BME100 f2017:Group9 W0800 L1

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OUR TEAM

Name: Rayan Alnami
Name: Ricardo Avila Person
Name: Renee Chao
Name: Nadene Hubbard
Name: Erik Sandoval-Ansel
Name: Irene Zhang

LAB 1 WRITE-UP

Health Care Issue


One of the problems that plague developing countries is the rampant disease that impede the growth of their civilization. There are so many different afflictions that stem from problems with sanitation and famine, and while treatable, resources are scarce in third world countries. According to statistics from the United Nations Children's Fund [1], for example, there are "about one million child deaths" per year due to malaria, a disease caused by a parasite carried by mosquitoes, which are born from standing water. This, along with other diseases such as cholera, Typhoid fever, measles, tetanus, and Hib, are all treatable or preventable through vaccination [2]. Another statistic reported by Doctors without Borders states that "immunization helps avert an estimated 2.5 million deaths each year, as well as millions more bouts of illness and disability." [3] While governments and other helpful groups try to administer vaccines, they simply cannot cover most of the population. There are many reasons for this, including that "health services are poorly provided or inaccessible, [sic] families are uninformed or misinformed about when and why to bring their children for immunization" [4]. Funds for skilled labor and funds for vaccines themselves are also low, leading to difficulty for group immunity because the majority of the population must be immunized in order for there to be a lasting effect on the community.

While as a company, we cannot account for these obstacles, it is possible to try to fix the lack of skilled labor problem. Our solution is to mass produce cheap containers of vaccines that can be widely dispersed within a population and can be used easily enough to be self administered. These would be in the form of single use, disposable auto-injectors, each pre-packaged with a single dose of the vaccine. They would also include sanitizer to clean the area before vaccination. This way, there should be an increased spread of immunization within a community as people could do it themselves. It would only require a couple of trusted experts to educate the population on how to self-administer the vaccination and why they should.

This product will initially target the malaria parasite, which is common in third world countries, but can and will be modified for other common diseases.



Customer Validation


Here is a list of organizations/groups that could potentially be interested in buying our device:
Format:

* Organization/Group
**Contact info
**Website



Groups/organizations

1. MVI Path, Malaria Vaccine Initiative-

2. APMEN, Asia Pacific Malaria Elimination Network

3. ACTMalaria Foundation, Asian Collaborative Training Network for Malaria

4. Bill & Melinda Gates Foundation

5. Malaria No More

6. CDC Foundation

7. PATH

8. RollBack Malaria

9. USAID

10. WHO Global Malaria Programme

11. Against Malaria Foundation GiveWell

12. Jeffrey W Gaver MD Internal Doctor

  • 451 E University Dr Tempe, AZ 85281 ; (480) 965-3346

13. Paul Wilson PhD Global Health Policy

14. Doctors without Borders

15. WWARN WorldWide Antimalarial Resistance Network

16. The Karen Hospital- Nairobi City, Kenya

17. Ugandan Ministry of Health

18. Save the Children

19. Ministry of Health of Ghana

20. Doctors of the World


Competitors

Organization/Competitor | Advantages | Disadvantages |
Doctors Guaranteed effective vaccination delivery
 Chain of custody is secure  
 People trust people, rather than objects
Lack of doctors and educated workers so very few people can be vaccinated
 Funds to send doctors are low
 Security and safety of doctors in addition to that of vaccines adds to financial cost
 Forces doctors to focus on routine procedures rather than more important and immediately threatening issues
Our Product (Vaccine Administered by Disposable Autoinjector) Almost anyone could administer a vaccine
 Could be widely distributed
 Does not require any prior knowledge to use
 Does not require a professional to operate
People are managing their own doses
 Proper disposal of auto-injectors could be difficult, lead to more sanitation issues 
 Civilian access to needles is dangerous
 Culture against vaccination could be bigger issue without doctors as trusted experts



IP Position


The auto-injector industry is already quite filled.
EpiPen is one of the leading patent owners in the industry and they keep a tight hold in the market
There are also plenty of other designs out there that have been created in order to replace EpiPen such as Adrenaclick and Impax
When directly addressing the patent market for vaccine autoinjectors, there are different results
Most patents under this field require electricity or some other power source. Our device will be devoted toward a powerless pneumatic or spring based system to administer the liquid. Also, these other devices are meant to be reused via capsule/other methods, ours are meant to be disposed.


