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Biomedical Engineering

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One of the major challenges in biomedical engineering is how to deliver the benefits of modern medical understanding to people in developing nations. Here are some really cool ideas: WHO | Compendium of innovative health technologies for low-resource settings.

Charles Tritt

What We Teach

Posted by Charles Tritt May 13, 2014

This list of rules mirrors what we teach in MSOE's BE design sequence courses: http://www.qmed.com/mpmn/medtechpulse/10-rules-designing-great-medical-devices. It is nice to have some external validation of our ideas.

Our program is conducting a “stakeholder” survey to help us set curricular priorities. So far, nearly all (97%) of the respondents have been program alumni. This graphic lists the most common words in the responses to the “job description” question, with size corresponding to frequency. It gives an idea of what our allumni do…

SurveyJobDescriptions.PNG.png

The 2014 MSOE BE Senior Presentations will take place on Friday, May 23 from 8:30 to 10:30 am in the Grohmann Auditorium.  The “auditorium” is a large classroom like room on the first floor of the Grohmann Museum which is located at 1000 North Broadway, Milwaukee, 53202. Coffee and continental breakfast items will be provided.  The presentations will also be webcast on the MSOE Biomedical Engineering program channel on ustream (http://www.ustream.tv/channel/msoe-biomedical-engineering-program). While your wait for our video feed to start you can watch live video from the ISS at – http://www.ustream.tv/channel/iss-hdev-payload.

Parking will be available in any MSOE lot on the day of the presentations.

Presentation topics and schedule:

8:30 – 8:55 am           Team 2014-003 – Excessive Blood Loss, Massive Air Embolism, and Drug Administration Perfusion Simulator

9:00 – 9:25 am           Team 2014-004 – Electrocardiogram Derived-Respiration Laboratory System

9:30 – 9:55 am           Team 2014-001 – Pneumatic Research Device to Impact Traumatic Brain   Injury in an Experimental Rat Model

10:00 – 10:25 am      Team 2014-002 – Mobile Heat Illness Monitoring System (MHIMS)

The Senior Design Show, a poster session style event involving all MSOE programs, will take place after the presentations from 11:00 am to 2:30 pm. The biomedical engineering teams will be in MSOE’s Walter Schroeder Library for the design show.

Medical device cyber security is currently big issue in the medical device industry. Here is a short news story on the topic with some interesting links: http://www.qmed.com/news/fbi-warns-medical-device-hacking-risk.

The last paragraph struck me as particularly interesting. In the same way the post office sometimes gets blamed for lost checks that were never mailed, I think the FDA sometimes gets blamed for complicating things that medical devices companies don’t know how to or simply don’t want to do. I went to the FDA website and found the following Guidance Document: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077812.htm (those of you how have heard my FDA presentations know how useful guidance documents can be).

Many students become interested in biomedical engineering by way of prostheses. Creating prostheses is only a small part of what biomedical engineers do, but I think is appealing because the need is obvious and the devices are relatively easy to understand. Here is a link to a low cost prosthetic hand that has been developed in part in South Africa: http://www.qmed.com/mpmn/gallery/image/robohan (if you're impatient, start about 4 minutes into the video). I first heard about it while visiting an MSOE BE program alumnus there.

Here is a link to an article describing how four LVAD patients have died due to poor device instructions: http://www.qmed.com/news/thoratec-warns-hospitals-after-lvad-patients-deaths?cid=nl.qmed02. These incidents emphasize  the importance of the broad and careful considerations necessary to create safe and effective medical devices. In addition to “traditional” technical design issues, biomedical devices require careful consideration of everything from overall concept to packaging and labeling (including user instructions).

I just received notification that our program will be getting 5 Intel Galileo development boards (http://www.intel.com/content/www/us/en/do-it-yourself/galileo-maker-quark-board.html). These boards combine Arduino functionality with a Linux system-on-a-chip. Our intent is to use the boards to eliminate the need for a laptop or other external computer in design projects involving Arduino boards. They may also be useful in enhancing the capability of Arduino only design projects. Here is what I put in the application to get the boards:

How will you use the boards…

The Galileo boards would be used in selected capstone design projects in our biomedical engineering (BE) design sequence courses (BE-3002, BE-4000, BE-4001 & BE-4002). Students are currently responsible for obtaining their own hardware as needed for their projects, but are assisted in their efforts by the faculty. Over the past several years about half of all BE capstone projects have included Arduino embedded computers with about half of these programmed using the Arduino IDE and the remainder using other more advanced tools. A number of these projects also involve laptop computers to complete the user interfaces. The Galileo boards would be used to provide an intermediate solution between the simple LCD based Arduino interfaces and the need for connection with expensive and heavy laptops.

