Automated Insulin Preparation System Group 22: Brant Cauthorn Jessica Filderman Kellie Stoka

What is diabetes?  Insulin and Glucagon  Type I and Type II  Prevalence  366 million people worldwide 1  Cost  $465 billion a year worldwide 1 1 Chang, Maria. The Huffington Post, 13 September 2011.

How is diabetes treated?  Insulin injections  Types of insulin  Rapid  Short-acting  Intermediate  Long-acting

Problem: Prepare Injection Wrong  50% of people do it wrong 2  How to properly prepare an insulin injection  Where can you mess up?  Why people do it wrong:  Visual Impairment  Peripheral Neuropathy  Arthritis 2 Wartburg, Linda. Diabetes Health, 21 March 2009.

Problem: Skip Injections  Insulin is expensive  Average insulin user spends $11,476 a year 2  Skip injections to save money 2 Wartburg, Linda. Diabetes Health, 21 March 2009.

Problem: Dangerous to take wrong amount of insulin  Hyperglycemic  Fatigue, seizures, cardiac arrhythmias  Hypoglycemic  Impaired vision, fainting, seizures, comas  Health complications:  Blindness, amputation, death 3  May result in hospital visit 3 Health Action International. 16 August 2012.

Problem: Expensive Hospital Visits  Emergency Room visit  Hospitalization  Outpatient Care  Cost  Average $31,764 a year 2 2 Wartburg, Linda. Diabetes Health, 21 March 2009.

We need a product to fix these problems.

Existing Solution: Insulin Pens  How they work  Disposable  Novo Nordisk FlexTouch  Durable  Novo Nordisk NovoPen 3 visitors/education/diabetes/pages/insulin-pens-how-to-give-a-shot.aspx Campos, Carlos. Expert Opinion on Pharmacotherapy. September 2012

Existing Solution: Insulin Pens  Easier to use than syringe  Steadier  Easier to read  Easier to push down button  Expensive  Not for visually impaired  Dials are hard to use  Possible to not give complete dose  Most not sold in US

Existing Solution: Insulin Pump  Insulin-filled cartridge connected to catheter inserted into subcutaneous tissue  Continuously delivers insulin  Wear all the time  Expensive  Major brands:  Disentronic Medical Systems, Minimed Technologies, and Animas Lenhard, James M., Arch Intern Med, 22 October 2001

Apparatus for inserting a syringe needle into a vial (patent #3,853,158)  Helps with insertion of needle  Vial slides toward needle  User still has to draw out liquid themselves Whitty, Albert J. “Apparatus for inserting a syringe needle into a vial.” Patent 3,853, December 1974

Syringe loader and method (patent #4,434,820)  Fill 1 syringe with 2 liquids  Dosage gage and dosage stop indicator  User could set gage and stop indicator wrong Glass, John P. “Syringe loader and method.” Patent May 1984

Syringe filling device (patent #4,489,766)  Different size spacers to limit movement of plunger  Spacers may be too small or challenging for some users to set Montada, Benjamin V. “Syringe filling device.” Patent 4,489, December 1984

Automated drug preparation apparatus including syringe loading, preparation, and filling (patent #8,209,941)  Syringes banded together with web  Removes and replaces safety cap  Moves plunger  Too big and complicated for at home use  For hospital setting Osborne, Joel A. “Automated drug preparation apparatus including syringe loading, preparation and filling.” Patent 8,209, July 2012

Design Requirements  General:  Small size  Inexpensive  Can be used in a home setting  Operation:  Safe  Accurate  Not limited by user health conditions  Minimum functions:  Hold insulin vial(s)  Mix insulin vial(s)  Sterilize vial(s)  Uncap needles  Insert needle into vial(s)  Withdraw a specified amount of insulin

Design Specifications  General  Portability:  Size: Less than 0.03 m 3  Weight: 2-7 kg  Can stand alone on a table surface  Cost:  < $200 manufacturing cost  Operation:  Room temperature: 15-32° C  Altitude: 0-6,200 m above sea level  Highest livable altitude in U.S.  Aesthetics  Visually appealing  Not Bulky  Noise Level:  < 30 dB  Power:  Provide enough energy to run components  120V outlet?  Reliability/Safety:  ≥ 99.9% Reliable  ≥ 99.9% Accurate  No exposed sharps  No shock hazards  Heat: ≤ 49 C  Minimum heat required for a burn  Durability:  Sustainable impact force: N  Lifespan: 10 – 15 years  Software:  Easy to use GUI  Completed By: 03 December 2012

Design Specifications  Insulin Vial Storage and mixing  Storage  ≥ 2 vials  ≥ 1 syringe  Insulin vials protected from excess light  Vial Size:  At least standard 10 mg vials  Insulin Use  Allows any type of insulin  Mixing Function:  Speed:.2-.3 m/s  Duration: seconds  Safety:  ≥ 99.9% sterile  Parts not exposed to user while in use  Syringe Storage and Filling  Syringe Size:  At least U-100 size syringes  Speed of Filling:  ≤ 30 seconds  Force on Syringe:  Move plunger: N  Remove caps: N  Push needle into vial: N  Syringe Plunger Movement:  Range: m  Speed: m/s

Design Specifications  User Interface  Size:  m 2  Ease of use  ≤ 10 user steps  Visible GUI  Low dependence on motor function, vision, and cognitive function  Transmission speed:  ≤ 1 second delay

Schedule Tasks and Milestones3-Sep10-Sep17-Sep24-Sep1-Oct8-Oct15-Oct22-Oct29-Oct5-Nov12-Nov19-Nov26-Nov3-Dec10-Dec Project Initiation Project Selection & Client Confirmation Project Scope Preliminary Research Define Specifications Preliminary Oral Report Preliminary Written Report Product Design Website Design Risk Analysis Progress Oral Report Progress Written Report Material & Manufacturing Requirements Design Analysis Final Oral Report Final Written Report Poster Competition Tasks: Milestones:

Team Responsibilities  Brant – Website Design and Maintenance  Kellie – Material & Manufacturing Requirements  Jessica – Risk Analysis

Questions?