Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023
Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023

Rudolf Wagner

Global Director Quality Assurance & Regulatory Affairs, Huma

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It may seem obvious that patient safety and evidence of efficacy should be the greatest priorities for healthcare, but this isn’t always the case. While the world of pharmaceuticals is heavily regulated, less attention has traditionally been paid to medical devices, including software.

Healthcare has undergone a huge transformation in recent years and we are seeing a growing number of digital health apps, including our own Huma software. These digital platforms, usually known as software as a medical device (SaMD) or medical device software (MDSW), should also be properly regulated to ensure patient safety and provide devices that healthcare providers can trust. But right now, this isn’t the case. Just 7% of digital health ventures produce clinical trial data, and fewer than one in 10 digital health ventures make regulatory filings.1 A lack of oversight and regulation is bad for providers and patients, and for the sector as a whole - unsafe products risk a public or regulatory backlash against all digital platforms. 

It is relatively easy to see how proper clinical trials and regulation can be put in place for devices such as implants and pacemakers. But in such a fast-moving world as digital health, where there are many claims made that aren’t always backed up by robust evidence,2 what does this kind of regulatory oversight mean and how can it be done? 

Our platform is able to monitor patients of all ages with any condition - including infants and pregnant people - and can connect with a range of external devices, such as heart rate or blood sugar monitors.

Rudolf Wagner, Global Director Quality Assurance & Regulatory Affairs, Huma

What is Class IIb certification?

The MDR classification system is a legal framework put in place by the EU in May 2021 to reflect the potential risk of medical devices and improve regulation.3 For digital health products, the classification system works on two axes (see table 1):

  • The significance of the information and the impact on patients - low (informs clinical management), medium (drives clinical management) and high (directly diagnoses or treats a disease)
  • The state of the patient – non-serious (not life-threatening/not progressing fast), serious (if not properly treated promptly then condition could progress), and critical (life-threatening)

Huma’s remote patient monitoring (RPM) software platform collects data about patients’ health conditions via an app. Our platform enables clinicians to use this information to remotely monitor patients in any setting and, most importantly, help improve patient care.

We were not content to make digital health monitoring software that was restricted only to specific patient groups or diseases, or would only be suitable for mildly ill patients and would no longer be useful if they progressed to a more severe state.

We decided to aim for Class IIb certification as it falls in the sweet spot of covering the widest range of patients, short of the most critically ill, and offering the most useful insights to drive clinical decision-making. 

Our challenge was to achieve it.

Our journey to EU MDR Class IIb certification

The journey to achieving EU MDR Class IIb began back in October 2021. I joined Huma at this time to set up the quality control systems that would provide the level of evidence required for certification.

To obtain the EU MDR Class IIb mark, all our data needed to be thoroughly reviewed by an independent external body. Only once we’d shown the appropriate evidence for product safety and patient benefits, did we finally get awarded the certification.

There was an amazing sense of collaboration and everyone was working together tirelessly, day and night, to get the job done. There was seemingly endless document writing, reviewing, editing and collation, and it was an extremely thorough and intense process.

Throughout, the team has been outstanding - we just put our heads down and worked hard on getting it all together. I am so proud of what we have managed to do and the evidence we’ve pulled together to prove that our platform truly does what we claim.

What does this mean for Huma and our users?

We are thrilled to be the first health tech company with a EU MDR Class IIb certified disease agnostic RPM software platform, meeting the newest regulations and highest levels of patient safety in the EU and UK. Achieving external validation for this was no simple feat, as the bar for approval is set very high.

Our platform is able to monitor patients of all ages with any condition - including infants and pregnant people - and can connect with a range of external devices, such as heart rate or blood sugar monitors. 

Patients can feel confident they are in safe hands knowing that our product has been thoroughly vetted for efficacy and safety. Importantly, they can trust that the data they enter is properly guarded and that the software is appropriately flagging anything abnormal to clinicians.

Healthcare providers can also rest assured that our platform is proven to be safe with robust clinical evidence, and that it is certified from non-serious illness to life-threatening progression, right up to the hospital or ambulance door. 

Now we’ve gained EU MDR Class IIb certification for our digital health platform, we have to keep it. The world is watching us, and we have to maintain our commitment to ensuring patient safety. 

Moving forward, we’ll continue to build a solid evidence base for our digital platforms. It’s the right thing to do and it’s what we believe will bring the promise of the digital healthcare revolution to fruition, supporting healthcare providers and bringing genuine benefits and improved outcomes to patients.

