Our Work
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Clinical Affairs Case Studies
Case Study 1
Challenge: A neurovascular medical device company based in New York sought to launch a complex 3-year, 30-site clinical trial. They needed expert support to manage protocol development, site coordination, and regulatory alignment across multiple institutions.
Solution: KLEO led the project from trial design through execution, managing all clinical trial operations and ensuring adherence to stringent timelines. Our team streamlined communications between sites, provided regulatory guidance, and ensured compliance with FDA requirements throughout the trial process.
Outcome: The trial is on track to successfully enroll patients across all sites and achieve enrollment milestones within the projected time frame.
Case Study 2
Challenge: A urology-focused medical device company in Germany needed help developing an IDE protocol and preparing a pre-submission to the FDA for its new device.
Solution: KLEO worked closely with the company to draft a comprehensive IDE protocol that met both EU and FDA guidelines. We also coordinated the FDA pre-submission, ensuring all documentation was in order and aligned with regulatory requirements.
Outcome: The company received positive feedback from the FDA during the pre-submission process, including updated feedback that an animal study would not be required, positioning it for smooth entry into the U.S. market.
Regulatory Affairs Case Studies
Case Study 1
Challenge: A Montana-based medical device company in the sexual health space required a pre-submission to the FDA for their personal lubricant product. Navigating the complex regulatory landscape for sexual health products presented unique challenges, especially in preparing the right documentation.
Solution: KLEO guided the company through the regulatory requirements, prepared the pre-submission package, and worked directly with the FDA to ensure all elements met expectations.
Outcome: The pre-submission resulted in a clear regulatory pathway, setting the company up for future 510(k) submissions.
Case Study 2
Challenge: An Italy-based wound care medical device company needed to secure a 510(k) clearance for its product. The company's prior attempts at FDA submission had resulted in delays and requests for additional information.
Solution: KLEO provided comprehensive support in preparing and submitting the 510(k) application, addressing all technical requirements and communicating effectively with the FDA to resolve previous issues.
Outcome: The 510(k) clearance was successfully obtained in March 2024, allowing the company to begin marketing its product in the U.S.
Market Affairs Case Studies
Case Study 1
Challenge: A spine-focused medical device company in Texas faced challenges developing an effective reimbursement, coding, and payer relations strategy for its innovative device.
Solution: KLEO conducted a full market access analysis, identified appropriate reimbursement codes, and created a comprehensive payer relations strategy. We collaborated with commercial payers and provided coding education to ensure reimbursement pathways were clear.
Outcome: The company secured reimbursement from key payers, accelerating its product’s adoption in the U.S. market.
Case Study 2
Challenge: A urology medical device company in New Hampshire required an analysis of its CMS reimbursement pathways to navigate complexities in Medicare coverage.
Solution: KLEO conducted a thorough CMS reimbursement analysis, evaluated potential coding opportunities, and created a strategy to help the company achieve coverage for its urology device.
Outcome: The analysis provided the company with actionable insights and allowed it to align its pricing and reimbursement strategies with CMS guidelines, enhancing market penetration.
Medical Writing Case Studies
Case Study
Challenge: A Texas-based medical device company needed assistance with the publication of a retrospective single-site clinical study conducted at the Mayo Clinic, which required precise medical writing expertise to meet academic publication standards.
Solution: KLEO worked with clinical teams to develop a clear, concise manuscript that met journal guidelines. We ensured the publication was scientifically robust, with appropriate statistical analysis and clear articulation of findings.
Outcome: The study was successfully published in a leading medical journal, expanding the company’s publication portfolio and contributing valuable insights to the field.