ZiO Health’s transatlantic evidence generation journey

ZiO Health is a VC-backed medical technology and digital health company that has developed proprietary pocket-sized technology which brings lab testing to the point of use, helping improve patient drug treatment outcomes. CEO and Co-founder, Dr. Neel Patel reflects on their time on the DigitalHealth.London Evidence Generation Bootcamp and how the programme enhanced their knowledge around evidence generation in the UK.

About ZiO Health

Our proprietary biosensor technology is the basis of an AI-driven hand-held point-of-care device for therapeutic drug monitoring and precision dosing to improve patient drug treatment outcomes. It facilitates a proactive approach to dosing lifesaving medications by providing immediate data on the drug concentration in blood. The concentration result is inserted into ZiO Health’s AI-guided dosing model to provide an instant personalized dose, maximising drug treatment efficacy and minimising toxicity.

Monitoring certain medications’ therapeutic levels is important, especially when they have a narrow therapeutic target range or significant pharmacokinetic variability which often leads to severe toxicity or ineffective drug treatment (such as Vancomycin, Biologics, Tyrosine Kinase inhibitors, Carbamazepine etc.). 

Where we were prior to starting our DigitalHealth.London journey

We entered the DigitalHealth.London Evidence Generation Bootcamp programme for ZiO Health’s Point-of-Care (POC) therapeutic drug monitoring device that analyzes Vancomycin (VCM) concentration levels in whole blood. The POC device displays results of ‘free’ and ‘total’ VCM levels within 3-5 minutes. The accompanying software dosing model combines the concentration result with the patient’s health data to individualize dosing. 

By ensuring VCM doses are within therapeutic range, the platform can prevent nephrotoxicity and reduce: mortality, length of hospital stay, the use of less effective (and more expensive) substitutes to VCM, the use of intensive care facilities.

We had previously successfully completed performance and analytical studies in the USA, thus moving along the objectives required for FDA approval. And whilst we had gained valuable advice throughout the process in USA, we lacked the knowledge on what is specifically required for the UK’s NHS.

We’d had numerous conversations with NHS Trusts, the NIHR and experts within the industry, however, whilst all were very helpful, the environment was still complex to navigate and there seemed to be a lot of conflicting information that made it difficult for us to narrow down the key areas we needed to gain evidence for.

What we gained from the Evidence Generation Bootcamp programme

Fortunately, we were accepted into the DigitalHealth.London Evidence Generation Bootcamp programme. Throughout the Bootcamp, we were introduced to numerous resources available to startups to efficiently guide us through the evidence generation process required for NHS adoption.

These are some areas where we directly benefited:

• We were introduced to the NICE evidence standards framework for digital health technologies. This document not only helped us identify the gaps within our evidence generation plans, but also it was something we brought into ZiO Health’s internal meetings. This helped the team understand where we are, and what we must complete prior to UK market entry.
• Prior to starting the programme, we had developed clinical protocols for studies within the NHS that included a significant number of metrics to analyse. We were exposed to various experts who gave us further insight that helped narrow down the metrics required. This ultimately led to the ability to combine various studies and reduce our evidence generation costs.
• We learnt health economics was an area we needed to work on. The DigitaHealth.London team arranged a 1:1 with a health economist which enabled us to develop an in-depth understanding of the key health economic metrics required for NHS adoption.
• We were also made aware of various funding opportunities throughout the programme. Whilst these are all available online, it was good to hear opportunities suggested by DigitalHealth.London other digital health companies.

Building a long-lasting UK network

We have been through multiple accelerators in the recent years and as with all, the valuable ongoing benefit is always the relationships you build with other founders and the wider network you establish throughout the program. With DigitalHealth.London specifically, we are all going through the evidence generation process together so it was very helpful to discuss and learn from one another. The different experiences and backgrounds within the diverse cohort helped develop deep conversations that ultimately lead to the development of optimal approaches for evidence generation.

The programme was well aligned with ZiO Health’s current internal goals, allowing us to accelerate the process using the material, network and experts available to us during the programme. For this reason, we will be applying to further programmes that are offered by DigitalHealth.London.

If you would like to get in touch with us regarding our experience, potential research partnerships or to hear more about ZiO Health, please contact us at neel.patel@zio-health.com. You can also visit www.zio-health.com for further information.

DigitalHealth.London is delighted to publish blogs by the NHS staff and digital health companies we support through our programmes, as well as sector thought-leaders, experts and academics. Any opinions expressed within blogs published on our website are those of the author and not necessarily held by DigitalHealth.London. For more information, or if you would like to write a blog for our website, please email info@digitalHealth.london.

ZiO Health is part of the first cohort of the DigitalHealth.London Evidence Generation Bootcamp programme.

The DigitalHealth.London Evidence Generation Bootcamp is a collaborative programme funded by two of London’s Academic Health Science Networks – UCLPartners and the Health Innovation Network – MedCity, CW+ and receives match funding from the European Regional Development Fund.