This document discusses the growing role of electronics, software, and connectivity in medical devices. It notes that computer control and software allow for customization and refinements through updates. Wireless technologies are also spreading to medical devices and fueling growth in mobile health markets like vital signs monitoring. The market for clinical medical devices is expected to surpass consumer devices by 2020 due to larger revenue streams from value-added software services. The document also discusses how startups are working on point-of-care diagnostic devices but need guidance on defining user needs, and how personalized care is driving innovation through mobile health devices that enable remote monitoring.
The Future of Artificial Intelligence and Quality Management in Hospitals By....Healthcare consultant
The medical device industry has noticed this factor and uses it to save lives. Artificial intelligence (AI) in the life sciences industry is capable of more than one could imagine and it’s changing the future. For example, one organization is creating AI-based voice robot technology, which, according to an article in Management Matters Network, will deliver custom prescriptive advice to managers using strengths and performance data to help better coach and engage employees.
Automated audit management has served as a great source of information to delve deeper into data with predictive intelligence regarding safety and compliance. Leading safety metrics provide:
• Total number of noncompliances
• Number of near-misses enabling investigation to prevent potential incidents
• The time it takes to complete post-audit corrective and preventive actions
• Easy-to-view previous findings for corrective action launches and findings
• Automated audit management software that centralizes all risk items and allows users to automatically assess them and generate reports quickly to pinpoint high-risk gaps that may otherwise go unnoticed
Convergence of AI, IoT, Big Data and Blockchain: A Review.
Kefa Rabah .
Mara Research, Nairobi, Kenya .
Abstract
Data is the lifeblood of any business. Today, big data has applications in just about every industry – retail, healthcare,
financial services, government, agriculture, customer service among others. Any organization that can assimilate data
to answer nagging questions about their operations can benefit from big data. In overall, the demand for big data
transcend across all sectors and business. Those who work to understand their customers’ business and their problems
will be able to proactively identify big data solutions appropriate to their needs, and thus gain competitive advantage
over their competitors. Job demand for people with big data skill-set is also in the rise especially professional,
scientific and technical services; information technology; manufacturing; and finance and insurance; and retail.
DevOps is baseless without the cloud. IoT needs cloud to operate efficiently, for computing is required by the cloud
operate efficiently. AI remained only as model up until the advent of big data. Blockchain and related distributed
ledger technologies are disrupting the technology sector as we know it. The confluence of technologies is just
inevitable and often they are beneficial especially today when usher in the 4th industrial revolution (Rabah, 2017a)
and the forth coming machine economy (Rabah, 2018). More-so, data is a key ingredient of approaches to developing
AI and machine learning, which are now being applied to a wide variety of uses, from stock trading to chatbots to
self-driving cars. There is barely a business or human activity today that is not considered as a target for AI in future
years and decades.
The 10 most innovative medical devices companies 2018insightscare
Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.”
LEADING HEALTHCARE PROVIDER MODERNIZES ITS ENTIRE CUSTOMER SERVICE DEPARTMENT...NetCom Learning
NetCom Learning first engaged this organization to help bring their vision of a one-stop-health destination to life. We created
a training solution that facilitated strategy workshops with cross-functional internal employees to align them with the overall
brand strategy.
The Future of Artificial Intelligence and Quality Management in Hospitals By....Healthcare consultant
The medical device industry has noticed this factor and uses it to save lives. Artificial intelligence (AI) in the life sciences industry is capable of more than one could imagine and it’s changing the future. For example, one organization is creating AI-based voice robot technology, which, according to an article in Management Matters Network, will deliver custom prescriptive advice to managers using strengths and performance data to help better coach and engage employees.
Automated audit management has served as a great source of information to delve deeper into data with predictive intelligence regarding safety and compliance. Leading safety metrics provide:
• Total number of noncompliances
• Number of near-misses enabling investigation to prevent potential incidents
• The time it takes to complete post-audit corrective and preventive actions
• Easy-to-view previous findings for corrective action launches and findings
• Automated audit management software that centralizes all risk items and allows users to automatically assess them and generate reports quickly to pinpoint high-risk gaps that may otherwise go unnoticed
Convergence of AI, IoT, Big Data and Blockchain: A Review.
Kefa Rabah .
Mara Research, Nairobi, Kenya .
Abstract
Data is the lifeblood of any business. Today, big data has applications in just about every industry – retail, healthcare,
financial services, government, agriculture, customer service among others. Any organization that can assimilate data
to answer nagging questions about their operations can benefit from big data. In overall, the demand for big data
transcend across all sectors and business. Those who work to understand their customers’ business and their problems
will be able to proactively identify big data solutions appropriate to their needs, and thus gain competitive advantage
over their competitors. Job demand for people with big data skill-set is also in the rise especially professional,
scientific and technical services; information technology; manufacturing; and finance and insurance; and retail.
DevOps is baseless without the cloud. IoT needs cloud to operate efficiently, for computing is required by the cloud
operate efficiently. AI remained only as model up until the advent of big data. Blockchain and related distributed
ledger technologies are disrupting the technology sector as we know it. The confluence of technologies is just
inevitable and often they are beneficial especially today when usher in the 4th industrial revolution (Rabah, 2017a)
and the forth coming machine economy (Rabah, 2018). More-so, data is a key ingredient of approaches to developing
AI and machine learning, which are now being applied to a wide variety of uses, from stock trading to chatbots to
self-driving cars. There is barely a business or human activity today that is not considered as a target for AI in future
years and decades.
The 10 most innovative medical devices companies 2018insightscare
Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.”
LEADING HEALTHCARE PROVIDER MODERNIZES ITS ENTIRE CUSTOMER SERVICE DEPARTMENT...NetCom Learning
NetCom Learning first engaged this organization to help bring their vision of a one-stop-health destination to life. We created
a training solution that facilitated strategy workshops with cross-functional internal employees to align them with the overall
brand strategy.
The study is taken up because of a huge number of start-ups entering into the Healthcare Services Industry.
