Explore North America’s Largest Annual Medtech Event

What are you doing February 6-8, 2018? How about coming by to visit with people from Creation Technologies manufacturing and design teams at Booth 546 at Medical Design & Manufacturing (MD&M) West ?

It’s going to be quite an event this year, and we’re really looking forward to reconnecting with industry friends as well as meeting new people. MD&M West is always a great place to solve existing challenges and be inspired by everything new in the MedTech industry.

At MD&M West you’ll find the largest showcase of MedTech suppliers in the country, plus a full spectrum of solutions across the advanced design and manufacturing supply chain. Whether you’re interested in product design, new materials, intelligent sensors, testing solutions, components, packaging, or anything else needed to bring your concept to market, you can source from more than 2,000 cutting-edge suppliers in a time-saving format. Free presentations, interactive events, and fun activities throughout the expo make this a can’t-miss event.

Featuring its biggest program yet, the MD&M West conference will deliver four tracks of expert-led MedTech education you won’t find anywhere else — plus additional smart manufacturing and 3D printing programs — all with unlimited track hopping.   This year MD&M offers a full day of conferences focused on Medical Device Security.  This rigorous conference program will address security and privacy challenges for connected healthcare devices.

This is your chance to get up to speed with the strategies and techniques that turn concepts into competitive products. Curated with the help of an expert advisory team, this unmatched program is made by the industry for the industry and packed with information crucial to every stage in the development process.

Learn about Creation Technologies’ flexible model, integrated solutions and dedicated Customer-Focused Teams and how we offer a complete customized solution that delivers what our customers need…their way. Creation’s experience and robust systems help OEMs avoid costly surprises, get to market faster and scalability to achieve your business goals.

We would love to meet you and learn more about how we can help you meet your future goals. Drop by Booth #546 and learn how we do it.

You can use our Promo Code:  Special when registering and receive a free Expo Pass or 20% off Conference Pricing

Hope to see you there!

 

The ROI of UDI Legislation…Is There Any?

med-device-coded-3

As Director of Regulatory & Quality for Creation Design Services, I continuously ask the question, “Is there value-add with the new UDI System?”

The regulations to make medical devices safer and with the highest possible quality are constantly evolving. A good example of this has been the implementation of the Medical Device UDI System.

The Food and Drug Administration (FDA) UDI System focuses on labeling medical devices with a unique device identifier (UDI) in human and machine-readable format. The legislation came into effect in 2013 and the implementation period continues until 2020. If you’re a regulatory professional in the medical device industry today, most likely UDI compliance is part of your daily conversation.

According to the FDA, a primary initiative behind UDI labeling is to improve device traceability throughout the life of the product in order to:

“Improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation”

However, validating that claim can be challenging.

How can the industry measure the ROI for UDI implementation?

 

Measuring the Benefits of UDI Labelling

Here are three tangible metrics that can be possibly used to gauge the benefits of UDI labeling:

  • Adverse Events – a reduction in future Medical Device Reporting (MDR) would suggest problem devices are identified and recalled earlier with UDI tracking.
  • PMA / 510(k) approval and clearance process time – UDI provides diligent post-market monitoring and analysis of medical device applications to support new uses and new medical benefit claims.
  • Device Recalls – UDI can quickly track down locations of end users for stop-use/ recall bulletins.

Adding UDI information to a patient’s electronic health record (EHR) may also improve the efficiency of health care insurance claims. In a recent letter from the Centers for Medicare & Medicaid Services (CMS), UDI information may “improve device oversight and monitoring and support more robust research”, however, according to AAMI and the U.S. Department of Health and Human Services, changes in workflow and updates to the billing and claim process would have to be implemented before this could happen. And this is a financial and resource burden the CMS apparently would not be willing to absorb themselves at this time.

 

Analysis and Prevention: ROI from a Holistic Approach

So will the UDI requirement provide additional patient safety? And is there a monetary benefit to gain as well?

I believe there are clear benefits of the UDI legislation, however, simply placing a new label format on a device will have little effect if the whole global supply chain and healthcare industry miss their cues.

In my mind, there are two key elements.

1. Good data and strong analysis with actionable correction

The onus falls on field reporting. Period.

ROI will only be realized with accurate identification of questionable devices and timely reporting of adverse events.

Traceability, swift recalls, root-cause analysis of failures and unambiguous conclusions are paramount to the success of the UDI program.

