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.

Breaking Through Time-to-Market Barriers with Concurrent Engineering

How Does Your Product Development Cycle Stack Up?

Did you know that Deere & Company reduced product development time for construction equipment by 60%, and IBM reduced direct costs in system assembly by 50%? And how did Fuji Xerox’s FX-3500 copier immediately capture 60% of the relevant domestic market?

All are historical reference points to be sure, and yielded varying short- and long-term ROI for each company.

But there’s no question that the ROI was significant.

So what about in 2017?  Today, how are some of the most successful companies in the world achieving these measurable differences in development and commercialization times, product quality, and ultimate customer satisfaction?

Same answer as in 2016, 2015, 2014…

By breaking down walls with an integrated view of product commercialization (as well as everything that comes afterward), including leveraging proven methodologies like concurrent engineering.


Concurrent Engineering

Concurrent Engineering is not a new (or disruptive) idea.

But it takes a design-thinking and strategic mindset, and it requires exceptional program management and a lot of communication.

That may sound hard, and it is!

A common definition of concurrent engineering is that it’s a team-driven approach in which design engineering, manufacturing, product and test engineering and other teams are integrated and aligned on the same critical path to reduce the time required to bring a new product to market.

Building on the Toyota Production System and subsequent application of concurrent engineering, the automotive industry adopted concurrent engineering models in the early 1990s. Many electronics and pharmaceutical companies followed suit and adapted the approach for their own needs in the early 2000s.

However, the barriers for collaboration across disciplines, teams and partners stubbornly persist today, particularly in organizations where skills and responsibilities remain in siloes and resources are allocated according to each team’s budget and KPIs.

Today we operate in an environment where everyone is connected, online, and capable of taking action on that “great idea” 24/7.

To capitalize, the traditional linear and sequential system of product development – the ‘over-the-wall’ approach – must become a thing of the past for companies to succeed in 2017 and beyond.


Your Product Development Ecosystem – Flexible or Fixed?

With an integrated, concurrent engineering approach, everyone from design, engineering, purchasing, manufacturing, marketing, and finance is a stakeholder from product conception to marketplace.

More importantly, with an integrated approach, all of these stakeholders must be aligned and focused on the same timeline and outcome.

That may sound complex, and it is!

But the results are impressive:

  • Fewer design changes;
  • Fewer delays;
  • A higher quality and more innovative customer-centric product; and
  • A product (and brand) with staying power.

R&D and design engineers, for example, are often two steps removed from customer interaction.  With an integrated and flexible development model, they can gain insight by collaborating with field and technical salespeople who have direct contact with customers.  Just like ‘going to the gemba’ (to carry through with the Lean analogy), these are the folks that have the best information about what really matters in their marketplace for their solutions.

A 2009 survey found that implementing a concurrent engineering model positively affects development time, quality, and productivity.


  • 30-70% Less Development Time
  • 60-90% Fewer Engineering Changes
  • 20-90% Faster Time to Market
  • 200-600% Improvement in Quality
  • 20-110% Increased Productivity in Management/Admin Functions
  • 20-120 % Higher Return on Capital Investment

Not bad.


My Layman’s Take on the Role (and Power) of Concurrent Engineering and Integrated Teams

Fast-changing end-customer demand and needs, more varied and technically complex products, and more stringent regulatory and quality requirements can all easily be barriers to rapid product development and commercialization.

But in parallel (or, concurrently!), highly engaged teams and advanced, online collaboration tools are accelerating the development process, taking advantage of this 24/7 connected ecosystem.

Glass half full or glass half empty?

Just imagine what’s possible with expert, multi-disciplined teams working together.  Especially when you can annex the power of exceptional partners to help you fill the gaps.

At the end of the day, in my role, I (get to) see concurrent engineering as a technical methodology that’s analogous to what all of us folks working in tech really want…

…a highly collaborative, systems-driven way for us to work together (be it with our in-house teams or outsourcing partners) to get things done that benefit our companies and benefit our customers.

I believe that integrated teams and concurrent engineering are a fast-forward button for time-to-market.

3 Keys to a Successful, Large-Scale Product Transfer

For OEMs, switching your manufacturing solution is not as simple as switching your cable provider. Whether you build in-house or are using a contract manufacturer (CM), transferring a family of products to a new facility or partner can be a very complex, time-consuming, and expensive process.

With so many factors to consider – from cost to assessing manufacturing capabilities and engineering expertise – just qualifying and selecting a new contract manufacturer can take several months alone.

Time is money and the faster the transition, the better.


3 Keys to Product Transfer Success


1. Have a Product Transfer Roadmap – With Many Checkpoints

Coming up with a detailed transfer plan may sound obvious, but many OEMs underestimate the impact that expert project management has on executing a large-scale product transfer. For a company that has multiple product lines to transfer, there are many concurrent timelines that need to be addressed.

A strategic, clear and documented plan from the get-go helps manage the various moving parts. Consistent communication with all the appropriate stakeholders can be especially difficult considering the number of teams involved in a large-scale transfer of products.

It is also important to have a project management system that tracks timelines, checklists, and stores key documents.