The curiosity to know about the factor(s) which influence the user to use a particular website and perceive a particular service to be the basic necessity led us to make use of factor analysis.
The study shows that even though a large majority of Indians are unaware of these services or have not availed it yet, the future for these services looks promising as a large percentage of people have shown their willingness in availing these services.
I hope that this study would benefit the healthcare start-ups to provide a better solution to the existential problems and eventually benefiting the people at large.
The 10 most innovative medical devices companies 2018insightscare
Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.”
AI in Healthcare: From Hype to Impact (updated)Mei Chen, PhD
The primary goal of this workshop is to help health professionals gain a critical understanding of the various types of AI technologies available so they can make wise decisions and invest AI for healthcare improvement.
The 10 most innovative digital healthcare solution providers 2018 convertedinsightscare
Such healthcare providers always foster a healthy team environment at their workplace and engage in behaviors that benefit the team and display empathic behaviors when interacting with patients and their family members. To highlight such great healthcare providers, we have come up with an issue of “The 10 Most Innovative Digital Healthcare Solution Providers 2018”.
Current Trends of Wearable Technology Devices in Clinical DiagnosticsAwladHussain3
Wearable devices are real-time, and noninvasive biosensors allow for the continuous monitoring of individuals and thus provide sufficient information for determining health status and even preliminary medical diagnosis. This presentation briefly introduces the latest advances in wearable healthcare systems, which can be used for real-time diagnosis and treatment of patients.
10 most advanced medical imaging solution providersinsightscare
Insights Care has curated a list of “10 Most Advanced Medical Imaging Solution Providers”, we have listed the leading companies that are augmenting the clinical imaging niche with their novel solutions.
Artificial Intelligence in the Hospital SettingDaniel Faggella
This presentation was given at the AI Applications Summit (an event for healthcare and pharma professionals) in December 2017. The presentation itself covers to current traction of artificial intelligence in the hospital setting, as well as the unique challenges of applying AI in healthcare (including compliance, resistance from some doctors, the "black box" problem of machine learning, and more). Includes references to Machine Learning in Healthcare Executive Consensus: https://www.techemergence.com/machine-learning-in-healthcare-executive-consensus/
Disrupting Conventional Therapies with Digital TherapiesMedullan
Join this webinar to learn about:
Bio 2.0 - what it is, what problems it aims to address, why it's important now, and what leading indicators of its potential have we seen in the market.
The new clinical development patterns that will emerge to help Life Science companies bring digital therapies and solutions to market in a predictable and sustainable way.
The potential roadblocks, the regulatory ambiguity, and its potential for clarity as these patterns take hold.
Many will still find it hard to decide what initiatives to scale up and how to determine which pathways to follow, as it’s unclear what digital success will look like five years from now. This series aims to bring innovators and industry leaders together to imagine what success could be and discuss ways to get there.
The 10 best e healthcare solution provider companies dec 2017Merry D'souza
Given the potential benefits of e-Healthcare, Insight Success introducing some of the most prominent organizations in the
industry who are capable of leading their clients towards excellence by supporting them beyond the advisory level.
“The 10 Best E-Healthcare Solution Provider Companies” issue aspires to assist organizations to find the right
technology partner who has the resources and skills to deliver smart e-healthcare solutions with scalability and
inventiveness.
The 10 Most Impactful Healthcare Solution Providers of 2019Mirror Review
There have been some monumental healthcare industry challenges in recent years. One was the move towards value-based (VB) medicine whereby positive outcomes would result from fewer office visits and readmissions into inpatient facilities. The fee-for-service model with patients continually returning for their next appointments would disappear.
Digital Healthcare Trends: Transformation Towards Better Care RelationshipKumaraguru Veerasamy
Digital health encompasses digital care programs, technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and to make medicine more personalized and precise. With the increasing adoption of telemedicine, wearable devices, mobile health apps (especially during the recent COVID-19 pandemic) and VR/AR; digital health is poised to take healthcare forward.
Enterprise Mobile and Client Management Demands a Rethinking of Work, Play an...Dana Gardner
Transcript of a Briefings Direct podcast on the new landscape sculpted by the increasing use of mobile and BYOD and how Dell is helping companies navigate that terrain.
The 20 most disruptive healthcare solution providers 2018insightscare
With an idea to acknowledge the fast-growing companies, contributing extraordinarily to the revolution of disruption in healthcare, we bring to you the special edition of “The 20 Most Disruptive Healthcare Solution Providers 2018”.
The study is taken up because of a huge number of start-ups entering into the Healthcare Services Industry.
The curiosity to know about the factor(s) which influence the user to use a particular website and perceive a particular service to be the basic necessity led us to make use of factor analysis.
The study shows that even though a large majority of Indians are unaware of these services or have not availed it yet, the future for these services looks promising as a large percentage of people have shown their willingness in availing these services.
I hope that this study would benefit the healthcare start-ups to provide a better solution to the existential problems and eventually benefiting the people at large.
The 10 most innovative medical devices companies 2018insightscare
Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.”
AI in Healthcare: From Hype to Impact (updated)Mei Chen, PhD
The primary goal of this workshop is to help health professionals gain a critical understanding of the various types of AI technologies available so they can make wise decisions and invest AI for healthcare improvement.
The 10 most innovative digital healthcare solution providers 2018 convertedinsightscare
Such healthcare providers always foster a healthy team environment at their workplace and engage in behaviors that benefit the team and display empathic behaviors when interacting with patients and their family members. To highlight such great healthcare providers, we have come up with an issue of “The 10 Most Innovative Digital Healthcare Solution Providers 2018”.
Current Trends of Wearable Technology Devices in Clinical DiagnosticsAwladHussain3
Wearable devices are real-time, and noninvasive biosensors allow for the continuous monitoring of individuals and thus provide sufficient information for determining health status and even preliminary medical diagnosis. This presentation briefly introduces the latest advances in wearable healthcare systems, which can be used for real-time diagnosis and treatment of patients.