2. Harm Reduction as part of the bigger picture

Reducing the number of adverse events can decrease the cost of healthcare for all of us.

When a patient is injured or dies due to product or user negligence, the cost of litigation is passed on to you and me. According to U.S. mortality statistics, preventable medical errors claim 400,000 people each year. It’s one of the top killers in the U.S., third only to heart disease and cancer, costing a staggering $1 trillion each year.

So as a regulatory professional, advocate of the FDA’s UDI vision, and occasional patient, I look forward to finally seeing the benefits of a fully implemented system.

I believe that ROI will come via: faster FDA premarket notification and approval submissions, a reduction in harm from misuse of a medical device, and a reduction in overall healthcare costs.

 

UPDATE (October 27, 2016):

Creation Technologies recently launched its FDA UDI Compliance Program in their global manufacturing and design operations. In a move to ensure medical product safety and quality, all ten of Creation’s manufacturing locations will now require FDA UDI compliance and labeling for all Class I, Class II, and Class III medical devices.

Read the full press release here.

 

3 Questions Medical Device OEMs (Should) Have for New Contract Design and Manufacturing Partners

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Today, it’s more common than ever for medical device OEMs to outsource significant portions of their design and manufacturing. The medical industry’s many regulations make this process especially complex.

As Director of Regulatory & Quality for Creation Design Services, I’m often asked about our capabilities across the product life cycle from design through after-market support. Here are a few questions I hear often.

 

1. Do You Have Proven Medical Experience?

The bottom line is, medical device OEMs want a partner with experience – especially regulatory experience.

Off the bat, they are probably going to ask about our FDA-registered product portfolio. They want to see that we have experience working with other companies in the industry.  Much of this information is actually public knowledge that can be found on the FDA website.

Medical OEMs are also looking for regulatory expertise that spans the entire product lifecycle – a partner that can take a drawing on a napkin and see it through to manufacturing transfer, all while meeting FDA requirements. That positions them for a successful 510K or PMA submission experience.

 

 2. Can You Provide Manufacturing AND Design Services?

Creation’s customers today want a full turnkey solution. They are looking for support from the minute they walk in the door with an idea, through the shipment of their first manufacturing pallet, to sustaining engineering at a product’s end-of-life.

Why?

  • Flexibility

A design partner offers medical device OEMs an immediate, expert way to supplement their product development teams.

This could mean adding capacity in existing areas to meet time and cost targets.  This could also mean adding functional expertise in product development, test fixture design, test engineering, component obsolescence redesign, value engineering, etc.

  • No Nasty Regulatory or Quality Surprises

Experienced design engineers who understand the regulatory documentation and submission process help make the transition into manufacturing seamless.

Experienced manufacturing teams who understand the regulatory requirements in a volume production environment help keep auditors and end customers satisfied and safe.

When both the design and manufacturing teams are working cohesively and have a standardized process, any issues can be easily and proactively identified, communicated and solved.

  •  Saving Time and Money

An integrated design and manufacturing team streamlines the New Product Introduction process and ensures consistency from cradle to grave.  From accelerated speed-to-market to higher-quality products, this saves medical OEMs both time and money.

 

3. Can You Support My Product Once in the Field?

Attention to a product shouldn’t end when the device leaves the manufacturing floor. Every medical OEM should target EMS providers that offer after-market services like firmware upgrades, repairs, routine calibration and service.

After all in the medical industry, an OEM can’t tell their customer, “Just put it in a box and send it back to us.”

From a regulatory standpoint, the product needs to go back through a formal process. All modifications must be documented in the DHR – Device History Record – and the provider must be able to provide a detailed record of those changes that are traceable, by serial number, back to that device.

After-market and end-of-life support processes must also take health and safety into account. For example, repair or calibration procedures may need to include decontamination or similar elimination of risk – both to the provider’s employees as well as to the ultimate end user.

At the end of the day, medical device OEMs can trust their outsourcing only to an experienced EMS provider that understands the product life cycle requirements of this highly regulated environment. Questions like these help companies qualify new outsourcing partners. 

Lucky for me that in my role at Creation, I get to say ‘Yes’ to all three.

 

To learn more about Creation Technologies, be sure to attend Getting More Bang for Your Buck: Innovating within Cost Constraints” , at BIOMEDevice in Boston, MA on April 14, 2016.

