Hilda Scharen-Guivel
About Hilda Scharen-Guivel
Hilda Scharen-Guivel, age 54, is an independent director of IRADIMED (IRMD) serving since 2022, with 25+ years in federal healthcare and medical device regulation, including as Program Director at FDA’s Center for Devices and Radiological Health (CDRH) where she led the Medical Device Development Tools program; she retired as a Captain of the U.S. Public Health Service in 2022 and holds a B.S. in Biomedical Engineering and a Master’s in Engineering from the Catholic University of America . She brings deep FDA regulatory strategy, policy, and risk expertise to the Board .
Past Roles
| Organization | Role | Tenure | Committees/Impact |
|---|---|---|---|
| U.S. Food & Drug Administration (CDRH) | Program Director | 2017–2022 | Led and implemented the Medical Device Development Tools (MDDT) program |
| U.S. Public Health Service (USPHS) | Captain (retired) | Through 2022 | 25+ year federal career across FDA, HHS, and NIH; retired in 2022 |
External Roles
| Organization | Role | Tenure | Committees/Focus |
|---|---|---|---|
| St. Anthony’s Hospital (BayCare Health System) | Board of Trustees | Since Jan 2025 | Clinical Excellence Committee (since Feb 2025), Finance Committee (since Feb 2024) |
| Tampa Bay Technology Incubator (TBTI) | Council of Professionals (Member) | Since Jan 2022 | Advisory engagement with USF/USF Connect (guest speaker) |
Board Governance
- Independence: Determined independent under NASDAQ 5605(a)(2) .
- Committee assignments: Member, Audit Committee and Compensation Committee; both committees comprised solely of independent directors; Audit Chair: Monty Allen; Compensation Chair: Anthony Vuoto .
- Attendance and engagement: Board met 7 times in 2024; Scharen-Guivel attended 100% of Board meetings; she also attended the 2024 annual meeting of stockholders . Audit Committee held 8 meetings; Compensation Committee held 6 meetings in 2024 .
- Executive sessions: Non-management directors meet in executive session from time to time; sessions are led by the Audit Committee chair .
- Board leadership context: CEO serves as Chair; Board maintains majority independent membership and reviews structure periodically; no Lead Independent Director disclosed .
Fixed Compensation
- Non-employee director fee schedule (paid quarterly): Board retainer $50,000; Audit Committee chair $15,000; Compensation Committee chair $10,000; Audit member $7,500; Compensation member $5,000; no per-meeting fees; annual RSU grant targeted at $100,000 value with two-year vesting .
| 2024 Director Compensation (IRMD) | Amount |
|---|---|
| Cash fees (Board + Audit member + Comp member) | $62,500 |
| Equity (RSU grant, grant-date fair value) | $99,950 |
| Total | $162,450 |
Notes: Non-employee director fees paid in arrears quarterly; annual RSU grant determined by dividing $100,000 target by closing price on grant date; two-year vesting .
Performance Compensation
- Equity structure: Non-employee directors receive time-based RSUs; no options or performance-conditioned equity are disclosed for directors .
| Performance Metric Framework (Directors) | Detail |
|---|---|
| Metrics tied to director compensation | None disclosed; time-based RSUs only (two-year vest) |
- Outstanding awards: Scharen-Guivel had 4,775 unvested stock awards outstanding as of Dec 31, 2024 .
Other Directorships & Interlocks
| Category | Detail |
|---|---|
| Current public company boards | None disclosed for Scharen-Guivel |
| Private/non-profit/academic roles | St. Anthony’s Hospital trustee; TBTI Council; USF/USF Connect guest speaker |
| Interlocks or related-party exposure | No related-person transactions disclosed involving Scharen-Guivel |
Expertise & Qualifications
- FDA regulatory strategy, policy, and risk management (Program Director, FDA CDRH; led MDDT program) .
- Biomedical engineering education (B.S.) and Master’s in Engineering, Catholic University of America .
- Senior federal service leadership; retired USPHS Captain (public health system experience) .
Equity Ownership
| Ownership Detail | Amount |
|---|---|
| Beneficial ownership (common shares) | 4,729 shares (<1% of outstanding) as of April 21, 2025 |
| Unvested stock awards (as of 12/31/2024) | 4,775 units |
| Hedging/Pledging | Company prohibits hedging transactions by directors, officers, and employees under Insider Trading Policy; pledging not specified in proxy |
Governance Assessment
-
Strengths
- Independent director serving on both Audit and Compensation Committees; both committees fully independent, enhancing oversight of financial reporting, cybersecurity risk (Audit) and pay practices (Compensation) .
- Strong engagement: 100% Board attendance in 2024; attended 2024 annual meeting, signaling accessibility to shareholders .
- Director pay design mixes cash and time-vested equity (approx. $62.5k cash; ~$100k equity), aligning incentives with long-term shareholder value; no option grants or per-meeting fees disclosed .
- Company-level safeguards include anti-hedging policy and an exchange/SEC-compliant clawback policy for incentive-based compensation (the latter applies to executive officers), reflecting attention to risk and accountability .
- Section 16 compliance: the only late filing disclosed for 2024 was by CFO John Glenn; no late filings disclosed for Scharen-Guivel .
-
Watch items / RED FLAGS (governance context)
- CEO/Chair role combined; Board asserts periodic review, but no Lead Independent Director disclosed—places added emphasis on the independence and effectiveness of committee oversight .
- No standing nominating committee; nominations handled by the Board, with independent directors selecting nominees, but formalized independent nomination oversight is limited .
- One non-independent director due to familial relationship with an executive officer (James Hawkins), a minor independence dilution that heightens the importance of independent committee work .
- Related-party transaction at company level: headquarters lease with entity controlled by CEO; Audit Committee policy governs related-person transactions; not linked to Scharen-Guivel but a standing governance consideration for investors .
Board Governance (Key Reference Table)
| Item | Detail |
|---|---|
| Independence | Independent under NASDAQ 5605(a)(2) |
| Committees | Audit Committee (member); Compensation Committee (member) |
| Committee chairs | Not a chair; Audit Chair: Monty Allen; Compensation Chair: Anthony Vuoto |
| Attendance | 100% of 7 Board meetings in 2024; attended 2024 annual meeting |
| Executive sessions | Non-management sessions led by Audit Committee chair |
| Board leadership | CEO is Chair; majority independent; no LID disclosed |
Director Compensation Detail (2024)
| Component | Amount/Terms |
|---|---|
| Board retainer | $50,000 cash |
| Audit Committee member fee | $7,500 cash |
| Compensation Committee member fee | $5,000 cash |
| Equity grant | RSUs with grant-date fair value ~$100,000; two-year vesting |
| Actual 2024 totals (Scharen-Guivel) | Cash $62,500; Equity $99,950; Total $162,450 |
| Unvested awards at 12/31/24 | 4,775 units |
Related-Party/Conflicts Policy
- The Audit Committee reviews, approves or disapproves related-person transactions under a written policy; the 2024 disclosed related-party transaction concerns a facility lease with an entity controlled by the CEO; no transactions involving Scharen-Guivel were disclosed .
Insider Filing Compliance
| 2024 Section 16 Compliance | Status |
|---|---|
| Scharen-Guivel | No late filings disclosed (only late Form 4 was by CFO John Glenn) |