New Generation Auto-Injectors - DALI Medical Devices
New Generation Auto-Injectors - DALI Medical Devices
New Generation Auto-Injectors - DALI Medical Devices
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International Patents Pending<br />
<strong>New</strong> <strong>Generation</strong><br />
<strong>Auto</strong>-<strong>Injectors</strong><br />
for Drugs in<br />
Prefilled Syringes or Vials<br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
The Universe of Pre-filled Syringes and Injection <strong>Devices</strong><br />
Oct 23-25, 2006<br />
Presentation Outline<br />
• Introduction – ELCAM and <strong>DALI</strong><br />
• <strong>New</strong> <strong>Generation</strong> Disposable <strong>Auto</strong>-<strong>Injectors</strong> –<br />
Features<br />
• Proof-of-Concept Studies:<br />
Disposable <strong>Auto</strong>-<strong>Injectors</strong> for Drugs in<br />
Vials / Prefilled Syringes:<br />
– Usability Study: from problem to solution<br />
– In-vivo Animal Study<br />
• Other Platforms (SEDAI, <strong>Auto</strong>-Needle …)<br />
2 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
1
Product Lines<br />
• Stopcocks<br />
• Manifolds<br />
• Needle-less<br />
• Valves<br />
• Disposable Pressure Transducers<br />
• I3D—<strong>Auto</strong>-<strong>Injectors</strong><br />
3<br />
Elcam <strong>Medical</strong> Facility<br />
• 27,000 sq. ft. of class 100,000 clean rooms<br />
• Second facility to open in mid-year 2007<br />
• Precision injection molding processes –<br />
including 2C<br />
• Fully automated production floor utilizing<br />
custom made assembly machines<br />
4<br />
2
Elcam’s Partners<br />
• Arrow<br />
• Baxter<br />
• Edwards<br />
• Sicor Pharmaceuticals<br />
• Hospira<br />
• Abbott<br />
• B. Braun<br />
• St. Jude<br />
• U.S. Surgical<br />
• Cardinal Health<br />
• Applied <strong>Medical</strong><br />
• Medtronic<br />
• Utah <strong>Medical</strong><br />
• Cook<br />
• ICU <strong>Medical</strong><br />
• Bard<br />
• Argon<br />
5<br />
<strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
• <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong> brings over 15 years of<br />
product development experience<br />
• Over 10 years in the field of <strong>Auto</strong>matic Drug<br />
Delivery <strong>Devices</strong><br />
• Specializing in innovative proprietary Injectable<br />
Drug Delivery <strong>Devices</strong> for self-administration<br />
Fully-Disposable <strong>Auto</strong>-<strong>Injectors</strong><br />
(FUDAI)<br />
Semi-Disposable <strong>Auto</strong>-Injector<br />
(SEDAI)<br />
<strong>Auto</strong>matic-Needle<br />
(AN)<br />
6 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
3
<strong>New</strong> <strong>Generation</strong> Disposable<br />
<strong>Auto</strong>-<strong>Injectors</strong> – Features<br />
Fully-Disposable<br />
<strong>Auto</strong>-Injector<br />
for<br />
Drugs in Vials<br />
(FUDAI DV)<br />
• Safe & Simple<br />
• Less Pain<br />
• Injection starts only after<br />
full needle penetration<br />
• Easy drug reconstitution<br />
and aspiration from vials<br />
• Single or multiple vials<br />
Fully-Disposable<br />
<strong>Auto</strong>-Injector<br />
for<br />
Pre-filled Syringe<br />
(FUDAI PFS)<br />
7 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
Background<br />
• Developed with a major pharmaceutical company<br />
• Drug in vial (expensive)<br />
• Generally elderly patient population (50-75 years)<br />
• Frequent or infrequent injections<br />
• Market transition from injection by healthcare<br />
providers to self-injection at home<br />
• Design Concept: a Plunger Rod is used to fill the<br />
drug from the vial into the injector<br />
8 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
4
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
Device Used in the Study<br />
• Note Plunger tip design<br />
• Note no Device Labeling was used<br />
9 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
The Problem<br />
• In a usability study performed in the US with 28<br />
participants, occasionally, some people pushed on<br />
the Plunger Rod instead of pressing the Inject<br />
Button for activation (while not looking at the<br />