 

Creation Technologies Achieves Milestone Company-Wide ISO 13485 Medical Device Certification

Medical equipment in the ICU ward in hospital

In the medical device industry, the reliability of a product is critical for patient safety. If a device has design flaws, missing due diligence documentation, or perceived gaps in compliance, an OEM’s credibility and ability to deliver a high-quality and safe product on deadline comes into question in the marketplace.

At Creation, we understand the importance of our customers’ brand equity. Every day, I get to see the commitment our manufacturing teams have to delivering high-quality products on time. Maybe more importantly in my role as a Director of Quality and Regulatory, I also see how we analyze and provide evidentiary documentation to meet and exceed the compliance standards required in the highly-regulated medical device industry.

I’m very proud that Creation Technologies has achieved our strategic milestone to provide third-party validation of our high-reliability and quality inherent to successful medical device manufacturing and design. Today, I’m excited to say that all Creation global manufacturing and design locations now have ISO 13485 Certification.

The ISO 13485 Certification is an internationally recognized quality standard for medical devices and diagnostics. With this thorough and effective quality management system in place company-wide, I know that our customers can continue to count on us to commercialize their innovative products that have the utmost consideration for long-term patient safety and sustainability in the marketplace.

Read the full press release here: http://www.prweb.com/releases/2016/02/prweb13208185.htm

3 Areas for Improvement in the Medical Device Industry in 2016

smart medical doctor hand drawing network with operating room as concept

These are exciting times to work in healthcare. With advancements in research and innovation, the medical device industry continues to push the envelope, saving lives and improving the quality of living for people across the globe.

But even with all of the game-changing products that have been recently introduced such as LifeWatch’s Mobile Cardiac Telemetry (MCT) patch, or Medtronic’s new superDimension lung navigation software, there are still many barriers and process inefficiencies that are detrimental to innovation.

As Director of Regulatory & Quality for Creation Design Services, I see both the technical and business challenges of taking new medical products to market every day. As we begin the new year, I’d like to share my view of three ways we can do better.

 

1. Address the High Cost of Regulatory Requirements

Whether we’re talking about medical devices, pharmaceuticals, or veterinary medicine, medical companies are constantly challenged to keep up with the never-ending changes to regulatory requirements. As a quality and regulatory professional, I am constantly thinking about these changes and their impact.

For example, there are costs associated with allocating resources and time to understand any new legislation and standards.

There are costs associated with acquiring new certifications themselves, not to mention all of the preparation, due diligence and training that must come first.

There are costs associated with providing ongoing training for your people.

Depending on the number and type of products produced, and the number of people you employ, these costs are not trivial and can run into the millions.

And passing these costs onto the consumer, or worse, the costs of non-compliance, may take you right out of competition.

How would costs of compliance be altered if softcopy standards were public domain? Or if “eLearning” were entirely non-profit?

 

2. Reduce Lengthy Delays in FDA Premarket Notification / Premarket Approval

There are substantial delays in the process of marketing a medical product in the United States from FDA submission to approval. A device with a predicate, for instance, can take 180 days for the FDA to grant clearance to market. Class 3 devices requiring premarket approval can take even longer.

These delays can result in loss of potential revenue, leading to increased unit costs because of amortization.

And what about the loss of potential benefit to society?

Because of these costs and delays, some innovative products never get to market.  Both startups and Fortune 500s alike elect not to pursue some concepts because of this barrier to market entry.

What would happen if the FDA hired more submission reviewers?  Or if the FDA addressed existing internal administrative hurdles?

 

3. Simplify Complex and Fragmented Global Legislation

There are many quality and regulatory legislative requirements around the globe. Some of these are region-specific.  Some are industry- or product-specific.

As much as the International Organization for Standardization (ISO) advocates a homogeneous approach to regulatory requirements, this harmonization is not yet a reality.

For example, the FDA 21CFR820 regulation versus the ISO 13485 standard. These two requirements are very similar, however will most likely never merge. For those wishing to market in Japan on the other hand, the requirements of the Pharmaceutical and Medical Device Law (PMDL) must be independently met.

Comprehending, executing and sustaining the in-depth requirements of multiple standards is a constant burden.

If a globally harmonized standard existed, how else could these time and resources be spent?

 

Looking Forward in 2016

In conclusion, can the industry be more Lean, while still maintaining public safety and integrity?

How can we apply the Theory of Constraints to the industry as a whole?

Without a doubt, the medical device industry matures each year and while I look forward to the advancements in 2016, there is always room for improvement. Imagine if companies did not have to worry so much about barriers, but rather, focus more time into innovation and collaboration. The possibilities could be limitless.