10 most advanced medical imaging solution providersinsightscare
Insights Care has curated a list of “10 Most Advanced Medical Imaging Solution Providers”, we have listed the leading companies that are augmenting the clinical imaging niche with their novel solutions.
Artificial Intelligence in the Hospital SettingDaniel Faggella
This presentation was given at the AI Applications Summit (an event for healthcare and pharma professionals) in December 2017. The presentation itself covers to current traction of artificial intelligence in the hospital setting, as well as the unique challenges of applying AI in healthcare (including compliance, resistance from some doctors, the "black box" problem of machine learning, and more). Includes references to Machine Learning in Healthcare Executive Consensus: https://www.techemergence.com/machine-learning-in-healthcare-executive-consensus/
Disrupting Conventional Therapies with Digital TherapiesMedullan
Join this webinar to learn about:
Bio 2.0 - what it is, what problems it aims to address, why it's important now, and what leading indicators of its potential have we seen in the market.
The new clinical development patterns that will emerge to help Life Science companies bring digital therapies and solutions to market in a predictable and sustainable way.
The potential roadblocks, the regulatory ambiguity, and its potential for clarity as these patterns take hold.
Many will still find it hard to decide what initiatives to scale up and how to determine which pathways to follow, as it’s unclear what digital success will look like five years from now. This series aims to bring innovators and industry leaders together to imagine what success could be and discuss ways to get there.
The 10 best e healthcare solution provider companies dec 2017Merry D'souza
Given the potential benefits of e-Healthcare, Insight Success introducing some of the most prominent organizations in the
industry who are capable of leading their clients towards excellence by supporting them beyond the advisory level.
“The 10 Best E-Healthcare Solution Provider Companies” issue aspires to assist organizations to find the right
technology partner who has the resources and skills to deliver smart e-healthcare solutions with scalability and
inventiveness.
The 10 Most Impactful Healthcare Solution Providers of 2019Mirror Review
There have been some monumental healthcare industry challenges in recent years. One was the move towards value-based (VB) medicine whereby positive outcomes would result from fewer office visits and readmissions into inpatient facilities. The fee-for-service model with patients continually returning for their next appointments would disappear.
Digital Healthcare Trends: Transformation Towards Better Care RelationshipKumaraguru Veerasamy
Digital health encompasses digital care programs, technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and to make medicine more personalized and precise. With the increasing adoption of telemedicine, wearable devices, mobile health apps (especially during the recent COVID-19 pandemic) and VR/AR; digital health is poised to take healthcare forward.
Enterprise Mobile and Client Management Demands a Rethinking of Work, Play an...Dana Gardner
Transcript of a Briefings Direct podcast on the new landscape sculpted by the increasing use of mobile and BYOD and how Dell is helping companies navigate that terrain.
The 20 most disruptive healthcare solution providers 2018insightscare
With an idea to acknowledge the fast-growing companies, contributing extraordinarily to the revolution of disruption in healthcare, we bring to you the special edition of “The 20 Most Disruptive Healthcare Solution Providers 2018”.
Strategija ranog i predškolskog vaspitanja i obrazovanja u Crnoj Gori - Arija...unicefmne
Podgorica, 27. oktobar, 2015 - Prezentacija sa medjunarodne konferencije "Kvalitet, inkluzija i inovacije – temelji za budućnost", organizovane od strane UNICEF-a i Ministarstva prosvjete.
Analysis of hanif kureishi’s “my son the fanatic” and “my beautiful laundret...Muhammad Aqeel Hayder
The purpose of this study is to identify and describe postmodernist themes in two short stories written by Hanif Kureishi, My Son the Fanatic and My Beautiful Launderette. As postmodern era embodies some distinctive themes and techniques for instance fragmentation, pastiche, metafiction, minimalism, tecnoculture, hyperreality and intertextuality etc this paper will explore such themes and techniques in above mentioned literary works.
Deloitte research found that while many medtech companies are well-positioned to drive the future of health, they likely won’t be able to do it alone. Rather than focusing on making incremental
improvements to their devices, they should focus on using transformative and cognitive technologies
to enhance products and offer services. They could do this by developing or partnering to acquire
sophisticated data analytics capabilities, getting much closer to the consumer, and leveraging new
cognitive technologies to improve operations.
Intelligence in the Internet of Medical Things (IoMT) EraDashTechnologiesInc
What is IoMT, and how is it related to IoT? The Internet of Things (IoT) is a network of interconnected smart devices. The network enables users to control devices remotely through software applications, while at the same time, data is collected through strategic touchpoints. Once processed with computing power, the data collected can be used for various purposes, including healthcare.
This blog explains what IoMT is and how it plays a vital role in its implementation and future healthcare development.
What is IoMT?
IoMT is a connected infrastructure of medical devices, software applications, and health systems and services.
And while a growing pool and general adoption of IoT technologies are benefiting many industries, it’s a wave of sensor-based tools including wearables and stand-alone devices for remote patient monitoring and the marriage of internet-connected medical devices with patient information that ultimately set the IoMT ecosystem apart.
How the Internet of Things Is Transforming Medical DevicesCognizant
The Internet of Things (IoT) should be a central focus for medical device companies, as IoT dramatically expands and enhances the field for the entire stakeholder ecosystem. We offer a roadmap for medical devices companies seeking a wise and effective path forward with IoT.
Leveraging the Internet of Things to Improve Patient OutcomesAlex Taser
This public thought leader dialogue reinforced that we are in midst of a technology-enabled revolution in healthcare. A world of IoT sensors and the Big Data it enables has the power to personalize and improve care, predict conditions, and enable access and affordable service to previously under-reached communities.
Rather than a sci-fi fantasty, the future of IoT healthcare is already here. While fractured, the technology exists and its capabilities are growing exponentially. The success in ensuring patient health and empowerment hinges on our ability to shift the culture of care, rethink incentives, collaborate across systems, and put the patient voice at the center of it all.
