Are Innovation and Collaboration Inherently Linked?

Creation Technologies President and CEO at MEDTECH 2015

How are solution providers like Creation Technologies innovating to drive long-term growth and success as companies, and as business leaders in manufacturing and the high-tech sector? Collaboration plays a defining role.

Bhawnesh Mathur, Creation’s President and CEO, recently shared his thoughts on collaboration throughout the business ecosystem on the Manufacturing Innovation panel on the Strategy & Development Track at MEDTECH 2015 in Buffalo, New York:

“The world has discovered that you don’t have to have a lot of patents [to be successful]. We say that patents are a measure of how innovative we are, or that our country is, but that isn’t necessarily the case.

I think what we’ve learned in the last several years is that collaboration between, i) academia and businesses, and ii) businesses working together and sharing resources and costs, creates technology that makes the country more innovative, and helps the country become more growth-oriented.

With the deployment of NNMI – the National Network for Manufacturing Innovation where companies and academia are working together – that [organizations] are working together because I think they believe that we can develop technology better, faster, that way. I think they believe we’ll create more jobs in North America that way, they believe there is a faster route to innovation that way. It’s a model that doesn’t [provide a particular company with] a lot of patents.

I think what’s happened to the world over the last several years is that, while I absolutely agree with [others on the panel] that you have to protect customers’ intellectual property, and trade secrets and capture [critical information] in your QMS (Quality Management System), that this fear that we’ve got to have thousands or millions of patents to be “good” is something that runs contrary to collaboration and working together to [create] a more robust economy.”

Now us marketing folk are always thinking about our value proposition and how we can drive customer success. At Creation, though, it’s literally everyone across the company who thinks about our enterprise value as more than just a measure of growing revenue and improving profitability. As more than just a function of winning business.

I’m proud, and lucky, to have a CEO, a leadership team, and a company culture dedicated to building strategic partnerships through collaboration, candor and shared objectives. A team that sees collaboration as intrinsically tied to innovation and long-term success. As the responsibility of a corporation in the economic ecosystem.


To the MEDTECH conference attendees, Bhawnesh posed the question:

“Do we want to share with each other, or patent what we know? It’s an interesting dilemma. My observation is that [the global mindset] is changing more toward working together and delivering more success.”

Our motto of Working Together to Build the Future is core to the value we believe Creation Technologies provides as an EMS partner. What role do strategic relationships and collaboration play in your organization’s plans for growth and long-range contribution as a business leader?

 
Watch the video:
 

 

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?

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

 

 

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.

Smart Manufacturing for Smart Lighting Systems

Smart LED Lighting Systems require Smart Manufacturing Solutions
Smart LED Lighting Systems require Smart Manufacturing Solutions

Besides generating bigger electric bills, wasted lighting energy also takes an environmental toll.

Lighting  rivals that of light-duty vehicles for global energy consumption
Lighting rivals that of light-duty vehicles for global energy consumption. Source: Earth Policy Institute: http://www.earth-policy.org/data_highlights/2011/highlights15

Did you know? Lighting consumption has accounted for almost 20% of the world’s electricity demand.

Even more surprising: Lighting rivals the global automobile fleet in carbon emissions.

Modern, efficient fluorescent and LED lighting systems and technologies help dramatically to reduce waste and improve experience.

And thanks to M2M devices and IT automation, Creation Technologies’ OEM customers are now developing smart lighting systems that leverage the Internet of Things.

These forward-thinking lighting companies are changing everything.

 

Smart Lighting Systems

At their most fundamental, smart lighting systems use data to make automatic, real-time adjustments.

Light and motion sensors measure when and how a space is being used, and automated controls adjust light levels to match environmental conditions.

When daylight floods a room, for example, smart lighting can react and dim artificial light to maintain the same light level and reduce energy consumption.

Even better than their reactive capabilities, these same systems can also use predictive analytics to anticipate needs.

In our example room, smart lighting will recognize that there are greater odds of more artificial light being required when the room is occupied after sunset than at noon, and plan accordingly.

Smart Manufacturing for Lighting Systems

All contemporary lighting systems require particular manufacturing considerations and capabilities. Some examples:

  1. Materials Management:

    As semiconductors, LEDs come off the fab with a range of operating characteristics. (This is one reason why early LED products didn’t initially live up to their advertised life spans).

    Binning, or the testing, characterizing and classifying of each LED according to its individual performance characteristics, helps LED lighting OEMs and their outsourcing partners remedy this problem.

    To manage the complexity of LED binning; however, a manufacturer of LED lighting systems like Creation must have rigorous systems for procurement, incoming inspection and materials handling.