What are your biggest Medical design and manufacturing headaches?  Drop by
our Booth #571 at MD&M West in Anaheim, CA on February 9-11

 

 

Innovation, Influence and Impact: An Interview with MedTech’s Jessica Crawford

I had an opportunity to catch up with Jessica Crawford, President of New York-based MedTech, heading into the week of MEDTECH 2015. Jessica and I discussed today’s most significant opportunities and business challenges for bioscience and medical technology OEMs.

 

MedTech's Jessica Crawford Interview with Creation Technologies

Janelle Urchenko: Tell us more about the origins of MedTech. I understand it grew from the idea of transforming Upstate New York into a knowledge-based economy.

Jessica Crawford: MedTech was founded in 2004 by four New York State bioscience and medical technology (Bio/Med) companies – Bristol-Myers Squibb, ConMed Corporation, Sensis Corporation (acquired by Saab in 2011), and Welch Allyn.

MedTech was formed at the urging of then New York Senator Hilary Clinton in response to an economic development plan recommending closer collaboration among medical products and services firms to help grow the region’s knowledge-based economy. The idea was that by acting together we would have greater success, benefitting industry as well as the entire region with more knowledge-based jobs, which are higher paying with greater economic impact.

Our mission is really an economic development one – forming an epicenter of Bio/Med activity by developing the relationships, tools and programs that enable New York State companies to bring tomorrow’s medical solutions to the healthcare marketplace.

MedTech provides a single voice for the Bio/Med industry and also encompasses the entire ecosystem – from innovators to suppliers and academic research to service providers – providing a vehicle for collaboration and the sharing of best practices.

 

JU: What’s your vision for the evolution of this ecosystem, and how is it relevant in today’s changing economic climate?

JC: This couldn’t be more relevant than in today’s dynamic industry landscape. In today’s ever-evolving healthcare marketplace, identifying untapped potential is essential for success.

Partnerships emerge through investments, consolidation and public-private collaborations, bringing together payers, providers and patients to improve care and reduce costs.

At the heart of this convergence is creativity, building momentum for growth. Through purposeful collisions – industry and academia; entrepreneurs and business leaders; domestic and abroad – convergence drives progress through the development of new technology, product enhancements and radical innovation.

MedTech will be highlighting this and more at our annual conference, MEDTECH 2015 “Convergence: Building Momentum for Growth” on October 14-15 in Buffalo, NY.

 

MEDTECH 2014

 

JU: We’re certainly looking forward to some great discussion, and maybe even a little debate, at the conference!  Also to meeting new people from other MedTech member companies. What is it about New York that attracts medical and biotech businesses? And how are these companies leveraging the growing MedTech community to engage their customers in the area and beyond?

JC: New York is among the top tier of states in the size of its bioscience industry and the scale and reach of its bioscience research complex.

Here are some of what I think are very exciting stats:

  • State firms employ nearly 75,000 in the biosciences.
  • New York’s academic institutions conducted $3.5 billion in bioscience academic research and development in 2012.
  • State institutions, both academic and non-academic, have received $1.9 billion in funding from the National Institutes of Health in 2013 alone.
  • New York inventors were issued nearly 6,400 patents from 2009 through 2013 in bioscience-related technologies.
  • In each of these key metrics of the scale and innovative nature of the biosciences, New York is among the top 10 states. (From Battelle/BIO State Bioscience Jobs, Investments and Innovation 2014)

MedTech connects New York State’s Bio/Med industry through collaboration, education and advocacy. MEDTECH 2015 is a prime example. It draws more than 300 decision-makers from throughout the industry, and offers unmatched opportunities to strengthen and build new relationships with industry leaders and meet new partners, resources and customers. Our signature Collaboration & Growth Track also offers partnering opportunities with some of our industry’s foremost companies, this year including Air Liquide Healthcare, AMRI, Johnson & Johnson and PARC – a Xerox Company.

We’re also very excited that this year’s conference is in Buffalo, NY. The energy and momentum surrounding the Bio/Med industry in Western New York is palpable and is a testament to the capital infusion by New York State and local industry into its downtown core.

In the last five years alone, Western New York has experienced a four percent growth in Bio/Med employment, yielding $5.6 billion in total economic impact.

