Huma builds regulated Software as a Medical Device (SaMD) solutions
Building a SaMD is complex. Launching it across several continents is even more challenging, but the hardest part is scaling and sustaining it across thousands of hospitals, clinics and patients. When you see our technology, infrastructure and innovation in operation, you will understand why some of the world's biggest life science companies have chosen to use Huma.
Winner of the 2022 Prix Galien International award for digital health, 'pharma's Nobel prize'1
Active users across our platforms2
Adherence and retention rates across our care and research deployments3
Devices have been shipped in support of our projects2
Hospitals and clinics use our technologies to make sustainable impacts for patients2
Huma's digital-first health platforms support a network of 27m patients2
Launching your SaMD solutions
We advance connected care, helping you build and scale complex SaMD digital companions that are intuitive to use and eagerly adopted.
Our experienced team of Engineers, Designers, Clinicians and Project Managers can rapidly launch and sustain bespoke products with our device, disease and cloud agnostic platform.
Speed your way to market success
Ready-to-deploy, proven modules
Secure, scalable, and fully compliant: our platform accelerates time to market for regulated digital health products — including companion apps, patient support and engagement programs.
Our ready-to-deploy modules include:
Improving patient outcomes
Request details of features
Transforming healthcare
Registered and able to immediately place products in 33 countries.
Capable of supporting all language requirements.
Self-service modular platform to enable rapid configuration.
"The Most Important Healthcare Design of 2021" by Fast Company
Industry-leading and flexible IoMT integration
We are certified under ISO 27001, Cyber Essentials Plus and we are 21 CFR and GxP compliant
Cloud-agnostic platform that can run on any system
Can be deployed across multiple therapeutic areas
Transforming healthcare and
patient impact with our partners
Registered and able to immediately place products in 33 countries, including the EU, UK, US, Australia, South Africa and Saudi Arabia
Capable of supporting all language requirements with deployments in European languages as well as Arabic and Mandarin or Cantonese
Self-service modular platform to enable rapid configuration of digital health and SaMD products
Selected as a finalist for "The Most Important Healthcare Design of 2021" by Fast Company
Industry-leading and flexible IoMT integration with privileged access to raw data from connected devices
We are certified under ISO 27001, Cyber Essentials Plus and we are 21 CFR and GxP compliant
Cloud-agnostic platform that can run on any system and is currently live on Azure, AWS, Google, Oracle and Alibaba
Can be deployed across multiple therapeutic areas including, cancer, cardiac, metabolic, neurological and respiratory
Orthopaedics, Diabetes, Heart health
Connect with us and our partners
We have successfully deployed some of the largest SaMD solutions across multiple patient populations, including heart failure, cardio metabolic disease, pulmonary hypertension and more.
See examples
"I got great comfort having the app – it’s like having your very own digital doctor at home!"
Orthopaedic pathway optimisation
Huma is partnering with Smith & Nephew to enable better care and research in Orthopaedics. Our companion app solution provides care throughout the peri-operative pathway by delivering educational content, questionnaires, telemedicine, activity and vital sign tracking to ensure patients are well prepared for their surgery and supported after.
Care teams and sponsors use the aggregated, anonymised data to correlate outcomes with the type of knee/hip implant, surgery, and rehabilitation approach to support further improvements in care delivery. The solution is currently in use on key client sites to support the patient pathway whilst enabling faster return to regular surgery rates during COVID-19.
patient satisfaction in using the Huma app5
countries in the process of launch across EMEA2
reduction in unnecessary readmissions and average length of stay3
SaMD solution for patients living with diabetes
Using the Huma platform, pharma partners and healthcare organisations improve how patients manage their chronic disease and subsequently their quality of life.
Huma is supporting the Discover-NOW programme with AstraZeneca, the NHS and other consortium partners to enable remote care for people living with Type 2 Diabetes. Together, we are creating a novel real-world data set to support high quality research, with the ambition of improving long-term Type-2 diabetes care and outcomes.
average weight loss6
Patient adherence rate6
average reduction in HbA1c8
Heart Health
In partnership with a leading pharmaceutical company, we are co-developing a primary prevention platform to increase awareness of heart health and drive conversations with healthcare professionals around preventative care.
- ‘Digital-only’ clinically validated⁷ risk assessment educates users about their heart health, without needing to visit their doctor
- Interactive data-capture ‘modules’ create an engaging and informative user experience
- Tried-and-trusted educational content drives awareness of heart health and preventative care
Increase in heart health awareness8
Intending to visit HCP as a result of Huma solution8
Did not expect the Heart Health risk result they received8
Compliance built-in
EU MDD
& MDR
ISO13485
ISO27001
21CFR820 US
FDA Class I
exempt
IEC/ISO62304
IEC 82304-1
ISO14971
ISO14155
IEC62366
CyberEssentials
CyberEssentials
Plus
Approved
Pharma Supplier
Regulatory
Intelligence
Global
Regulatory
Footprint
EU MDD
& MDR
EC Directive 93/42 and 2017/745 CE Class I
ISO13485
Medical Device ISO Standard & basis for MDSAP
ISO27001
Information Security Management system
21CFR820 US
FDA Class I
exempt
US Food and Drug Administration Medical Device regulation
IEC/ISO62304
Software Life Cycle Process
IEC 82304-1
Health Software - Part 1: General requirements for product safety
ISO14971
Risk management ISO Standard
ISO14155
Clinical investigation of medical devices for human subjects
IEC62366
Usability Standard for Software as s Medical Device
CyberEssentials
United Kingdom certification scheme for protection in cyber security
CyberEssentials
Plus
United Kingdom certification scheme independently validated by an accredited third party
Approved
Pharma Supplier
Audited and approved supplier to Major Pharma companies (Bayer, S*N, Janssen, Parexel)
Regulatory
Intelligence
Monitoring of global regulatory requirements (EMERGO, Advena, Monitoring of CA websites)
Global
Regulatory
Footprint
Enabled Market Access by registration with major regulations (US, EU, UK, Middle East, Africa and APAC)
World-leading healthcare
companies partner with Huma
Talk to us
Talk to us
Shanghai
Room 123, 13th Floor
Shanghai Tower
No. 501 Yincheng Middle Road
China
For all China enquiries
Hamburg
(DACH-Region)
Huma Therapeutics GmbH
Raboisen 32
20095 Hamburg
For all enquiries