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Making an impact

3000+

3000+ hospitals and clinics supported across Huma platforms to secure the most sustainable impact for patients1

×2

Our platform can almost double clinical capacity and reduce readmission rates by >30%3

27m+

Huma's digital-first health platforms support a network of 27m patients1

1m+

Over 1 million devices have been shipped in support of our projects and we know what it takes to deploy at scale1

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Selected as one of 'The Most Important Healthcare Design of 2021' by Fast Company5

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Sources:

  1. Galen Growth, Clinical Strength in Digital Health (2022)  https://www.galengrowth.com/product/clinical-strength-in-digital-health/
  2. Day S, Shah V, Kaganoff S, Powelson S, Mathews SC. Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis. J Med Internet Res. 2022 Jun 20;24(6):e37677. DOI:10.2196/37677.
  3. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf
Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023
Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023

Huma joins digital pioneers to advance health equity in care and research

Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity. Accompanied by Chief Financial and Strategy Officer, Ingeborg Oie, Dan is looking forward to connecting with other attendees to explore how Huma’s digital health platform can make healthcare more equitable, and advances proactive, predictive care.

Huma joins digital pioneers to advance health equity in care and research

Date:Wednesday, January 18, 2023
Time:4:15 - 5:15 p.m. CET
Location:Ice Village, Eisbahnstrasse 5, Davos, Switzerland
Dan will join the Digital Health Action Alliance panel at Davos to discuss Turning the Tide in Non-Communicable Disease Care Through Digital Health and Community Connection. Huma has a long history of advancing the care of non-communicable diseases (NCDs) such as heart disease, cancer, diabetes and lung conditions. Huma’s innovative remote patient monitoring platform enables broad patient recruitment, reduces reliance on in-person clinic visits and increases health system efficiency.
*This session is open to registered Annual Meeting 2023 participants and Affiliate badge holders.

Huma is one of the first to sign the Zero Health Gaps Pledge

Huma is one of the first signatories to the Zero Health Gaps Pledge, the World Economic Forum’s Global Health Equity Network’s (GHEN) initiative. Huma supports GHEN’s ambition to build a future without disparities in health or wellbeing outcomes. Huma’s digital platform has been built on a deep clinical knowledge of complex patient needs and how people engage with technology and we are committed to ensuring our technology promotes health equity. We are proud to work with governments, hospital groups, universities, life science and technology companies to bring greater scale and impact and help all people live longer, fuller lives.

Huma at World Economic Forum

Global Innovators and Tech Pioneers
Dec 2022: Huma selected to join 100 innovative companies on a two-year journey as part of the World Economic Forum’s initiatives, activities and events, bringing their cutting-edge insight and fresh thinking to critical global discussions.
Learn more
Working Together, Restoring Trust
May 2022: With the aim to address economic, environmental, political, and social fault-lines exacerbated by the COVID-19 pandemic, Dan Vahdat speaks at WEF annual meeting about the importance of scientific collaboration.
Learn more
Accelerating innovation and breaking new ground
October 2022: Dan joined the WEF Biotech Future Forum 2022 to discuss how start-ups are breaking new ground in biotech and changing the way we interact with the world, but also how the sector can earn trust, scale successfully and spot the brightest innovations.
Learn more
Making connections at Davos
Jan 2019: Dan attended WEF as an unofficial attendee and spoke to CNBC about the importance of meeting in-person to make connections.
Learn more
Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
Comment

Our digital health platform is now certified as an EU MDR Class IIb medical device - but what does that actually mean?

March 23, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com

It may seem obvious that patient safety and evidence of efficacy should be the greatest priorities for healthcare, but this isn’t always the case. While the world of pharmaceuticals is heavily regulated, less attention has traditionally been paid to medical devices, including software.

Healthcare has undergone a huge transformation in recent years and we are seeing a growing number of digital health apps, including our own Huma software. These digital platforms, usually known as software as a medical device (SaMD) or medical device software (MDSW), should also be properly regulated to ensure patient safety and provide devices that healthcare providers can trust. But right now, this isn’t the case. Just 7% of digital health ventures produce clinical trial data, and fewer than one in 10 digital health ventures make regulatory filings.1 A lack of oversight and regulation is bad for providers and patients, and for the sector as a whole - unsafe products risk a public or regulatory backlash against all digital platforms. 

It is relatively easy to see how proper clinical trials and regulation can be put in place for devices such as implants and pacemakers. But in such a fast-moving world as digital health, where there are many claims made that aren’t always backed up by robust evidence,2 what does this kind of regulatory oversight mean and how can it be done? 

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About Huma

Huma began its journey in 2011, when the company was founded in London. Since then, Huma has grown to become a global healthcare company, spanning across multiple geographies and operating across four continents.

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