Securing insurance coverage and reimbursement is becoming increasingly important in commercial success in the world of medical devices. To help clients navigate that critical phase, MDREX has appointed a new Senior Expert, Ms. Lee Ji; a reimbursement and fee expert with 23 years at the Health Insurance Review & Assessment Service (HIRA).
Why this matters
- Many medical device and technology companies obtain regulatory approval but struggle with coverage pathways such as new health technology assessment or existing tech determination, and reimbursement strategies such as reimbursable, non-reimbursable, or selective reimbursable. These challenges often delay market entry or prevent expected revenue realization.
- MDREX’s expanded team now offers deeper, practice-oriented reimbursement strategies grounded in direct HIRA experience and an intimate understanding of decision-making and operational processes inside the payer.
About Ms. Lee Ji
- 23 years at HIRA, directly involved in design and overall operation of insurance system.
- Determination of existing-technology status
- Implementation of deferral of nHTA
- Operation of selective reimbursement and re-evaluations (e.g., NGS re-evaluation)
- Implementation of "Moon Care" Preliminary reimbursement policy
- Has deep understanding of the relationship between real life clinical environment and HIRA through management of post-market activities
- Operating the Medical Review and Assessment Committee
- Provider education
- Appeals
- On-site investigations
- Participated in pilot payment programs and fee schedule design
- Has the capability to respond to policy changes and regulatory risks, enabling her to develop strategies that go beyond simple advisory work and reflect actual policy trends and system operations.
How MDREX’s strengthened team helps you
- Combines regulatory approval support with robust reimbursement planning to turn approvals into real-world utilization and revenue.
- Offers strategies based on deep payer-side experience (including advisor Byun Eui-hyung’s 30+ years in health insurance policy and assessment) and hands-on operational know-how.
- Delivers feasible, implementation-focused plans that reflect HIRA’s internal decision structures and the needs of clinical stakeholders.
If you’d like an assessment of your product or technology’s insurance coverage prospects, optimal market-entry strategy, or potential regulatory/policy risks, contact MDREX at pro@mdrex.co.kr.
MDREX is committed to helping your product move beyond approval to clinical adoption and market success.
