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BME 1 Fall Quarter 2021: Project 2 - Medical Devices & Tissue-Engineered Products


Pending Deadlines

There are 3 deadlines for this assignment:

  1. each group to decide which device topic will pursue and what each member's role will be - by TH, OCT 28
  2. identify a device patent and conduct literature review on device - submit Progress Report in form of an annotated bibliography reflecting description of journal articles, and device design that is being re-engineered from patent submission by TU, NOV 2
  3. submit final report by TH, NOV 10.  Final report should reflect a salient patent that is to be modified by adding two new claims that reflect their proposed modifications. 

Jobs at Zot Medical

Each member of the group will assume one of the following jobs in this new start-up company:

  1. Leader
  2. Editor
  3. Patent Researcher
  4. Journal Researcher
  5. Curator
  6. Art Director

Statistics Resources

Project 2 - Patent & Regulatory Plans for a Medical Device

For this assignment due November 10 you will select a BME device or technology used in cardiology, treating wound healing, skin lesions, or orthopedic conditions, conduct a literature search about it and describe the use and operation of the device or technology in a paper.  There are many resources for this and a select list of resources that you can readily find and use follows these notes.  A more extended list of resources is on the Biomedical Engineering Subject Guide or elsewhere in this Course Guide.  Please start by carefully reading the assignment so that you know what is expected of each group.  These notes follow that assignment. 

The Subject Guide for Patents will be particularly helpful and useful.    Remember, patents are defined by jurisdiction, and being awarded a patent takes a long time and patent applications are also included in the US Patent & Trademark Office database. 

It is required that at least  2 members of each group attend one of the 2 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.   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 conducting a patent search.  There are 2 sessions for each product/device.  Please register at least 4 hours in advance and if you need an alternative time, please schedule 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.  Group Appointments are scheduled from Sunday, January 31 - Friday, February 5 registering with your UCI eMail account at

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 device types from which to choose are:

  1.  Tissue-engineered articular cartilage for regenerating focal cartilage lesions - see Kwon and Brown article, Surgical and tissue engineering strategies for articular cartilage and meniscus repair (Nature Reviews Rheumatology, posted in Canvas or sent to class -                                                          (  see also MACI by Vericel and the video or BioCartilage by Arthrex or  DeNovo NT by Zimmer 
  2.  Tissue-engineered skin for regenerating skin lesions - see Dermagraft from Organogenesis 
  3.  Device for the repair of ligaments and tendons - see JewelACL from Neoligaments and product videos; and full descriptive documentation from Manual
  4. Orthopaedic external fixators - see TrueLok from Orthofix
  5.  Percutaneous ventricular restoration technology - see Parachute Implant by Cardiokinetix
  6. Heart valve replacement - see Perimount Plus by Edwards Lifesciences - and company product description.     You will want to look for Model 6900P-6900PTFX in the ASM database noted below. 


You will choose the disease type or condition that warrants attention that this device can effect:

  • Atherosclerosis
  • Valvular Disease
  • Cardiac Arrhythmia
  • Injury  or Accident, caused by fall, sports or athletic participation
  • Burns or other lasting wounds
  • Skeletal or birth defects

Each group member will participate in the research of the cardiology patient - the symptoms, disease, recommended treatment/therapy; (determine if treating adults or pediatric patients); cover the engineering literature (materials, size of device, effectiveness, etc), data of the marketplace demand because of the global or domestic demand for the device due to incidence rates of specific heart disease or condition; finding the US patent(s) and how they will be re-engineered, revised or redesigned but they will assume specific responsibilities to focus on the final submission in the following way:

  1. leader - keep everyone on track, project moving forward, meet all deadlines
  2. editor - edit submission to have one common voice
  3. patent researcher - make sure that patent selection meets all criteria
  4. journal researcher - reviews & searches the medical literature making sure the criteria are met (review articles - latest 5 yrs; most current over 1-2 yrs)
  5. curator - synthesizes research process
  6. art director - manages the images and makes sure that new illustrations for the patent redesign are complete and clear

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
  • what are the general strategies employed for correcting disease- related malfunctions?
  • select a specific device and design (patent) underlying the technology that  you chose.  Choose only ONE PATENT.
  • identify 2 claims you propose to add to the patented device toward improving it.  The claims must be novel and non-obvious. 
  • describe how the claims will be implemented in the existing product. 
  • which FDA regulation pathway should be followed. 

Basic Reference Tools

MedlinePlus - medical encyclopedia

PubMed Health - More technical content used and referenced by practitioners and researchers. Will link to PubMed journals but also give you background information, provide images, etc.

information on Sports Injuries - see MedlinePlus overview; Safe Kids Worldwide; American Physical Therapy Association Data; National Health Statistics Report from CDC, 2016

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

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 & 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.

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

AccessMedicine - medical casebooks in different specialties, can easily be searched at chapter level

AccessSurgery - medical books focusing on surgical procedures

Essential Cardiology: Principles and Practice, 3rd ed., 2013 - medical textbook

Hurst's, The Heart, 14th ed., 2017 - medical textbook

Textbook of Interventional Cardiology, 7th ed., 2016

Cardiology Essentials in Clinical Practice (2012) - medical textbook

Cardiology (by Crawford), 3rd ed., 2010 - Science Library (SL) Bar WG 100 C2655 2010 - medical textbook

Netter's Cardiology, 2nd ed., 2010 - Science Library (SL) - WG 120 N474 2010

Fitzpatrick's Dermatology in General Medicine, 8th ed, - look under tissue engineered skin

PubMed - database to search clinical journal literature in medicine - use UC eLinks or publisher's icon for access to fulltext

Scopus - large database with strong STEM coverage; includes journal articles and patents - use UC eLinks or publisher's icon for access to fulltext

Regenerative Medicine - a journal that covers tissue engineering and its applications for medical conditions and cures.

