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MedTech Series x Charlton Regulatory Consulting

The medical technology field has always been intertwined with regulation and companies have often faced complexities when it comes to adhering to those regulations. But with the industry expanding more into the digital realm encompassing both MedTech and HealthTech solutions, regulation is becoming even harder to navigate for those innovating in the field.



With Charlton Regulatory Consulting

Halston Group has collaborated with Dr Iain Charlton from Charlton Regulatory Consulting, an expert in medical device regulation, to investigate the current MedTech landscape, how MedTechs can prepare for regulation as part of their route to market, and also how regulation is adapting to emerging technology trends.

MedTech Collaboration

The MedTech footprint is growing, and the industry is in a time of fast-paced innovation, with 1 in 12 of all UK patents filed at the European Patent Office from the medical technology industry.

According to the UK Government, there are 4,190 businesses operating in the MedTech space, contributing £27 billion in annual turnover to the economy.

Most of the entrepreneurs leading this growth have come from a clinical background, with many still acting practitioners. Their experience in the healthcare sector has enabled them to develop unique solutions that are truly needed by the health system and the wider public. However, whilst these entrepreneurs are experts in their chosen medical field, they often don’t have extensive knowledge of the regulatory landscape and tend to seek external support.

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“The MedTech Market is lively, thriving and changing. The market needs technology that makes healthcare pathways more efficient and effective – global healthcare provision is stretched with a massive nursing shortfall that is predicted to get worse. More and more companies are developing innovative healthcare and medical device software to meet this demand. A clear trend is in AI, and this is having a big impact, offering much better performance in diagnostics and informing treatment of conditions. It is being used more and more by innovators, and the regulators are allowing more and more AI based devices onto the market. Competition seems high in the healthcare app space, in particular apps and services being marketed directly to consumers and the healthcare providers. A lot of new services claim to improve the efficiency and efficacy of many different clinical pathways, diagnose diseases and conditions better, and provide healthcare providers with much better clinical tools.”


Dr Iain Charlton – Charlton Regulatory Consulting

Navigating MedTech Regulatory Challenges

Both the MedTech and HealthTech fields are moving at a rapid pace, with entrepreneurs delivering ground-breaking innovations to the healthcare sector. But as one of the most regulated sectors, these innovations need to abide by current and upcoming legislation. Charlton Regulatory Consulting provides advice and support to companies who are producing healthcare technology and medical device software.


“We help navigate regulations and industry standards when bringing new products to market, covering regulations on medical devices, privacy and security, and the standards needed to provide service and software to customers in the UK, EU and US. We’re especially attuned to early-stage companies, spinning out of Universities or clinical research, with a new idea in healthcare, but an uncertain route to the market. We can also help these companies as well as more established companies with the work involved in gaining software medical device clearance in the UK, EU and US, and in complying with the standards required to work with the NHS” 

– Dr Iain Charlton – Charlton Regulatory Consulting

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Interested in Collaborating?