There are 3 deadlines for this assignment:
Each member of the group will assume one of the following jobs in this new start-up company:
The following should be included in your assignment or bibliography:
The following elements should be included in your final paper. For the Progress Check you should provide evidence that you have found the following:
Make sure that the paper includes the following:
for MACI - Matrix-induced autologous chondrocyte implantation - 2011, patent granted 2011 to Aastrom, previous name of Vericel. See here for corporate history. The MarketLine data for the history of Vericel is here. Vericel web presence here. The US patent was just approved and awarded to Vericel in January 2024 and is # 11,857,170 B2
for Sapien 3 Transcatheter - According to this introduction to the TAVR and this note about patient eligibility. In this spec, the following patents are mentioned:
8,454,685
5,411,552
6,214,054
6,547,827
6,561,970
6,908,481
7,214,344
7,510,575
7,530,253
7,585,321
7,780,723
7,846,203
7,993,394
8,057,540
8,382,826
8,591,575
9,439,762
And corresponding foreign patents
for Dermagraft - Organogenesis acquires Dermagraft fron Shire in 2014; Organogenesis website; Original patents are by Gail & Brian Naughton found in the World Patent database (1999) and in the USPTO Patent 4,963,489. Federal Register report of the determination of regulatory review period for purposes of patent extension (2004). Documentation from the FDA noting the name change from Dermagraft to TransCyte happened in 1988
Incorporating some multimedia may be of interest to your audience demonstrating how the device functions, what it look like, etc.
For this assignment due Wednesday, February 28, 2024 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, all the prompts and deadlines 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 as well as in other patent finding databases including Google Patents. The USPTO patent search database is called Patent Public Search See box below for additional information.
It is required that at least 2 members of each group attend one of the 3 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. 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 Sunday, February 11 - Friday, February 16, 2024 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 device types from which to choose are:
You will choose the disease type or condition that warrants attention that this device can effect:
Each group member will participate in the research of the 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:
Research should cover:
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 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.
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.
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 - these 6 textbooks that follow may be helpful to learn more about the heart condition the device will correct but may not be the best place to learn about the device - check journal literature for that.
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
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 - can search Patents in Scopus from around the world. See notes for that below in Searching/FInding Patents box under Scopus.
Regenerative Medicine - a journal that covers tissue engineering and its applications for medical conditions and cures. Part of the Future Medicine portfolio.
Future Cardiology - a journal that can be searched for articles about cardiovascular procedures and technologies. Part of the Future Medicine portfolio
Advances in Wound Care - a journal dedicated to treatments in wound care.
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
Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers, Dec 2022
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, 2024 Update published in Circulation, January 25, 2024 with revisions.
Heart Disease and Statistics, 2023 Update published in Circulation, January 25, 2023 with revisions.
Heart Disease and Statistics, 2022 Update published in Circulation, January 26, 2022 with revisions.
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
American Heart Month 2024 - Toolkits- from CDC
Society of Thoracic Surgeons Adult Cardiac Surgery Database 2021 Update on Outcomes and Quality - June 2021
Data & Statistics from the CDC - not always at the disease level needed
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
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. The unique identifier for a patent is the Patent number - the higher the number the more recently it was approved. 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. You will want to review the claims as that is what you are expanding upon to reshape or re-engineer the device to make it more responsive. 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.
Patents are known to protect ideas and intellectual property. There are two kinds of patents: those that have been approved and those that have applications still pending The latter is protected once filed but remember that it can take several years to get approval. In the US, in late September 2022 the USPTO released a new Patent Search database and it is recommended that you review the following guides and tutorials before you search it. Searching the basic index only allows you to search one term in each line with only two lines; in the advanced search you can combine terms with AND, OR, NOT and enter parentheses - an example of a search strategy string may be ((tavr OR transcatheter) AND aortic AND sapien) - you will retrieve first those in the queue for consideration and then those patents that have been approved or awarded.
For additional information, become familiar with the following:
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.
A patent is a legal document acknowledging an invention as the intellectual property of its inventor. Though they fall under legal materials, references for patents follow standard APA Style, rather than the legal style used for things like court cases and laws.
To cite a patent in APA Style, list the name of the inventor, the year it was issued (in parentheses), the title of the patent (in italics), the patent number, the name of the issuing body, and the URL if available.
| Format | Inventor name, Initials. (Year). Title of patent (Country/Region Patent No. Number). Issuing Body. URL |
|---|---|
| Reference list | Ghatak, S. (2019). Immunization testing system (U.S. Patent No. 10,788,482). U.S. Patent and Trademark Office. https://rb.gy/ik0fb0 |
| In-text citation | (Ghatak, 2019) |
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