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!

 

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.

 

Beyond Design and NPI: Lifecycle Visibility Yields Cost-Savings for Medical Device OEMs

Stethoscope Laying on Stacks of Hundred Dollar Bills with Narrow Depth of Field.

In the medical device industry, there can sometimes be a disconnect in both the priorities and collaborative communication between design engineering and manufacturing operations teams.

This disconnect can be significant to a medical device OEM’s bottom line, especially when time to market is delayed and unnecessary supply chain costs accumulate quickly.

I’ve been fortunate enough to work in both the product design and electronics manufacturing world. I recently had the chance to speak with Editor in Chief of PlasticsToday, Norbert Sparrow, about medical device design strategies that I’ve seen make things much easier for development and commercialization teams, including:

  • Front-loading design work through ‘hobbyist’ platforms
  • Having a structured process in place when working with regulated industries
  • Gaining a thorough understanding of the manufacturing process including supply chain

I’ll be talking more about this at the BIOMEDevice exhibition and conference in Boston on April 14th.

I’d love to hear your ideas to make the commercialization process easier for all involved, and hope to see you there!

 

Read the full PlasticsToday Article

 

Speed and the Bottom Line: Rapid Prototyping is a Fiscal Game Changer

Breadboard and Jumper Cable Wires close up on white background

We have all heard the buzz around 3D printing as a tool for prototyping and low-volume manufacturing. As 3D printing technology progresses and becomes more accessible, demand is expected to jump from $1.3 billion in 2012 to $5.2 billion in 2020.

Being new to Creation Technologies – and the electronics manufacturing industry – I assumed that when our OEM customers mentioned “rapid prototyping”, they meant 3D printing. This isn’t the case.

In our industry, Rapid Prototyping refers to an accelerated product development model, and most of the time it’s done without a 3D printer.

So What is Rapid Prototyping?

Rapid Prototyping is designed to get new products out to market in the quickest and most efficient manner. Companies that offer Rapid Prototyping services, find ways to significantly condense the new product development cycle, through either technology or in-house expertise.

OEMs in the electronics manufacturing industry are typically looking for experienced companies that can assist them with product documentation, complete test strategies, supply chain demand, and DFX services.

When done right, rapid prototyping can increase an OEM’s top-line revenue and extend their product lifecycles by ensuring that their product features at launch are actually the features their customers need.

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Get to Market Faster

“If you are not first you are last.”

This is the reality when it comes to new product introduction. With ramped up competition and technology advancing daily, businesses – both startups and established – need to get their new products to market quicker, smarter and as cost efficiently as possible.

Making good decisions early can create the competitive advantage companies need to maximize revenue opportunities. Rapid prototyping can help.

Look at a company like Xerox. Last year, with printer sales declining, the company adopted a rapid prototyping approach to streamline their production cycle for their value-added services.

Xerox focused on smaller, more customized projects so that they could give (and get) instant feedback early in the process. With the help of this rapid feedback loop, products like the Digital Nurse Assistant were commercialized several months quicker than it would had Xerox opted for a more traditional approach.

Million-Dollar Errors in New Product Development

Regardless of whether they build in-house or outsource, OEMs need to maneuver through industry requirements, eliminate costly design mistakes, and ensure quality early in the process.

Rapid prototyping is a smart option for OEMs looking to do this quickly, especially if they leverage a partner that is rich in end-to-end expertise. (Did I mention that Creation Technologies specializes in end-to-end solutions for OEMs?)

In many situations, prototyping and manufacturing are done in isolation. Not only are opportunities for improvement overlooked, critical information often gets misinterpreted in the process, adding unnecessary costs and time onto the development process.

Creation Technologies’ Business Development Director for Creation Express Services, Michelle Angel, has worked with product innovators in the Bay Area for two decades. Today, she’s focused on creating high-impact solutions for Creation’s rapid prototyping customers. Michelle told me that if a mistake is not identified or fixed at the prototyping stage and moves into production, the simple error could cost a customer hundreds of thousands, maybe even millions of dollars.

Are you making million-dollar errors in a time where every competitive advantage matters?

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!

Dec 10 Workshop: Making the Transition from Design to Manufacturing

Tips for design engineers to make a successful transition from design to manufacturing
Tips for design engineers to make a successful transition from design to manufacturing

You wake up clammy, in a cold sweat.

