PRECODE™ is a system

The PRECODE™ System is a proprietary consulting framework designed to integrate health economics, reimbursement strategy, and evidence generation into the earliest stages of medical device and diagnostic innovation—before regulatory approval.

By aligning clinical development with coding, coverage, and payment objectives from day one, the PRECODE™ System reduces market access risk and accelerates adoption under programs like Breakthrough Device Designation (BDD) and New Technology Add-On Payment (NTAP).

Carter Lonsberry is the architect of the PRECODE™ System and a nationally recognized leader in health technology reimbursement strategy. With over 25 years of experience in the medical device industry—including senior roles at companies like Synthes, Medtronic, NuVasive, and as former CEO of Icotec Medical Inc.—Carter has been on the front lines of bringing breakthrough technologies to market.

While leading Icotec’s U.S. business, Carter played a pivotal role in securing Breakthrough Device Designation (BDD)and guiding the company through the complex New Technology Add-On Payment (NTAP) process. That firsthand experience revealed a critical flaw in the industry: too many companies chase reimbursement after FDA approval, leading to costly delays, missed opportunities, and underperformance at launch.

In response, Carter created the PRECODE™ System—Pre-Regulatory Economic Coding & Outcomes Design for Evidence—a new methodology that flips the reimbursement model on its head. PRECODE™ embeds reimbursement thinking at the earliest stages of development, aligning clinical, regulatory, and economic value from day one.

As the founder of Lonsberry Consulting™ and a designated standards developer working toward ANSI alignment, Carter now helps MedTech innovators avoid costly missteps and accelerate access through PRECODE™. His work sits at the intersection of innovation, regulation, and payment policy, and is actively shaping the future of how breakthrough technologies reach patients—and get paid for.

• Led BDD/NTAP strategy for a spine tumor technology featured in NCCN guidelines
• Founder of Hospital Rep Safety Solutions (HRSS), a federally listed Patient Safety Organization (PSO)
• Developer of PRECODE™, a commercialization methodology for MedTech startups, strategists, and investors
• Trusted advisor to health systems, MedTech boards, standards bodies, and regulators

PRECODE™ is an independent methodology developed by Carter Lonsberry and is not affiliated with or endorsed by any former employers.

We specialize in helping MedTech companies navigate the complex path from breakthrough innovation to reimbursement and adoption. Whether you're an early-stage startup or an established device manufacturer pursuing Breakthrough Device Designation (BDD), NTAP, or market access, our services are built around one principle: reimbursement begins before the FDA.

Through our proprietary PRECODE™ System—Pre-Regulatory Economic Coding & Outcomes Design for Evidence—we provide strategic guidance that aligns regulatory, clinical, and economic milestones to ensure your innovation reaches patients and gets paid for.

PRECODE™ Strategy Development

• Aligns product development with reimbursement and payer expectations
• Custom playbooks for BDD, NTAP, and TPT eligibility
• Identifies gaps in coding, payment, and evidence strategy

Market Access Roadmapping

• Coding pathway assessment (CPT, ICD-10-PCS, HCPCS)
• Coverage strategy (CMS, commercial payers, MACs)
• Value proposition and health economics positioning

NTAP Justification & Submission Support

• Full NTAP application development or review
• Cost comparison and DRG impact modeling
• Clinical evidence synthesis aligned with CMS expectations

BDD Opportunity Assessment

• Evaluate eligibility for FDA’s Breakthrough Device Program
• Support with submission narrative and unmet need framing
• Link regulatory milestones to future CMS and payer objectives

Executive Workshops & Team Training

• Custom sessions on PRECODE™, reimbursement strategy, and FDA–CMS alignment
• Ideal for executive teams, market access leads, and investor groups

Fractional Consulting & Board Advisory

• Retained strategic support for emerging MedTech companies
• Board-level insight on reimbursement risk, pricing, and value creation

• Proven track record with NTAP-approved and guideline-listed technologies
• Deep understanding of reimbursement-first strategy and FDA–CMS interactions
• Founder-led expertise with real-world commercialization success
• A proactive approach that saves time, reduces risk, and increases valuation