If you’re outsourcing, verify that your EMS partner has a tool that captures detailed and strategic actions and milestones, and will drive regularly scheduled meetings to keep your project on schedule. Your company will have full visibility during the process and specific processes are guaranteed to be addressed, improved, and executed on.


2. Assess Early to Incorporate Improvements

The opportunity to improve is why most OEMs choose to switch their manufacturing strategy. This is why selecting an EMS partner with experience and the appropriate resources is so vital to your long-term success.

In the planning stage of the transfer, your EMS partner’s engineers can assess existing equipment and test processes, and make recommendations to improve or upgrade.  Your partner’s engineers and supply chain team can also make value engineering recommendations that mitigate your costs and risks and accelerate launch timelines.

Re-evaluating your manufacturing processes with your new EMS partner from the beginning will help identify gaps in documentation, streamline your supply chain, and make the necessary enhancements to your equipment and facilities.


3. If You’re Outsourcing, Make Sure It’s Not a CM’s First Rodeo

A large-scale product transfer is a gargantuan task. Depending on a variety of factors, like the number of products, the complexity of the manufacturing and test, and the complexity of the supply chain and fulfillment model, transitioning to a new partner or in-house facility can take as long as a year to complete.

Partnering with an inexperienced contract manufacturer can lead to both strategic and tactical mistakes that will cost your company time and resources.

EMS partners with good track records are able to understand the needs of the OEM and map out a strategic transfer plan and execute it on schedule. They will have the expertise to provide recommendations, understand regulatory requirements and cost implications of the decisions you will have to make along the way.  (We all know that nothing ever goes exactly as planned!)

Most importantly, an experienced EMS provider will know how to communicate effectively and proactively with their customer throughout the transition, and offer guidance and program management leadership every step of the way.

At Creation, we routinely accelerate product transfers for OEMs with multiple product lines, many of which have complex designs and programs.

In our experience, we have learned that these 3 Keys to Product Transfer Success streamline the product transfer process, especially a large-scale one, making it as efficient and cost-effective as possible. In the end, that makes all the difference.

A Case for Mixed Model Line Design in Complex, High Mix, Electronics Manufacturing


Manufacturing facility design is like puzzle-solving, where managing space and operational efficiencies can pose a challenge – especially during periods of growth.

Do we carve out more manufacturing space within our existing facility? Do we acquire more manufacturing space? Or do we continue to find new ways to optimize existing product flow?

At Creation, the manufacturing model as we know it is largely based on triggers to build right-sized batches that are built on dedicated and segregated lines. We often get requests from our Production Team Leaders for more floor space and workbenches when we partner with a new customer or launch additional programs. At first glance, this expansion can seem necessary to avoid mixing products on the same workstations.

So why is it that auto manufacturers can build a seemingly infinite number of different products all on the same production line, sometimes concurrently, and ramp up and down (within reason) without having to expand?

In my role as Continuous Improvement Coach in our Vancouver manufacturing facility, I’m continually looking for solutions that make our production processes flexible and scalable while factoring in existing space constraints.

Luckily, this is also a hot manufacturing industry topic and there are many good ideas being shared, like at the Mixed Model Line Design workshop I and some other process minded team members attended, hosted by Toyota and facilitated by the Leonardo Group.

At a high level, Mixed Model Line Design is a Lean manufacturing methodology to optimizing the value streams of multiple, similar products with mostly the same workstations and equipment, at the highest possible productivity level, without compromising quality.

The specific focus of the Toyota-Leonardo Group workshop was optimizing product flow to scale with customer demand, accelerating the production process with more predictability.

Here are a few takeaways that resonated with us as transferable to Creation’s manufacturing environment of complex electronic devices and programs.


Design Thinking: Get Granular

In Creation’s Lean Manufacturing environment, we are always thorough and intentional in designing our work cells and manufacturing lines to achieve maximum efficiency.

This process involves Product, Process, Test and Quality Engineering, our Production Team, and often our customers. We break down our processes, balance all work elements, and design flow and workstations for optimal floor space usage. But we can get even more granular.

For example, our supply chain team procures materials from our suppliers based on a Plan for Every Part (PFEP) strategy. Once materials reach Creation, we’ve optimized the process by which they are delivered and replenished to our manufacturing cells at line-side stock.  We can take it a step even further to optimize the process by which those materials are delivered to each operator in the cell at their point of use.

Similarly, we can design in more specifics around how product moves along the production line. Today we consider quality and inspection criteria, ergonomics and sequence, but we could also specify how many pieces at a time, or whether they’re on a tray or in a box at the point of transfer.

We can also design flow based on a multitude of factors that affect a line’s ability to meet takt time (the maximum amount of time in which a product needs to be produced to meet the pace of customer demand).

I think you get the picture.


Lean Thinking in Action

Our test case Production Team was apprehensive about trying something new, but after trialing Mixed Model Line Design in one cell with one product family to assess its effectiveness, they are excited about the promising results seen so far.

  • The team has increased capacity by 100% on the target product family. Increases have also been noted for other products, even before a focused effort to optimize.
  • Footprint has been reduced by 570 sq. feet or 10% of previously occupied space.