instructions for use)<br />
• Result: Spillage of expensive drug<br />
Oops… What do<br />
we do now???<br />
10 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
5
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
The Way to Solution<br />
• About 40 solutions were screened…<br />
• From which 4 reached the ―finals‖….<br />
Parameters Considered:<br />
Usability, Manufacturability, COGS, Timeline<br />
11 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
The Way to Solution<br />
• Chosen Solution…<br />
12 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
6
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
The “Elizabeth Show”:<br />
A 70 years old lady with<br />
Essential Tremor<br />
operating the FUDAI DV<br />
An Example for a<br />
Successful Operation<br />
13 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
FUDAI DV Usability Case Study:<br />
from problem to solution<br />
Lessons Learned<br />
• Whatever you think users will do – they would find<br />
a way to make it even worse…<br />
• Device labels can make the difference<br />
• Perform as many usability trials as possible<br />
• NOTE: There is always a better way / easy way to<br />
do it – it’s just a matter of time and money<br />
14 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
7
In-vivo Animal Case Study:<br />
successfully performed as expected<br />
Injection into Pig - Example from X-Ray video<br />
• 0.5 mL or 1.0 mL<br />
• 6 injections /<br />
device / volume<br />
15 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
In-vivo Animal Case Study:<br />
successfully performed as expected<br />
Before Activation<br />
0.00 sec.<br />
Needle Penetration<br />
0.04 sec.<br />
Drug Injection<br />
0.08 sec.<br />
16 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
8
In-vivo Animal Case Study:<br />
successfully performed as expected<br />
Conclusions<br />
In-vivo injection with the injectors (FUDAI, SEDAI, AN)<br />
work as expected:<br />
√ Full needle penetration<br />
√ Complete SC dose injection<br />
√ MOST IMPORTANT: Injection performed with the<br />
FUDAI / SEDAI starts ONLY AFTER full needle<br />
penetration is achieved<br />
X<br />
17 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
<strong>New</strong> <strong>Generation</strong> Disposable<br />
<strong>Auto</strong>-<strong>Injectors</strong> – Features<br />
Fully-Disposable<br />
<strong>Auto</strong>-Injector<br />
for<br />
Drugs in Vials<br />
(FUDAI DV)<br />
• Safe & Simple<br />
• Less Pain<br />
• Injection starts only after<br />
full needle penetration<br />
• Easy drug reconstitution<br />
and aspiration from vials<br />
• Single or multiple vials<br />
Fully-Disposable<br />
<strong>Auto</strong>-Injector<br />
for<br />
Pre-filled Syringe<br />
(FUDAI PFS)<br />
18 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
9
Thank you for your attention<br />
and for waking up so early…<br />
See us also at the<br />
AAPS Annual Meeting<br />
San Antonio, TX<br />
Booth: 2091<br />
Contact (Head Office):<br />
Dr. Menachem Zucker<br />
VP Marketing, Sales & Business Development<br />
Elcam <strong>Medical</strong><br />
Kibbutz Bar’Am, 13860, Israel<br />
Tel: +972-4-698 8890 (Direct)<br />
+972-4-698 8120<br />
Fax: +972-4-698 0777<br />
Email: menachem@elcam.co.il<br />
www.elcam-medical.com<br />
Contact (USA):<br />
Lloyd Fishman<br />
VP Marketing & Business Development<br />
Elcam <strong>Medical</strong> Inc.<br />
2 University Plaza, Suite 620<br />
Hackensack, NJ 07601, USA<br />
Tel: 201-457 1120 (x 103)<br />
Fax: 201-457 1125<br />
Email: lloyd.fishman@elcam-medical.com<br />
www.elcam-medical.com<br />
Contact:<br />
David Daily<br />
CEO<br />
<strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
2 Rojanski St’, <strong>New</strong> Ind. Zone<br />
Rishon LeZion 75706, Israel<br />
Tel: +972-3-951 9675<br />
Fax: +972-3-951 9649<br />
Email: ddaily@dalimed.com<br />
10
Drug injection<br />
0.08 sec.<br />
21 David Daily, <strong>DALI</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Lloyd Fishman, ELCAM <strong>Medical</strong><br />
October 25, 2006<br />
Universe of PFS & Injection <strong>Devices</strong><br />
11
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