Future Cardiology - a journal that can be searched for articles about cardiovascular procedures and technologies

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

Annual Reviews - group of different journals such as the Annual Review of Physiology, Annual Review of Medicine, Annual Review of Biomedical Engineering, etc

Academic Search Complete - covers a range of subjects with links to fulltext literature & also via UC eLinks - search by disease and application that will improve patent

Medical Device Register - Science Library (SL) Bar (5th floor) W 26 M489 2012 - this is the latest edition - Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices  

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

Heart Disease and Statistics, 2020 Update published in Circulation, January 31, 2020 with revisions.

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 article)

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

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

Medical Device Link - The platform website for the medical device industry, provides news, information, employment and recruiting services, as well as collaborative opportunities for people who design, manufacture, and market medical devices.

Cleveland Clinic- medical practice with a renowned reputation in cardiology/thoracic surgery - also review different issues of Cardiac Consult, the latest innovations and state-of-the art technologies and techniques in cardiothoracic care.

STS (Society of Thoracic Surgeons) Public Reporting System - This STS Public Reporting initiative allows participants in the STS National Database to voluntarily report their surgical outcomes to the public on the STS website.  As of January 1, 2018, the STS National Database has four components, each focusing on a different area of cardiothoracic surgery—Adult Cardiac Surgery, General Thoracic Surgery, and Congenital Heart Surgery, as well as mechanical circulatory support via the Intermacs Database. The Database has grown exponentially over the years, both in terms of participation and stature.

Mayo Clinic - large scale medical group/hospital with renowned specialists

PATENT RESOURCES - the following sources are highly recommended but for additional direction, please consult the Subject Guide for Patents - you will be restricting your searches to US Patents and there is a box there for how to read & understand a patent.  When using some of the following databases, you may find some references to European patents (EP#) - sometimes US companies, like Medtronics register for foreign patents hoping that it will take less time to successfully be awarded the patent.  Opening up the illustrations or drawings in some patent databases may require special TIFF software - record the patent # and search in another database or follow instructions on how to download special TIFF software. 

Liaison Librarian

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Julia Gelfand
Office: Science Library 228

Phone: 949-824-4971


Bibliography & References - Due February 9, 2021

Your annotated bibliography should include the following elements and content and be submitted in APA format:

  1. References should be included that demonstrate the following content:  Statistics/data of procedures, specific heart disease or condition in recent past & expected in near future; risks associated with procedures; journal reviews from the medical and engineering literature (materials, technology, design, electrical, mechanical) from last five years; and some very recent literature indicating or referencing latest approaches from last 2-3 years
  2. A patent that you will select must be cited with the following information: Patent Number, Inventor names, and Date in your USPTO citation, plus 2 (two) claimants and suggest how you will re-engineer it to make specific improvements
  3. Include 6 -10 citations with annotations in which you will want to suggest how you are proposing to redesign the device to make improvements

Outline of Report for Project 2

The final report, with a strict limit of 6pp is due TH, Feb 18 and should include:

  1. Title page: title, course, TA, names/jobs/signature of group members - 2 points
  2. Abstract - 500 words max - summary of entire project - 4 points
  3. Background - 1-2 pp - Relevant biological & anatomical features of normal & diseased cases; incidence & impact statistics of the disease or condition. - 10 points
  4. Competitive landscape - 1-2 pp - 10 points - existing products similar to the one chosen.  Pros/Cons of current products
  5. Description of specific device patent 1-2 pp - 10 points
  6. Proposed improvements (with 2 claims) - re-engineering - provide 2 new claims indicating new capability or technology to be implemented - 1-2 pp - 10 points
  7. Description of product FDA regulatory pathway - 1-2 pp - 10 points
  8. Conclusion - .5 page - 5 points
  9. References - 1 page - 4 points
  10. Figures including schematic of proposed device - reasonable limit - 15 points - to be embedded in text (not as a separate page/section) and numbered with a caption at the bottom
  11. Formatting, appearance, and smoothly connecting each section - editing - 10 points
  12. Total - 6pp minus title page, abstract, references

Sources for References

The following information sources should be consulted and cited in your report:

Reference or bibliographic resources:

  • Statistics databases
  • Journal review articles from last 5 years
  • new research articles from last 3 years (no access to Elsevier published content from 2019+)

Patent - older or more recent or new - be able to describe improvements you propose to make

Annotated bibliography - briefly describe ideas that are developing in project report



How to Read a Patent

For background information, the Patent FAQ may answer some basic questions.  Use a Patent Glossary if you need help with definitions.  Patents appear to be outlined with numbers - these are Standard Field Codes or "INID codes" for international agreed numbers for the identification of bibliographic data and are consistent with patents from around the world. A review of how to read a patent will be helpful.

  • Drawings - each figure is numbered and explained  - sometimes they are broken up into several sub-figures and they can also show a 3D view with parts numbered for identification.
  • Specification - the basic text but does not include the claims.  Provides the summary of the invention and describes the drawings.
  • Claims - the most important part of a patent - often written in legalistic style.  Two types of claims: Independent & Dependent where the latter only has meaning when combined with a preceding claim and the former claim stands alone.  Usually the broadest claims of the patent are at the top or front of the list of what the patent is supposed to achieve or do.