UDI Conference Takeaways

In addition to announcing and explaining the final UDI rule, presenters at the conference offered a wealth of advice for medical device manufacturers preparing to comply with the regulation. For those of you who were unable to attend the conference, we’ve selected some highlights for you:

Terrie Reid, Associate Director for Informatics, who has worked incredibly hard to create the infrastructure for the Global Unique Device Identifier Database (GUDID, pronounced, “Good-ID”), cited these keys to UDI implementation:

1. Act now – the sooner implementation begins, the lower the overall costs are likely to be.
2. Advocate for change – know the benefits of UDI and share them widely among colleagues.
3. Build a great team – this will ensure that implementation goes smoothly.
4. Partner with all key stakeholders – and communicate constantly and clearly with all of them.

In his presentation, Ken Koldan, co-chair of the AIM North America UDI Committee and CEO of FLEXcon, laid out five simple steps to UDI compliance:

1. Identify which accredited issuing agency from whom you are going to acquire codes (GS1, HIBCC and ICCBA are the only accredited agencies)
2. Reformat your Product Identifier (PI) to match UDI requirement.
3. Mark your products with you Automatic Identification Code (AIDC) technology
4. Register the device with the FDA Database
5. Ship out the device

We’re grateful to all of the presenters for sharing their thoughts about UDI. We’d also like to commend the UDI team on their exceptional work to create a regulation that will have such a positive impact on public health. We look forward to providing AIDC and data submission solutions to manufacturers as they work to implement these important changes.

UDI Final Rule: Timeline and Exceptions

by Foster Sayers

As noted in my last blog post, the final rule for Unique Device Identification (UDI) was published today, September 24, 2013, to the Federal Registry. Which means the clock is now ticking.

Within one year (by September 24, 2014) all Class III medical devices must bear a UDI. 

Within two years (by September 24, 2015) Class II and Class I implants and life-sustaining devices must bear a UDI. 

Within three years (by September 24, 2016) remainder of Class II devices must bear a UDI. 

Within five years (by September 24, 2018) Class I devices must bear a UDI.

There are some exceptions. The industry has been given three years to make existing inventory compliant. Class I devices do not need to include production identifiers and thus will not require dynamic printing/packaging. Shipping containers are exempt. Individual single use devices, such as ones that come in shelf packs, are exempt.

One of the most notable exemptions was related to kits and combination products. If there is a UDI on a kit or combination product then the constituent parts are exempt from having UDI.

There is no longer any reason to delay. The time to begin implementing UDI is now. If you’re in search of a solution or would like to understand more, please contact us.

UDI Final Rule

by Foster Sayers

At 8:45 this morning the FDA pre-published the long anticipated final rule on Unique Device Identification.

Jay Crowley, the architect of the Global Unique Device Identification Database and leader of the UDI initiative made the announcement at the UDI conference in Baltimore to much applause.

The final rule will allow many organizations to move forward with their UDI projects with the certainty needed in order to ensure their efforts will lead to compliance.

As of now, the rule is available in PDF format only. Crowley announced at the conference that he expected the publication would appear in it's official final format on the Federal Register's website by Tuesday, September 24.

In my next blog post I will touch on some of the key differences between the proposed rule and the final rule published this morning.

RossPPD to Exhibit at UDI Conference Later This Week

by Foster Sayers

RossPPD is pleased to be exhibiting at the UDI conference this week in Baltimore on the 19th and 20th. This conference will be the place to find out all of the final guidance on what the new FDA mandate on Unique Device Identification will require of your organization.

While the final rule on UDI has not yet been published, it has been submitted to the Office of Management and Budget (OMB). There is a chance it will be published in time for the conference. However, if it is not published then the rule is final enough that it can be discussed in depth and guidance can be given. Jay Crowley, the architect behind UDI, will be presenting in order to provide everyone with guidance on implementing the rule.

If you’re going to attend, be sure to come by our booth to see a demo of MDDTrack, RossPPD’s comprehensive solution for UDI submissions to the GUDID, electronic instructions for use, and item level risk management.

Ross will partner with your organization to guide not only regulatory, but also packaging, IT and marketing through the process of getting set up to implement your UDI solution. If you’d like to understand how, please come see us at our booth, 13 A, on the UDI conference exhibition floor.