    The business systems used by the manufacturer must also provide detailed component and production traceability.

  2. Quality System Management & Regulatory Expertise:

    Lighting OEMs require an exacting level of quality for their high-performance products. (Imagine the disastrous consequences of significant roadway lighting failures).

    Their manufacturing partners building their lighting systems need quality management expertise that demonstrates compliance with whichever standards a product demands.

    These could include IPC-610 Class II, UL certification, or environmental regulations like RoHS (Restriction of Hazardous Substances).

    One of Creation’s lighting systems customers in our Mexicali business unit, for example, measures us against the automotive PPAP (Production Part Approval Process) standard to ensure their products have industry-leading lifespans and performance ratings.

  3. Communications and Instrumentation Expertise:

    As smart lighting systems evolve and become more complex, Lighting OEMs will need to draw on the expertise of their outsourcing partners.

    Given the degree with which these lighting systems will need to leverage device-to-device communications and advanced controllers and diagnostics, the OEMs who choose a design and manufacturing partner that has the in-house expertise in these fields would be…

    Dare I say it…

    Smart.

We’d love to tell you more about what we’re doing at Creation Technologies to make manufacturing lighting systems more than just a shot in the dark! (I couldn’t resist). Contact us anytime.

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.

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.

10 Things You Need to Know about Manufacturing FDA-Approved Medical Devices

Manufacturing FDA-Approved Medical Devices
There are many critical elements to quality manufacturing of FDA-Approved medical devices

The purpose of the Food and Drug Administration (FDA) is to safeguard the health of the American public through the regulation of certain products, including medical devices and food-processing equipment. Health Canada has a similar mandate.

The FDA and Health Canada have full federal authority to ban and recall any products deemed dangerous.

They can also suspend or revoke registration or licensing of an establishment, effectively shutting down manufacturing facilities. Investigations can lead as far as criminal prosecution.

As outlined in a Business Case for Quality at a recent Pharmaceutical Quality System Conference, there are many costs of non-compliance, including:

  • Direct costs (e.g. scrapped materials, production time)
  • Remediation costs (issue identification, correction and reporting)
  • Regulatory action costs (legal, logistical)
  • Market share costs (lost opportunities)
  • Reputational costs (loss of goodwill)

According to FDA regulations, “the finished device manufacturer”, or the OEM, “bears overall responsibility for the safety and effectiveness of the finished device and must control all contractors under 21 CFR 820.”

It’s obvious that a government-issued, publicly visible ‘stop-production’ order can be catastrophic to a customer base, a brand, and a bottom-line.

So how do OEMs evaluate their processes and supply chains when commercializing a new medical device?

And how can OEMs looking for a manufacturing partner for a medical device assess whether the EMS provider is compliant with the Quality System Requirements and Current Good Manufacturing Practices critical to passing an FDA audit?

We can offer some tips based on our own experience manufacturing FDA-approved medical devices and other products in highly regulated industries.

 

3 Things You Need to Know about
Manufacturing FDA-Approved Medical Devices

    1. A Gap Analysis Will Protect Your Investment

      Knowing the right way forward begins with understanding your current state.

      A Gap Analysis will require you to have an intimate understanding of the regulation and identify where you have procedural inadequacies.

      A good manufacturing partner will ultimately help you address some of these gaps.

        • Go through each step of the regulation.

       

        • Identify and size up the gaps in your documentation system first, then look at the implementation gaps.

       

      • Find an expert resource for advice, don’t reinvent the wheel. Consultants and other resources are available to help you address a particularly weak area.

 

    1. Get Your Team On Board

      Similar to many practices that stem from technical initiatives, it’s not enough if it’s only the management team that understands the implications of the regulations. We can’t stress this enough!

      Everyone with their hands on FDA-approved product needs to understand the consequences of deviating from procedure.

      For example, a production associate may not realize the full significance of a Line Clearance Procedure…until a process deviation results in product mix-up, which results in a product recall. Or maybe until two similar labels get confused, which results in a patient receiving incorrect care.

      Waiting until the “until” is not acceptable!

        • Roll out comprehensive communications programs to connect the product with the end customer.

       

      • Ensure everyone involved in building FDA-approved medical devices understands the impact of their work!

 

Good team communications and documentation are essential elements
Good team communications and documentation are essential elements
  1. Build a Robust Training Program and Keep Complete Training Records

    There’s perhaps nothing more critical than traceability to the process of manufacturing regulated products like medical devices.

    Because of product significance and legal liability, a document trail is essential.

    More importantly, should an adverse event take place, visibility of the processes and parties involved can help save lives.