Your heart is racing over 120BPM and you feel anxiety like you have never felt before.

It’s because of your dream.

This dream wasn’t the usual, where your teeth fell out, or your teenage self showed up at the wrong building for a final exam. No, this was much worse.

This time, you had a dream about your project. Your newly designed, much anticipated product that will change everything for your company.

In your dream, you were in a room with a big clock. Tick-tock. Tick-tock. The hands were moving fast.

Every minute, a sales guy would come in and ask if you were done yet.

Each time you’d answer, “Not quite”.

Then a marketing person would arrive and ask you to make just a “little” change.

Every time you glanced at the clock, the hands were moving even faster.

Sales guy. Marketing.

Tick-tock.

Finally, at your wit’s end, you completed adding every ‘little’ change and tore out of the room. “I’ve done it! Here it is!”

You looked around. Your boss and the large team of people wearing clean, white suits looked back at you. “But how will we make it?” they asked, over and over in a slow, rhythmic chant.

That’s when you woke up.

 

 

It is now time to change the drenched sheets and sign up for ‘DFX and You: Making the Transition from Design to Manufacturing’.

 

Making the Transition from Design to Manufacturing

For even the most experienced designers, Product Development can be a real challenge.

Making sense of product requirements, satisfying all major stakeholders, and ensuring that the product is well-designed for commercial success are all critical processes.

As experienced designers and manufacturers, we can help.

Partnering with LifeScience Alley for a December 10th ‘DFX’ Workshop

On December 10th, Creation is partnering with LifeScience Alleyto host a workshop that will offer design engineers some key tips to ensure successful product development.

Sign up today for “DFX and You: Making the Transition from Design to Manufacturing”, at Hamline University Minneapolis.

Nate Bullerman, Engineering Leader in our St Peter, Minnesota business unit, and I will outline some of the standard design practices you should embrace to ensure a smooth transition to manufacturing – the first time, and every time.

We’ll also arm you with information that you can provide to your sales and marketing teams to optimize the process and ease your mind.

And did we mention that we’ll be giving attendees a pretty cool handout, ‘The Successful Engineer’s Guide to DFM Success’?

Hope to see you there!

Of course, if you’re interested but can’t make it, just let me know and I’d be more than happy to walk you through some of the material.

Digital Imaging Re-Images the Future

Future of Digital Imaging
Future of Digital Imaging

The CCD image sensor was invented in 1969 by Bell Laboratories scientists Willard S. Boyle and George E. Smith, and it launched a digital imaging explosion so significant that it earned the duo the Nobel Prize in Physics.

Today, digital imaging sensor technology continues to improve light sensitivity and image quality.

Exciting products are being introduced at lightning speed, like sensors that use organic material instead of silicon for the photosensitive layer, and graphene-based image sensors that are 1,000 times more sensitive to light than most commercial CMOSs or CCDs.

And imaging equipment designers are finding ways to leverage advancements in M2M and communications infrastructure to improve customer experiences.

Here’s a look at some of the innovations on the imaging scene.

Medical Imaging

Creation Technologies designs and builds products for customers using medical imaging to improve healthcare
Creation Technologies designs and builds products for customers using medical imaging to improve healthcare

Cost considerations and the drive to improve healthcare have pushed the market toward filmless imaging. Its creative applications are fueling a global medical imaging equipment market that’s expected to reach a value of $35.4 billion by 2019.

Creation Technologies designs and builds many products for our customers who employ the CT, MRI and ultrasound technologies that remain the cornerstones of medical imaging.

We’re also seeing new technology and devices that will transform healthcare as we know it…like this “digital mirror” that shows you your organs in real time.

This unique imaging device combines Microsoft’s Kinect camera with medical imaging scans. It captures high-resolution images of bones and organs and projects them on to a mirror-like screen, so that you can see your body moving. This “inside-out” look could easily help a doctor’s verbal explanation come alive.

Thermographic Imaging

Thermal and heat signatures provide a world of information and save lives.
Thermal and heat signatures provide a world of information and save lives.

Thermal and heat signatures in the ground beneath us provide a world of information.

Handheld devices equipped with forward-looking infrared radiometry give scientists more accurate information that helps monitor and predict volcano eruptions and earthquakes.

