The ROI of UDI Legislation…Is There Any?

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

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

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

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

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

However, validating that claim can be challenging.

How can the industry measure the ROI for UDI implementation?

 

Measuring the Benefits of UDI Labelling

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

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

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

 

Analysis and Prevention: ROI from a Holistic Approach

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

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

In my mind, there are two key elements.

1. Good data and strong analysis with actionable correction

The onus falls on field reporting. Period.

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

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

2. Harm Reduction as part of the bigger picture

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

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

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

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

 

UPDATE (October 27, 2016):

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

Read the full press release here.

 

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

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

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

 

1. Do You Have Proven Medical Experience?

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

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

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

 

 2. Can You Provide Manufacturing AND Design Services?

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

Why?

  • Flexibility

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

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

  • No Nasty Regulatory or Quality Surprises

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

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

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

  •  Saving Time and Money

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

 

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

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

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

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

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

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

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

 

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

 

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

Medical equipment in the ICU ward in hospital

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

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

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

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

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

3 Areas for Improvement in the Medical Device Industry in 2016

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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

 

 

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