The Potential of Digital and Remote Care Post-Pandemic-Iain Ansell, Team Cons...marcus evans Network
Ahead of the marcus evans Medical Device Manufacturing Summit 2021, Iain Ansell discusses the future of digital health and how manufacturers can ensure connected devices are user centric
Disruptive Insurance Product Innovation Using IoT in HealthcareAmazon Web Services
Potential for consumer healthcare
1. No more non-value apps – consumers want insights
2. Lifestyle and Wellness platforms will win
3. Data INTENSITY = New OPPORTUNITY
4. Real Time is the NORM
5. Machines learn to IMPROVE our lives
Speakers:
Gaurav Sharma, Senior Industry Principal and Lead for Finacle on Cloud business, Infosys Finacle
&
Michael Braendle, Principal Cloud Architect, Professional Services, AWS
The Telecom, Media and Communication industry seems to be more promising as new-age technologies, new ecosystems and advanced use cases are coming to the fore. We see 5G finally moving from hype to reality with leading telcos rolling out the first commercial 5G networks. Now, 2020 is expected to see a further boost to the fifth generation of networks with companies across industries set to benefit from the higher speeds, lower latency and better connectivity on offer. We at The DataTech Labs Inc help the Telcos to accelerate the race to develop value while continuing to reduce costs in connectivity and differentiate with ultra fast networks. We help you meet an increasing competitive pressure on core business while finding blue ocean growth strategies to sustain in the market. Working in collaboration with us, you will be well positioned to offer improved capabilities and create new business opportunities.
Health Care is facing massive transformation. There is a lot to be learned from the Internet Industry and open standards like OpenID, OAuth and Microformats.
The Fourth Industrial Revolution will permanently change how medical device companies do business. Historically, the medical device industry has created tremendous value via the creation of therapeutic devices. It is now time for the industry to invest more effort in analytics-based solutions that enable seamless, real-time care management.
The Work Ahead: How Data and Digital Mastery Will Usher In an Era of Innovati...Cognizant
In this installment of our Work Ahead series, we focus on the impact of digital transformation on the life sciences industry and what it will take to transform an industry value chain in need of drastic modernization.
* Artificial Intelligence can revolutionize customer engagement
* Treat the patient journey, not just the stops along the way
* Operating model: “industrialized digital”
2023 and Beyond-Healthcare App Development Trends You Can’t Ignore.pdfTechugo
In the rapidly evolving world of healthcare, mobile app development has emerged as a game-changer. With the pandemic and the increasing use of smartphones, the demand for healthcare apps is only expected to rise in the coming years. In this context, it is important for healthcare organizations to stay updated with the latest trends in app development to ensure they are providing the best possible care for their patients.
Digital Innovation in Healthcare - MIT ID InnovationPankaj Deshpande
Want to know the benefits of digital innovation in healthcare? Have a look. MIT ID innovation works on pioneering creative and experimental techniques that help designers become better doers.
To know more details, visit : https://mitidinnovation.com/recreation/digital-innovation-in-healthcare/
Similar to Personalized Care Drives Medical Product Innovation_D2P_Feb15 (20)
The Collaboration Imperative - Why it's Critical (D2P Aug15 CoverStory)
Personalized Care Drives Medical Product Innovation_D2P_Feb15
1. 58
It’s hard to talk about medical devices without getting into
what makes them tick. As with so many other products that are
entering the commercial marketplace today, it all starts with elec-
tronics, which play a key role in control management, monitoring
of medical device function, and—most recently—connectivity.
“What’s really neat about electronics today is that so much of it
is computer controlled,” said David Estes, senior systems engineer
at Digicom Electronics, an electronics manufacturing services
provider based in Oakland, California. “And, of course, with
computer control, you have the concept of software. The really
nifty part about software is that it allows the instant customization
of devices to incorporate very finely honed ideas and concepts
and their operation. It also allows for the incorporation of refine-
ments through software updates, just as your phone is updated.
So I think that’s one of the nicest aspects of electronics today.”
Welcome to the new age of smart, connected products, where
the smooth interaction of electronics, software, and hardware
is fast becoming a central design requirement that knows no
boundaries. Wireless technologies that fueled the rise of con-
sumer electronics have quickly spread to the medical device
industry, where they’re reshaping product designs and spurring
new business models. Lux Research, a market research firm
focused on emerging technologies, sees big things ahead for
mobile health (mHealth) devices, projecting eight-fold growth
in the market from $5.1 billion in 2013 to $41.8 billion in 2023.
Rising adoption of clinical vital signs monitoring devices and in
vitro diagnostic (IVD) devices are expected to drive growth in
the mHealth market, according to Lux, which anticipates vital
signs monitoring devices to grow from a $372 million market in
2013 to $16 billion in 2023.
“Consumer devices have seen a lot of hype, but clinical devices
will surpass their consumer counterparts in revenues by 2020,
helped by value-added software services and generally larger
revenue streams,” said Lux Research Associate Nick Kurkjy,
lead author of the report, “mHealth Showdown: Consumer and
Clinical Devices’ Battle for Market Dominance,” released last July.
“Clinical markets will be able to pay much more for comparable
services, especially if a device is able to reduce patient recovery
times or readmission rates, which can lead to outsized cost savings
for the health care provider,” he added in a release from Lux.
Point-of-care diagnostics is spawning its fair share of startups
COVER STORY
Personalized Care Drives
Innovation in Medical Product
Design and Manufacturing
But the more things change, the more they stay the same, as medical device OEMs
hold fast to requirements for quality, reliability, and shorter lead times.
By Mark Shortt
seeking to build a business around, for example, innovative sens-
ing technologies that “bring the device to the patient” wherever
he or she may be. But even if they’ve been fortunate enough to
receive funding to get started, many of the founders of these
companies really don’t have a good understanding of what their
product ultimately needs to do in the marketplace, said John Zeis,
president of the Plastics and Single Use Disposables Business at
Foundry Medical Innovations (FMI), a Carlsbad, Calif.-based
medical and diagnostics device development firm that provides
engineering services and serves as an incubator for cutting edge
medical technology.
