NICE ESF & Hardian: The perfect recipe for bringing healthtech to market

TLDR: NICE ESF is a set of standards that digital health technologies should adhere to in order to be commissioned by the NHS. Set yourself and your solution up for success by using ESF as a guide to demonstrate the clinical effectiveness and cost-benefit evidence ready for a NICE health technology assessment (HTA).

Why does the ESF matter?

In August 2022, the UK’s National Institute for Health and Care Excellence (NICE) updated the Evidence Standards Framework (ESF) for digital health technologies (DHTs). 

But how does this latest update change what you need to do? 

The update provides explicit guidance on how to ensure your solution has the best possible chance of succeeding in the NHS. Developed in collaboration with NHS England, Public Health England, MedCity, public and expert (yes, we were involved too!) consultation. To help you get hands-on with the guidance, we explained everything you need to know about it here.

When operating in healthcare, we must not lose sight of the bigger picture - evidence ensures that clinicians and patients are protected from harm. With an increasing number of solutions entering the health and care sectors, commissioners are overwhelmed with choice. ESF is an important resource, not only for digital health companies to demonstrate the clinical evidence, cost-effectiveness and understanding of regulatory pathways for a solution, but it also supports commissioners to effectively and consistently evaluate DHTs.

Although navigating these frameworks can feel like a minefield, there is no need to bury your head in the sand! As specialists in protecting, regulating and validating healthtech solutions, we have been working with standards for a long time. Our multidisciplinary team has a wealth of experience in guiding companies through the process, helping to develop the real-world clinical and economic evidence required for these standards. The latest ESF update outlines 21 standards organised into five groups, each mirroring various DHT product development stages. In a world that seems confusing, we like to keep things simple and so our core services map directly to the NICE ESF (take a look at figure 1) – jump on board and we can help you demonstrate your clinical performance and define your economic value proposition hassle-free, and with far fewer sleepless nights!

How can Hardian help you meet the ESF?

In the spirit of simplicity, let’s start by breaking down exactly what the 5 groups of standards refer to: 

Design factors: Standards 1-9 identify key aspects of the design process that impact the DHT's value to the health and care system, including ensuring the technology has the appropriate technical standards for safety and reliability. 

Describing value: Standards 10-13 apply across all DHTs and provide information that helps build their value proposition.

Demonstrating performance: Standards 14 to 16 are designed to ensure that the DHT meets its performance expectations in the real-world.

Delivering value: Standards 17&18 apply to all DHTs and show exactly how they should demonstrate their value for money in the NHS market.

Deployment considerations: Standards 19-21 help to ensure that the claimed benefits of the DHT can be realised in practice.

Here are some of the ways we can help you piece the ESF puzzle together, to set your company and solution up for NICE HTA success:

Regulatory (R) – We leverage our technical and clinical expertise (our team is comprised of software engineers, experienced regulatory auditors and clinicians) to help with the development of the cornerstone regulatory documents required to demonstrate the DHT quality (ISO13485), usability (ISO62366) and intended use. So that ticks off standards 1,2 and 10.

Strategy (S) – Getting all your ducks in a row to make sure you’re approaching the NHS market in the right way is critical. We can help you bring together scientific validity, regulation, health economics and procurement to identify the best routes to market and create a cohesive go-to-market strategy. So, to make sure your solution is hitting standards 3, 5, 16 & 19-21, we’ll work with you on your strategy, literature research, data practices and monitoring to make sure your solution has the evidence it needs. 

Clinical (C) – Let’s get clinical. Clinical research, evidence generation and reporting, critical appraisal, and medical affairs we’ve done it all. It doesn’t have to be an endless maze if you’re working with people in the know, and together we can help your company to fulfill standards; 4, 6-9, 11-12 & 14-15. 

Health economics (H) – If you want to succeed, there is no point being economical with the truth - from budget impact modelling to cost-effectiveness analysis our health economics experts help you to better understand, define and communicate the exact economic value proposition of your company’s solution for the NHS, which is central to standards 13 & 17-18. 

Figure 1: 21 evidence standards arranged by groups mapped against our core services.

After spending valuable time, effort, and money to meet the ESF standards, achieve your NICE HTA and bring your solution to market, don’t let intellectual property (IP) fall by the wayside. IP often represents a large proportion of the value of a business, so you need to make sure that your business and solution are protected. It’s not included within the ESF, but our team of experts frequently works with early to mid-stage medical device companies to capture and protect this value, giving peace of mind, and fewer again sleepless nights. 

You can find out more about how we’ve worked with other companies, Neuronostics explains how we helped secure its initial CE mark and US-based company Koios Medical has shared its experience of working with us to gain traction in Europe.

Remember, getting healthtech to market doesn’t have to be difficult. We’re here to make it simple. So, if you want to know how we can help your company, you know where to find us…