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BME 1 Fall Quarter 2021: Project 3 - Dev of Business Plan for Tissue Engr & Medical Device Products


Support for Specific Group Projects

You can continue your group's work from project 2 on one of these medical devices and tissue-engineered products and the medical conditions they treat:

  1. Tissue-engineered articular cartilage for regenerating focal cartilage lesions (MACI) - for ACL & Meniscus repair
  2. Tissue-engineered skin for regenerating skin lesions (Dermagraft) - for diabetic ulcers, burns, etc
  3. Device for the repair of ligaments and tendons (JewelACL) - for anterior cruciate ligament (ACL) reconstruction
  4. Orthopaedic external fixator (TrueLok) - indicated for fixation of Charcot foot, cavus foot, pes planus, ankle arthrodesis, lower extremity fractures, and trauma and post-trauma deformity,
  5. Percutaneous ventricular restoration technology (Parachute Implant) - for ischemic heart failure and myocardial infarction
  6. Heart valve replacement (Perimount Plus) - for arrhythmia

Outline of Project Summary - Due 3/9

The Project summary outline should include:

  1. Summary page (1p)
    1. company information and device name
    2. problem/disease and significance
    3. current detection strategies
    4. functional & operational details of device (design)
    5. degree of innovation in device
    6. prototyping, testing, regulatory and manufacturing plans
    7. expected costs
  2. Device schematic - (1p, with description of features)
  3. References (1p) in APA format



Schematics, Animations, Videos

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

Relevant New Books

First Submission due Febrary 25

Submit by February 25 the following information:

  • the disease, injury or trauma that will be helped by this tissue engineering or medical device product
  • roles and assignments (different from previous projects)
    • leader/editor
    • marketing director
    • R&D engineer
    • manufacturing engineer
    • regulatory/IP director
    • financial officer
  • you may want to consider how you will deal with schematics, animations, images.

Project 3 - Tissue Engineering and Medical Device Products

In order to work on this project, you are basically writing a business plan to develop the medical device or tissue-engineered product that your group is working on in a new independent start up company that will address the following questions:

  1. what disease or medical condition is being addressed, what is the scale or population effected by this
  2. what will this device achieve and how, with what materials
  3. what is the specific approach for the new device
  4. what would you name your company
  5. what would you name your device - clarifies concept but is still "catchy" to garner attention among the competition
  6. convince potential funders that you can translate your ideas into reality

Library Assistance is available by appointments February 23- March 1, 2021 and by special appointment by contacting Engineering Librarian - PLEASE REGISTER AT LEAST 4 HOURS IN ADVANCE.  Multiple sections can be scheduled at the same time for the same device and can be made at 

Each group is also encouraged to rehearse its presentation by holding practice sessions via Zoom or another platform that works for all group members

The project assignment requires that by February 25 each group (same groups as Project 2) will submit the following information:

Choice of medical device or tissue -engineering product:

Then you will address the following components as you develop a business plan for your product:

  • what disease and patient base is your group planning to target -
  • what critical need are you to focus on addressing?
  • what is the specific approach for the new device?
  • the name of your proposed company that you are forming to undertake this initiative
  • the name for your device - catchy so that it will be remembered and be successful in being sold

Then there are two parts after you determine which device topic to pursue and what each member's new job (leader/manager, marketing, device design, R&D staff, regulatory officer (FDA or equivalent in international/global context) manufacturing, accountant, & presentation editor  will be:

  1. DUE: Tuesday, March 9 - a 5-page summary document containing:
    1. Title page - Page 1
      1. company information and device name and team members
    2. Summary page - Pages 2-3
  1. Paragraph 1 - problem disease & importance - incidence of use
  2. Paragraph 2 - Competitive landscape - current detection strategies
  3. Paragraph 3 - Design - describing functional operational details of device & range of innovation of device
  4. Paragraph 4 - Prototyping, testing and manufacturing plans
  5. Paragraph 5 - IP plans and regulatory process (patents, FDA Pathways)
  6. Paragraph 6 - Cost Analysis - expected costs and pricing
  7. Page 4:  product's device schematic - describe features; artistic vision, images
  8. Page 5 - References
  9. DUE March 16 - presentation - following this outline for a 15 minute presentation., including 3 min saved for questions - must submit the powerpoint slides in advance
    1. Executive Summary: introduction slide: device, company, employees and jobs; impact & scope of disease (Leader)
    2. Market Analysis: goals, customers, innovation (Marketing Researcher)
    3. Current detection strategies in developed & developing world  & proposed device (Designer)
    4. Testing plan - device description, design, prototyping, testing, manufacture (R&D Researchers/Regulatory & IP consultants)
    5.  Cost analysis (Accountant)
    6. Summary (Editor)

