A Good Defense: How Transparency is Vital in a Guarded Industry

defense testimonial

Any OEM that works in the aerospace and defense industry understands that it’s a demanding and complex sector. Much like the medical device industry, it is a heavily regulated community with strict protocols and documentation.

That is why the ability to demonstrate traceability is a top priority when aerospace and defense OEMs are assessing potential EMS partners. With all military devices tied to government, every purchase, component, and product change has to be tracked and made available at any point.

So for contract manufacturers trying to play in this space, offering traceability is not so much a differentiator as it is a requirement. But just because any EMS provider can technically meet the documentation requirements doesn’t mean they all adhere to the same standards.

For example, when a contract manufacturer for a defense customer receives a part, they capture that information and record it into some kind of storing system, whether that is an Excel spreadsheet or paper copies filed away in boxes.

While there is no wrong way to provide traceability – you either do it or you don’t – there is something to be said about a contract manufacturer having a platform that can simplify and organize the process.

At Creation, we use the Vision Customer Portal, which provides all of our OEMs quality and supply chain data that can be easily accessed at any point. It is intuitive, robust and provides real-time information.

Recently, I caught up with Bruce Schallenberg, one of our Customer-Focused Team Leaders (CFTL) in Mississauga, who oversees a large defense OEM. He elaborated on the reasons why his customer trusts Creation and the Vision platform to manage all product traceability.

User Friendly

“Defense customers love the robustness of our Vision system. They like how thorough the platform is as far as compiling and tracking important data, but they also appreciate how simple it is to navigate. We have a very intuitive system with multiple hyperlinks, where you can pull up product and component history in a matter of seconds. And the fact that we can get reports out of it is a huge plus. I can put in a serial number for a part and click on it and it will show me all the serial numbers for that particular job. Even though they don’t always need that information, they just like the fact that they can put their fingers on that data if need be.”

Detailed Documentation

“It’s the overall level of transparency that seems to resonate with military customers. Typically, they’re used to organizations who are slow and maybe non-responsive. Our combination of a customer focused team (CFT) and a detailed database, is an ideal model for them because they get a high level of responsiveness and they have peace of mind that they can pull data on any product or component at any time. In terms of monitoring quality and being able to deliver quality reports, I think we do that better than anyone.”

Something for Everyone

“The nice thing about Vision is that it appeals to all levels of an organization. The buyers like it because they have transparency and can have visibility on their orders. The engineers like it for the technical data they can extract. And the quality people like it to see the history of components used and any changes to the product. So really with Vision, they are getting access to a tool that allows them to access to different types of information throughout the product cycle that they would otherwise not have access to in any other organization. It definitely bodes well because it makes them more efficient.”

Creation is formally meeting the DFAR mandated NIST 800-171 requirements. Our Vision systems is providing the tight security of Controlled Unclassified Information (CUI) that the defense industry now demands. We’re currently engaged with a 3rd party consulting/auditing firm that is accessing our compliance to 800-171. Any gaps will be identified in a formal audit late September and corrective actions completed by Dec 31, 2017.

Creation Technologies Gains Fourth AS9100 Certified Manufacturing Facility

Electronics designer & manufacturer illustrates commitment to contract manufacturing of Defense and Aerospace products.

Creation Technologies, a leading electronics manufacturing services provider today announced that its electronics manufacturing facility in Vancouver, B.C. Canada has obtained AS9100 Certification.  The news comes on the heels of the company’s recent certifications of their manufacturing facilities in San Jose, California, Dallas, Texas and Mississauga, Ontario.

“We are extremely proud of this accomplishment,” said Mark Krzyczkowski, VP and General Manager.  “The AS9100 certification is the standard to which aerospace and defense suppliers are measured.  This accomplishment is proof of our continuous improvement efforts and assurances made by our team to deliver the highest quality standards and a continued commitment to manufacturing excellence.”

The aerospace and defense industry is highly regulated and demands the highest level of quality standards for the development and manufacture of products.  This AS9100 Quality Management System (QMS) standard is widely adopted to promote continuous product and process improvement in the aerospace and defense industry.

“This is another milestone in our effort to serve those market segments that we feel are integral to the growth of our business,” said Joe Garcia, Vice President of Business Development.  “This achievement is a testament to the hard work and effort that has gone into building a world class quality system and something which we take great pride in obtaining.  We look forward to continued growth of our current and potential new customers in the Military, Defense and Security markets.

