If you were to tell some people that one of the most frustrating aspects of the development of a drug delivery device would be the little clicks that it makes as part of its operation, they would probably think you had lost your sense of priority.
Device developers know this - whether human factors experts or industrial designers, mechanical engineers, or risk analysis teams - yet this aspect of device design, like many others, is frequently not given the attention it deserves. So why is a click so important?
In an issue of IPT (Innovations in Pharmaceutical Technology) magazine, Team Consulting's David Harris explores the benefits of dry powder inhalers for a range of new therapeutic areas, outside of traditional asthma and COPD treatments.
In an issue of IPT (Innovations in Pharmaceutical Technology) magazine, Team Consulting's David Harris explores the benefits of dry powder inhalers for a range of new therapeutic areas, outside of traditional asthma and COPD treatments.
Device Usability and Compliance: The Implications, Opportunities and Requirem...Team Consulting Ltd
Andy Fry and Julian Dixon presented during the Parenteral Drug Association's (PDA) Prefilled Syringes SIG in March 2011 on the hot topic of device usability and compliance.
Designing for battery-powered and battery-packed medical devices, EPD&T, Dec ...Team Consulting Ltd
Team's Jonathan Oakley writes about designing the 'graceful shutdown'. When power starts to run out in a medical device it is important to think about which parts of the system are affected and at what stage.
First published in EPD&T in December 2013 http://www.epdtonthenet.net/
We think it is important to think ahead and to consider what issues the medical industry will be facing in the future.
As we near 2015 we’ve decided to use this as a half-way point. In this infographic we’ve reflected on significant global changes over the last 15 years and looked at the forecasts for the next 15. The result is a glimpse of what challenges healthcare will face in 2030. Can we do anything today to change the future? Or if we accept this vision of the future what do we need to do now to best prepare?
Appealing to Users: Designing Inhalers to Maximize Compliance and Minimize Mi...Team Consulting Ltd
Team Consulting's head of human factors and usability, Julian Dixon, presented on the subject of designing inhalers to maximise compliance and minimise misuse.
Please note: Image quality has been degraded by Slideshare during upload.
Appealing to users: developing usable & desirable devicesTeam Consulting Ltd
Julian Dixon, Team's Director of Human Factors, delivered this presentation at the 2nd World Pre-filled Syringes Summit in Washington in September 2012
David Harris, principal consultant at Team Consulting, was invited by the DDL organising comittee to present the case for DPIs at the Drug Delivery to the Lung (DDL) conference in December 2011
OIP Device Design: Approaches to Creating Successful Products for Patient UseTeam Consulting Ltd
Ben Cox, Senior Consultant at Team Consulting, presented this at the World Congress of the International Society for Aerosols in Medicine in April 2013
ONdrugDelivery - The advantages of designing high-resistance swirl chambers f...Team Consulting Ltd
In this article, David Harris, Head of Respiratory Drug Delivery, Team Consulting, taps into a powerful combination of detailed anatomical and functional understanding of the human respiratory system, pulmonary drug delivery technology and formulation expertise, and mathematical modelling techniques, in order to put forward the case for high-resistance swirl chambers in dry-powder inhalers, and a rational strategy for optimising the design and thus maximising therapeutic efficacy.
Are electronically enabled delivery devices (EEDDs) the future?Team Consulting Ltd
Team's Andy Fry looks at the role that electronically enabled drug delivery devices could play. This presentation was delivered at Management Forum's Injectable Drug Delivery conference in London in March 2012.
White Paper: Improving the Ergonomic Workstation - An Innovative Ultrasound S...Carestream
In the white paper below, Caroyln T. Coffin, MPH, RDMS, RVT, RDCS, Sound Ergonomics, LLC, outlines the ergonomics of the new CARESTREAM Touch Ultrasound System (pending FDA 510(k) clearance).
Coffin covers the how the various features of the Touch Ultrasound System contribute to creating comfortable work postures for sonographers. It ix explained that through design and intuitive functionality, a sonographer can reduce stress and frustration when using the system, which both can contribute to a vulnerability to work-related musculoskeltal disorders.
This handbook is written to show how greater control can be gained over total product reliability by the utilization of Accelerated Stress Testing techniques (AST)
Calibration is a comparison between measurements – one of known magnitude or correctness made or set with one device and another measurement made in as similar a way as possible with a second device.
