A proactive approach on a unified, global scale with Compliance Navigator
BSI spoke to George Odero from Hologic, to learn more about why they chose Compliance Navigator as their solution to manage compliance.
“ When we set about looking for a new system, we had some golden objectives in mind… developing a standardized, more proactive system and a single, secure, unified portal…allowing team members to create, edit and monitor standards activity and track regulations.”
Background
Founded over 30 years ago, Hologic is a leading international healthcare and diagnostics company, with a focus on Breast & Skeletal Health, Diagnostic, GYN Surgical and Medical Aesthetic Solutions. Developing, manufacturing and supplying premium diagnostic products, medical imaging systems and surgical products around the world requires specialist knowledge of risk in each and every marketplace.
As Hologic’s Director of Corporate Regulatory Affairs, Systems and Standards, George Odero is responsible for developing and establishing the company’s global regulatory affairs strategy. With the need for a fast-to-market approach at the very core of his business, keeping on top of standards and regulatory changes is his top priority. Odero needs to provide expert guidance on regulations and standards throughout the company, which means ensuring those who need it have access to the latest regulatory intelligence.
The customer need
Prior to purchasing Compliance Navigator, the process of keeping abreast of the latest standards intelligence was not ideal for Odero and his team. It was all very well knowing which standards were relevant, but the key issue was knowing if these would change, and most importantly, when. No other system on the market was able to deliver what he wanted – a content management system with a proactive notifications system. Hologic wanted one centralized portal to track standards, with a robust structure, which would allow them to add external documents and records, and manage regulatory change. With everything in one place there would be less of a margin for error. When he discovered Compliance Navigator, Odero was drawn most of all to its notifications system. Medical device compliance is “a very dynamic area and we wanted to keep on top of changes” , Odero says. He needed to know ahead of time which standards were changing, particularly in the light of so many alterations and modifications that will result from the new EU Medical Devices and In Vitro Diagnostic Regulations. For an organization the size of Hologic, any delays in bringing products to market is very costly, and the sheer frequency of changes to medical device standards and regulations is a major issue.
With Compliance Navigator, his team could anticipate and prepare in advance for changes before they happened, saving time, and ultimately, money. “One of the most compelling reasons (for purchasing Compliance Navigator) was the proactive notifications system” says George. “It…helps us with our gap assessment for new regulations, saving valuable time and costs.” In addition, Hologic is an international and expanding organization, and Odero was looking for a common, integrated and standardized system, which could function well across multiple locations, facilitating global growth. It was essential that team members in all of Hologic’s multiple business units could access a single, secure portal from anywhere around the globe, to ensure they all work with the exact same information. Compliance Navigator was able to offer Odero exactly what he was looking for - a workflow tool accessible across his entire team. “When we set about looking for a new system, we had some golden objectives in mind…developing a standardized, more proactive system and a single, secure, unified portal…allowing team members to create, edit and monitor standards activity and track regulations. We wanted a structure which allowed for external documents to be integrated into the content management system, a robust structure which allows for ongoing and updated regulation changes.”
“Compliance Navigator has made for an accelerated workflow….saving valuable time and cost, and with long-term benefits for patient safety.”
The solution
Having used Compliance Navigator for a year now, Odero has found that it provides all the functionality of Hologic’s ideal workflow tool. Before Compliance Navigator, Odero’s team was waiting for notifications that standards had changed before they were able to put compliance mechanisms in place. They are now setting up a corporate standards committee who review and evaluate all the changes brought to their attention by Compliance Navigator’s notifications. “This saves a lot of time as you can easily find yourself out of compliance, which then has cost implications to the business, as well as the potential risk to patient safety and recalls.” Not only has the proactive nature of notifications made for an accelerated workflow, it has widerreaching, long-term benefits in that it eliminates risk. Moving across from their old system to Compliance Navigator was a complicated procedure for Hologic, with so many cross-functional teams using standards across multiple divisions and sites. There was a lot to think about, but, “The training and the help with implementation was great.”
BSI helped Odero and his team put together a template to identify who the stakeholders were, in order to roll Compliance Navigator out across all their sites. “BSI have done a great job with providing ongoing training, which was key to the implementation process and rollout”. As a result, getting access and started with Compliance Navigator was easy. BSI provided training over the phone, and facilitated onsite lunch and learning sessions. “The BSI team has been very responsive to questions and providing solutions”, Odero explains.” It’s been a key component of user satisfaction, especially when moving from one system to another, and so far the uptake has been pretty good.”
“The BSI team has been very responsive to questions and providing solutions…It’s been a key component of user satisfaction.”
Customer benefits
Odero now receives a lot of feedback from his user base that Compliance Navigator is “easy to use and very user friendly…” Hologic’s previous system did not offer much in the way of additional value. As a result, Odero was additionally pleased with Compliance Navigator’s Smart Support and expert commentary features, which use top industry experts, and which he says are “really good and a key strength”. He explained that the Smart Support guidance to the new EU Medical Device and In VitroDiagnostic Regulations “is very timely and helpful in complying with the new medical device regulations”.
This additional content offered by Compliance Navigator has had a hugely positive impact on the Hologic quality management system, and the combined content, smart tools and organizationwide access has helped make his job, and his team’s, easier and more efficient. In light of this, Odero explains that using Compliance Navigator “has not only met our expectations with regard to proactive notifications and customization, but in some cases it has exceeded them”.
