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Use Case
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Better Decisions, Faster Submissions for MedTech Companies
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Navigating the FDA’s regulatory landscape can be complex. We provide data-driven insights to help you understand and meet regulatory requirements efficiently, reducing time to market.
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Our Data
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Reimbursement codes
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Explore our comprehensive collection of HCPCS codes, APC codes, and DRG codes, used for accurately reporting standardize medical billing.
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60,000 Clinical Trial PDFs
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We wrote custom code to acquire and process Protocols, Statistical Analysis Plans (“SAPs”) and Informed Consent Forms (“ICFs”) from ClinicalTrials.gov
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92,000 FDA Medical devices 510k PDFs
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From the FDA’s website we acquired and processed approval documents for medical devices called “510(k)s” with over 92,000 individual PDFs with 660,000 unique pages.
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Roles we serve
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We assist founders by offering a clear and concise overview of their projects, highlighting key areas such as market potential, business strategy, and financial projections. This information is tailored to enhance investor presentations, making it easier to communicate the value and potential of your venture effectively.
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We offer a “guided tour” of MedTech-specific technical requirements
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We assist regulatory specialists by providing concise summaries of essential regulatory data, including adverse event reports from the FDA.
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We support healthcare marketers by providing detailed reimbursement data at national, state, and provider levels. This information aids in understanding payment trends and optimizing pricing strategies across various markets. Additionally, we facilitate connections with key opinion leaders (KOLs); influential healthcare professionals and researchers who can enhance the credibility and reach of marketing campaigns.
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We provide access to previous Instructions for use from top companies.
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we deliver an unbiased perspective on the true market size, offering a valuable comparison of a startup’s performance against larger industry players and providing a crucial “reality check” on the often-optimistic claims made by emerging companies.
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Our services provide customized reports tailored to the specific needs and stage of each participating company, complemented by expert guidance to help these startups navigate their growth and development effectively.
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What is your desired pathway?
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GUIDED PATHWAYS
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Regulatory
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Bringing a medical device to market requires navigating complex regulatory frameworks like FDA, EU MDR, and Medicare standards. We provide the regulatory data you need to streamline approvals, reduce compliance risks, and bring your device to market faster.
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Reimbursement
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Reimbursement is the key to commercial success in MedTech. Understanding who pays for your device, how much they reimburse, and which hospitals and doctors prescribe similar products can make or break your market entry. We can help you navigate Medicare, and reimbursement systems.
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Technical
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Technical leads, R&D engineers, and product developers need structured data to ensure safety, compliance, and performance. We can provide real-world regulatory and testing insights to help you make informed design decisions.
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Marketing
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Launching a MedTech product successfully means understanding market demand, competitor positioning, and key opinion leaders (KOLs). We provide the data you need to refine your marketing, sales, and distribution strategies.
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Post Marketing
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Getting FDA approval is just the beginning, you need to track device performance, safety, and market trends to maintain compliance and improve future designs. We can provide the data to help you track adverse events, manage risk, and refine your post-market strategy.
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Secure Funding
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Investors and venture capitalists expect hard data to validate MedTech market opportunities. We equips firms with the regulatory, market, and reimbursement data they need to secure funding. We will work with you to draft your pitch slide to increase your chances.
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