“One of the things that we try to really get our customers to
do a good job of, on the front end, is defining what the user’s
needs are and really understanding what need we’re servicing,”
said Zeis in an interview. “We try to guide them towards ‘What are
your user needs and what does this product really need to do?’ as
opposed to, ‘Hey, let’s just make this nice gadget that looks cool
and can diagnose something on a bread board.”
After helping a customer define the user’s needs, FMI will
follow the project all the way through to manufacturing. “We can
make the molds, and then, once we verify that the parts function
Digicom Electronics’ component placement process is geared toward
flexibility, fast changeover, quick setup, and excellent accuracy and
repeatability. Photo courtesy of Digicom Electronics.
2.
3. 60 DESIGN-2-PART magazine • February 2015
properly, we’ll find the critical tolerances
and dimensions, and critical features and
critical functions, and then help spec out
potential manufacturers,” Zeis said. “And
then we’ll work with those manufacturers
to give the product a transition.”
Paul DiPerna, president of the Systems
Engineering and Incubation businesses at
FMI, said that a number of manufactur-
ing improvements, including the growing
reliance on rapid prototyping and 3D
printing technologies, has contributed
to “a strong expectation of getting things
done faster than ever before.” Because of
this, he said, medical device OEMs are
looking for companies that have experi-
ence in completing projects similar to
what they’re trying to accomplish.
“I think the expectation of the length
of the project has gotten very aggressive,”
he said. “A lot of people will come to us
because of our prior expertise, and their
expectation is to hit the ground running.
If you’re working on something in the
diabetes space, you want to be sure that
the company has done other things in
that space. I think that’s a trend, whereas,
before, it was more about your specific
technical expertise. For now, it’s more
about where you’ve been.”
Pia Kumar, director of corporate de-
velopment for Mayfield Plastics, a custom
thermoforming company based in Sutton,
Massachusetts, can vouch for medical
device OEMs’ reliance on suppliers that
have experience in medical manufactur-
ing. Mayfield, which recently completed
a highly cosmetic, complex, multi-piece
housing assembly for a major medical
OEM customer, has more than 40 years
of experience in the industry. The com-
pany has won awards from the Society of
Plastics Engineers (SPE) Thermoforming
Division in multiple categories, including
Best Pressure Formed Parts.
“When a new customer comes to us,
they want to know that they are working
with a company with experience, a com-
pany that understands the highly cosmetic
and functionally exacting requirements
of this market,” said Kumar. “Along with
Mayfield’s track record of successfully
working with major medical device OEMs,
our in-house engineering, design services
and tooling are important differentiators
for customers.” For more on Mayfield
Plastics, see page 96.
DiPerna also said that he’s seeing
a trend toward more entrepreneurial
startups, even among people who are un-
employed. “Nowadays, people say, ‘I could
get a job, I could do some consulting, or I
could start a company. Whereas, 10 years
ago, it was pretty unusual for people to
talk that way; now, it’s almost everybody.
Now that things are improving, there’s a
lot more activity in the air.”
Wireless Medical Devices
Enabling Personalized
Healthcare
Point-of-care products are part of a
rapidly evolving movement in health-
care today toward more personalized
care—an aim enabled and supported by
the pervasive adoption of wireless-based
mobile health (mHealth) devices for
remote monitoring and assessment.
“There are a lot of personalized
care products out there that attempt
to get information onto your Android
or iPhone about everything imagin-
able—your weight, your heart rate, what
you did, where you were,” said DiPerna.
“There’s a lot of this information get-
ting to the patient, and there’s a whole
medication adherence field that’s begin-
ning to evolve. It’s in its infancy, as far as
getting people to actually take care of
themselves, as well as take their existing
4. 61February 2015 • www.d2pmagazine.com
therapies. The whole economics of that
is starting to be really understood, and a
lot of the changes in the Affordable Care
[Act] are motivating people to begin to
work in that area. So that’s an area that
I see taking off in the next few years.”
The Center for Disease Control
(CDC) estimates that medication non-
adherence—the problem of patients’ not
taking their prescriptions—is responsible
for adding some $300 billion per year
in costs to the United States healthcare
system, according to Michael Morena,
chief operating officer of AdhereTech, a
small startup company in New York City.
Morena and AdhereTech CEO Josh Stein
started the company two years ago with
the aim of bringing to market a smart,
wireless pill bottle that electronically
reminds patients to take their medica-
tions and provides alerts to caregivers if
doses are missed.
AdhereTech has developed a first
generation Smart Pill Bottle that’s cur-
rently in trials, and is now working with
Intelligent Product Solutions (IPS), a
New York-based product design com-
pany, to develop the next generation
of the product. The second generation
of the product, due out in mid-2015, is
expected to be smaller, less expensive,
and easier to mass manufacture, and to
provide additional user enhancements,
such as longer battery life, a larger cap,
and capacity to hold a higher volume of
medication.
Morena says that medication non-
adherence also represents “about $100
billion a year” in lost revenues for
U.S. pharmaceutical companies, while
contributing to approximately 100,000
deaths a year.
“It’s considered a very large prob-
lem in health care, and the way we’re
approaching it is we’re developing a
cellular, connected smart pill bottle
that is distributed to patients for free
at the pharmacy, so that we can track
their behavior in real time and generate
interventions based on their behavior
or lack of behavior,” Morena said in an
interview. “So when people don’t take
their medication, we can detect that in
real time and generate a reminder. We
can also solicit feedback when people
aren’t taking their meds, and find out
why. There may be reasons other than
forgetfulness. For example, if someone’s
dealing with side effects or financial stress
as a result of their medication, we can
AdhereTech is working with Intelligent Product
Solutions, a New York-based product design
company, to develop the next generation of its
wireless Smart Pill Bottle, which electronically
reminds patients to take their medications
and provides alerts to caregivers if doses are
missed. Photo courtesy of AdhereTech/IPS.
detect when they’re not taking it and
then provide them that information by
connecting them to the right person at
the right time.”
