Dr. Bethany Young - Biomedical Engineering Case Studies (Hydrogels, Ear Health, and Male Contraception)
Speaker and context
Dr. Bethany Young: engineer focused on designing and delivering long-lasting, non-hormonal male contraception; based in Charlottesville; leads efforts in neurocutaneous and delivery systems for biomedical devices; passionate about mentoring and broad career pathways in biomedical engineering.
Audience interaction: encouraged questions; emphasized a journey from biology to engineering to industry.
Career and education timeline
Undergraduate: University of Richmond; major in Biology; considered medical school, nursing, and environmental science before pivoting to biomedical engineering.
Early exposure: volunteered in a regenerative medicine lab at UC (University of California) during senior year after emailing Dr. Heiss; discovered interest in biomedical treatment through hands-on lab work and seeing cells under a microscope.
Graduate studies: pursued a Master’s in Biomedical Engineering (initial plan to stop at Master’s) and then continued to PhD; remained focused on industry rather than academia.
PhD and industry move: stayed for PhD at Rebecca Heights; transitioned to a startup, Companogen, as one of its first three employees; later moved to LifeNet Health (about 1,500 employees) and then to Contraline (≈18 employees).
Perspective gained: experience across startup and large-company environments; preference for startup culture and broad, hands-on roles.
Why biomedical engineering and the throughline to industry
Core motivation: apply engineering principles to medical/biological problems; good at translating doctor needs into practical design solutions.
Critical aspect of a successful product: ensure that a device actually fits a doctor’s workflow and is usable in real patient care (avoiding devices that look good on paper but fail in the OR).
Role philosophy: bridge bench research and clinical use; focus on solutions doctors will actually use.
Startup vs. big company experiences
Companogen (startup): early hiring gave exposure to all aspects of product development; excitement and risk of startup life.
LifeNet Health (big company): larger organization with more defined roles; learned value of processes, collaboration, and scale; enjoyed the depth of expertise but preferred the versatility of startups.
Current stance: still values startup mindset but has broad experience to bring to product development.
Case study: hydrogel-based therapy for chronic tympanic membrane perforation (ear health)
Problem background
Chronic tympanic membrane perforation occurs in about 7 ext{ ext%} of cases where tubes are used; standard of care is a highly invasive surgery entering behind the ear, with costs around and long recovery.
About a million ear-tube procedures are performed annually, highlighting the scale of the problem.
Solution concept
Use a hydrogel that can be applied directly to the eardrum via the ear canal and cured in place with blue light (dental curing light) to form a glue-like seal and promote healing.
Aim: non-surgical, outpatient procedure suitable for pediatric patients to fix chronic perforations and avoid invasive skull-base surgery.
Product development approach and early design inputs
Start with user needs: no anesthesia required, quick procedure (target of ~10 minutes), compatible with ENT workflow, fits through standard ear speculum, and allows one-handed operation while maintaining visualization.
Tradeoffs: minimize heat from curing light, avoid over-heating surrounding tissue, manage light exposure to ensure complete curing without harming adjacent tissues.
Iterative process emphasized: rapid prototyping with 3D-printed models; many iterations to match surgeon feedback (roughly “at least 20” iterations).
Design iterations and features developed
Initial gel and curing setup: a yellow/blue powdery gel in a test tube with a dental curing light; crosslinker used; curing converts gel to a cohesive, schließlich gummy-like solid.
Size and form factor: reduced device diameter to fit the narrow ear canal; ensured enough light to cure the entire gel layer on the eardrum.
Light and energy considerations: adjusted power and spot size so curing occurs across the targeted eardrum tissue without overheating tissue.
Delivery and tooling: explored syringes and other applicators but doctors preferred using their own tools; thus, the design favored compatibility with existing instruments.
Packaging and shelf-life: developed custom packaging to keep the gel dry until use; included a tear-strip mechanism to mix saline and gel just before application and to load the gel into a dispensing tray.
Ergonomics and workflow integration: used a heavier light source positioned away from the hand to reduce surgeon hand fatigue and improve control; added a disposable fiber-optic delivery system and a foot pedal to keep hands free.
Manufacturing and testing considerations
Fiber optics: longer light-delivery fiber required; engaged a contractor with expertise to ensure power retention over length and disposability for sterility.
“Do not overengineer”: cameras in the scope were considered but not adopted early due to FDA data load and increased risk; microscopes with cameras remained the standard in current practice.
Rapid trials and user feedback: continuous doctor input to ensure the device meets real-world needs; responsiveness to surgeon suggestions to avoid clunky designs.
Clinical and preclinical testing milestones
Preclinical testing: animal models used to assess healing and safety prior to human trials.
Animal model: chinchilla ears used due to similarity in eardrum structure; compared hydrogel (PERFECT Gel) against existing surgical approaches (Epifilm as a competing option).
Outcome indicators: regrowth of a three-layer tympanic membrane (epithelium, mucosal layer, and connective/ Dense tissue) with the new hydrogel, demonstrating functional restoration of the tympanic membrane.
Clinical translation prompts: demonstrated better or at least equivalent healing with the hydrogel, justifying progression to human trials.
