Christine Luk, MBE is an Associate Regulatory Affairs Manager at Proxima Clinical Research where she manages regulatory projects and personnel and prepares deliverables across all stages of development.  Prior to joining the Proxima team, Christine served as an Associate Principal at a company developing medical device and drug therapeutics from concept to commercialization. There, she combined engineering and entrepreneurial roles to lead multidisciplinary teams for the development of medical devices start-ups in indications including fetal surgery, neonates, pediatrics, urology, gynecology, IVDs, and cardiology. Christine contributed to project management, fundraising and business development, engineering product development following ISO 13485, and writing and leading regulatory interactions.

Christine received her Master of Bioengineering in the Global Medical Innovation program from Rice University. While completing her Masters, she co-founded a startup developing devices for women’s health and worked as an R&D engineer to develop novel electrophysiology devices and long-term implants. Her Bachelor’s is in Biochemistry and Cell Biology with a minor in Global Health Technologies from Rice University, where she also developed medical devices for low-resource settings with Rice 360° Institute for Global Health.

Christine is a judge and mentor for Texas New Ventures Competition, Rice Business Plan Competition, MedTech Innovator, UT Dell Medical School Texas Health Catalyst, and Rice Global Medical Innovation, and is an advisory board member for Rice 360°. Christine also serves as the Portfolio Manager assisting two hundred companies for the Southwest National Pediatric Medical Device Innovation Consortium (SWPDC) and is passionate about helping innovators successfully navigate the pathway to market.

Rice University: Biochemistry and Cell Biology, B.A.

Rice University: Bioengineering, M.B.E.

Proxima Clinical Research, Inc., Houston, Texas
Associate Regulatory Affairs Manager

Brevitest Technologies, Inc., Houston, TX 
Product Development Engineer

FDA Southwest National Pediatric Device Innovation Consortium (SWPDC), Houston, TX
Portfolio Manager

Fannin Partners, LLC, Houston, TX
Entrepreneurship Fellow
Senior Entrepreneurship Fellow
Associate Principal

LilySpec, LLC, Houston, TX
Co-Founder, Chief Technology Officer

Johnson & Johnson Center for Device Innovation, Houston, TX 
Medical Device Engineering Intern

Bioengineering and Global Health Technologies Senior Capstone Design, Rice University, Houston, TX 
Teaching Assistant and Mentor‍

Establishment Labs, Alajuela, Costa Rica 
Medical Device R&D Intern

Bartel Lab, Wiess School of Natural Sciences, Rice University, Houston, TX 
Undergraduate Researcher

INTEGRIS Health Baptist Medical Center, Oklahoma City, OK 
Pharmacy Technician

Christine has played an important role in the development of the following medical products:

1. Drug for Infectious Disease Treatment  
2. Medical Device- Vaginal Speculum
3. Medical Device- Premature Infant Nutrition
4. Medical Device- Right Heart Catheter
5. Medical Device- IVD for COVID-19 Antibody Detection
6. Medical Device- Implant for Neurogenic Bladder
7. Medical Device- Device for Stress Urinary Incontinence
8. Medical Device- Tissue Expander for Breast Reconstruction
9. Medical Device-
10. Medical Device for Urine Flow Measurement
11. Medical Device for Spinal Fusion
12. Medical Device for Neuromodulation (x4)
13. Medical Device- Software for Wound Management
14. Medical Device- Surgical Robot
15. Medical Device- Vascularization imaging surgical device
16. Medical Device- Catheter Guidewire
17. Medical Device- Balloon Catheter
18. Medical Device- Heart Valve
19. Medical Device- Left Ventricular Assist Device (LVAD) or MCS (x4)
20. Medical Device- Non-Invasive Blood Pressure Monitor (x3)
21. Medical Device- Software for Atrial Fibrillation Detection
22. Medical Device- Biliary Catheter and Pump
23. Medical Device- Software for Flow Cytometry Data Analysis
24. Medical Device- Detection of Cerebral Blood Flow for Stroke Rehabilitation
25. Medical Device- IVD for Melanoma Risk Assessment
26. Medical Device- Anchors for Fetoscopic Surgeries
27. Medical Device- Gastric Sleeve and Anchor
28. Medical Device- Breast Localization Wire
29. Medical Device- Gallbladder Cryoablation
30. Medical Device- Noise attenuation for neonates
31. Medical Device- Surgical margin detection device (x2)
32. Medical Device- Organ Perfusion Device
33. Medical Device- Perfusion Catheter
34. Medical Device- Surgical Adhesion Material
35. Medical Device- IVD for bacterial detection
36. Medical Device- Sleep apnea relief
37. Medical Device- Vascular patch
38. Medical Device- Software for radiology  
39. Medical Device- Heart Rhythm management device
40. Medical Device- Laboratory Robots
41. Medical Device- Gastroscope
42. Medical Device- Software for cancer management
43. Medical Device- Software for autism treatment
44. Medical Device- Intra-urethral valve pump and activator
45. Medical Device- IVD for Barret’s Esophagus  
46. Medical Device- IVD for necrotizing enterocolitis  
47. Medical Device- Camera for ophthalmology
48. Medical Device- Infusion pump
49. Medical Device- Software for depressive disorder
50. Medical Device- Stroke Cooling Device  
51. Medical Device- Ventilator
52. Medical Device- IVD for COVID-19
53. Medical Device- Infant feeding measurement device

Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery
NICHD SBIR Phase II grant
Role: PI
M.J. Heffernan (Contact PI); C. Luk (PI)

Southwest National Pediatric Device Innovation Consortium (SWPDC)
US FDA P50 grant
Role: Portfolio Manager  
C. Koh (Contact PI)

Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients
NIDDK SBIR Phase I grant
Role: Project Engineer
M.J. Heffernan (PI)

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