About Creation Technologies

Creation Technologies is an Electronics Manufacturing Services (EMS) provider focused on building premier customer relationships with companies in the Instrumentation & Industrial, Medical, Wireless & Communications, Security & Environment, Defense, Multimedia & Computers and Transportation markets.

Creation provides start-to-finish manufacturing and supply chain solutions—from design and new product development to final integration, product distribution and after-market services—to its customers across North America and worldwide.

Creation’s financial strength, employee ownership philosophy and commitment to ongoing investment in its technical capabilities have created a highly stable partner for original equipment manufacturers.

The company of approximately 3,000 people operates 10 Manufacturing Facilities, 2 Design Centers and 2 Rapid Prototyping Centers with locations in British Columbia, California, Colorado, Texas, Minnesota, Wisconsin, Illinois, Ontario, Mexico and China.

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.

 

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

 

 

EMS Industry Still Conflicted over Conflict Minerals

PERMITTED USE: This image may be downloaded or is otherwise provided at no charge for one-time use for coverage or promotion of National Geographic magazine dated October 2013 and exclusively in conjunction thereof.  No copying, distribution or archiving permitted.  Sublicensing, sale or resale is prohibited. REQUIRED CREDIT AND CAPTION: All image uses must bear the copyright notice and be properly credited to the relevant photographer, as shown in this metadata, and must be accompanied by a caption, which makes reference to NGM.  Any uses in which the image appears without proper copyright notice, photographer credit and a caption referencing NGM are subject to paid licensing. You MUST follow these requirements if using the images: 1. Include mandatory photo credit with each image © Marcus Bleasdale/National Geographic 2. Show the October cover of National Geographic somewhere in the post (credit: National Geographic) 3. Provide a prominent link to: http://ngm.nationalgeographic.com/2013/10/conflict-minerals/bleasdale-photography 4. Mention that the images are "from the October issue of National Geographic magazine.” Workers rip the earth apart in search of gold at the Sufferance mine in the Ituri region. Much of Congo’s gold, more than $600 million worth a year, is smuggled across borders.
Photo: Marcus Bleasdale/National Geographic

How well do you know your supply chain? Does your supply chain have Conflict Minerals?

These are the questions manufacturers around the globe are being forced to answer as part of the Conflict Minerals legislation.

The aim of the law is to dissuade companies from engaging in trade that supports regional conflicts and human rights abuses.

A worthy cause, but many electronics companies – even global giants like Apple and Intel – are discovering that complying is no easy matter.

Under Section 1502 of the 2010 Dodd-Frank Act, companies filing with the Securities and Exchange Commission (SEC) are required to determine whether their products contain conflict minerals (tin, tantalum, tungsten and gold) that are necessary to the functionality of the product.

If so, they must determine whether the minerals originated from the legislation’s Covered Countries, like the Democratic Republic of the Congo, known to have associations with terrorist groups.

And unless the materials are from a recycled or scrap source, companies must also conduct due diligence on the origin and chain of custody.

The Cost of Compliance

The time, resources and capital necessary to identify the origin of these raw minerals has been challenging for companies, if not impossible.

According to a recent WSJ article:

 “90% of the 1,262 companies that filed conflict-mineral reports with U.S. securities regulators last year said they couldn’t determine whether their products are conflict-free.”

As commodities, a good portion of these minerals are bought on the open market, making the paper trail for some raw materials almost untraceable.

So what’s a company to do?

At Creation, we’ve seen many of our OEM customers face this challenge head on by outsourcing this process to leaders in the compliance reporting field.  These providers, like Creation partner GreenSoft Technology, help by gathering intelligence and maintaining product and component data.

We’ve even seen some OEMs adopt a very proactive Design for Environment / Design for Supply Chain strategy in order to describe their products as “DRC conflict-free.”

CM3
Photo: Marcus Bleasdale/National Geographic

Evolving Requirements

Despite all of the challenges and the approach a company takes, most organizations are on side with the legislation.  After all, it’s intended to eradicate the exploitation of people, terrorist-funded operations, and human rights abuses.

The business challenge remains how to navigate the reporting requirements as the legislation continues to evolve.