Who knows? All of our Production Team Leaders may soon be asking for Mixed Model Line Design in their own areas instead of more floor space and benches.

Stay tuned for a follow-up post on our progress and results.



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


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.


  • Flexibility

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

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

  • No Nasty Regulatory or Quality Surprises

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

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

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

  •  Saving Time and Money

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


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

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

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

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

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

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

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


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


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

Medical equipment in the ICU ward in hospital

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

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

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

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

Read the full press release here:

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



Green Manufacturing: Signing off on Paperless

Human hand winner sticks of pile of paper, victory over bureaucracy concept

Advancements in technology has been eradicating the need for paper documentation for businesses across many industries.

Going ‘green’ and ‘lean’ are clichés in their own right, but the changes have become more and more apparent in recent past. We have already seen the publishing industry make the plunge to predominantly digital.

However, in the manufacturing sector, many documents are still processed the traditional way by being printed out. In most organizations, 63 percent of the paper being printed out are due to the need for signatures.

For example, when an EMS provider manufactures goods for say, a medical device company (or other companies in industries with specific protocols and laws), there is a large paper trail related to compliance and engineering specs that requires several signatures. By the time the process is closed, multiple printouts of the document (which could be over 50 pages if it has engineering drawings) have been signed, scanned and circulated to multiple people, possibly in distant locations.

This results in an abundance of paper records, which end up costing companies a significant amount of space, time, money, and in terms of the environment, trees.

The boxes and cabinets necessary to store all the physical documents not only take up space, but they are also inefficient. Locating files manually could take drastically longer than tracking the document electronically.

Manufacturers also have to factor in the time wasted in signing a document, scanning it and having to circulate to another person in a remote location to do the exact same thing. This is not even taking into account if there are revisions to the document.

The financial implications tied to physical documentation are higher than you might think. The average employee who has signing authority signs an average of 250 documents a year, which adds roughly $1,350 in annual paper-related costs. For large companies, this figure can easily exceed $100,000 per year.

Cost and Resource Reduction

Transitioning to paperless manufacturing lowers the cost of doing business for companies. It eliminates paper and ink expenses, it allows employees to focus on other tasks, and it frees up physical storage space that can be used more productively.

One of the ways manufacturers are going paperless is through digital signatures. Using services that allow companies to sign, file and distribute electronically can reduce the $1,350 per signer annual cost to under $100. It can also decrease paper consumption by over 50 percent, which is hugely beneficial for “green” companies looking to not only reduce overhead expenses but lessen their environmental impact.

However, going paperless can be a challenge for manufacturers. With a lot of industries like medical and security typically having strict protocols related to documentation, making sure that digital signing complies with regulatory standards can present some barriers. As a result, there are still companies and organizations that only accept ink-based signatures.

There are also costs to invest in the technology, including hiring somebody to run and implement it. Making the transition can also take time, as you migrate over from your past protocols. For some organizations, this can take up to a few years to fully integrate.

Eventually, all manufacturing facilities will operate 100 percent paperless, it just takes planning and the proper sign-off.

Free Technical Paper to Help You Verify the Elimination of Flux Residue

Flux residue cleaning: miniaturization presents unique challenges
Miniaturization Presents Unique Challenges

Over the course of my career, I’ve seen firsthand the impact that organizations like SMTA and IPC can have on the electronics industry. At Creation Technologies, we’re proud to be a long-standing member of SMTA and appreciate the work that it has done to establish standards, strengthen skills and further the success of its members.

Through these prestigious associations, Creation plays an active role in accelerating the growth of the global electronics industry for both newcomers and long-time industry leaders alike.

A Decade of Dedication

Over the last 10 years, the Process Engineering team at Creation – Mississauga has been a regular participant and contributor to SMTA’s International Conference on Soldering and Reliability (ICSR) in Toronto.

I’ve welcomed the opportunity to attend as part of this team, engaging in good discussion and sharing Creation’s knowledge in surface mount assembly and related processes.

Smaller Components, Bigger Cleaning Challenge

The continued miniaturization of electronic components presents a unique challenge to product reliability. One of these challenges is in processing and cleaning during assembly.

Today’s ever-smaller components mean smaller clearances. This increases the probability of flux residue or surface contamination during processing, which in turn leads to reliability risks that can only be mitigated through ensuring total flux removal.

If flux residue is left on the board, it can reduce yields, and even cause significant field failures.

The paper discusses multiple cleaning methods to remove flux.
The paper discusses multiple cleaning methods to remove flux.

Clean-Cut Methods

Creation takes pride in ensuring the reliability of the products we build for our customers, and have established methods that ensure this total flux removal.

To learn more about how Creation accomplishes this, our technical paper, written by Flavius Dehel and myself, can be downloaded from the SMTA website. It describes Creation’s systematic development of methods that aid us in total removal of flux residue:

Free Download for SMTA Members:
Technical Paper | Verification of Cleaning Under Leadless Components

This download is free for SMTA members and is available to non-members for a nominal fee.

We hope that this paper provides you with some more insight into the impact that the cleaning process can have on product quality. Please let us know if we can answer any questions by sending us an email.

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!



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