Introducing the RossPPD Product Suite

by Brittany Sutton

Ross PPD is focused on solutions for biomedical companies by offering products that provide supply chain management, paper instructions for use, and medial adherence. Their product line includes MDDTrack, IFUTrack, and PharTrack.

MDDTrack: Track and Trace Products Individually

The FDA' proposed ruling on Unique Device Identifiers (UDI) should be finalized by the UDI Conference this September. MDDTrack will help companies comply with the regulation by linking a QR code (the physical UDI) on the packaging to a unique URL. This allows items to be tracked through every step of the supply chain.

MDDTrack also allows a company to address a product recall down to the specific item or lot using the UDI, which allows you to micro-target the recall in real time to solve the issue faster and more efficiently.

IFUTrack: Eliminate Paper and Save Money

In March of 2013, the European Commission began allowing electronic instructions for use instead of paper IFUs. This ruling allows companies to save enormous amounts of printing costs and time, and allows the consumer to access the eIFU in their native language more easily. IFUTrack is a simple user-friendly interface and allows you to download your eIFUs by scanning the QR code on the packaging.

PharTrack: PBMs and Medical Adherence

Medical Adherence is a worldwide problem that reduces the revenue Pharmacy Benefit Managers receive. PharTrack helps increase medical adherence and therefore gives more revenue to the PBM through unique URLs on prescriptions

PharTrack allows patient to quickly scan their code and click a button to record they’ve taken their daily dose. This will help PBMs capture revenue lost when patients do not adhere to medication schedules, and it will also keep patients healthier and refilling on time.

Find out more about Ross’ solutions at rossppd.com/products.

FDA Guidelines on Electronic Records

by Foster Sayers

21 CFR 11, title 21, part 11 of the Code of Federal Regulations concerns the FDA’s guidelines on electronic records and electronic signatures. Part 11 sets forth the criteria under which electronic records and signatures can be deemed to be of equivalent reliability to paper records.

For medical device manufacturers Part 11 requires them to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

To date, Part 11 has already been impacting manufacturers that are creating instructions for use electronically and taking other paper records to a digital format.

As UDI approaches, Part 11 will be operative as companies prepare the electronic submissions of data that will go to the FDA. MDDTrack is fully compliant with Part 11 and helps organizations ensure that audit trails and all relevant documentation fully follows all FDA guidelines.

Moving Instructions For Use (IFUs) Online: A Path to Improved Care

Last year, the Pharmaceutical and Biomedical Device industries generated a combined total of $850 billion in revenue. Our partnerships in the industry have revealed that companies consistently spend one one-thousandth of their revenues on printing. This means that the two industries allocated an estimated $850 million to printing IFUs in one year alone. Imagine what could be done with a sum like this across the industry: price cuts on existing products, additional job creation, more attention to quality control, or any number of measures that would help accomplish the end goal of healthcare efforts—improving quality of life and saving life-years of patients.

How can we cut these costs and enable companies to reallocate resources to more critical areas? The answer is simple: we can allow them to replace printed IFUs with electronic ones (eIFUs). The European Union has already issued a regulation (207-2012), effective since March of 2013, permitting the use of eIFUs for certain devices.

Unfortunately, regulation 207-2012 only allows eIFUs to replace printed instructions for very specific use cases: the eIFU must be intended exclusively for a healthcare provider and the device to which it refers must be implantable, contain a built-in system that visually displays instructions for use, or be stand-alone software.

Though the regulation affects a limited number of products, this legislation is setting precedent for digital distribution of information that was previously required in print. In addition to reducing costs, the move towards digital distribution has numerous benefits to biomedical manufacturing companies and the end users of their products. These benefits include:

-Increasing the speed at which devices get to market.
-Reducing the risk of lost IFUs, which can result in improper use of devices.
-Reducing carbon emissions associated with the preparation and distribution of products.

We applaud companies like Medcomp, Abbot Vascular, and Medtronic that have already made their IFUs available online. Not only are they ensuring that patients and their healthcare providers have constant access to the most updated information about their medications or devices, but they are positioning themselves to eliminate paper instructions when the FDA inevitably follows the EU Commission’s lead and permits a full replacement. 