 

MEDTECH 2014 -2

JU: MedTech’s focus seems to be on community, scalability and tools for success in today’s competitive marketplace. With regard to tools — how are MedTech companies measuring success these days? Is the focus still on speed to market, or are you seeing a shift with new competitive pressures?

JC: With the onset of the Affordable Care Act, the business of healthcare has changed dramatically as the focus has shifted to health outcomes and behavioral changes.

For example, information-leveraging technologies including smartphone applications and sensors are empowering patients with transparent information and giving them more control over their health. Further, to help reduce costs and improve quality, companies are changing the way they innovate and identifying efficiencies in production.

Our Manufacturing Innovation” panel at MEDTECH 2015 also features industry experts, including, as you know, Creation Technologies President and CEO Bhawnesh Mathur.  This session will examine how new technologies, partnerships and initiatives in manufacturing are reducing costs and production time, while also developing custom solutions including personalized devices, prototypes and injection molding.

I’m looking forward to hearing Bhawnesh speak to new industry trends and resources that you are leveraging for your customers, as well as how Creation’s customers are innovating for their own marketplaces.

 

Creation Technologies Medical Devices

JU: MedTech talks about the vibrant community at its epicenter. Is there a success story you can share? What do you think are the indicators of a successful relationship?

JC: MedTech means different things to each of our members. Consequently, success or value for one may mean something completely different to another.

Member Bill Rader, president and CEO of Efferent Labs, Inc. participated in a MedTech Metro event in 2014, making a presentation on his development stage bio-device company focused on implantable biosensors. Someone in the audience followed up with him afterward and encouraged him to apply for the 43North Competition – the world’s largest business competition with $5 million in cash prizes.

Bill took the advice and applied. He later learned he was a semi-finalist and ultimately took home second place and $500,000 and more in cash and incentives to locate in Buffalo, NY.

Efferent Labs, Inc. is now on the fast track toward success – made possible through a MedTech connection.

 

JU: Back to the origins of MedTech and its goals – this year’s MEDTECH 2015 conference surfaces some new areas of focus like, “How to Play Nice with Others”.  What is your prediction for medical device companies in the next year?  What might be some hot topics at MEDTECH 2016?

JC: The theme for MEDTECH 2015 is focused on convergence and how new industry trends are leading to unique opportunities for partnering and investment. To remain competitive, industry stakeholders including payers, providers and patients, are coming together in novel ways.

Consolidation has become the norm as bigger appears to be better in the post Affordable Care Act world. Traditional consumer giants like Google and Samsung with either technical expertise or market share are also leveraging strategic partners to enter the Bio/Med industry. This paradigm shift is heating up competition and creating unique opportunities for collaboration.

This year’s “How to Play Nice with Others” panel discusses emerging channels for consumables and the repurposing of technology to appeal to varying populations, as well as the challenges that arise from new players entering the healthcare market.

And it’s unlikely that these trends are behind us.

Provider systems around the country are following payers’ moves, also entering into new relationships at a feverish pace. Just this year, Barnabas Health and Robert Wood Johnson Health System combined their 11 hospitals to form New Jersey’s largest health system and Prime Healthcare Services’ takeover of six-hospital Daughters of Charity Health System. And private practice acquisitions are happening daily in the health delivery space.

MEDTECH 2016 will continue take on these trends and more when we return to Albany, NY next fall.

 

If you haven’t already registered, it’s not too late! I believe there are still a few tickets left for MEDTECH 2015, which you can get by contacting events@medtech.org.

I’m looking forward to hearing all about MEDTECH 2015 from Jessica and the folks at MedTech, as well as from Bhawnesh and the other Creation folks who are attending.

If you missed it, Bhawnesh shared a sneak peek here of his thoughts around the complex subject of Manufacturing Innovation in medical devices.

And maybe Connie Griffin will publish a recap to go along with her lead-up post to the conference that presents an interesting perspective on the impact manufacturing and the medical community are having on revitalization in New York State.

 

The Innovation Challenge: Creation Article in Medical Design Technology

When it comes to medical devices, the subject of innovation is very complex. With drivers like government spending, a complicated regulatory landscape, the Internet of Everything and the personalized patient experience, there’s a lot to talk about.

It’s no wonder that MEDTECH 2015 features a panel of experts discussing Manufacturing Innovation!

We’re excited that Creation’s President and CEO, Bhawnesh Mathur, will be among these experts in Buffalo, New York, this Thursday.

Want a sneak preview of Bhawnesh’s thoughts?

