April 2018 - rfxcel.com

HDA Roundup from the FDA Public Meetings

HDA round up from the FDA Public Meetings on: FMD, DSCSA and Compliance

With the Falsified Medicines Directive (FMD), the Drug Supply Chain Security Act (DSCSA) and serialization compliance being the hot topics within the pharma industry, we wanted to roundup the latest news and opinions across the market today and from FDA Public Meetings.

On March 26th, The Healthcare Distribution Alliance (HDA) submitted written public comments to the FDA.  The comment was in response to the third and final FDA Public Meetings  held on February 28th 2018, to explore the enhanced drug distribution security provisions under the Drug Supply Chain Security Act (DSCSA).

HDA summarised its views with three separate takeaways:

  1. Deeper insight into areas of the industry consensus and confusion

With consensus on a distributed data architecture and the operational importance of aggregation and inference, there remains confusion on the details around terms or phrases in the law (e.g., “facilitate the gathering”) and interoperability.

Whilst the system is standards based and some foundational work will be done in 2019, many specifics still need to be developed — including further details around the system(s) FDA and the supply chain envision in 2023.

  1. The initial expectations for the 2023 system

There is a clear need for continued work to resolve issues related to expectations, technology and processes – and what the industry feels it can achieve within the current milestones.

Whilst the shared goals of patient safety and access are clear, there is an industry concern that certain analytics and interoperability functionality might not be currently possible based on a distributed architecture with today’s technology.

  1. The differing perspectives and challenges of FDA and trading partners

The HDA welcomed the participation from a larger industry group, including regulators and distributors, regarding concerns and to understand thinking and current approaches and challenges to achieving DSCSA compliance. Reaching 2023 must be a highly collaborative endeavour and the FDA meetings provided a unique forum to discuss these across sectors.

In addition, in late March rfxcel hosted a webinar alongside the Belgian-based, non-profit European Medicines Verification Organisation (EMVO) to discuss the on-boarding of partners to the European Medicines Verification System (EMVS). The EMVS was set up in response to the 2011 Falsified Medicines Directive (FMD) and designed to help Europeans identify and prevent consumption of falsified medicines.

With 100+ attendees, rfxcel and EMVO outlined the EU FMD/ Delegated Regulation, discussed exactly how to on-board your organisation and how to choose a gateway provider (IT Partner).  Both Fanny Trenteseaux of EMVO and Mark Davison of rfxcel, took the audience through a step-by-step guide to on-boarding.

From both the webinar and the recent HDA public submission, rfxcel’s main recommendations for successful serialization include:

1: Get executive buy-in: do not underestimate the significance of serialization

2: Assemble a multi-disciplinary team: include representatives from manufacturing, supply chain, IT, legal/regulatory and partner/contract management to understand how serialization can be applied across multiple organisational boundaries

3: Establish long-term user requirements to ensure you’re ‘future ready’: create a design template that is flexible enough to be interoperable and implementable between national systems and provides the flexibility to adapt to change as it happens.

4: Understand the data implications of FMD & DSCSA – and where the datasets reside across your organization

5: Choose the right software, and consider quality; data validation and network connectivity carefully

6: Choose the right partner – find a vendor that can partner with you to design responsive solutions that go beyond technology, and who is committed to your success

7: Act now: With the biggest price of non-compliance being your inability to ship product, is it worth the risk?

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FDA Public Meetings



rfxcel Drives LATAM Expansion

rfxcel announced today that they will expand their capability to enable LATAM Life Science(s) organizations to meet serialization and regulatory compliance requirements throughout Latin America and around the globe.

rfxcel is excited to announce the addition of Vinicius (Vinnie) Bagnarolli to their growing team of industry experts. Vinnie will be serving as the Commercial Director for Latin America. He will be responsible for driving rfxcel’s overall sales strategy and offerings to both existing and new clients throughout the region.

Vinnie joins rfxcel with an impressive resume; he has played leading roles with organizations such as Dell and Oracle. Prior to studying International Business Management in Canada, Vinnie managed a “technology stack” (Database, Middleware and Business Intelligence) division in São Paulo, Brazil that served both the Health Care and Life Sciences industries. Vinnie credits his success to his belief in educating both himself and his customers to be a reference in the industry. Most recently, he managed a Healthcare Global Business Unit and reported directly to the VP of Sales at Oracle’s headquarters in Redwood City, CA.