RossPPD offers a cloud-based eIFU management system. If you are looking to move your IFUs online, find out more at http://www.rossppd.com/products/ifutrack.

Product Spotlight: MDD Track

by Brittany Sutton

With plans to finalize the Unique Device Identification rule by this September, the FDA is putting the pressure on manufacturers of medical devices to come up with a plan to provide UDIs on their products.

Ross PPD’s MDD Track not only helps manufacturers comply with the regulation, but also to manage to supply chains, conduct micro-targeted product recalls, and save money by using electronic instructions for use. Here are some more detailed benefits using MDD Track offers:

Improved Supply Chain Management

MDDTrack™ uses unique websites to assign UDIs for each individual medical device. The supplier scans a QR code on the packaging of the product, which assigns the UDI at the point of production so that companies can track the item through every step of the supply chain. Users can also scan the codes at point of purchase to check item history and alerts, which will reassure them about the safety of the device.

Improved Product Recall Management

Company leaders can use UDIs to place a recall down to the specific item or lot. Being able to micro-target a recall in real time will allow companies to remove faulty devices from the market more efficiently, saving money and possibly lives.

Easier Access to IFUs

In March of 2013, the European Commission began allowing electronic instructions for use for medical devices instead of paper IFUs. This ruling allows companies to reduce printing costs and to save time, and allows the consumer to access the eIFU in their native language more easily. MDD Track makes the process easier and quicker by assigning an individual product’s eIFU to the QR code on the packaging. The specific eIFU can be accessed through our simple interface with just a few clicks.

Find out more about Ross’ MDDTrack at rossppd.com/products/mddtrack.

Status of FDA Regulation and UDI Pros/Cons

by Brittany Sutton

The FDA is finalizing their proposed rule to require a Unique Device Identifier (UDI) for each medical device. Though this ruling has been pushed back several times, the decision should be ready by the UDI Conference led by the FDA this September. While companies wait for the final ruling, they weigh the costs and benefits of using UDIs.

Cons

Companies who don’t support UDIs cite cost of implementation as their main concern. A new system would have to be put in place to assign each device with a unique device identifier, and they need to ensure they are paired correctly. This will take time to get used to and may require the company to outsource to solve their problem more easily.

Pros

Despite these negatives, UDIs will offer companies many more positives. Companies will be able to keep track of every single item they produce. This will provide micro-targeted recalls and would therefore save money and protect consumers. Companies will be able to target specific items or lots for recalls instead of total recalls. This will help help brands stay strong by reducing the scale and therefore media coverage of recalls and by increasing consumer confidence in the safety of their products.

Tracking inventory at this level will also help companies manage their supply chain more efficiently. If an individual item needs to be located, it will be easily accessible with its UDI. Patients will receive their medical devices more quickly, and medical companies can connect with healthcare professionals using the devices instantly whenever necessary.

Companies that produce any Class III medical devices will have to act most urgently, as they will only have one year from the release date of the ruling to comply with the regulation.

Ross PPD is excited to offer low-cost, efficient solutions for UDIs. Find out more at rossppd.com/products/mddtrack.

Strengthening Inner City Economies: Ross and the ICIC

Ross PPD Corporation has been nominated by JumpStart to attend the 2013 Inner City Capital Connections (ICCC) seminar in Cleveland, OH on August 14, 2013. This is the second consecutive nomination Ross has received to participate in the ICCC seminar. Ross hopes to build upon last year’s overwhelming success that started with the New York City 2012 ICCC Annual Conference. The goal for this year is to raise capital and generate revenue tenfold from 2012. The 2012 fund raise, led by Mayfly Capital of Boston, MA, allowed Ross to co-develop a patented web-based platform with 121nexus of Providence, RI.

About ICIC and the ICCC conference:

The Initiative for a Competitive Inner City aims to strengthen inner city economies by providing education and information to the businesses, governments and investors that reside in them. Grounded in research, ICIC helps public and private sector leaders identify economic drivers and industry growth clusters while educating inner city businesses on the ins-and-outs of competing for capital succeeding in urban environments (Source: ICIC Fact Sheet). Combined, these factors contribute to job creation where it matters most: in urban environments like Cleveland all across the U.S.