Device Usability and Compliance: The Implications, Opportunities and Requirem...Team Consulting Ltd
Andy Fry and Julian Dixon presented during the Parenteral Drug Association's (PDA) Prefilled Syringes SIG in March 2011 on the hot topic of device usability and compliance.
Designing for battery-powered and battery-packed medical devices, EPD&T, Dec ...Team Consulting Ltd
Team's Jonathan Oakley writes about designing the 'graceful shutdown'. When power starts to run out in a medical device it is important to think about which parts of the system are affected and at what stage.
First published in EPD&T in December 2013 http://www.epdtonthenet.net/
We think it is important to think ahead and to consider what issues the medical industry will be facing in the future.
As we near 2015 we’ve decided to use this as a half-way point. In this infographic we’ve reflected on significant global changes over the last 15 years and looked at the forecasts for the next 15. The result is a glimpse of what challenges healthcare will face in 2030. Can we do anything today to change the future? Or if we accept this vision of the future what do we need to do now to best prepare?
Appealing to Users: Designing Inhalers to Maximize Compliance and Minimize Mi...Team Consulting Ltd
Team Consulting's head of human factors and usability, Julian Dixon, presented on the subject of designing inhalers to maximise compliance and minimise misuse.
Please note: Image quality has been degraded by Slideshare during upload.
Appealing to users: developing usable & desirable devicesTeam Consulting Ltd
Julian Dixon, Team's Director of Human Factors, delivered this presentation at the 2nd World Pre-filled Syringes Summit in Washington in September 2012
David Harris, principal consultant at Team Consulting, was invited by the DDL organising comittee to present the case for DPIs at the Drug Delivery to the Lung (DDL) conference in December 2011
OIP Device Design: Approaches to Creating Successful Products for Patient UseTeam Consulting Ltd
Ben Cox, Senior Consultant at Team Consulting, presented this at the World Congress of the International Society for Aerosols in Medicine in April 2013
ONdrugDelivery - The advantages of designing high-resistance swirl chambers f...Team Consulting Ltd
In this article, David Harris, Head of Respiratory Drug Delivery, Team Consulting, taps into a powerful combination of detailed anatomical and functional understanding of the human respiratory system, pulmonary drug delivery technology and formulation expertise, and mathematical modelling techniques, in order to put forward the case for high-resistance swirl chambers in dry-powder inhalers, and a rational strategy for optimising the design and thus maximising therapeutic efficacy.
Are electronically enabled delivery devices (EEDDs) the future?Team Consulting Ltd
Team's Andy Fry looks at the role that electronically enabled drug delivery devices could play. This presentation was delivered at Management Forum's Injectable Drug Delivery conference in London in March 2012.
White Paper: Improving the Ergonomic Workstation - An Innovative Ultrasound S...Carestream
In the white paper below, Caroyln T. Coffin, MPH, RDMS, RVT, RDCS, Sound Ergonomics, LLC, outlines the ergonomics of the new CARESTREAM Touch Ultrasound System (pending FDA 510(k) clearance).
Coffin covers the how the various features of the Touch Ultrasound System contribute to creating comfortable work postures for sonographers. It ix explained that through design and intuitive functionality, a sonographer can reduce stress and frustration when using the system, which both can contribute to a vulnerability to work-related musculoskeltal disorders.
This handbook is written to show how greater control can be gained over total product reliability by the utilization of Accelerated Stress Testing techniques (AST)
Calibration is a comparison between measurements – one of known magnitude or correctness made or set with one device and another measurement made in as similar a way as possible with a second device.