Epipen/Automatic injector [5]

Publication Number: US6767336B1
Assignee: Sheldon Kaplan
File Date:2003-01-09
The automatic injector is a spring and piston based injector based on the release of potential energy. After the removal of the safety cap, the user may position the injector onto their skin so that when pressed, the compressed spring inside will push the needle into the tissue, and the liquid medication will be released through the needle.
https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00000.png https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00002.png https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00002.png https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00003.png https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00004.png https://patentimages.storage.googleapis.com/thumbnails/US6767336B1/US06767336-20040727-D00005.png

Disposable auto-injector for prefilled syringes[6]

Publication Number: US5681291A
Assignee: Tebro
File Date: 1993-10-18
The disposable auto-injector for prefilled syringes takes a normal syringe and by using two devices that hold syringe, allows for first, automatic needle penetration, and second, the actual injection of medication into the tissue. It also automatically covers the needle after injection to avoid injury.
https://patentimages.storage.googleapis.com/thumbnails/pages/US5681291-1.png

Apparatus and methods for self-administration of vaccines and other medicaments[7]

Publication Number: US9555191 B2
Assignee: Kaleo, Inc
File Date: 2016-02-16
This auto-injector uses electronics to both remind the user to administer the vaccine and to administer the vaccine itself.
https://patentimages.storage.googleapis.com/d9/9d/a3/43095938cdface/US09555191-20170131-D00000.png

Injection apparatus[8]

Publication Number: WO2000007530A3
Filing Date: 2 Aug 1999
Assignee: Insite Vision Inc
This product focuses on the injection of certain agents into thin tissues.

Needle injection-facilitating device[9]

Publication Number: WO2000061209A1 *
Filing Date: 17 Sep 1999
Assignee: Thomas Randall Inkpen
This device helps stabilize and guide the syringe that will be injected into a subject, necessary for the creation of auto-injectors for self-administration of drugs or vaccines.

Vaccine delivery device[10]

Publication Number: WO2002083214A1 *
Filing Date: 5 Apr 2002
Assignee: Glaxosmithkline Biologicals S.A.
The product describes the use of prefilled vaccines being delivered by syringe.

Microneedle transdermal transport device[11]

Publication Number: WO2003037404A1 *
Filing Date: 21 Oct 2002
Assignee: Massachusetts Institute Of Technology
This product uses microneedles as a transport system that includes a reservoir and can include an actuator, sensor and pump to administer the fluid.

与注射器一起使用的组件[12]

Publication Number: CN102858390A *
Filing Date: 11 Mar 2011
Assignee: Sid科技有限责任公司
This product is a kind of syringe used in administering drugs.

Dermale Zugangsvorrichtung[13]

Publication Number: DE102010001506A1 *
Filing Date: 2 Feb 2010
Assignee: Vosseler, Michael, 78073
This product is a dermal access device for intradermal injection use.
http://patentimages.storage.googleapis.com/thumbnails/DE102010001506A1/00230000.png

Vaccine delivery device[14]

Publication Number: EP2098259A1 *
Filing Date: 5 Apr 2002
Assignee: Glaxosmithkline Biologicals S.A.
This is a product that involves a pre-filled vaccine delivery mechanism through syringe.

Methods of ophthalmic administration[15]

Publication Number: US6378526
Filing Date: 3 Aug 1998
Assignee: Insite Vision, Incorporated
This patent details a method of intrascleral injection.
http://patentimages.storage.googleapis.com/thumbnails/US6378526B1/US06378526-20020430-D00000.png

Transdermal transport device with suction[16]

Publication Number: US7066922
Filing Date: 21 Oct 2002
Assignee: Massachusetts Institute Of Technology
This patent uses a reservoir of the active agent that includes the a vacuum generator.
http://patentimages.storage.googleapis.com/thumbnails/US7066922B2/US07066922-20060627-D00000.png

Microneedle transdermal transport device[17]

Publication Number: US7364568
Filing Date: 21 Oct 2002
Assignee:Massachusetts Institute Of Technology
This device uses microneedles to administer drugs through the dermis.
http://patentimages.storage.googleapis.com/thumbnails/US7364568B2/US07364568-20080429-D00000.png

Microneedle transport device[18]

Publication Number: US7429258
Filing Date: 9 Sep 2002
Assignee: Massachusetts Institute Of Technology
This microneedle device uses two actuators to drive the needles into the tissue and to administer the medication. http://patentimages.storage.googleapis.com/thumbnails/US7429258B2/US07429258-20080930-D00000.png

