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.
Friday, August 30, 2013
Monday, August 19, 2013
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.
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.
Monday, August 12, 2013
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.
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.
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.
Friday, August 9, 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.
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.
Monday, August 5, 2013
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.
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.
Subscribe to:
Posts (Atom)