Needs and Emerging Trends of Remote SensingHillary Green
Published In: Proc. SPIE 9116, Next-Generation Robots and Systems
Date: 4 June 2014
From the earliest need to be able to see an enemy over a hill to sending semi-autonomous platforms with advanced sensor packages out into space, humans have wanted to know more about what is around them. Issues of distance are being minimized through advances in technology to the point where remote control of a sensor is useful but sensing by way of a non-collocated sensor is better. We are not content to just sense what is physically nearby. However, it is not always practical or possible to move sensors to an area of interest; we must be able to sense at a distance. This requires not only new technologies but new approaches; our need to sense at a distance is ever changing with newer challenges. As a result, remote sensing is not limited to relocating a sensor but is expanded into possibly deducing or inferring from available information. Sensing at a distance is the heart of remote sensing. Much of the sensing technology today is focused on analysis of electromagnetic radiation and sound. While these are important and the most mature areas of sensing, this paper seeks to identify future sensing possibilities by looking beyond light and sound. By drawing a parallel to the five human senses, we can then identify the existing and some of the future possibilities. A further narrowing of the field of sensing causes us to look specifically at robotic sensing. It is here that this paper will be directed
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton RoboticsICS
As medical device and robotics technology mature and grow more capable they also become more complex, requiring focus on usability aspects from both a user experience (UX) design and regulatory perspective. These new applications, such as exoskeletons, demand a seamless interaction between the device and the user. That means designers and developers must improve utility while mitigating inherent risks.
This online panel will explore how to approach UX design for medtech and how it should plug into a product development cycle leading to a 510(k) submission. We will share lessons learned from studying exoskeletons for military applications, and explain how they can be applied to medical/rehabilitative applications.
If you’ve been consciously ignoring wearables and fitness technology (I know a lot of people in the fitness industry who are), now might be the time to start paying attention. ACSM (American
College of Sports Medicine®) crowned wearable technology as the number one fitness trend of 2016. Enormous sums of venture capital dollars are flowing into the broader space of fitness technology and the digital disruption of the fitness space is not a matter of if but when. For the savvy operator, these technological developments will present a new set of tools to enhance their brand promise to members.
As technology advances, more and more medical devices are being engineered with multiple functions. According to the FDA, any product that has at least one medical device function and one non-device function is considered a “multiple function device product”. At the end of July, the FDA finalized an April 2018 draft guidance that clarifies how the agency will assess the impact of the non-device functions of a product...
The FMEA embodies a process that is intended to identify equipment failure modes, their causes, and finally the effects that might result should these failure modes occur during product operation.
DELPH is a software suite for gophysical data acquisition, processing and interpretation. It features side-scan sonar, seismic and sub-bottom profiler as well as magnetometer analysis. Capable of working with very large multi-sensor datasets, it automates data processing and simplifies operations for geophysicists and hydrographers.
The advantages of a connected device can be explored through the different categories of needs, by trialling a range of solutions and considering a framework of manageable steps.
Thinking Human by Julian Dixon, PMPS Inhalation Technology SupplementTeam Consulting Ltd
As medical device companies strive to make their products more user-friendly, it becomes clear that listening to the end user is an important part of the process. Through small-scale studies and human factor analysis, inhalers can be developed that are simple and easy to use.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Engineering the perfect click for drug delivery devices
1. January 2014 Vol 14 No 1 www.drug-dev.com
IN THIS
ISSUE
Second
Quadrant 22
Marshall Crew, PhD
Device
Engineering 26
Chris Hurlstone
Deterring
Opiod Abuse 34
Cindy H. Dubin
Lyophilization
Packaging 42
Thomas Otto
Drug Delivery
Innovation 66
Amy Heintz, PhD
Data
Management 68
Martin Magazzolo
The science & business of drug development in specialty pharma, biotechnology, and drug delivery
Derek
Hennecke
Six Reasons Why
the Affordable
Care Act May Be
a Bad-Tasting
Medicine That
Could Heal Our
Industry
Geoff Carr, PhD
Developing &
Validating an Efficient
Method to Determine
Residuals of
Hormone Products
by LC-MS After
Cleaning Equipment
Justin M.
Wright, PhD
Delivering the Next
Generation in Glass
Prefillable Syringes
INTERVIEW WITH
EMD MILLIPORE’S
HEAD OF PORTFOLIO
DEVELOPMENT
STEFFEN DENZINGER
* DD&D Jan 2014 Covers.qxp_DDT Cover/Back April 2006.qx 1/3/14 4:59 PM Page 2
2. DrugDevelopment&DeliveryJanuary2014Vol14No1
26
I
f you were to tell some people that one of the most
frustrating aspects of the development of a drug delivery
device would be the little clicks that it makes as part of its
operation, they would probably think you had lost your sense of
priority. Yet time and time again, the engineering of the click
becomes a real and serious issue. Device developers know this -
whether human factors experts or industrial designers, mechanical
engineers, or risk analysis teams - yet this aspect of device design,
like many others, is frequently not given the attention it deserves.