The jobs to be performed are noted below - choose new roles than you have performed for previous projects and again everyone should be involved in research:

  • leadership (Leader/Manager)
  • device design (Designer)
  • R&D (research and design) (Researchers -2)
  • manufacturing (Manufacturer/Business Contact/Industrialist)
  • market research & evaluation - analysis, customers, innovation (Market Analyst)
  • Cost analysis (Accountant)
  • Summary (Editor)


Resources: The resources listed below include databases - consider what your search strategy should be and make sure that after reading the abstract that you use the UC eLinks to determine if the journal article is available


Other resources follow and you should also consult sources on the Project 2 tab:

Data about Medical Conditions

Finding out what the demographic needs are for certain conditions is critical for this assignment.  We have many tools for this:

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

Diabetic Foot: Facts and Figures

Nemours Foundation - dedicated to the health and wellbeing of children

Shriners Hospitals for Children - pediatric set of specialized hospitals dedicated to burns, wound care and other medical needs of children

rns, wound care and other medical needs of children

Heart Disease and Statistics, 2021 Update published in Circulation, January 27, 2021 with revisions.

Heart Disease and Stroke Statistics, 2020 Update

Heart Disease & Stroke Statistics, 2019 Update from American College of Cardiology

Heart Disease, Stroke, and Research Statistics at a Glance, 2019 from AHA with Summary

Cardiac Procedures and Surgeries - Data from the AHA  

Society of Thoracic Surgeons Adult Cardiac Surgery Database 2018 Update on Outcomes and Quality - January 2018 (published by Elsevier, don't have access to 2019+ articles)

Data & Statistics from the CDC - not always at the disease level needed

Facts & Statistics for Sports Injuries - from National Safety Council, 2017

Sports Injury Statistics (Johns Hopkins University)

17 Sports Injury Statistics & Facts for a Healthier 2021

ACL Injury Statistics:

Update on ACL Injuries and Treatment, 2020

 Anterior Cruciate Ligament Knee Injuries, 2020

ACL Hospital Statistics from 1997-2017


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

American Association of Tissue Banks

Liaison Librarian

Profile Photo
Julia Gelfand
Office: Science Library 228

Phone: 949-824-4971


Getting Help - Appointment with Librarian

Please contact Julia Gelfand, Engineering Librarian for an appointment as a group or individually to review information sources and other assistance you need for this assignment.

Outline of Presentation

The outline of the presentation (remember only 15 min including questions) should include:

  1. Executive summary - info about the company, employees and jobs (Leader prepares/presents)
  2. Market analysis - goals, customers, innovation (Marketing Researcher)
  3. Device description: design, prototyping, testing, manufacture, regulatory compliance (Design, R&D, Regulatory, Manufacturing)
  4. Cost analysis (Accountant)
  5. Summary (Editor)

Goal is no more than 1 slide per minute so total slidedeck should contain 10-12 slides in total.

Remember, less text may be more content if visually illustrated well.  Anticipate questions from audience and prepare additional slides that may address those issues. 

Also, consider taking advantage of Zoom to rehearse your presentation.

About Pitching an Idea

There are many resources that will help you pitch an idea. 

For Data about Incidence Rates

For specific incidence rates per population either domestically and globally or in a particular country, consider researching the specific trust or sponsorship organization like for Multiple Sclerosis (MS) contact the MS Trust

Pricing your medical device

Depending on the materials, where the product will be manufactured, packaged, the distribution channels, each of these variables and others will contribute to the ultimate pricing of the device and whether it can be used in different parts of the world due to affordability.  These options may help you come up with a pricing formula:

Materials, Equipment and Instrumentation

Hints for each device

1.  Heart Valves - BCC has a new report on Transcatheter Treatment: Procedures and Heart Valve Market (March 2021) - Use VPN

2. Google the FDA Guidance Document, USFDA-CDRH Draft Guidance Document for Heart Valves Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications

3.  From Frost and Sullivant - see Report, "Innovations in Implantables, Imagine Systems and Digital Medical Device Platforms from 27 February 2020 on Transcatheter Valve Replacement System to Treat Mitral and Tricuspid Regurgitation"

4. From Frost & Sullivan see 2009 report on "The Next major Medical Device Blockbuster: Transcatheter Valves"

2. For groups working on external fixators, especially for fractures of the Tibia bone, this JHU Medical report on Tibia and Fibula Fractures may be helpful. 

For anything having to do with ACL tears or conditions, make sure that you specify if this is a sports injury or from osteoarthritis or another condition to compromised the ACL.