With prices dropping on thermal cameras, home and building inspectors can now carry handheld devices that display thermal images of variations detected behind building surfaces. Hidden problems such as inadequate insulation, plumbing leaks, air duct leaks, and issues with electrical wiring now literally come to light.

At Creation, we’re proud to design and produce these innovative products for our customers who are at the forefront of this industry.

3D Cameras

Off-the-shelf technology can advance OEM imaging capabilities
Off-the-shelf technology can advance OEM imaging capabilities

Spectacular new consumer imaging products like the Lytro Illum light-field camera emerge daily, it seems. The Lytro Illum is able to focus at variable depths and to capture light on multiple planes. This technology lets users take photos in low-light environments without a flash, refocus images after-the-fact, and create 3D imagery from a single shot.

This technology may prove extremely useful in security and medical applications, where OEMs can take advantage of off-the-shelf technology that meets reliability requirements for critical applications.

We Can Help You Develop Imaging Products That Matter

In an industry traveling at the speed of light, digital imaging OEMs are focused on the technology and services that set their company apart from competitors.

Through Continuous Improvement and tailored solutions, Creation helps our customers improve time-to-market so that they can concentrate on what they do best: developing products that matter.

Boyle and Smith probably couldn’t have imagined — or imaged — the range of important imaging products their CCD would make possible today.

Learn how Creation’s design and manufacturing solutions for complex imaging products can help increase your profitability.

Medical Devices Innovation: LifeScience Alley & Creation Technologies

Creation Technologies Sponsors LifeScience Alley Conference for Medical Devices

For many decades, Minnesota (and indeed, the Mid-West) has been a critical hub for development in Life Sciences, Pharmaceutical, Biotechnology and Medical Devices.

For a Biomedical Engineer-cum-EMS Industry Professional like me, this era of innovation and technological advancement in the Medical industry, and Medical Devices in particular, is extremely exciting.

I wanted to write a quick post to let everyone know that Creation Technologies and Creation Design Services are this year’s Innovation Station sponsors at the LifeScience Alley, LSA 2014: The Health Technology Leadership Conference, on November 19th at the Minneapolis Convention Center!

LifeScience Alley, its members and people, are great. Much more info about the organization and its members can be found on their great new website, but here’s the overview for anyone not familiar with LSA:

With a 28-year track record of providing valuable services and results-oriented outcomes to its members, LifeScience Alley improves the life science operating environment and enables business success through educating workforces, influencing state and federal public policy, supporting advancement in research and technological innovation and fostering industry connections.

Creation Technologies is exceptionally pleased to be a partner at this year’s conference. We know it will be a great success for LifeScience Alley, as it is every year.

We’ll be sharing more about the conference and our exciting Innovation Station exhibit in the coming months. (Drum roll, please!)

Until then, I’d love to chat about the medical devices and other things that we’re designing at Creation Design Services. Give me a call at 262.501.6686 or send me an email any time.

My colleague, Katie, also loves to “talk tech” and can fill you in on exciting happenings at Creation’s manufacturing business units in Minnesota, Wisconsin, Illinois and beyond. She can be reached at 651.242.4344 and any time by email as well.

We invite you to come to any of our Creation Design Centers or Manufacturing Business Units anytime for a visit, check us out at www.creationtech.com.

We look forward to seeing you at LSA 2014 in Minnesota in November!

US Dept of Commerce Conference: Key EU Environmental Updates

EU Environmental Legislation: US Dept of Commerce Update
EU Environmental Legislation: US Dept of Commerce Update

Do you sell Electrical & Electronic Equipment, including Medical devices, into the European Union?

Do you and your company need to understand EU environmental legislation and its changing scope?

Good news! In May, the US Department of Commerce is hosting a free conference to provide an update on key EU directives.

The conference will take place on May 5th, from 9:15am-12:00pm, in Washington, D.C.