So why is a click so important?
For many drug delivery devices, including inhalers but
particularly pen and autoinjectors, the feedback users receive from
a device during the sequence of use can be critical in helping them
achieve effective and complete delivery of their medication.
Designers will endeavour to make device use as intuitive as
possible, but the products that we are considering are used by
people from all walks of life, of all ages and physical condition, so
intuitiveness is not always easy to achieve. Hence, feedback from
the device can help give the user confidence that they are carrying
out the steps required correctly, especially when these steps are
part of the instructions for use and, if appropriate, patient training.
WAIT FOR THE CLICK…
Take the Asmabec®
Clickhaler®
for example, a dry powder
inhaler for asthma treatment. The IFU instructs the user to “press
the dosing button down firmly once until it clicks, then release.”
Or the Aranesp®
SureClick®
autoinjector IFU, which references
first and second clicks, with the instruction to “Wait until the
second click before lifting the injector from the injection site.”
And then there is the ClikSTAR®
Lantus®
for injection of insulin -
“screw in the insulin cartridge holder until it clicks into place…”
Or, as a final example, the Advair®
Diskus®
- the current world
best seller - which has three basic instruction steps: “Open, Click,
Inhale.” All these instruction steps are critical to achieving
successful delivery of a full dose, and all are dependent on the
user hearing and correctly interpreting the click.
THE CLUE IS IN THE NAMES…
So clicks are vitally important for users, and yet we see time
and again they are not good enough. Engineers and designers face
F I G U R E 1
Clickhaler®
, SureClick®
& ClikSTAR®
Devices
F I G U R E 2
Raw Acoustic Waveform
Engineering the Perfect Click for Drug
Delivery Devices
By: Chris Hurlstone
26-33-Advanced Delivery Devices-DDD Jan 2014.qxp_Layout 1 1/3/14 5:05 PM Page 26
3. this issue frequently, and there
is a wealth of evidence from
user research - formative and
summative - that highlights not
only the criticality of these
audible cues and how they
combine with other aspects of
interaction design to influence
user behavior, but also what
happens when clicks are not
right. Subtle variations can
mean the difference between
success and failure when self-
administering vital medication,
and as there won’t always be a
second chance, the user must be
certain that they have received the medication they need. Yet clicks
are different to other critical characteristics of device performance,
such as actuation forces or dose volumes, in that they are not so easy
to define and describe. We know what we want when we hear it - and
we know what we don’t want as well - but how can we describe
clicks accurately? Maybe we should start with defining what a good
click “looks” like?
VISUALIZING THE PERFECT CLICK
It is one thing to recognize the importance of a device
performance characteristic, but
quite another to know how to
engineer it; to know how to
develop, optimize, and verify a
characteristic so that we get
what we need, when we need it,
every time.
We can (usually) describe
quite easily, in subjective terms,
what we want from the click that
a device has to make. For
example, we can say that it
needs to be clear, distinct,
gentle, or that it needs to give an
indication of quality, robustness,
or re-assurance. And it certainly
mustn’t be scary or alarming. We know what we mean and it is
certainly a good idea to think in these terms to begin with. But to
really get into the detail, we need to establish a more objective set of
descriptors that allow us to define good and bad clicks.
A good - and fairly obvious - starting point is to look at a click’s
acoustic waveform. This is the best way to characterise a sound, after
all, and that is primarily what a click is. With high-quality recording
equipment and software, it is relatively straightforward to obtain a
high-resolution acoustic signal, in terms of amplitude versus time.
But care must be taken when recording the sounds, especially if you
wish to exclude external (consequential) sounds such as
reverberation. If you want to isolate the click fully from all external
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F I G U R E 3
Smoothed Acoustic Waveform
F I G U R E 4
Smoothed Acoustic Waveform With Power Regression Functions
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4. sounds, then a sound-proof anechoic chamber will be necessary. Bear
in mind though, that a click heard in a chamber is not how the user
will hear it. Similar consideration needs to be given to the way you
hold the device, as quite often the caseworks will act as soundboards.
Once you have obtained the acoustic waveform (Figure 2, which
shows a typical waveform for a device click), you can then apply a
range of smoothing and clipping algorithms to give an amplitude
envelope that can be characterized for each of the click’s two main
stages - attack and decay - as shown in Figures 3 and 4. This
approach is a little different to applying a standard ADSR (Attack,
Decay, Sustain, and Release) envelope as might be done in other
acoustic analyses. However, clicks are by their nature very short
acoustic events, and if we can reduce the level of detail while
retaining the level of characterization needed to work effectively, that
is generally a good thing.
