BME 1 Winter Quarter 2025

This project has 3 deliverables each group has to submit:

1. Focus Meeting Data Submission due Thurs.,11/21
2. Project Summary - due Tues, 12/3
3. Presentation - due Thurs, 12/10 - 10:30-12:30 - slide-deck to be uploaded to Canvas by 10:30am

What is the difference between the Business Plan and the Pitch?  The second deliverable or the  Written Document due on 12/3 is a shortened or summarized version of a business plan.  That submission should provide specific details of what that comprises in the project 3 prompt.  The pitch is the 15-minute presentation that will be made on 12/10.

Medical Devices and Tissue-Engineered Products - you can choose from the same product you worked on in Project 2 or change:

1. Tissue-Engineered articular cartilage for regenerating focal cartilage lesions
2. Tissue-engineered skin for regenerating skin lesions
3. Heart valve replacement

How close does the proposed medical device have to be to the devices you reviewed in Project 2?

• In general they should be close, but not the same exact product.  Groups have been asked to come up with new improvements/claims for their products, so there should be some adjustments or new technologies introduced.  However, we are not looking for the students to reinvent things or develop entirely new products.  For example, it might be reasonable to combine MACI with a bone component to address osteochondral defects, adjust the hydrogel composition and cell seeding so it can be used to treat meniscus tears, or infuse it with slow-release growth factors to improve its efficacy.  This example can be applied to thinking about the other two assignment options.

Composition of Group- should choose different role - everyone will conduct research

1. Leader - keeping everyone one track - data about medical condition, rate of incidence
2. Editor - edit submission to have one common voice -
3. Marketing Director - researches target market, describes product's innovation and special features; identifies market audience
4. R&D Engineer - describes the design and testing of the product
5. Manufacturing Engineer - develops a strategy for manufacturing and scaling the product; where, how
6. Regulatory/IP Director - strategizes a plan for bring the product to market through the FDA and protecting any relevant intellectual property issues

It is required that at least 2 members of each group attend one of the 3 information sessions scheduled for each device or product.  That means that those who attend must share notes with the others and make sure everyone is prepared and understands what resources are associated with each task or ask that the session be recorded  All members are encouraged to attend and you can all attend the same session or different ones.  Please contact the Engineering Librarian if these times don't work, and as many as possible are encouraged to come especially if you need help in putting together a business plan..  There are 3 sessions for each product/device.  Please register at least 4 hours in advance.  This week is a very tight schedule and it may not be possible to schedule an alternative time, please try if necessary by sending me an eMail with several times the group can make it and I will confirm and add to the schedule with a zoom link, but it may not be until the following weekend.  Group Appointments are scheduled from Tuesday, November 19- Saturday, November 23 and you will register with your UCI eMail account at   http://tinyurl.com/yc9kp7nf

If the above URL does not allow you to click through to sign in, please cut and paste and re-enter in a new browser window. 

The following resources will lend to a thorough research for your 5pp Progress Report and the final presentation:

Research should cover:

• incidence and impact statistics of the disease - see sources under Project 1 for data collected by CDC
• relevant biological and anatomical features of normal and diseased cases
• current clinical treatments and how this device will impact treatments in a positive way
• what are the general strategies employed for correcting disease- related malfunctions
• full discussion of how your product will perform and contribute to better health outcomes
• what materials will be used, how product will be assembled, fabricated, manufactured, distributed, and priced
• which FDA regulation pathway should be followed. 

Basic Reference Tools - in addition to those listed for Project 2

MedlinePlus - medical encyclopedia

Academic Entrepreneurship for Medical and Health Scientists - the collection chapters included in this eBook compilation from the University of Pennsylvania  that may be most useful are on Medical Device Development, Ideation, IP and Regulation. Recommended chapters:

American Heart Association - information for patients describing heart conditions and recommended treatments; good source for background information - use the tabs marked Conditions or Research to navigate website

Heart Disease and Statistics, 2024 Update published in Circulation, January 25, 2024 with revisions.

Diabetic Foot Ulcer Data, - From American College of Foot and Ankle Surgeons, 2019

Diabetic Foot: Facts and Figures

Facts & Statistics for Sports Injuries - from National Safety Council, 2020

ACL Tear Statistics and Trends, 2022

ACL Tears in the National Football League, 2013-20

Human Wounds and its Burdens - OA Article covers wound care statistics are not always reported; however diabetes related foot ulcers are covered in the literature or in promotional literature, market reports or presentations from the American College of Physicians

ASM Medical Devices Database - has a very strong cardiovascular section including one on medical devices - and covers the development & latest technologies - well illustrated with diagrams; can search under each medical specialty for product or device and click through to FDA Guidance Documents

BCC Research - a database of marketing analyses in the healthcare marketplace; go to Healthcare category and search for device topic

Frost and Sullivan Healthcare -  this group of marketing research reports requires a login using a UCINetID and does not allow for copying except by snipping in the html format.  You will enter your topic, then select the industries along the left side-bar, followed by the deliverables and the region and your search output will indicate the year of the reports retrieved.

Plunkett Research Online - Market research, industry statistics, trends and in-depth analysis of top companies that are included in the major industry coverage of Biotechnology,, Health Care, etc  Click on the "Market Research and Trends" for individual chapters that are updated at least annually and sometimes semi-annually.

Factiva - fulltext content from Business News sources - defaults to most recent 3 months but you can adjust it to longer periods of time and sort it in any way you want.

Statista - A statistics portal that provides access to many data topics and facts from a wide range of sources that can be cited with total source noted.

Instructions: Under the heading "Latest Research", limit the "Market" tab from "Any" to "Healthcare" to view full-text reports. Use the pull-down menu for Type to select Industry wide or Technology driven analyses or Mega Trends or other sources before clicking on Update.  Recommended that you search specific device.

Handbook of Materials for Medical Devices, 2003

Materials Science and Engineering Collection Database - mostly a full-text database of engineering content

Compendex - online version of Engineering Index - will cover medical device literature - use UC eLinks for access to content

Additional sources for business data on Medical Devices are found on the Entrepreneurship Research Guide under "Research by Topic" and then under "Medical Devices" for:

• Industry/market
• Competitors
• Patents
• health Condictions
• FDA/Regulatory
• Reimbursement
• Standards
• Pipeline
• Academic & trade Articles
• eBooks

Incorporating some multimedia may be of interest to your audience demonstrating how the device functions, what it look like, etc.

These Point-of-Care resources noted below offer insights in medical updates that physicians use when consulting with a patient about a certain condition:

On the Entrepreneurship Research Guide, under Business Model Research there are resources listed on Business Plans with a tab for Examples & Templates - check out the different resources and examples that you can adopt.  Find a template that you think refers to your product or device and adopt it to describe your idea.  Providing as much information as possible will be useful to your audience.

In addition, Business Model Canvas Template allows users to explore and identify Key Partners, Key Activities, Value Propositions, Customer Relationships, Customer Segments, Key Resources and Channels, Cost Structure and Revenue Streams.

Using the "Finding & Using Images" may also retrieve some PPT slides or images of your ideas that you can use to illustrate your ideas.  You can click on Google Maps and when you find an image you are interested in using, click on the "Visit" to get the source and be able to cite from where the images are published.

Located in the MRC in the Science Library, the Presentation Studio is available for students & campus affiliates to rehearse individual and group presentations.  Reserve the room when you want to rehearse your presentation - you or your group can record your presentation, replay it to see how the audience will perceive your delivery, and practice it as much as you want perfecting the delivery and increasing your confidence as a public speaker.