Here’s his article published this morning in Medical Design Technology:


Innovation Challenge for Medical Device OEMs: Creation Technologies Bhawnesh Mathur

Innovation Challenge for Medical Device OEMs: Navigating the Regulatory Environment

 

 

Innovation and Manufacturing Fuel Economic Renewal

Early in my career, a big part of my job was to coordinate company involvement in various trade shows across North America. I have worked hundreds of industry and association events over the years. As a result, most tradeshows and conferences can look the same to me and I rarely get excited to attend.

However, I am truly excited to attend the MEDTECH 2015: Convergence | Building Momentum for Growth conference in Buffalo, NY on October 14th and 15th. Here’s why.

Passion for Innovation

My excitement is both personal and professional. I’ve enjoyed my career in engineering and manufacturing over the years because I enjoy seeing how things are made. You could say that innovation truly inspires me.

For Creation Technologies and so many within the electronics manufacturing industry, we believe innovation is at the core of commercialization and manufacturing success. Without new ideas driving new technologies and new products, there would be no manufacturing sector. We’d lose a big economic driver.

Economic Opportunity

Over the last 10 years, there have been significant shifts in manufacturing in North America. I’ve travelled across many provinces and states, visiting businesses in small towns and big cities. I’ve been witness to the struggle of businesses and have seen the very real impact on local economies when a company is forced to close its doors, as well as the impact on people and their families when those jobs are lost.

The entire premise of MEDTECH 2015 is to bring together brilliant minds in healthcare, sharing new ideas and technologies that will elevate the medical industry to new levels. MedTech member companies are innovative and bringing new products to market. As a result, MedTech member companies are growing and creating new employment opportunities across the New York State and beyond, which is a good thing for everyone.

Medical Industry Driving Renewal and Growth

I am excited that Creation is a member of MedTech, and we are looking forward to great discussion at the conference in Buffalo.

I look forward to hearing the thoughts of Bhawnesh Mathur, Creation’s President and CEO, as he discusses the theme of Manufacturing Innovation as part of a panel of experts.

I also look forward to learning more about the cutting-edge technologies and products in development by our OEM customers.

Creation Technologies’ mission statement is to ‘enrich lives’ and we are proud to support MedTech and its innovative member companies. There is no doubt the ideas shared at MEDTECH 2015 will spark change and revitalize communities.

And that’s something to get excited about.

Healthcare’s Slice of IoT: Wirelessly Connected Medical Devices

Connected Medical Devices and IoT
Connected Medical Devices and IoT

The billion-device, billion-dollar Internet of Things (IoT) holds the potential to dramatically transform healthcare.

Wirelessly connected medical devices increase patient mobility while giving healthcare professionals real-time access to patient data, throughout the hospital, and at the point of care.

Devices that were previously tied to a computer can now communicate wirelessly with one another using Bluetooth, ZigBee or over a hospital’s existing Wi-Fi network.

Today, for instance, an EMG machine used to detect neuromuscular abnormalities can wirelessly transmit critical-care data to other local devices or maintenance data back to the OEM.

This stream of information provides an optimal experience for users, while enabling medical device companies to improve product functionality.

Connected Medical Devices: Risk and Reward

Connected medical devices hold tremendous promise for medical device manufacturers. According to the Groupe Speciale Mobile Association (GSMA), network-enabled medical devices represent a potential revenue opportunity of $6.6 billion.

Medical OEMs, however, face particular technical challenges when it comes to the IoT and connected medical devices.

  1. While integrating sensors into a toaster can produce a handy consumer device, safely and securely integrating wireless connectivity into a new or existing medical device can be life-saving.
  2. Wireless connectivity also adds a new level of complexity to medical device design and development.The FDA recommends that medical OEMs take the following into consideration:
    • Selection of wireless technology
    • Quality of service
    • Coexistence
    • Security
    • Electromagnetic Compatibility (EMC)
  3. Design validation must also include risk analysis of the RF wireless communications and control functions.
  4. Determining the best wireless scheme also depends upon a device’s unique environment, as well as the required level of privacy support and cybersecurity.

It’s important to note that not all devices need to connect to the Internet; they may simply need to connect to a few other local devices. Different schemes also have varying password and encryption methods.

Improving the patient experience with wireless medical diagnostics
Improving the patient experience with wireless medical diagnostics

Connectivity Know-How

Through stringent device testing, design validation, and the verification methods necessary to meet regulatory requirements, EMS providers with wireless communications expertise can help medical OEMs overcome the unique challenges of wireless-connectivity integration.

