Problem Statement
Epidural hematoma (EDH) can occur after craniotomy (a common neurological surgery) when blood accumulates between the dura mater and the skull. Current closure methods require surgeons to manually suture the dura to the bone flap, taking 20–30 minutes and leaving little margin for error. Alternative methods, such as the “Watering Can Technique,” add 20 more minutes, increasing time, costs, and risk of postoperative complications. The problem was the lack of an efficient, reliable method to close the dura-bone space that prevents EDH while reducing operation time.
FOCs
My team identified multiple functions, objectives, and constraints that were then ranked in their relevance to the project, using various metrics.
| Primary Function |
Prevent the collection of blood in the epidural space |
| Secondary Functions |
Secure the dura to the skull Stabilize arterial/venous bleeds Support dura regeneration |
| Key Objectives |
Save >10 minutes compared to current suturing methods Compatibility with bone flaps 2–14 cm in diameter |
| Constraints |
Must not damage the dura (strain <11±3%) Must withstand sterilization at 132–135°C Must not increase intracranial pressure (>1.5 mmHg) Must use biocompatible materials (ISO 10993) |
Proposed Solution — Bioadhesive Dura Mesh
Using structured idea generation and selection (65 ideas → 3 alternatives → final choice through Pugh matrix), the team selected the Bioadhesive Dura Mesh as the optimal design.
How It Works?
A biodegradable, adhesive-coated mesh is placed between the dura and the inner skull surface, creating a tight seal that eliminates the epidural space. The mesh encourages natural tissue bonding, requires no sutures, and can be trimmed to any flap size.
Why is this design successful?
- Saves ~10 minutes of OR time
- Requires minimal training (simple placement)
- Works for all relevant bone-flap sizes
- Low manufacturing cost (PGA/PLA-based adhesives)
- Reduces equipment load and complexity.
Project Summary
This project applied a full engineering design process—problem analysis, research, FOCs, idea generation, objective scoring, and feasibility assessment—to develop a clinically relevant medical device concept. The Bioadhesive Dura Mesh addresses the core clinical gap by reducing closure time while maintaining safety, biocompatibility, and ease of use. The proposed solution was accepted by the team's client and approved by industry professionals.
I developed skills in engineering design, materials selection, and systems-level trade-off analysis, which are essential for building ML-enabled medical or robotic applications that often operate in various environments, where safety is the most critical parameter.