Current status and outlook
Company is ~15 years old; product is in clinical trials, targeting FDA clearance and possible acquisition by a larger company after approval.
The entrepreneur emphasized the long development timeline typical of biotech/medical devices and the value of starting with a problem that matters to patients and clinicians.
Patient impact and professional takeaway
The goal is to reduce invasive surgeries, shorten recovery, and improve quality of life for pediatric and adult patients with chronic ear perforations.
Personal fulfillment from helping patients and offering solutions when traditional therapies fall short.
Other experiences relevant to product development
LifeNet Health: organ donation and tissue bank; roles spanned from research to development and occasional field marketing; learned to operate in a nonprofit, mission-driven environment; experience with tissue preservation technologies.
Associate Product Manager / marketing experience: involved in direct engagement with doctors, travel for field work, and understanding the physician’s perspective on product adoption; learned to balance science with market needs and regulatory considerations.
Perspective on medical devices and tissue engineering
Hydrogels as a versatile platform: used in multiple anatomical sites (muscle, tendons, reproductive system, nervous system, etc.). The same underlying material class enables a wide range of applications; the innovation lies in the delivery method, device design, and user workflow.
Current and future male contraception initiatives
Rationale for male contraception options
Historically, few male contraceptives exist; emphasis on shared responsibility in reproductive health.
Men express interest in having more control and choice regarding contraception.
Hydrogel-based vas deferens contraception (your current project)
Mechanism: inject a hydrogel into the vas deferens to block sperm flow; the gel degrades over time (approximately ) and is absorbed, with fertility potentially returning after degradation.
Design goals: non-permanent, reversible contraception; duration is designed to be around two years with gradual degradation.
Key design challenges and approaches
Diameter constraint: vas deferens diameter is < ; device components and tools must fit within a very small bore.
Degradation control: ensure the gel degrades around two years and that the end of the window aligns with fertility considerations; worst-case safety emphasis to avoid unintended pregnancies.
Reversal feasibility: on-demand reversal is a major R&D focus; exploring mechanisms to remove or bypass the gel without major surgery.
Prototyping and iteration: looked at off-the-shelf angioplasty devices and tubing as starting points; rapid prototyping with micro-fabrication and laser-cut tooling.
Clinical development pathway
Currently in clinical trials in Australia, chosen due to societal acceptance and regulatory pathway readiness; aim to gather data to support acceptance in the U.S. and elsewhere.
NIH-licensed topical male contraception (external product)
A separate product licensed from the NIH exists: a topical gel applied daily on the shoulder area that interferes with sperm production by modulating testosterone; includes a dose of testosterone to maintain systemic levels.
Status: in Phase II with plans to advance to Phase III; notable as the only male contraceptive to reach Phase II and move toward Phase III.
Conceptual design philosophy for these programs
Leverage hydrogel materials and biomedical engineering to create non-permanent, reversible solutions that respect user control and medical feasibility.
Use cross-disciplinary insights (microfabrication, materials science, pharmacology, surgical workflows) to tailor devices to tiny anatomical spaces and real-world clinical practices.
Strategic takeaways and advice for students
Problem-first and user-centered design: start with a real clinical need and rigorously validate with end-users (doctors, patients).
Avoid overengineering: add features only when they clearly improve patient outcomes or workflow efficiency; extra features often slow regulatory approval.
Rapid prototyping is essential: use 3D printing and quick-turnaround iterations to test usability and fit with clinicians.
Build cross-functional experience: combining bench science with business/marketing experience enhances ability to translate research into marketable products.
Understand regulatory pathways early: preclinical testing, animal studies, and human factors studies shape the path to FDA approval and eventual commercialization.
Engage with local ecosystems: networks like Virginia Bio can provide industry exposure, opportunities, and resources for students.
Quick reference to key numbers and terms
Chronic tympanic membrane perforation prevalence: of cases with tubes lingering.
Traditional surgery cost for chronic perforation: $18,000 per procedure.
Annual ear-tube procedures: ~ worldwide.
Hydrogel device diameter in vas deferens: < 1\text{ mm}.
Duration of vas deferens hydrogel contraception: before natural degradation.
Trial location for vas deferens hydrogel: Australia (clinical trials ongoing).
Years in development for the ear hydrogel company (at time of talk): ~15 years; product in clinical trials with anticipated FDA process after trials.
Time for a vasectomy-like procedure used in current development: ~ per procedure (no-scalpel technique).
Phase status for NIH-licensed topical gel: Phase II (moving toward Phase III).
Year reference for clinical trials started in this program: .
Quick glossary
ENT: Ear, Nose, and Throat.
FDA: U.S. Food and Drug Administration (regulatory body governing medical devices and therapies).
No-scalpel vasectomy: a minimally invasive vasectomy technique used in current clinical workflows.
Epifilm / PERFECT Gel: competing or comparative tympanic membrane repair approaches used in preclinical studies.
Final takeaway
The speaker illustrates a career path that blends biology, engineering, startups, and clinical need, culminating in hydrogel-based solutions with real patient impact and challenging regulatory journeys. The work highlights the value of patient-centered design, iterative prototyping, and cross-disciplinary collaboration in biomedical engineering.