Faculty Projects
Development of a New Mechanical Engineering Course - Design and Manufacturing of Medical Devices

DTR Student group photo

Project Manager

Jeremy Keys, Assistant Professor of Instruction, Mechanical Engineering

Amount Requested

$7,500

Summary

This project details the development of a new course for Mechanical Engineering undergraduate students: Design and Manufacturing of Medical Devices. In this course, we will develop students’ understanding of the full lifecycle of medical device development, starting from conceptual design and concluding with regulatory compliance.

To accomplish this goal, students will be tasked with a quarter-long design project where they will work as a class to build a tool kit for an orthopedic surgical operation (in this case, an ACL reconstruction surgery). As a class, students will develop a list of required components for the surgery, and then break out into sub-teams who will each design, manufacture, and test a single component for the tooling set.

Over the course of this project, students will gain significant practice in needs-identification for end-users (i.e., surgeons), rapid prototyping and design iteration, development of manufacturing drawings, complying with engineering standards, and design validation through testing.

This course will provide students with insight into the challenges of design and manufacturing which are unique to medical device design. As these devices play a crucial role in supporting human life, they are subject to high standards of reliability, biocompatibility, and risk-mitigation. This course will provide an in-depth, industry-specific window to these topics which will greatly help to prepare students to succeed in a future career in this industry.

Planned Activities/Investments

In this class, students will be educated on fundamental anatomical, biomechanical, and biochemical factors influencing medical device design. Devices must be biocompatible, wear-resistant, and highly reliable. In the scope of manufacturing, these requirements manifest through adherence to various engineering standards. The use of these standards (including FDA, ASTM, ISO, ANSI, etc.) is an essential skill in the biomedical industry, yet historically has played a minimal role in the instruction of design courses at Northwestern. In this course, students will learn to identify key standards which guide the regulatory compliance of medical devices and will then apply this skill towards the development and testing of their own designs.

Students will then be tasked with executing the design, manufacturing, and validation of a device used in an orthopedic surgical procedure. Collectively, as a class, these components will serve to make up a surgical kit for the execution of an ACL reconstruction surgery. Each student group will focus on the development of one component from the surgical kit.  For this tool, students will develop:

  1. A mechanical design report, demonstrating calculations to determine critical dimensions of the component which enable design performance such that all critical failure modes are averted
  2. A list of all critical engineering standards to which their component must adhere
  3. A manufacturing plan, which includes engineering drawings which specify critical dimensions, tolerances, materials, surface finishes, and any required post-processing (including sterilization and packaging protocols)
  4. A manufactured prototype produced through a rapid prototyping service, or the Northwestern Machine Shop
  5. A mechanical testing report, demonstrating adherence to all relevant engineering standards

These deliverables aim to closely model the product development lifecycle that students will encounter as design engineers in the medical device industry, which will ensure that they are highly competitive as they enter the job market.

Impact

McCormick Undergraduate and Graduate Students in Mechanical Engineering, Manufacturing and Design Engineering, and Biomedical Engineering programs will benefit from this project. In Mechanical Engineering, this course will count as a concentration requirement for students in the Design, Manufacturing, and ME Breadth Concentration. This course will also count as an elective for the prospective Master of Science in Manufacturing program.

This course will provide these students with practical, hands-on, industry-relevant experience which will enhance their competitiveness in the highly lucrative medical device job market. In particular, compliance to engineering standards is an especially valuable skill in industry (a cursory search of medical device engineering jobs reveals high interest in students with existing familiarity with FDA and ISO standards), yet few existing courses provide substantial practice with these types of standards.

We will monitor this project through student feedback (in the form of CTECs) and tracking student progression beyond Northwestern, monitoring their interest-in and pursuit-of careers in the medical device industry.

Sustainability

Pending the success of the launch of this course in the Winter of 2025, this will become a regularly offered elective course in the Mechanical Engineering department. Beyond the limits of Murphy funding, we will continue to identify funding sources through additional grants, industry partnerships, and departmental funding once this course becomes a core offering of the Mechanical Engineering department. This course aligns with Dean Schuh’s strategic initiatives for McCormick (under the criteria of Design for Healthcare) and will thus play a significant role in the school’s continuing growth in this area for supporting our undergraduate students.

Many of the components purchased through this initial funding will be re-usable for future iterations of the class (including model joints and engineering standards). The use of other consumables for the course may be reduced over time, as we optimize the running of the course.

Deliverables

  1. A highly interactive curriculum will be developed for the instruction of a new course on the Design and Manufacture of Medical Devices.
  2. Students will design, manufacture, and test surgical tools, ensuring compliance to engineering standards.

Budget Overview

  • $320 – Model Knee Joints (Knee with Fibula, Patella, and Four Ligaments, Full Length (sawbones.com))
  • $360 – Desktop Clamps (https://www.mcmaster.com/8464A63/)
    Students will use knee joints (supported by clamps) to model a surgical work-flow to understand usability factors associated with each tool in the surgical kit.
  • $1,000 – Engineering Standards (Including IEC 62366-1:2015, ISO 14971:2007, ISO 14155, ASTM F543-23, and ISO:9626:2016)
    Engineering standards will educate students on the manufacturing, testing, and inspection processes necessary to produce medical devices suitable for clinical use.
  • $100 – Sawbones Foam (https://www.sawbones.com/block-20-foam-1522-03-laminated-on-one-side-w-50-3mm-foam-1522-08-finished-size-4-5-x-3-25-x-1-5-1522-440.html)
    Sawbones Foam is used for testing surgical tools used for fixing tissue to bone (as in an ACL reconstruction surgery)
  • $5,000 – Materials and Prototyping Services
    To manufacture and test their designs, students will have a budget of $500 per team. Depending on the team’s design, they may need raw materials or to pay for rapid prototyping (i.e., 3D-printing or CNC services) for manufacturing. This budget may also be used to rent testing equipment to validate compliance to engineering standards.
  • $720 – Model Surgical Tools
    Additional tooling will demonstrate specialized functions of specific components in an orthopedic surgical toolkit. These will also be used to help students model usability factors encountered by surgeons in the surgical suite.

    Total Budget Amount: $7,500

Matching Funds

The Mechanical Engineering department may offer supplemental funding to support Honoraria for guest speakers, and the purchase of other incidental costs for the running of this course.