Once completed, the characterization of the acoustic waveform
will result in a set of parameters that can be used to describe each
click in a simplified but more manageable way. This opens up
opportunities for specifying (and hence also verifying) clicks, for
comparing different clicks in order to improve or optimize them, or
for comparing the consistency of the same click, perhaps under
different conditions, such as hot or cold temperatures.
As well as looking at the amplitude waveform of the sound, it is
also possible to use Fast Fourier Transform analysis to obtain a
spectrum of sound frequencies that make up the click. Off-the-shelf
software packages can carry out this analysis very quickly and
effectively (Figure 5 shows a screen capture from the Audacity
software package, which is one possible tool). As for the amplitude
waveform, these outputs can then be clipped and smoothed as
appropriate to give a more readily applicable tool when seeking to
characterise the click’s acoustic signature.
How much detail is required when capturing and analysing the
sound characteristics of the device will vary on a case-by-case basis.
The point here is to show that, through careful application of
reasonably accessible tools and methodologies, important acoustic
device characteristics can be readily described, analysed, and
understood.
WHAT INFLUENCES CLICK CHARACTERISTICS?
When considering click characteristics, the first thing to
determine is what is actually making the click, which might not be
what you think. A typical click will involve a deflecting member with
a relatively sharp tipped form somewhere on its length; this rides
over a step or falls off an edge, which causes it to snap back. In some
embodiments, the substantial part of the click will be generated by
this deflected member returning quickly and striking a surface, but in
many cases, it is the action of the tip falling off the edge - so that the
member accelerates through the air - which generates the sound
energy. This is further combined, to differing degrees, with vibration
of the edge feature itself (and any features that support it) as these
are also likely to vibrate to some extent due to the rapid removal of
the reaction force.
Because sound is a very low-energy phenomenon, it only takes
small variations in system properties, such as feature stiffness,
inertia, additional system vibrations (for example a rattle), or
damping, to result in very different sounds. Hence, material
properties (modulus, density) feature design, joint characteristics (if
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F I G U R E 5
Frequency Spectrum
F I G U R E 6
FEA Study Output for Peak Stresses in a
Deflecting Member
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5. the click features are part of an assembly), and how the device is held
or secured can all influence the characteristic. When developing a set
of click features, all of these elements need to be considered, just as
when investigating an unwanted click in an existing system. In the
latter case, it may also be worth using high-speed video - possibly
synchronized with acoustic measurements - to establish exactly what
is happening at the instant of the click. Things may not be what they
seem…
HOW REPEATABLE WILL THE CLICK BE?
Any variation in the design parameters that influence the system
properties previously described will clearly result in a variation in the
click that we hear. Some parameters will be relatively constant once
the design specification is finalized, but others can also vary through
the lifecycle of device use.
The impact of temperature on material - and hence feature
stiffness - needs to be considered, and material selection will clearly
be a driving factor. Material suppliers DuPontTM
, for example,
provides information on which of its polymer grades might be most
appropriate for a particular application, and provide an interesting
case study on their Delrin®
100ST super tough grade used within the
automotive industry. It is selected for a combination of properties,
including toughness and flex fatigue at temperature extremes in order
to ensure the required auditory safety signal (in other words, the
click) is achieved on replacement of a fuel filler cap.
This automotive example may be an extreme case in terms of
possible temperature of use (the material is approved for use from
-40°C to +80°C), but it is easy to envisage scenarios in which the
environment of use of a medical device, though not as extreme, is
either difficult to control (for example, the emergency use inhaler or
injector) or different to the conditions anticipated by the designer
(such as a device used straight after removal from a fridge, where it
is stored due to the nature of the drug formulation). Also, the
nominal form and stiffness of the key features may not remain
constant throughout device life; permanent strain may arise from
over-stressing, fatigue (due to repeated use or play by the user), or
creep, which can occur if the design allows the main click features to
be left in a deflected, stressed position for significant periods of time.
