A bespoke quality system for a growing Australian wellness company
Drop Bio Health is an Australian at-home health technology company that delivers personalized, evidence-based health and wellness insight by combining lifestyle data with biomarker analysis from fingerprick blood samples collected at home.
The company focuses on supporting employees, patients and health insurance members to understand and take control of their health.
Laboratory testing of these small blood samples, collected with Class IIa in vitro diagnostic kits, takes place at Drop Bio Health’s accredited laboratory at the University of New South Wales in Sydney, Australia.
The company also supports decentralized clinical trials, helping pharmaceutical and academic researchers extend the reach of their research into people's homes.
Central to the successful delivery of blood test and analysis services is consumer and clinician trust.
In the wake of the incredible Theranos scandal, trust and believability is more important and harder to achieve for blood testing companies.
Drop Bio Health’s co-founder and CEO Phil Hayes-St Clair knew that a strong quality and compliance focus was essential for the company to succeed.
We took a view at the beginning of the company journey that we wouldn't shy away from regulation.
In fact, we'd focused on becoming leaders in the space.
One of the factors that led us to Qualio was that we needed bespoke software that'd let us do outstanding quality management.
To complicate matters, the organization's 'wellness' offering doesn't fit neatly into either an in vitro diagnostic medical device or therapeutic category.
Digital medical device expert Dr. Lee Walsh was engaged by Drop Bio Health soon after he departed the TGA to establish his advisor business, Platypus MedTech Consulting.
He recommended that the company replace the online workflow system they were using for quality management and upgrade to a dedicated eQMS.
Dr. Walsh helped Phil and the team to review the eQMS market for the perfect vendor, keeping Drop Bio Health's unique requirements in mind.
Adaptability and scalability were both crucial, since the company plans to offer a range of wellness and medical device products in the future.
Qualio was identified as the optimal choice, and Drop Bio Health went live with their new quality system in August 2022.
Qualio empowered Phil and his team with a purpose-built, cloud-based quality system connecting the entire business.
Unlike with their legacy system, Qualio Events gives Drop Bio the ability to track and analyze quality issues, then fix them for continuous improvement.
Key quality documents like SOPs are now controlled in a dedicated eQMS, and Phil notes a new culture of ownership and input permeating across the organization.
Most significantly, the company's new approach to quality has already helped a new product emerge - with Version 2 of Drop Bio Health's WellBeing experience launched 'off the back' of the quality framework built inside Qualio.
Drop Bio Health now has big plans for the future, with Qualio 'at the center':
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