Who is Enable Injections?
Enable Injections is a developer of on-body delivery devices designed to self-administer high-volume and high-viscosity therapeutics. Today, their disruptive technology, enFuse™, has the potential to allow patients to safely, conveniently and cost-effectively administer treatments outside of a clinical facility for cancer, Parkinson’s, Crohn’s, rheumatoid arthritis and more—helping to revolutionize the way patients receive their infusions.
Establishing a Strong Foundation
Enable Injections’ groundbreaking technology holds the potential to completely revolutionize the way patients receive critical treatment—and the company knew it was time to bring its technology to market on a large scale. Over the next five years, Enable Injections’ goal was to bring millions of units to market with their pharma partners.
However, with this goal in sight, Enable Injections needed to address a key challenge: working through FDA approvals and bringing a combination of products to market is a complicated and lengthy process that involves a lot of money and a great number of people. But once approvals are granted, the new pace can shift quickly and, like accelerating into a turn, precision performance is needed to successfully maneuver it.
To make the jump from small start-up to big business, Enable Injections Executive Vice President and Chief Financial Officer Tim Flaherty knew he needed an enterprise IT system that could support its growth. “We have pharmaceutical firms talking about millions of devices for one drug, and with seven partners in the pipeline, we can see how those volumes will balloon,” Flaherty said. “We have to make sure that we have a system that can scale smartly—and quickly.”
Partnering for Success
Like most startups, Enable Injections had limited financial resources to accomplish its technology goals. Finding a solution that could deliver the results it required at a price point it could afford would be challenging. The company needed a creative solution. Navisite worked with the medical device manufacturer to discover what its business needs and pain points were, determine its constraints and then decide the order in which recommended solutions needed to happen.
“We could see where our business was heading and knew we needed to be prepared for it, but we also wanted a practical approach that allowed us to easily expand when the time was right,” said Flaherty.
Using SAP S/4HANA, Navisite built a flexible solution capable of tracking manufactured products expressly per FDA regulations. While this approach may seem logical, these functions are not typically available to mid-market companies running smaller ERP systems. Now, with S/4HANA at its digital core, Enable Injections is benefitting from a fully integrated system to support finance and costing, production planning, materials management, quality management, product lifecycle management, compliance, document management and more. This has also helped the company automate the management of tedious FDA requirements, including training, traceability, recall handling and documentation—helping to reduce the amount of paperwork, simplify compliance and tighten controls. And, because many pharmaceutical companies also run on SAP software, Enable Injections realized seamless integration with its partners. “Without the guidance provided by Navisite, this would be impossible,” Flaherty added.
Building a Future Proof Company
Knowing that building for the future would need to happen over an extended period, Enable Injections wanted to establish a long-term relationship with a strategic business advisor.
“As a company in the startup stages, we don’t need every module of SAP S/4HANA right away,” Flaherty said. “Rather, we were looking for a phased approach that could support our needs as we grow into them.”
Based on priorities the Enable Injections team identified during its initial conversations, Navisite recommended a four-phased approach:
• Phase One – Financial Module
• Phase Two – Materials Management; Sales and Distribution; Production Planning; Financial Controlling; Document Management; SAP SuccessFactors – Employee Central: Performance, Goals, and Learning modules
• Phase Three – Product Lifecycle Management (Part 1) Plant Maintenance; Quality Management SAP SuccessFactors – Recruiting, Onboarding (Part 1)
• Phase Four – Product Lifecycle Management (Part 2); SAP SuccessFactors – Recruiting, Onboarding (Part 2); Regulatory Tools Enable Injections is now on a clear trajectory to success, supported by the strong foundation of SAP S/4HANA delivered by Navisite.
The company is experiencing rapid employee growth and its partnerships continue to stack up—and that’s just the beginning. The largest growth is expected in the next three to five years, as approvals help bring the on-body infuser to the market. “The end result was a lower-cost alternative to big-bang implementations typically undertaken by larger enterprises. It’s incredible. When we tell our pharmaceutical partners that we run our business on SAP, they are always pleasantly surprised,” said Flaherty. “We’re ready to keep growing and developing with Navisite at our side. With their strategic guidance and our foundational SAP infrastructure, we’re prepared for whatever comes next.”