What is the course focus…

These are BE design courses. In them, students must produce working prototypes. All projects are biomedical engineering related. Some projects involve the design of medical devices, but others cover other aspects of the field including assistive technologies, athletic equipment, and research related devices. While the devices being designed differ, all projects involve the basic design process including compliance with FDA requirements and international standards as appropriate. Most projects involve the integration of analog electronics, mechanical components and software. The consideration of human factors in the user interface design is stressed.

The boards are scheduled to arrive within 30 days. The award also includes free access to the “Getting Started with Intel Galileo” by Matt Richardson e-book. Intel has also created a Maker Community and a Maker Community for universities - https://communities.intel.com/community/makers and https://communities.intel.com/community/makers/universities.

Thank you Intel.

Congratulations to two Class of 2015 design teams for placing in MSOE's business plan competition. Team gluocChem finished 2nd and will receive $1,500 and Team Neonate finished 4th and will receive $500.

Congratulation to BE design teams 15-1 (Novel Glucose Monitor) and 15-2 (Neonate Cardiopulmonary Bypass Simulator) for being selected as finalists in this year’s MSOE Business Plan Competition. Good job and good luck in the final round.

This has the potential, really the likelihood, to be the medical breakthrough of the decade: http://www.usatoday.com/story/tech/2014/01/16/google-smart-contact-lens/4540727/?csp=fbfanpage. Continuous glucose monitoring is the holy grail of biomedical engineering. There has been numerous attempts to develop a workable technology, but they've all had serious shortcomings. This one might just work.

We plan to webcast the Class of 2015 MSOE biomedical engineering junior design project presentations live from 5:00 to 7:30 pm CST (GMT -6) on Thursday, December 12, 2013. See them at: http://www.ustream.tv/channel/msoe-biomedical-engineering-program. If all goes well, the presentations will also be recorded for later viewing. Note that this is an experiment, so we will be using the annoying ad supported version of ustream.tv.

Project Topics are:

• Plasma (Blood) Glucose Monitoring System

• Neonate Cardiopulmonary Bypass Simulator

• In utero Spinal Bifida Cystica Repair System

• Knee Joint Ultrasound Phantom

• Total Knee Replacement Surgical Aid

• Feedback System for Competitive Rowers

• Head Injury Research Device

An after dinner keynote presentation by MSOE BE program alumnus Brian R. Biersach, President and Senior Biomedical Engineer at Medical Equipment Compliance Associates, LLC will be also be webcast starting at around 8:10 pm.

This event is sponsored by MSOE and the Milwaukee Section of IEEE.

Please forward this message to others you think might be interested. I will be tracking the number of viewers to determine if these webcasts are worthwhile.

Charles Tritt

FDA CDRH Priority List

Posted by Charles Tritt Dec 5, 2013

The Center for Devices and Radiologic Health (CDRH) is the part of the FDA that deals with medical device regulations. As part of a new law, they will now annually publish a list of their priorities for the coming year. The complete  2014 list can be found at:

CDRH Fiscal Year 2014 (FY 2014) Proposed Guidance Development

Biomedical engineers should be aware of the items on this. Here are some highlights that I noticed:

Final Guidance Topics

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

The Pre-Submission Program and Meetings with FDA Staff

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

Types of Communication During the Review of Medical Device Submissions

Applying Human Factors and Usability Engineering to Optimize Medical Device Design

Global Unique Device Identification Database

Design Considerations for Pivotal Clinical Investigations for Medical Devices

Draft Guidance Topics

Benefit-Risk Determinations in Premarket Notifications (510(k)s)

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Custom Devices

Hearing Aids and Personal Sound Amplification Products (PSAPs)

Here are a couple of links to Biomedical Engineering employment statistics.

Clearly, the job market for program graduates is very good. Students should still start early, use the resources provided by MSOE's Career Services office and work hard at finding a good position.

MSOE is very fortunate to have an alumnus, Brian Biersach, deeply involved in medical device testing, standards and compliance. In fact, he runs a company,  Medical Equipment Compliance Associates (MECA Home: IEC 60601-1 Standards Compliance and Certification (IEC, UL, AAMI, CSA, EN)) that provides medical device testing services. Brian is very supportive of our program allowing class field trips to his company's labs, often hiring our students as interns and frequently speaking to our classes.

A particular useful resource he has provided online to the medical device design community is an extensive summary of international medical device standards. This list is available at: http://mecalabs.com/assets/meca-60601-ed3-standards-list-(2013-10-15).pdf. I urge students to consult this list as they investigate standards that may apply to their capstone design project.