A few weeks ago, the U.S. Court of Appeals reaffirmed its previous ruling that requiring companies to declare a Conflict Minerals compliance status is “compelled free speech” and violates the First Amendment. But that doesn’t let companies off the hook as the rest of the legislation remains in effect.

As GreenSoft said in a recent blog post:

Although Affected companies will still be required to report or disclose their conflict mineral data, the provision requiring companies to state whether their products are “DRC conflict free,” “not been found to be DRC conflict free” or “DRC conflict undeterminable” has been struck down.

Making Smart Supply Chain Decisions

While the debate continues, and the legislation and the guidelines evolve, the fact is that companies are still struggling to comply. The IPC association has recently published a white paper that is designed to help guide companies through the process.

OEMs, (especially those filing with the SEC directly), rely heavily on their partners to help them navigate the changes, collect the necessary information, and stay informed.

At Creation, we will continue to help our customers make smart Design for Environment decisions, as we work with our supply chain partners to make the data collection and reporting process easier.

We believe the key is partnering with the right suppliers.  Suppliers that are responsive, ethical, credible, and educated about how they impact product compliance in the end-to-end supply chain.

 

How do you feel about the recent U.S court of Appeals Decision? Will it affect your current strategy to comply with Conflict Minerals legislation?

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

 

 

IPC Government & Electronics Industry Leadership Conference in D.C.

Creation CEO Bhawnesh Mathur discusses the electronics industry with Congressman Tim Walz of Minnesota with Congressman Tim Walz of Minnesota
IPC’s IMPACT 2014: Creation Technologies CEO Bhawnesh Mathur discusses the electronics industry with Congressman Tim Walz of Minnesota

I believe strongly that the electronics industry and EMS providers such as Creation Technologies have key roles to play in the ongoing development of technology leadership.

I also believe that as today’s business leaders, we have a responsibility to do what we can to create economic opportunity and growth in our communities.

One way we can foster this growth is through activism in the industry associations that bring together and give a voice to our varied perspectives and expertise. As such, I currently sit on the IPC Board of Directors and serve as Chairman of the IPC Government Relations Steering Committee.

IPC Government Relations Committee & IMPACT 2014

The mandate of the IPC Government Relations program is to support the industry by “promoting policies that foster economic growth, job creation and enhance international competitiveness”, addressing key issues like tax, trade and environmental technology policy.

To that end, on June 10 and 11, I had the pleasure of spending time with 16 other executives from IPC member-companies while participating in IMPACT 2014: IPC on Capitol Hill in Washington, D.C.

The purpose of the conference was to share with senior American policymakers our collective perspective on current challenges and opportunities, and IPC was very successful in arranging a series of meetings to discuss specific initiatives that we believe will benefit our customers and strengthen the electronics industry.

These initiatives sparked thought-provoking discussion with all of the U.S. Government leaders with whom we met. It was an added pleasure to have the chance to meet with Members of Congress representing communities in which Creation has business units, specifically Senator John Cornyn and Congressman Lamar Smith of Texas, Congressman Andy Barr of Kentucky, Congressman Paul Ryan from Wisconsin, Congressman Tim Walz of Minnesota, and Congressman Brad Schneider of Illinois.

Bhawnesh joins IPC Government Relations Committee colleagues and IPC President and CEO John Mitchell in a light-hearted moment with Senator Mark Warner
Bhawnesh joins IPC Government Relations Committee colleagues and IPC President and CEO John Mitchell in a light-hearted moment with Senator Mark Warner
Congressman Brad Schneider of Illinois and Creation Technologies CEO Bhawnesh Mathur
Congressman Brad Schneider of Illinois and Creation Technologies CEO Bhawnesh Mathur

Some of the summit’s leading issues were:

Manufacturing and the economy: Support for domestic innovation and manufacturing through the creation and full funding of the National Network for Manufacturing Innovation (NNMI), and passage of S. 1468/H.R. 2996, the Revitalize American Manufacturing and Innovation Act (RAMI). The NNMI is a public-private partnership that draws on the resources of the federal government, local governments, universities, research institutes and industry to accelerate R&D of manufacturing technologies with commercial applications. IPC is working with its members and the government to influence the selection of the next round of R&D programs in areas such as flexible hybrid electronics and electronic packaging and reliability.

Environmental regulation: A bipartisan effort to reform the Toxic Substances Control Act (TSCA) and promote recycling of manufacturing byproducts.