Controlled needle-free transport[19]

Publication Number: US7833189
Filing Date: 13 Feb 2006
Assignee: Massachusetts Institute Of Technology
This device uses an electromagnetic actuator to administer a fluid. http://patentimages.storage.googleapis.com/thumbnails/US7833189B2/US07833189-20101116-D00000.png

Needle-free injector device with autoloading capability[20]

Publication Number: US8172790
Filing Date: 31 Aug 2007
Assignee: Massachusetts Institute Of Technology
This involves using a controllable magnet and electromagnetic actuator with a nozzle to administer the fluid.
http://patentimages.storage.googleapis.com/thumbnails/US8172790B2/US08172790-20120508-D00000.png

Controlled needle-free transport[21]

Publication Number: US8328755
Filing Date: 18 Oct 2010
Assignee: Massachusetts Institute Of Technology
This device uses a needle-free method of transferring the fluid from the reservoir to the tissue.
http://patentimages.storage.googleapis.com/thumbnails/US8328755B2/US08328755-20121211-D00000.png

Non-live trivalent influenza vaccine for one-dose intradermal delivery[22]

Publication Number: US8557251
Filing Date: 13 Jun 2007
Assignee: Glaxosmithkline Biologicals, Sa
This patent is specifically about a vaccine for influenza.

Improvements relating to the insertion of a medical needle[23]

Publication Number: US8758300
Filing Date: 29 Mar 2007
Assignee: Olberon Medical Innovation Sas
This patent is about the partial insertion of a needle into the body.
http://patentimages.storage.googleapis.com/thumbnails/US8758300B2/US08758300-20140624-D00000.png

Intravenous needle insertion or cannulation[24]

Publication Number: US8795229
Filing Date: 24 May 2007
Assignee: Olberon Medical Innovation Sas
This patent describes a manner of inserting an intravenous needle into the body.
http://patentimages.storage.googleapis.com/thumbnails/US8795229B2/US08795229-20140805-D00000.png

Intradermal pen adapter[25]

Publication Number: US8876764
Filing Date: 20 Jan 2012
Assignee: Sid Technologies, Llc
This patent describes a pen that helps inject fluid into the tissue.
https://patentimages.storage.googleapis.com/8f/bb/42/0ca72dde2ce4e8/US08876764-20141104-D00000.png

Controlled needle-free transport[26]

Publication Number: US8992466
Filing Date: 7 Dec 2012
Assignee: Massachusetts Institute Of Technology
This patent involves an electromagnetic actuator that directs fluid from the reservoir to the body.
https://patentimages.storage.googleapis.com/thumbnails/US7833189B2/US07833189-20101116-D00000.png

Intradermal injection adapter[27]

Publication Number: US9089655
Filing Date: 23 Jul 2010
Assignee: Sid Technologies, Llc
This patent is a method of injecting fluid into the tissue with a transparent portion.
https://patentimages.storage.googleapis.com/07/d9/05/e938a4683c3b46/US09089655-20150728-D00000.png

Fundability Worksheet Scores

Competitors: 1

There is a huge market for auto-injectors and there is a large market for vaccines, but there is a very slim market for auto injecting vaccines, and disposable means of vaccination are similarly small. The difficulty is that currently, there has been only one way of administering vaccines in third world countries: through doctors and normal syringes. However, the idea is that by introducing a way of self-administering vaccines, or by requiring no skill or intensive training to administer the vaccines, immunization will be more readily available to communities, and more widespread as well. Due to the advantages outweighing the current status quo, and the constant research into how to make vaccination more common and effective in third world countries, a disposable auto-injector of vaccines should be adaptable as a new and more efficient way of immunization. As a result, the current score for our product is a 1.


Customer Validation: 1

Customer validation is scored a one due to lack of feedback. However, it is believed that while doctors and other medical professionals will be cautious towards the idea of self-administered vaccinations or vaccines administered by people with non-medical backgrounds or training, the eventual ability of the actual medically trained professionals to focus on treatment rather than prevention should make the disposable auto-injector of vaccines a realistic product. Cultures and governments that are hesitant against vaccination may feel the same towards the use of auto-injectors, but those can be assuaged with a few trusted experts in the field as well as the intervention by organizations that work in these countries. The organizations will also be able to gather funds to send more "multi-use" volunteers and professionals that can teach people to administer the drugs as well as do other things in their time there.