Dana DeMeo, who has been working
directly with AdhereTech as chief techni-
5. 62 DESIGN-2-PART magazine • February 2015
cal officer at Intelligent Product Solutions, calls the AdhereTech
Smart Pill Bottle a unique and novel solution. “It’s an intelli-
gent pill bottle that has electronics inside, and it’s completely
standalone,” DeMeo said. “It has a cellphone radio inside that’s
already pre-configured when you receive it. As a patient, there’s
really no setup that you have to do. You receive a bottle like you
normally would, the prescription’s inside, and the only real dif-
ference to you is that it will occasionally beep and light up to
remind you when to take it. And that’s really it.”
The pill bottle, which requires no syncing or programming,
is designed for simplicity because its users—the least adherent
patients—are the least likely to buy a product, set it up, and help
themselves, Morena said. Rather than trying to sell the product
to them, AdhereTech would rather give them the pill bottle.
“You don’t have to learn how to use it; you don’t have to
worry about how it works, and the reason we make it that way
is we want people to benefit from it right off the bat,” Morena
said. “We don’t want any friction. It comes with the medication
in it; the idea being that when it comes to the patient, they use
it no differently than a regular, standard pill bottle. They open
and close it like a standard pill bottle; they take pills out of it
like a standard pill bottle, and they don’t have to charge it. It
can work for up to 90 days on a full charge, where it will actu-
ally come to the patient fully charged. The idea is that you get
all the benefits without having to do any additional work, and
we see that as our unique approach to solving the problem of
medication non-adherence.”
Mitch Maiman, president of Intelligent Product Solutions,
says that wireless medical devices are an emerging product
category that IPS is well prepared to handle. “One of the ar-
eas where we provide a lot of core competence is in smart and
wirelessly connected devices,” said Maiman. “Because of our
experience, a lot of us having been ex-Symbol, ex-Motorola
people, we have a lot of expertise in wireless communications
in all forms—everything from low level things like ZigBee and
Bluetooth, and near field, up to Wi-Fi and GPS and wide area
radio communications. There’s a lot more things going on, and
you’re seeing them all over the place in terms of connected
devices. This is an area where we have a lot of competence.”
Another consumer electronics trend that’s rolling into the
medical space is the increasing preference for wearable devices
with monitoring capabilities. Maiman also touts IPS’s capabili-
ties in this area. “When you talk about wearable, body mounted
and body worn technology, especially when you get into mis-
sion critical things, like in the medical space, this is where we
have a lot of domain expertise,” Maiman said. “There are a lot
of nuances to designing a wearable device that’s reliable, that
somebody can wear all day long and all night long, that they
can wear in all kinds of conditions—like when it’s 100 degrees
outside and 90 percent relative humidity. We’ve got a lot of
experience in what it takes to make devices that are reliable
over a long period of time, and in wearable devices that work
in those kinds of environments.
“We’ve worked in medication dispensing systems before and
we’ve done work in computer navigation methods for quadriple-
gics, who are unable to manipulate a cursor control, but yet they
need to interact with a computer,” he continued. “We’re doing
work right now on mobile and fixed mounted defibrillators. So
it’s a pretty broad range of products, but the common thread is
that there’s a lot of electronics, and they’re all smart.”
6. 63February 2015 • www.d2pmagazine.com
What to Look for in an
Electronics Manufacturing
Services Provider
Quality, a universal concern across
complex product manufacturing market
segments, is at the top of every medical
device manufacturer’s list of priorities
when selecting an electronics manufac-
turing services (EMS) provider. But it’s
also important to consider the location
of the manufacturer, the degree and
type of service and support that they
provide, and whether or not the person
you interact with is a high-level engineer,
according to a white paper recently
released by Oakland, California-based
Digicom Electronics. The white paper,
“What Medical Device Companies Need to
Consider in Selecting an EMS Company,”
was co-authored by Digicom executives
Mo Ohady, general manager, and David
Estes, engineering specialist.
“Although most EMS companies per-
form the same basic services, every EMS
is different,” explained Ohady in a release
from Digicom Electronics. “You can tell
when you walk into a place, examine the
equipment and processes, and speak to
the people. It’s important to use due
diligence in choosing an EMS company,
but the rewards can be great. A properly
functioning EMS brings decades of experi-
ence and knowledge to embrace and en-
hance the product you want to build in a
time-efficient and cost-effective manner.”
A big part of choosing a supplier in-
volves deciding if you want your product
to be manufactured close to where your
company is located, or close to where
the product will be distributed or sold,
say Ohady and Estes. Factors to consider
when weighing the location of a supplier
include the complexity of the device, the
need for intellectual property protection,
shipping costs and time, and the degree
of supplier involvement that you’ll expect
throughout the manufacturing process.
Manufacturing at a great distance
from home—say, the other side of the
world—can become a problem when a
production issue arises, Estes said in a
phone interview. “If you need to travel
there to resolve the problem because
the expertise to do that just doesn’t exist
at that location, then you’re looking at
maybe a $20,000 trip to travel overseas,
and the delays that that introduces.
And so being local allows a very quick
response to resolve an issue and get on
with production.”
Digicom, because of its location in the
San Francisco Bay area, offers a special ad-
vantage to local OEMs. “We are certified to
California standards, and so when you’re
building medical devices in California,
we are approved of,” Ohady said. “We are
registered with the FDA; that addresses
the U.S. built devices and those that are
distributed throughout the United States.
And the ISO 13485 [certification] tops
it by addressing most of the rest of the
world’s regulatory issues and compliance.”
Ohady got to know his colleague, Da-
vid Estes, when Estes was once a potential
customer of Digicom. At the time, Estes
was doing considerable research as part
of the process of selecting a manufac-
turer for a product that he was helping
to develop. “He has a very rich level of
experience,” Ohady said.
“I can say, from a device manufacturer
point of view, that selecting a manufac-
turer when one has little manufacturing
experience is really daunting,” said Estes.