EU Legislation Highlighted at the Conference

RoHS (Restriction of Hazardous Substances) Recast

  • Recent coverage of medical/electrical equipment and monitoring and control instruments
  • Potential revision of the list of Restricted Substances
  • Implications arising from the new edition of the ‘Blue Guide’

WEEE (Waste Electrical and Electronic Equipment) Recast – Just Implemented across Europe

  • Information about several key changes from the original WEEE Directive
  • New, just-released FAQ document (which can be found here)

ErP (Energy Related Products) Directive

  • Newly adopted implementing measures
  • Development of a new work plan covering many types of products
  • Product labeling

Batteries Directive

  • New amendments to the Directive
  • The issue of ‘removability’

Key speakers:

Steve Andrews – United Kingdom, Head of Environmental Regulation Unit and Policy Lead
Chris Smith – United Kingdom, Technical Manager and Operational Manager
Guenter Hoermindinger – First Counselor for Environment, EU Delegation to the United States

Registration information and the link to the Government release can be found here on the export.gov site.

“Why Did You Become A…?” A Series on Inspiration & Motivation

Why Did You Become...?

The other day I happened across a great post over at Design News. (If you’re at all interested in Design Engineering, you should give the site a look).

“Why Did You Become an Engineer?”, was the question Design News posed to their System & Product Design Engineering group on LinkedIn. The roundup post by Alexander Wolfe tells some of the group’s stories, giving us a peek into the mind of the weird and wonderful specialist that is the Design Engineer.

Though I’m not a Design Engineer, I can certainly relate to the moments and people in my life that captivated and motivated me. It’s also human nature to seek out social connection and to wonder “Why?”, and so it’s always interesting and inspiring to read the personal stories that people are willing to share.

I thought the “Why Did You Become…” idea was one worth spreading, and started asking people at Creation, “Why?” Luckily, we have great people and they were happy to share.

Here’s our first story, from Perry Nader, the Supply Chain Leader in our Dallas business unit.

It will surprise you.

“In the late 70’s I moved from Ottawa, Canada to San Francisco, California. An old friend and I had decided to open a small restaurant in San Francisco’s financial district.

The restaurant was a cute little breakfast-and-lunch diner, called MARAZCEK’S after a fictional character in a book that my friend had read in his childhood.

We were both the cooks and also managed all the suppliers, inventory, registers, employees etc. The restaurant was located right in front of the big old Mamma Bell (AT&T) building, and at lunch time we practically had people lined up 3-deep along the sidewalk.

Life was good until the early 80s, when a court decision forced Mamma Bell to break into a bunch of little Baby Bells, and the big building with all of the ‘lunch bunches’ went poof!!

We filed bankruptcy and lost every penny we had.

I practically became homeless.

I was lucky to have another old friend who lent me a hand and took me into his house in a suburb of Los Angeles.

My friend attended a university that catered to government employees and aviation professionals, and I was able to get a part-time/on-call job at the university’s cafeteria. I was hopeful that once I showed them my skills, part-time would turn into full-time and maybe I could even manage the place.

That year at the cafeteria, I met Janice. Janice was the Secretary, (yes, in those days that was the proper title), to Dean of Government Sponsored Educational and Training Programs. She and I became very good friends.

I often went to visit Janice in her office while she was on her break. One day, I started telling her the story of the restaurant and of my past. As I was talking, the door to the Dean’s office opened and the Dean stepped out.

“May I see you in my office please?” he said, pointing. Of course I said yes.

The Dean told me that there was a government grant for re-training of government employees on Closed-Loop Manufacturing Resource Planning (MRP II). He took the time to explain it to me, referred me to the work of Joseph Orlicky and Oliver Wight, and invited me to meet with him again.

After a few more meetings he told me that based on my basic knowledge of procurement and inventory management, he thought that I could qualify for the training. Two months later I got the grant approval and training acceptance letter.

The program was 12 months, full-time, not only for MRP II but also some government-specific manufacturing process training. Our first project was setting up the entire planning process for a garage door opener.

We entered the BOM and routings in an ERP system, configured, planned, scheduled, managed inventory, sales orders, A/P, A/R, G/L… You name it, we did it. This was cutting-edge stuff.

Six months into training I received my advanced certification.

It’s funny how life works.

Several years before coming to Creation, 30 plus years after starting my career in supply chain, I was working as Director of Supply Chain and Operations for one of the divisions of a company called Chamberlain….one of the largest manufacturers of residential garage door openers in the world.”


How have you been inspired by the experiences of others?

What are some of the great ways you’ve seen these experiences change people?

And of course, why did you become an engineer, supply chain professional, teacher, historian…wherever your career led you?

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