The ICCC, a national initiative, was created to connect small inner city businesses with each other and equity providers in order to increase their chances of accessing capital and achieving sustainable growth while combating the financing gap between inner and non-inner city businesses. The ICCC hosts free educational seminars in Chicago, Atlanta, Detroit and Cleveland that coach participants pitching to potential investors, strategy, talent management, raising capital and debt and equity finance. After the seminars, participants have the chance to move on to the ICCC Conference at Fortune Magazine in New York City. This year’s ICCC Conference will be held November 20-21, 2013.

Creating Jobs Close to Home: Ross, 121nexus and Venture for America

A new cohort of college graduates, full of best and brightest of their institutions, is doing something very few would expect: purposefully turning down large salaries at established corporations in order to work for two years at an early-stage startup in a lower-cost city. Modeled after Teach for America, Venture for America (VFA) currently trains and sends recent graduates to eight cities across the U.S. including Cleveland, OH, and Providence, RI.

121nexus, the company behind the technology powering MDDTrack™, IFUTrack™, PharTrack™ and Ross Personal Media ® products, is beginning a partnership with VFA and has hired a VFA Fellow to work at the Providence office. A two-year agreement with the startup and regular VFA meetings and assignments are required to ensure that Fellows are continually learning the ins-and-outs of business development and job creation.

Although Ross does not fit the mold to become a partner startup company of VFA, we are supportive of the organization’s work and have high expectations of the benefits that VFA will bring to the Cleveland area. It is VFA’s goal to generate 100,000 new US. Jobs by 2025 with priority placed on job creation in low-cost, lower-income cities. VFA targets companies in high-potential, high-growth industries such as renewable or sustainable energy development, biotech, nanotechnology and education innovation. To date, VFA has placed seven Fellows at Cleveland startups. It will hopefully be only a matter of time before the impact of these Fellows and VFA can be seen in cities like Cleveland across the U.S.

Ross PPD Corporation and 121nexus are portfolio companies of Mayfly Capital.

Ross to Exhibit at September UDI Conference

Ross PPD Corporation is set to exhibit at the Unique Device Identification Conference led by the Food & Drug Administration (FDA) in Baltimore, MD, on September 19 & 20, 2013. In addition to attending two days of educational sessions, Ross will host a booth in the exhibit hall to pilot our flagship UDI solution, MDDTrack™, for conference attendees.

The conference will feature Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, FDA, who will host multiple sessions detailing the UDI regulation and the next steps device manufacturers can take to work toward FDA compliance. Other topics of discussion will include the Global Medical Device Nomenclature (GMDN), the Global UDI Database (GUDID) and the Health Level Seven International Structured Product Labeling (HL7 SPL). 

Visit the UDI Conference site by August 19th to qualify for Advance Registration and to view the complete conference agenda.

Participating in the Unique Device Indentidication Track at MD&M East

At the Medical Device and Manufacturing (MD&M) East Conference last Tuesday, I had the pleasure of speaking about the new technology solutions that Ross PPD is offering for electronic instructions for use (eIFU) and unique device identification (UDI). I, as well as multiple other industry thought leaders, had the opportunity to present my views on the forthcoming FDA regulations mandating UDI compliance.

The consensus among all of the speakers was that the deadline for the final rule, which happened to be the next day, June 19, would be missed and in fact it was. Other speakers included Judy Bunch of QAConsulting, Jackie Elkins of Medtronic, Jeffrey Secunda of AdvaMed, Dennis Black of BD, John Roberts of GS1 Healthcare US, and Philip Lamory of Clarkston Consulting. They alternatively explained what to expect from UDI regulations and how to address compliance. 

The primary reason for UDI from an FDA perspective was identified as improved post-market surveillance. Various other benefits were discussed as well. While the FDA’s goal of improved post-market surveillance is clear, Ross PPD has another perspective how to best embrace UDI compliance and integrate it with eIFU. To us, UDI is about improved communication, which is also one component of eIFU. Our approach assigns unique URLs (unique websites) to each individual medical device and is aimed at ultimately optimizing end user accessibility and understandability.

For more information about Ross’ approach or to request a whitepaper please visit www.mddtrack.com. For more information on the MD&M East 2013 conference, visit www.mdmeast.com.