An entrepreneur who is developing new software to improve the quality and safety of digital health apps has secured a £350,000 investment from Mercia Fund Managers.
Sheena Macpherson’s company MIOTIFY is creating an online toolkit to help both developers and healthcare professionals to build medical apps and navigate key requirements needed for evidence in a regulatory submission. The funding follows the company’s recent success in securing a £555,000 grant from Innovate UK.
Sheena, who was previously Global Business Development Manager for Vodafone’s mobile health business, also acts as a consultant to AstraZeneca on software-as-a-medical-device projects. She launched MIOTIFY in response to the growing number of medical Internet of Things (IoT) devices, such as connected heart monitors, which provide new data to enable medics to monitor patients remotely and gather insights to inform their treatment.
However, before any such data can be used for medical purposes, the software or apps that interprets the data into meaningful information must be approved by regulators as safe for the intended use. The high cost and complex process involved in complying with the standards means that many of the current apps on the market are of poor quality and unsuitable for medical use.
MIOTIFY’s user-friendly system allows both developers and non-IT staff to create apps within a guided framework to help them build in quality from the start and auto-generate evidence to include in a submission for regulatory approval. The funding will allow MIOTIFY to complete the development of its patent pending system. MIOTIFY will be working with AstraZeneca’s Intelligent Pharmaceutical team.
Ashish Patel of Mercia Fund Managers said: “The digital revolution has the potential to transform healthcare but current products on the market are of varying quality. Due to the cost and lack of understanding of the importance of the requirements needed for gaining approvals, often those with real potential struggle to provide the right evidence to support their claims without significant investment. MIOTIFY aims to encourage more creators to start with quality and build a new generation of apps that can be trusted as safe and effective for medical use.”
MIOTIFY has assembled a team of expert advisers including Matt Bonam, global head of AstraZeneca’s Intelligent Pharmaceutical team; Sir Alastair Breckenridge, the former chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); barrister and physician Dr Peter Feldschreiber, a medical and healthcare law specialist; Glen Hodgson, who is Head of Healthcare at the international data standards authority GS1; Guillaume Nebout, Director of International Professional Services at Walgreens Boots Alliance; and Ian Shadforth, who is CTO at artificial intelligence (AI) diagnostic imaging company Analytics4life.
Tim Dempsey of Epiphany Capital assisted MIOTIFY with the fundraising and provided corporate finance advice.
Mills and Reeves provided legal advice to Mercia, while Turner Parkinson provided legal advice to MIOTIFY.