“It’s very much like going out to buy a car
when you really haven’t driven a car; you
don’t have that experience. And so it’s
critical that you select a manufacturer
7. that’s willing to accommodate your lack of knowledge and exper-
tise. It almost is like an educational process that occurs between
the manufacturer and the company.
“If the manufacturer is very large and is used to working with
very large companies that have a lot of experience, they may feel
it’s a burden to take on this chore of educating and working with
a customer that’s new to manufacturing,” he continued. “The
advantage for the manufacturer, though, is that it’s a potential
win-win because as one learns new products and overcomes new
problems, this becomes part of the repertoire of the manufac-
turer. And so the manufacturer can actually gain expertise in new
technology by working with new companies.”
Digicom marketing representative Andrea Roberts said it’s
important to work with an experienced engineer who can look at
your boards, box builds, or devices and tell you if your design is
going to work—that is, whether it can be manufactured. During
the prototype phase, experienced engineers can provide ideas
about better ways to manufacture the product, she said. Later,
when you want to build the product in volume, they can tell you
if the prototype can be transferred to volume manufacturing.
“There’s a whole lot that goes into it—the sourcing and the
whole picture of Design for Manufacturability,” she said. “And
that’s why you really need an engineer to work with you, to see
if that design can actually become a reality.”
Quality is much more of a concern with medical devices
because poor quality can directly affect safety and lead to fatal
consequences. It’s important to know what types of inspection
and tests are performed by an EMS provider, whether they have
tracking mechanisms in place, and how clean their printed circuit
boards are, said Ohady. That’s because quality is directly related
to the cleanliness of the boards, an issue that Digicom addresses
in its white paper, “Cleanliness of PCB Assemblies Leads to Medi-
cal Device Reliability.”
In the paper, Ohady and Estes discuss the important role
that cleanliness of electronic components and circuit boards
play in preventing component failure, as well as the benefits of
the company’s Diamond Track Cleaning Process. The process,
part of the company’s Diamond Track Manufacturing program,
employs a proprietary combination of chemicals, temperature,
wash cycles, and timing to render circuit boards extremely clean
and includes stringent test and evaluation procedures.
“Independent tests showed that boards that went through this
[Diamond Track] cleaning process tested 75 percent cleaner than
the 10-2 micrograms/in2
specified by IPC as its highest level of
clean,” they wrote. “In addition, a lab analysis for ion contamina-
tion found zero levels of sodium chloride ion contamination on
the assembled boards.” (The IPC is a global trade association that
serves the printed board and electronics assembly industries.)
The level of cleaning attainable by the Diamond Track process
is said to eliminate failures caused by board contamination and
make products less susceptible to corrosion-induced failures,
reducing the need for maintenance or repair. Medical device
manufacturers that use the process can realize significant cost
savings as a result, according to Ohady and Estes.
“When we’re looking at the devices now being made for the
medical device industry, including all the wireless and implant-
8. able devices, it is time to take a new look at cleanliness standards
and the processes used in manufacturing to ensure that these
products do not fail,” they wrote.
3D Printed Patient-Specific Implants
Wireless medical devices aren’t the only technology that’s
facilitating the trend toward personalized healthcare. Another
key enabler—one that’s providing some of the most impressive
examples of customization—is 3D printing, now being used to
produce patient-specific implants for reconstructive surgeries of
the skull, face, jaw, spine, hip, knee, foot, and ankle.
But although 3D printing is the most visible step in a process
that reduces lead times, it’s actually part of a larger digital thread
that begins with a medical imaging study—usually a CT scan
or MRI—of the patient’s anatomy. The digital thread includes,
among others, a medical image processing step that builds up a
3D model of the anatomy from the 2.5D representations of the
imaging study. It’s that 3D model of the patient’s unique anatomy
that becomes the basis for 3D printing of a personalized implant.
One of the more interesting companies in the space is 4WEB
Medical, an implant device company headquartered in Frisco,
Texas, that is reported to be the first company to receive FDA
clearance for an additive-manufactured spine implant. Founded
by company president Jessee Hunt, 4WEB Medical has combined
the novel 4WEB geometry—a building block for creating high-
strength, lightweight web structures—with leading edge 3D
printing to develop a proprietary implant platform.
Surgeons have implanted more than 3,000 of the company’s
3D printed,
orthopedic
t r u s s i m -
plants, which
are designed
with a dis-
tinctive open
architecture
that report-
edly allows
for up to 75
percent of the
implant to be
filled with
graft material
to maximize
the incorpo-
ration of bone. The 3D printed implants also have a unique,
roughened surface texture that is said to promote bone adher-
ence and, by increasing coefficient of friction, reduce the pos-
sibility that the implant will move from its original position.
Other companies that have achieved prominence in patient-
specific 3D printing include ConforMIS, developers of a propri-
etary iFit Image-to-Implant®
Process (see page 68), 3D Systems–
Medical Modeling, known for its role in integrating 3D printing
into a comprehensive digital thread for personalized medical
implants and surgery, and Oxford Performance Materials, a spe-
cialist in the high performance polymer, PEKK, that has received
4WEB Medical recently announced that surgeons have
implanted over 3,000 of the company’s 3D printed
orthopedic truss implants. Photo courtesy of 4WEB
Medical.
9. 66 DESIGN-2-PART magazine • February 2015
FDA clearance for the manufacture of
patient-specific cranial and facial implants
(see pp. 71, 124, and 150).
Another company, veteran-owned
Osiris Biomed 3D, is preparing to offer
3D printed, patient-specific implants that
it believes can further reduce lead times
to surgery. The company’s proprietary
software is expected to facilitate real-time
production of customized implants from
patients’ medical scans. If approved by the
FDA, the technology reportedly will en-
able surgeons to design and print custom
implants for immediate use in surgery.