National Security: A modernized export control regime with clear and appropriate controls on printed boards designed for defense electronics.

You can find more information in a blog post on IPC’s website: Electronics Industry Leaders Meet with U.S. Policy Makers on Capitol Hill

National Network for Manufacturing Innovation

The proposal for a National Network for Manufacturing Innovation is a compelling one.

Today we’re seeing manufacturing and technology innovation like never before. Entrepreneurship is one of Creation’s Core Values, and so it’s exciting to see our governments invest actively in leadership and development at both federal and local levels.

In Canada, we saw the Canada Accelerator and Incubator Program (CAIP) established in 2013 through the National Research Council’s Industrial Research Assistance Program (NRC-IRAP). Through short-term financial support to select incubators and accelerators, CAIP aims to “harness innovation” of small- and medium-sized business, providing the venture capital, expertise and infrastructure to fast-track new products and services to market.

In the U.S., the National Network for Manufacturing Innovation program has a similar goal, with the proposed legislation aiming to build a nationwide manufacturing innovation network with unparalleled reach and impact. Formation of this network is key in enabling Americans and American companies to excel in the development and commercialization of new technologies. Because Creation is a full-service electronics manufacturer with a specialization in turnkey product design services, this is something especially close to our hearts.

IPC Executives, Bhawnesh and electronics industry colleagues on IPC Government Relations Committee meeting with Senator John Cornyn
IPC Executives, Bhawnesh and electronics industry colleagues on IPC Government Relations Committee meeting with Senator John Cornyn

Working Together to Build the Future

At Creation, we see firsthand how electronics and electronics manufacturing continue to play pivotal roles in job creation, economic growth and technological advancement.

It’s heartening to see all stakeholders – from investors to entrepreneurs to business leaders to government to academia – invested in the manufacturing and technology ecosystems, and working together for transformation.

Forums like IPC’s IMPACT are essential to this kind of holistic collaboration, and it’s a privilege for me to take part. This year, as always, I learned a great deal from my fellow committee members and the elected officials with whom we had very good discussion, and I’m appreciative of everyone’s candor and insight. Thank you also to the IPC team for making the conference possible and for bringing government and industry leaders together to create alignment on key issues.

I look forward to IPC’s IMPACT 2015 and the opportunities it will bring to build relationships, awareness, and a bright future for the electronics industry.

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.

Success & The Transformation of MedTech

Changes to the MedTech Industry and Importance of Quality
Changes to the MedTech Industry and Importance of Quality

Transformation of MedTech

No matter your political opinion of the changes underway in the MedTech industry, one thing is clear: just as it already has, change is gonna come.

Many industry analysts point to new business models, increased innovation and a more holistic view of the medical ecosystem as the way forward.

In truth, isn’t that just good business?

After all, who wants to invest in, work for, partner with, or buy from, a company that doesn’t include empathy and advocacy for its end customers as a key driver of its value proposition?

We figure our customers are already doing some pretty amazing things for the business communities they serve.

In the case of our Medical customers, it’s possible that they’re already a step ahead of their competition given that it’s quite clear that they view these ‘business communities’ at their most elemental…the individuals whose lives are ultimately enriched and bettered. We’re proud to have partners like this.

It’s also clear that our Medical customers are strategists and innovators, always looking for new ways forward. It only follows that, in order to keep offering the best services to our customers and their end customers, EMS providers like Creation also need to keep pushing the envelope.

For our Medical partners, we believe this means offering solutions specifically focused on reducing R&D costs and time-to-market:

  • Expert full-product design and integrated manufacturing specifically for Medical Devices
  • Lean practices and leadership
  • Ready access to real-time data through a customer portal
  • Premium quality and technical expertise

 

Having FDA-registered business units, our most recent in our manufacturing locations in Milwaukee, Wisconsin and Lexington, Kentucky, for example, is one of the ways Creation is enabling our customers to move forward quickly and confidently.

As the MedTech industry continues to evolve, perhaps one of the most important characteristics an EMS provider can have is a customer-focused approach that mirrors the customer-focused approach that drives the Medical industry.

For Creation, this means taking an interest in, and having an understanding of, the industry drivers that help our customers anticipate requirements and capitalize on opportunity.

So, what drives your own value proposition?

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