IP Position: 1

The patent library for more auto-injectors is already saturated. The only reason why we are confident in that our product will be able to be used, is the simple fact that most of the patents in this field are expiring, especially due to the amount of time it would take for the product to be fully designed and implementable. Also, while there are many patents that have to do with auto-injectors, disposable auto-injectors, and automatic needle insertion in general, they do not include self sanitizing aspects that this product will have. Many of the patents currently in the library are also renewals or are for certain vaccination techniques, such as needle shields.

Sources

Works Cited

“Fact Sheet about Malaria.” World Health Organization, World Health Organization, Apr. 2017, http://www.who.int/mediacentre/factsheets/fs094/en/ . Accessed 5 Sept. 2017.

“First-Generation Vaccine.” Malaria Vaccine Initiative, 24 Apr. 2017, http://www.malariavaccine.org/malaria-and-vaccines/first-generation-vaccine. Accessed 5 Sept. 2017.

“Immunization.” How Does Immunization Work?, 27 Aug. 2004, http://www.unicef.org/immunization/index_how.html.

“Immunization.” UNICEF - Immunization - Why Are Children Dying?, 2 Mar. 2005, http://www.unicef.org/immunization/index_why.html. Accessed 5 Sept. 2017.

Pang, T. “Vaccination in Developing Countries: Problems, Challenges, and Opportunities .” Global Perspectives in Health , vol. 2. http://www.eolss.net/sample-chapters/c03/e1-14-05-06.pdf

“US5681291A - Disposable Auto-Injector for Prefilled Syringes.” Google Patents, Google, http://wwww.patents.google.com/patent/US5681291A/en?q=autoinjector. Accessed 5 Sept. 2017.

“Vaccine Delivery.” Bill & Melinda Gates Foundation, http://www.gatesfoundation.org/What-We-Do/Global-Development/Vaccine-Delivery.

“Water, Sanitation and Hygiene.” UNICEF, 17 June 2003, http://www.unicef.org/wash/index_wes_related.html. Accessed 5 Sept. 2017.

Wilson, Paul. “Giving Developing Countries the Best Shot: An Overview of Vaccine Access and R&D.” MSF USA, OXfam International , 11 May 2010, http://www.doctorswithoutborders.org/news-stories/special-report/giving-developing-countries-best-shot-overview-vaccine-access-and-rd.

Le, Cheminant Eric, and North Shore Laboratories Pty. Ltd. “Injection Device.” Google Books, 14 Sept. 1994, http://www.google.com.pg/patents/WO1995007722A1?cl=zh.

“US9089655B2 - Intradermal Injection Adapter.” Google Patents, Google, http://www.patents.google.com/patent/US9089655B2/en.

Inkpen, Thomas Randall, and Laura Jean Williamson. “ Needle Injection-Facilitating Device.” Google Books, 17 Sept. 1999, http://www.google.com.pg/patents/WO2000061209A1?cl=zh.


Patents


Kaplan, Sheldon. Automatic Injector. 09 Jan. 2003
Galli, Rosaria. Disposable Auto-Injector for Prefilled Syringes. 18 Oct. 1997.
Edwards, Erik. Apparatus and methods for self-administration of vaccines and other medicaments. 16 Feb. 2016
Insite Vision Inc. Injection Apparatus. 2 Aug 1999
Inkpen, Thomas. Needle injection-Facilitating device. 17 Sep 1999
Biologicals S.A., Galaxosmithkline. Vaccine Delivery Device. 5 Apr. 2002
Institute of Technology, Massachusetts. Microneedle Transdermal Transport Device. 21 Oct 2002
Sid科技有限责任公司. 与注射器一起使用的组件. 11 Mar. 2011
Vosseler, Michael, 78073. Dermal Zugangsvorrichtung. 2 Feb. 2010
Biologicals S.A. Glaxosmithkline, . Vaccine Delivery Device. 5 Apr. 2002
Insite Vision Inc. Methods of ophthalmic administration. 3 Aug. 1998
Institute of Technology, Massachusetts. Transdermal transport device with suction. 21 Oct 2002v Institute of Technology, Massachusetts. Microneedle Transdermal Transport Device. 21 Oct 2002
Institute of Technology, Massachusetts. Microneedle Transport Device. 9 Sep.2002
Institute of Technology, Massachusetts. Controlled Needle-Free Transport. 13 Feb 2006
Institute of Technology, Massachusetts. Needle-free injector device with autoloading capability. 31 Aug 2007
Institute of Technology, Massachusetts. Controlled needle-free transport. 18 Oct. 2010