With Creation’s long history of providing innovative design, manufacturing and test solutions for complex Communications products, over the last few years it’s been a rewarding experience for us to leverage this knowledge to help our Medical customers produce new devices quickly and reliably.

Safely and securely reducing time-to-market while reducing risk never felt healthier.

If you’d like more information about how we can help you with product development or manufacturing improvements for connected medical devices and M2M, please visit our website or let me know!

Proud to Build CardeaScreen’s Life-Saving Medical Device

Breakthrough Hand-Held CardeaScreen ECG Diagnostic Medical Device
Cardea Associates’ Breakthrough Hand-Held CardeaScreen ECG Diagnostic Medical Device

At Creation, a core element of our Purpose is enriching lives. Some days, we even get to save them.

A Breakthrough Medical Device

Sudden Cardiac Arrest (SCA) is a leading cause of death among adults over the age of 40. In the U.S. alone, more than 1,000 cases of SCA are reported per day, many of them in sport participants. Though the exact numbers are still undetermined, young people also suffer from SCA. The disease is fatal for 9 out of 10 people.

Thankfully, there are ways to identify risk and test for abnormal cardiac conditions.

Cardea Associates, founded by David Hadley, PhD and Victor Froelicher, MD, has developed a breakthrough, hand-held electrocardiographic (ECG) device that makes cardiac screening easier than ever before.

Developed with athletes in mind, the FDA-approved CardeaScreen ECG device provides affordable, high-quality diagnostic data that identifies life-threatening, quality of life-limiting cardiac conditions.

In other words, CardeaScreen helps save lives.

To build their ECG systems, Cardea Associates partnered with Creation Technologies. Today, we’re manufacturing these amazing medical devices in our Vancouver, Canada business unit.

In the Nick of Time

The Nick of Time Foundation has a mission to protect kids from SCA through education, legislation and free cardiac screening. Cardea Associates is a Nick of Time Foundation partner supporting this great cause.

In February, the Nick of Time Foundation used CardeaScreen devices built by the Creation team to conduct an onsite screening at Meadowdale High School in Washington State. Out of the 555 young hearts that were screened, 8 students were identified for immediate follow-up with 11 more for follow-up over the next year.

This screening helped to save the life of a 14-year old boy.

Jennifer Both shares her story and her thanks:

“I want to thank you so much for your part in bringing the Nick of Time Foundation heart screenings to MHS. I wound up bringing my two sons, ages 14 and 12 to the screening for a “routine” heart screening, thinking we would be in and out in a flash. It turned out a bit different than I had expected, but I am very grateful for this. My 14 year old wound up with three abnormal EKGs followed by an echocardiogram that showed he has a congenital heart defect!

I spoke with the cardiologist from Children’s Hospital and he explained that my son has WPW Syndrome, an electrical defect that usually doesn’t show up until adolescence or young adulthood. He has his follow up appointment for further testing this week.

I am a very proactive parent, and had seen symptoms in my son for two years. For the last two years he has complained of dizziness, light headedness and heart palpitations. I have even picked him up from his middle school because he was “sick”. The school secretary said he didn’t have a temperature, but he was lightheaded and pale. He just didn’t “seem” right, she said. I took him to his primary care physician, who listened to his heart and said it sounded fine. He suggested that he was an anxious child. From that perspective, I agreed and we went on about our business. Unfortunately, a routine doctor exam doesn’t include an EKG, and his heart defect was missed.

If it weren’t for all of you folks, I shudder to think what might have been for my family, and other families whose kids were diagnosed with heart problems that day as well.”

The Creation team is so proud to have amazing customers like Cardea Associates. The Creation–Vancouver team, in particular, is grateful to have played a part in helping the Nick of Time Foundation and CardeaScreen devices help the Both family.

Our Creation Technologies Vancouver team that builds the CardeaScreen medical device
Our Creation Technologies Vancouver team that builds the CardeaScreen medical device

A postscript for sports fans…

In addition to being used for screening in high schools in the greater Seattle region through the Nick of Time Foundation, CardeaScreen is used by a wide range of college and professional sports teams, including Stanford University, University of Washington, San Francisco 49ers, Golden State Warriors, San Jose Sharks, San Jose Earthquakes and Baycity Bandits.

Read more FAQs on the CardeaScreen website.

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