cover routine costs, and in some cases the device, in approved IDE studies. A coverage analysis decides, procedure by procedure, what the sponsor pays and what can be billed. Getting it wrong can mean double billing, with compliance consequences for sites and sponsors.
- Follow-up can last years. Implant studies often follow participants long after the procedure, so the budget and forecast have to cover a long tail of visits.
What device companies need from a budget platform
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Need
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Why it matters for devices
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1. Signed investigator agreements before activation
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Required under 21 CFR 812.43
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2. Procedure-level budgets
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Implant, imaging and follow-up visits cost very differently
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3. Sponsor-paid versus insurance-billed items
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Supports the coverage analysis and avoids double billing
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4. Device-specific costs
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Device training, proctoring, imaging reads, device returns
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5. Long follow-up forecasting
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Spend continues for years after the last implant
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6. Amendment and change order modelling
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Device iterations and protocol changes affect remaining visits
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Device evaluation checklist
- Show a site that is flagged until its investigator agreement is executed
- Build a budget with implant, imaging and follow-up visits
- Mark procedures as sponsor-paid or insurance-billed
- Add device training and imaging costs with limits
- Forecast spend across a multi-year follow-up
- Model a protocol change and show its cost by site
How Cloudbyz CTFM fits device companies
Cloudbyz CTFM is built natively on Salesforce with Cloudbyz CTMS, EDC and eTMF on the same platform. It tracks agreements from negotiation to execution, so CTMS can confirm an agreement is executed before a site is activated. Site budgets are built at visit and procedure level from templates and the visit plan, non-procedure costs such as training or imaging can be set with limits per unit, and payments can be split between institutions, investigators and other payees. The forecasting module projects spend over the full follow-up period and shows whether a change order is needed. Cloudbyz eTMF is already used by medical device customers to manage clinical documentation.
See CTFM for a device study
Book a demo or visit cloudbyz.com.
