When medical device startups experience bumps in the road, a full-throated belief in the company’s product and mission can be the difference between moving forward or closing up shop.
Axena Health’s story proves this ten times over. The company experienced one of the bigger bumps a startup can face—a cash crunch due to a tough fundraising environment. What made Axena so impressive is that instead of looking for new jobs, employees banded together through the crunch to provide patient care and provider support, purely because they believed in what they were creating. The company has since secured additional funding and is now growing faster than ever.
This is not your typical startup.
Axena’s Mission for Women’s Health
Axena Health is a women-led enterprise dedicated to transforming lives through their groundbreaking product, the Leva Pelvic Health System. Axena Health is committed to addressing pelvic floor disorders, which affect countless women worldwide. Leva provides an at-home therapeutic treatment for urinary and fecal incontinence. This innovative device has been proven effective through rigorous randomized controlled trials, marking a significant step forward in women's health care.
At the forefront of Axena Health's quality and regulatory operations is Jennifer Fitzgerald, whose insights into the company's journey showcase the spirit of Axena’s mission-driven team:
"We believe in our device and we believe that women are going to benefit from our device and the doctors who prescribe it are going to also see the benefit because they're going to have happier patients.”
How High-Quality Solutions Deliver High-Quality Products
As Fitzgerald shrewdly advises: “Anyone waiting for an FDA audit to determine if they have the right process is already too late.”
She knew that in their medtech environment, speed is key to handling complaints. For this growth stage, Axena needed a QMS that could provide the speed they needed to quickly pass audits. They needed agility and efficiency.
For example, Axena’s complaint handling activities are crucial, and this is an area that’s monitored extremely closely by the FDA. The top three areas the FDA cites for medical device company inspections are the lack of procedures for CAPA, complaints, and MDR. Fitzgerald knew this is where businesses often fail, and she was determined to control the process at Axena so the company could continue business operations without interruption.
To manage their customer base effectively, it was essential for Axena to have a system that allows quick and easy information input and integrates seamlessly with their complaint handling system.
Propel Software was the perfect fit.
Benefits of Propel for Axena Health:
1. Speed from Complaint to Resolution: Propel QMS, built on Salesforce, facilitates rapid handling of complaints for Axena. By leveraging Salesforce’s case form functionality, Axena efficiently feeds complaint records into Propel, ensuring a continuous product thread. This integration fosters seamless automated workflows and enterprise-wide collaboration. Consequently, Fitzgerald’s team can quickly act on customer cases, comply with FDA MDR reporting, and address potential adverse events and defects promptly. The system’s smooth operation and real-time visibility into issues empower them to take swift action, preventing delays and ensuring timely resolutions.
2. Accelerated Validation & Updates: Propel prioritizes validation efforts to help our customers achieve and maintain FDA compliance, while also allowing companies to configure processes for their unique and growing business needs. For Axena, that means cases leading to complaints are properly initiated, notifying the appropriate personnel and transferring necessary information seamlessly. Using Propel’s comprehensive validation package and easily extensible PQ validation, Axena can update their systems regularly without the burden of over-complicated validation, allowing them to adapt swiftly and efficiently.
Customer-Centricity Meets Quality Care
Axena has two customer groups: the healthcare providers who prescribe Leva, and the users of the device, primarily women undergoing 12 weeks of therapy.
To ensure product success, they crucially need to care for both groups. Prescribers trust their products to help their patients, meaning the device must be reliable and provide an excellent experience, leading to positive feedback and increased confidence. This feedback loop helps users and prescribers move confidently through the care pathway, supported by Axena’s dedication to user satisfaction and—of course—quality.
“It’s very beneficial for me that I work in an organization with a CEO that takes quality to heart,” said Fitzgerald. “It means quality is everybody's responsibility when it comes to our systems and maintaining FDA and quality compliance.”
With their robust approach to both maintaining high-quality standards and creating a customer-centric culture to develop the best possible device, all that’s left is to make sure women can access it.
“The next step for Axena is to continue with our relentless advocacy for positive insurance coverage. It's our firm belief that nearly every woman can benefit from Leva. And if they need it, they should have seamless access to it.”
Conclusion
Axena Health's journey is a testament to the power of innovation, quality, and a customer-centric approach focused on both patients and providers. Fueled by the efficiency and agility of Propel, Axena has streamlined their processes, ensured regulatory compliance, and maintained a relentless focus on improving patient outcomes. For anyone in the medical device industry looking to do the same Fitzgerald has these words of wisdom:
"First, have a good product that meets a need. Go into it assuming you are going to succeed and you are going to grow. Then, find a system that's going to grow with you.”
