Medical Design Briefs - August 2024 - 6
Intelligent Testing Capabilities
It's critical that the testing system hardware and software be easily adaptable to accommodate a range of autoinjector shapes and activation methods.
(Credit: Instron)
from a CDMO's perspective, their answer may be slightly
more nuanced. In many cases, the key question is not just
whether the CDMO can meet a client's requirements, but
how it can meet those requirements.
The EPRs for autoinjectors typically include assessing the
full range of cap removal force, activation force, injection
time, needle depth, delivered volume, patient feedback, and
passive safety mechanisms. To adequately evaluate these metrics,
many different measurement devices are required, including
a load cell, balance, machine vision camera, and a
microphone. A basic approach to performing this testing
would be to use multiple testing systems, each configured
with a different measurement device.
However, in practice, this introduces many challenges for a
CDMO. Firstly, considering these devices are commonly single
use, multiple device specimens must be tested to collect all the
required data. Not only is this costly and wasteful, but it also
leads to the second issue, which is that data must be aggregated
across all the separate systems to create a single comprehensive
report. The time required for testing and analysis is also significant,
considering that a batch of 60 or 100 devices may need to
be fully evaluated at a given time. There are also the financial
burdens associated with maintaining and operating multiple systems
and performing their annual calibrations, in addition to
the cost of the device specimens themselves. In this case, the
CDMO can technically meet their client's needs, but not in an
efficient or cost-effective way.
The ideal implementation of an autoinjector testing program
utilizes automation and intentional design to test each of
these parameters in a sequential run of a single device. Integration
of multiple measurements devices onto a single mechanical
testing system allows for a streamlined testing process, capable
of evaluating the full suite of EPRs in approximately one
minute depending on the length of the injection itself. The use
of a single system also ensures the data collection is all encompassing
and can produce a single batch report for review. UltiFULL
FUNCTIONALITY TESTING WITH A SINGLE SYSTEM
ACTIVATION
FORCE
CLICK
DETECTION
INJECTION
TIME
NEEDLE
DEPTH
DELIVERED
VOLUME
CAP REMOVAL
INJECTION
A series of tests are required to fully evaluate autoinjector performance. (Credit: Instron)
6
www.medicaldesignbriefs.com
Medical Design Briefs, August 2024
NEEDLE GUARD
LOCKOUT
https://www.medicaldesignbriefs.com
Medical Design Briefs - August 2024
Table of Contents for the Digital Edition of Medical Design Briefs - August 2024
Medical Design Briefs - August 2024 - CvrFlap1
Medical Design Briefs - August 2024 - CvrFlap2
Medical Design Briefs - August 2024 - Cover1
Medical Design Briefs - August 2024 - Cover2
Medical Design Briefs - August 2024 - 1
Medical Design Briefs - August 2024 - 2
Medical Design Briefs - August 2024 - 3
Medical Design Briefs - August 2024 - 4
Medical Design Briefs - August 2024 - 5
Medical Design Briefs - August 2024 - 6
Medical Design Briefs - August 2024 - 7
Medical Design Briefs - August 2024 - 8
Medical Design Briefs - August 2024 - 9
Medical Design Briefs - August 2024 - 10
Medical Design Briefs - August 2024 - 11
Medical Design Briefs - August 2024 - 12
Medical Design Briefs - August 2024 - 13
Medical Design Briefs - August 2024 - 14
Medical Design Briefs - August 2024 - 15
Medical Design Briefs - August 2024 - 16
Medical Design Briefs - August 2024 - 17
Medical Design Briefs - August 2024 - 18
Medical Design Briefs - August 2024 - 19
Medical Design Briefs - August 2024 - 20
Medical Design Briefs - August 2024 - 21
Medical Design Briefs - August 2024 - 22
Medical Design Briefs - August 2024 - 23
Medical Design Briefs - August 2024 - 24
Medical Design Briefs - August 2024 - 25
Medical Design Briefs - August 2024 - 26
Medical Design Briefs - August 2024 - 27
Medical Design Briefs - August 2024 - 28
Medical Design Briefs - August 2024 - 29
Medical Design Briefs - August 2024 - 30
Medical Design Briefs - August 2024 - 31
https://www.nxtbook.com/smg/techbriefs/24MDB09
https://www.nxtbook.com/smg/techbriefs/24MDB08
https://www.nxtbook.com/smg/techbriefs/24MDB07
https://www.nxtbook.com/smg/techbriefs/24MDB06
https://www.nxtbook.com/smg/techbriefs/24MDB05
https://www.nxtbook.com/smg/techbriefs/24MDB04
https://www.nxtbook.com/smg/techbriefs/24MDB03
https://www.nxtbook.com/smg/techbriefs/24MDB02
https://www.nxtbook.com/smg/techbriefs/24MDB01
https://www.nxtbook.com/smg/techbriefs/23MDB12
https://www.nxtbook.com/smg/techbriefs/23MDB11
https://www.nxtbook.com/smg/techbriefs/23MDB10
https://www.nxtbook.com/smg/techbriefs/23MDB09
https://www.nxtbook.com/smg/techbriefs/23MDB08
https://www.nxtbook.com/smg/techbriefs/23MDB07
https://www.nxtbook.com/smg/techbriefs/23MDB06
https://www.nxtbook.com/smg/techbriefs/23MDB05
https://www.nxtbook.com/smg/techbriefs/23MDB04
https://www.nxtbook.com/smg/techbriefs/23MDB03
https://www.nxtbook.com/smg/techbriefs/23MDB02
https://www.nxtbook.com/smg/techbriefs/23MDB01
https://www.nxtbook.com/smg/techbriefs/techleaders22
https://www.nxtbook.com/smg/techbriefs/22MDB12
https://www.nxtbook.com/smg/techbriefs/22MDB11
https://www.nxtbook.com/smg/techbriefs/22MDB10
https://www.nxtbook.com/smg/techbriefs/22MDB09
https://www.nxtbook.com/smg/techbriefs/22MDB08
https://www.nxtbook.com/smg/techbriefs/22MDB07
https://www.nxtbook.com/smg/techbriefs/22MDB06
https://www.nxtbook.com/smg/techbriefs/22MDB04
https://www.nxtbook.com/smg/techbriefs/techleaders21
https://www.nxtbook.com/smg/techbriefs/22MDB03
https://www.nxtbook.com/smg/techbriefs/22MDB02
https://www.nxtbook.com/smg/techbriefs/22MDB01
https://www.nxtbook.com/smg/techbriefs/21MDB12
https://www.nxtbook.com/smg/techbriefs/21MDB11
https://www.nxtbook.com/smg/techbriefs/21MDB10
https://www.nxtbook.com/smg/techbriefs/21MDB09
https://www.nxtbook.com/smg/techbriefs/21MDB08
https://www.nxtbook.com/smg/techbriefs/21MDB07
https://www.nxtbook.com/smg/techbriefs/21MDB06
https://www.nxtbook.com/smg/techbriefs/21MDB05
https://www.nxtbook.com/smg/techbriefs/21MDB04
https://www.nxtbook.com/smg/techbriefs/21MDB02
https://www.nxtbookmedia.com