“rfxcel’s mission is a great fit for Latin America” says Vinnie. “We need companies that want to thrive and who want to help people – rfxcel’s expansion into LATAM and around the globe is making a positive impact on society.” Vinnie went on to say “Being part of an organization that puts their customers first and helps ensure products are safer and free from counterfeits is something that I am proud to be a part of.”

As the pioneer and a leader of track and trace solutions for the Life Sciences industry, rfxcel provides a robust product platform as well as a full-service implementation/support model, that ensures customer success, patient safety and peace of mind. rfxcel would like to officially welcome Vinnie to the Team, and we look forward to the opportunity to help fulfill the serialization and compliance needs throughout Latin American countries.



rfxcel Responds to Fake News

Recently, a vendor posted a story about a troubled implementation and named rfxcel as the source of the problem.  Although the tactic struck me as unprofessional, it also indicated that our continued wins were clearly impacting this vendor’s expansion plans.  Since rfxcel does not engage in this type of “mud-slinging”, I decided to not rebut the posting and chose to continue to compete on our merits.

Unfortunately, the vendor has taken this to a new level and they are now emailing this story to our customers in an attempt to discredit rfxcel.  This new marketing campaign crosses the line of professional behavior.  In light of the vendor’s new marketing effort, I feel that it is important for rfxcel to set the record straight.

No customer is named in the vendor’s posting, and we have no idea who that customer could be as none of our customers experienced all of the problems cited in the posting.  As such, I cannot provide a rebuttal regarding all the points raised in the post, except to clarify a glaring issue; inference of security issues in our infrastructure is false.  rfxcel’s cloud solution has always been secure and remains secure today.  We maintain the highest industry recommended security measures and perform continuous 3rd party audits of our systems.  As a result, our systems have remained secured and we have never experienced a breach.

In addition to new customers that we have won when competing against this vendor, more than 10 customers have recently switched from this vendor to rfxcel.  These customers include global manufacturers, distributors and dispensers of various sizes.  The most common reasons these companies give for switching over are:  The vendor’s frequent updates kept “breaking” the system; Inability to get the vendor’s attention to help configure & integrate with partners; Hidden costs in terms of additional company resources and upcharges for services/features.

Among this growing list of switched customers is one of the largest US pharmacies who switched because the vendor’s solution could not process the large volumes required by this pharmacy.  This list also includes a manufacturing customer who switched from rfxcel to this vendor because of the vendor’s promise of lower prices – this customer recently re-signed with rfxcel after realizing that the lower prices came with lower levels of service and hidden upcharges.

Finally, I am reminded of a humorous twist to the Golden Rule that best illustrates the differences between our two companies, “Whoever makes the gold, makes the rules.”

Unlike this vendor, our growth is fueled by our customers and not by investment bankers.  rfxcel has developed and run a profitable business for over 10 years now.  Even with our recent investment, customers are the primary source of our cash flow.  This places customers at the center of our growth strategy.  rfxcel’s priorities and focus have always been based on our customer needs and not on the needs of investors who are driven by quick returns.  This is an important distinction that results in two very different business models.

PRIORITIES – our focus on customers permeates everything we do.  It guides how we reinvest our revenue; more than 50% is reinvested into our Engineering and Customer Success organizations which directly impact our customers.  We do not prioritize our spending on large Sales/Marketing teams and glitzy, self-promoting events.

CONTROL – our solution provides our customers with their own private instance of our software instead of a common copy that is shared with other companies.  We frankly don’t understand how a system could be validated and stay validated with any other approach. Our customers decide to upgrade when it is convenient for them instead of getting continuous upgrades based on the vendor’s schedule which can be destabilizing, especially in a validated manufacturing environment.

SERVICE – rfxcel provides a full service implementation.  We do the heavy lifting for our customer and ensure a consistent end-to-end experience.  We ensure that our customers are connected to their partners and we run a series of data validations based on our customers’ requirements to ensure that everything works properly.  Our services are fixed price to shift financial risk away from our customers.  In contrast, this vendor likes to tout their connections but leave their customers with a portal to complete the partner integration work themselves.

rfxcel is a fast growing company in a rapidly evolving business environment.  We understand that problems will occur but we remain fully committed to the success or our customers.  We live by the old fashioned motto, “The customer is king.”  It is not a cliché or convenient tag line.  It is how we conduct business.

For organizations that need a serialization, traceability or compliance solutions, I look forward to the opportunity to present our solution to you in the future.  For our existing customers, I want to extend a huge “Thank YOU”.  rfxcel remains fully committed to your success.  We are accountable to you, not the investment bankers.  Without you, there would be no rfxcel.

Glenn Abood
CEO and founder

To learn more contact us here.