      • Ensure that you have properly defined which documents constitute your Device Master Record (DMR) and Design History File (DHF) to avoid iteration.
        (Hint: if you aren’t familiar with the DMR and DHR, go back to your Gap Analysis. Alternatively, contact our Creation Design Services team who can walk you through the development process).
      • Construct a solid system for conducting and controlling training that accounts for all people that touch your product as it’s being manufactured.

     

    • Once training is completed, make sure that your training records are well-defined and available for review by an auditor or other party.

    If you need additional resources in constructing your training program, today there are many good courses available. We recommend AAMI (Association for the Advancement of Medical Instrumentation) for a variety of programs that are taught by experienced regulatory professionals and endorsed by the FDA.

Manufacturing top-quality medical devices takes a great deal of preparation, expertise and commitment. At Creation, we know that the investment is worth it.

We are very proud to partner with medical device OEMs who do so much to employ technology to improve the lives of people around the world.

Our first blog post dedicated to this important theme outlines the first three things you should consider when deciding how to manufacture your FDA-approved medical devices. Stay tuned for the next installment!

Creation Technologies Business Development is Making a Difference

Martha's Village & Kitchen with the Creation Technologies Business Development Team
Martha’s Village & Kitchen with the Creation Technologies Business Development Team

The Creation Technologies Business Development Team is making a difference in the field everyday…but recently not exactly like you might think.

Making a Difference Together

The Business Development Team at Creation Technologies meets annually to discuss ongoing customer needs and strategies, and 2014 was no different.

As an addition to this year’s summit, however, we wanted to find a community service project where we could help as a team during our week-long strategy session.

“Making a Difference” is part of the Creation Technologies culture. People in each Creation business unit are engaged within their own community, working regularly as a team to ‘enrich lives’ and ‘improve our world’.

Since our business development team is made up of people in all Creation locations, we don’t get to meet face-to-face very often. Why not Make a Difference together, given the opportunity!?

What do you do with 20 business development people and
2 hours of time?

Thanks to some research and some very helpful local contacts, we were able to get a great list of local non-profit organizations that might need our help.

I set to work exploring our options, and when I first spoke to Maribel Pimentel, Volunteer Relations Program Supervisor at Martha’s Village & Kitchen, it was obvious that this would be a good fit for our team project.

Based in Indio, California, Martha’s Village & Kitchen addresses the underlying causes of homelessness. The organization challenges each resident to become a better person, regaining their lives to become self-sufficient, productive citizens and passing their newfound independence and life skills on to their children and families.

With such a broad vision, Martha’s Village has a host of daily activities. Maribel was so excited to have a group of 20+ people available to come and help.

As it turned out, Bob Therieau, IT Director, needed help sorting through a massive amount of equipment that was taking over his office.

Desktops, monitors, mice, keyboards, phones, cables, cords, you name it, he had it.

A LOT of it.

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Some of the IT equipment donated to Martha's Village & Kitchen
Some of the IT equipment donated to
Martha’s Village & Kitchen

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Yet more of the IT equipment donations in Bob's office
Yet more of the IT equipment donations
in Bob’s office

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It just so happens that we have a little bit of experience with high-tech equipment!

We set out to remove all of the equipment from Bob’s office and sort through it. Unusable items would be recycled, and usable items returned to Bob’s office or sold in their thrift store to raise funds.

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One of our BD team members contemplating his options...where to begin?
One of our BD team members contemplating his options…where to begin?

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Members of our BD team putting their 5S skills to work!
Members of our BD team putting their 5S skills to work!

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Did we do it? Yes!! Two hours later we completed our mission and transformed Bob’s room from a cluttered to usable space.

Small Things, Big Impact

After our summit, we received some very kind words from Maribel:

Creation Technologies visited Martha’s Village & Kitchen on February 19 full of energy and motivation to help our IT department. For 2 hours they helped clean, sort and destroy equipment in our conference room. This was a huge project that has been in need of completion for quite some time; however, being a non-profit we are more times than not lacking the manpower. We are very thankful that Creation Technologies sought us out to give back to the Coachella Valley, a community that they were simply visiting. Little did I know, they would be one of the most fun, outgoing and organized groups that I would have had the pleasure of working with. I missed them as soon as they left.”

Our business development team really enjoyed spending time together, and it was made that much better by spending time with Martha’s Village and Kitchen.

A smiling Kathy and Randy show how good it feels to lend a hand
A smiling Kathy and Randy show how good it feels to lend a hand

Maribel’s words remind us that what can seem like little things can have big impact.

Is “Making a Difference” part of your 2014 strategy? Does your company have a community involvement initiative? What works well for your team?

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