Engineering analysis can be of assistance here and, for these
examples, finite element analysis is an effective way to develop
system understanding. For example, changes in material modulus
arising from temperature changes allow assessment of the impact on
contact forces (which relate to click energy), while a review of peak
strains and stresses (see Figure 6 for an example of an FEA study)
across the range of anticipated deflections will inform review of
susceptibility of the design to permanent deformation or creep.
Another aspect of variation inherent to a design is the
manufacturing tolerance that can be achieved, and tolerance analysis
is an indispensable tool for assessing these potential effects. We all
remember that the contact force for a deflected member (of the kind
shown in Figure 6) varies with the cube of the section thickness, but
understanding the combined impact of all likely variations -
including tolerances on diameters, ovality, or concentricity - is less
intuitive though readily achievable with a bit of basic MathCAD.
GOOD CLICKS - A QUESTION OF TIMING
Where tolerance analysis can also prove invaluable is in the
prediction of variation in the timing of a click. Going right back to
the use of clicks as a reference point in an IFU or PIL, if we are
asking the patient to react to the generation of a click from a device,
we need to be sure the click happens at the right time. This can be
critical if the click is linked to mechanisms that may influence dose
cutting or dose delivery, engagement/release of safety features, or
successful location/retention of a key element of the device. For such
critical features of a design, it is usually necessary to build in a
safety factor so that, allowing for system variations, the click will
always happen before or after (depending on the case in question) the
critical device state is achieved. Tolerance analysis then allows the
design engineer to assess what happens at the other end of the system
variance - how early or late - the click might occur, and what the
implication might be. Figure 7 shows a very basic tolerance stack
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F I G U R E 7
Tolerance Analysis for Click Timing
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that illustrates potential angular misalignment in the timing of two
diametrically opposite clicks which, in theory, should happen at the
same time, but in practice will probably not.
By building up a tolerance analysis in a mathematical
package, such as MathCAD, rather than in a spreadsheet, it is
comparatively straightforward to introduce more complex functions
and inter-relationships. This allows us to take into account complex
trigonometry or system dynamics, such as spring and frictional
forces, and hence achieve a much more comprehensive picture of a
system and its sensitivities and variations. Through use of statistical
methods, such as Monte Carlo analyses, and input data, including
desired and/or achieved process capabilities, a full picture of the
timing of a click relative to other key mechanism functions can be
derived for a range of manufactured devices - real or virtual.
CHOOSE YOUR WEAPONS….
This article has outlined a range of tools and techniques for
objectively describing many of the characteristics of a highly
subjective, but often important and overlooked, device performance
requirement - the click. Not all of this analysis is needed every time
a click is required or desired, but being aware of these options and
how they can be applied during the development process (not
during design verification and validation) puts the designer in a
stronger position. Device testing - from prototypes to pilot devices,
in the lab and in the hands of users - is of course another key part
of developing an effective click, but to rely solely on testing
without building an understanding of how the click is working risks
delays, through poorly guided design iteration, and potential
compromise on performance.
Yet, to reiterate what was said in the introduction, compromise
may simply not be an option. The need to engineer designs that
pose a minimum risk of use-error is one of the hot issues in
medical device development at the moment - a key focus of the US
and European regulatory bodies whose approval for product launch
is required. All aspects of user-device interaction can be critical to
success in this regard, including the humble click, and more and
more people in the industry are recognizing and learning this,
sometimes the hard way. And the hard way can be very hard
indeed. u
Chris Hurlstone is currently the Director of Engineering for Team
Consulting, directing the company’s engineering expertise and working
with the heads of development groups to ensure Team delivers
consistently world-class consultancy services and robust, reliable, user-
focused, and commercially successful device solutions. He is still very
much hands-on, especially in areas such as risk management, technical
audit, design verification, industrialization, and technical trouble-
shooting. Mr. Hurlstone has more than 15 years of experience with Team,
developing technologies and devices for healthcare markets. He has
successfully brought products to market in technical lead and project
management roles, including inhalers, injectors, and an award-winning
ophthalmoscope, and in the process, has worked extensively with global
suppliers of manufacturing and technical expertise. A named inventor on
numerous patents, he has a strong track record in delivering innovative
and robust solutions to many of Team’s international clients. Mr.
Hurlstone graduated from the University of Cambridge with a degree in
Mechanical Engineering and a post-graduate diploma in Design,
Manufacture, and Management.
B I O G R A P H Y
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