Osiris Biomed 3D has applied for a
patent for “single anesthetic reconstruc-
tive surgery,” which, the company says, will
allow a patient to be scanned and a custom
device or implant printed, sterilized, and
surgically implanted “on the operating
table,” all in one surgical procedure. The
company is preparing a highly mobile 3D
printing CONEX (contingency employ-
ment exercise) for the military that can
establish operating suites in a theater of
operations, reducing time to surgery for
wounded soldiers.
In a phone interview, Chief Operating
Officer Christopher Gerstle said that the
company will be initially using an FDM
(Fused Deposition Modeling) process
to ensure that, when starting to build
an implant, the build chamber is sterile
and contains no material from a previ-
ous build. “You’re extruding at very high
temperatures, which are sterile, and what
I refer to as the ‘nest within the box’ is
much more controllable at this point. So
it (FDM) is a good first step for us.”
Quick Response Manufacturing
Cuts Lead Times for Medical
Device OEMs
Gordon Knott had just gotten back
fromtheMD&MshowinSchaumburg,Illi-
nois,lastfallwhenweaskedhimwhattypes
of things the medical device manufactur-
ers who visited his booth wanted to know
about Alexandria Industries’ capabilities
for meeting their needs and solving their
engineering problems.
“The manufacturers we met with
asked about our lead times,” said Knott,
the medical market leader for Alexandria
Industries, a vertically integrated supplier
of engineered, customized aluminum ex-
trusions, as well as precision machining,
plastics molding, finishing, welding, and
assembly services. “Because we use Quick
Response Manufacturing (QRM), we are
able to offer some of the shortest lead
times in the industry, enabling us to com-
pete well with other suppliers.”
Quick Response Manufacturing, used
to cut lead times in all phases of manu-
facturing and office operations, allows
Alexandria to focus on the continuous
improvements of eliminating non-value-
addedwaste,improvingquality,andreduc-
ing cost. Since implementing QRM, the
company has reduced quote times from
12 days to three-to-five days, and extrusion
product lead times from 30 days to as little
as five days, Knott said. Significantly, QRM
has given Alexandria the opportunity to
gain a substantial foothold in markets,
including medical, that value short lead
times.
Medical is one of Alexandria’s prime
markets, accounting for “about 13 to
15 percent” of its total sales, said Patty
Hoffman, the company’s marketing and
communications specialist, in an interview
with D2P. “It’s not our biggest market, but
it’s definitely one of our larger ones, so
it’s a significant industry for us.” That’s
not surprising, given the company’s loca-
tion in Minnesota, one of the nation’s top
states for medical device innovation, and
its proximity to a thriving medtech hub—
Minneapolis/St. Paul—a little more than
10. 67February 2015 • www.d2pmagazine.com
130 miles to the southeast on Interstate 94.
Alexandriamanufacturesawidevariety
of components for the medical industry,
including components for durable and
electro-medical equipment. This includes
structural components for mobile or
stationary diagnostic equipment, moni-
tors, heat sinks, IV poles, medical carts,
structural equipment, X-ray systems, and
CT systems, among others. Knott said that
all of Alexandria’s manufacturing capabili-
ties are well-suited to address the product
development needs of its medical industry
customers, but customers typically choose
the company’s aluminum extrusion, preci-
sion machining, and welding services.
Having partnered with a number of
local medical device makers, Alexandria
Industries has developed a good un-
derstanding of some of the biggest con-
cerns that medical device manufacturers
have—and the constraints that they’re
up against—when attempting to bring a
medicalproducttomarket.Otherthanthe
high cost of bringing a product to market,
medicaldeviceOEMsstrugglewithmanag-
ing their supply base and making sure that
their products are safe to use, Knott said.
“Medical OEMs often need to manage
hundreds of suppliers, which is costly and
time-consuming,” he explained. “Add to
this the increasing trend in mega-mergers
and acquisitions, and an OEM’s supply
basecandoubleortriple.Themoresuppli-
ers, the more time, money, and significant
effort it takes to evaluate, qualify, and keep
a supplier list held to a manageable level.
“Product safety is also a top concern
for medical device OEMs,” he continued.
“Many medical products have movable
parts that interface directly with patients,
and anything that could potentially cause
harm—pinch, stab, or tip over on a pa-
tient—needs to be addressed. Medical
device manufacturers need to make sure
their suppliers know which parts and com-
ponent dimensions are essential to patient
safety and function. They will require that
suppliers identify dimensions that are es-
sential to safety.”
Alexandria’s ability to operate as a
one-stop component shop—a vertically in-
tegrated supplier that offers OEMs a single
source to design, produce, assemble, and
deliver a range of components—has direct
and positive implications for both cost and
lead time, two of the foremost concerns
that medical device companies have when
bringing a product to market. Medical
device OEMs who outsource component
manufacturingfrommultiple—often,hun-
dreds—of suppliers face stiff challenges
in managing these complex relationships
and purchasing processes, which can take
a heavy financial and logistical toll on their
resources. This ultimately slows product
time to market and drives up the cost for
the company.
“Instead of interacting with several
different suppliers, OEMs should find
a supplier who can help simplify their
supply chain needs by offering a range of
complementary manufacturing services so
they can do more of the work for them,”
Knott said. “OEMs should seek a supplier
who also offers value-added services, such
as design engineering assistance and ad-
vanced geometric dimensional accuracy,
to help reduce their time to market even
more.”
Executingonitsvisionofbeingasingle
source, vertically-integrated supplier of
“high quality, short lead-time engineered
products,” Alexandria Industries acquired
the plastic injection equipment assets of
a North Dakota-based manufacturer of
injection molded components in 2012.
These assets, as well as TIG and MIG weld-
ing services, were rolled into Alexandria’s
Wheaton, Minn., facility.
Knott also stressed the importance of
evaluating suppliers based on total-cost-
of-purchasing criteria instead of the cost
of the parts. That’s why it’s important to
seek suppliers that combine their manu-
facturing expertise with value-added ser-
vices like ease of purchasing, engineering
assistance, finishing, and assembly, he
said. For more on Alexandria Industries,
see page 74.