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How the UK can accelerate radiology AI adoption
It’s no secret that the deployment of artificial intelligence in radiology is lagging behind expectations. Discover five ways AI adoption can be accelerated.
How to get reimbursement for your AI medical device before regulatory approval
Launching an AI medical device startup is an adventure but with escalating costs threatening to slow your progress, the path to your first sale appears steep. We look at how you can get reimbursement for your AI medical device before regulatory approval.
How To Conduct Due Diligence On SaMD And AIaMD Acquisitions
Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.
Health Institution Exemptions for SaMD in Great Britain
Software as a Medical Device is getting easier to build. Because of this many hospitals and other healthcare providers are now developing their own software and AI medical devices in-house to serve their patients. Learn how health institution exemptions might apply to your in-house SaMD or AIaMD in Great Britain.
The Role of a Strong Market Strategy for SaMD
After investing significant amounts of time, capital, and resources into your healthcare innovation, the crucial next phase is to secure its market success. In this article, we take a look at the building blocks of a strong market strategy.
How do you safeguard success in the Software as Medical Device industry? An expert’s guide to intellectual property
In the medical device industry, the role of intellectual property cannot be overstated. Whether you're a founder of a medical device company or a professional in the field, understanding and protecting your IP is critical for the growth and sustainability of your business.
AI, Innovation and Regulation: Solving Healthtech Puzzles at the Hardian Healthtech Summit
We hosted our second annual Healthtech Summit, bringing together a diverse community of healthtech leaders to share their stories and learn from each other.
Taking the pain out of implementation for AI medical devices
The market launch of your AI product is a huge achievement. It is the point from which you should finally begin to enjoy returns on years of personal and financial investment. We take a look at best practice implementation strategy to ensure success.
Building a Go-To-Market Strategy with AlphaBiomics
We supported AlphaBiomics' co-founder and CEO, Anthony Williamson, to develop a go-to-market (GTM) strategy to help them bring precision medicine to chronic inflammatory diseases.
How to Level Up to Digital Therapeutics 2.0
Health technology suffered several setbacks the last few months, culminating with Pear Therapeutics recently filing for bankruptcy. Now it’s time to take stock, regroup and work to usher in the next generation of digital therapeutics.
All I Want for Christmas is… Reliable AI
AI-enabled health tech has had its share of ups and downs over the past few years. Hardian breaks down the obstacles and solutions to moving the space forward.
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 to be commissioned by the NHS and care system. 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 NICE health technology assessment (HTA).
Hardian Health Tech Summit: Lifting the veil on the realities of getting healthtech to market
To celebrate four years of client service, we held our very first Hardian Health Tech Summit event. Joined by many of our clients changing the game in the healthtech industry and keynote speakers from MHRA and NICE, we brought together a community of healthtech leaders for everyone to connect, share and learn.
NICE ESF: The what, when and how?
The UK's National Institute for Health and Care Excellence (NICE) released the latest evidence standards framework (ESF) for digital health technologies (DHTs). It's easy to see how standards updates can be confusing, however this update is an important one, and benefits everyone across the industry, from developers, through to healthcare services and patients.
Re-imagining information and outcomes in healthcare
'Personalised medicine' is accelerating in clinical interventions (e.g. in genomics, pharmaceuticals, surgical implants and synthetic organoids). Now it's time to think about 'personalised medicine' in terms of the data we use to make clinical decisions and measure outcomes.
Tools for AIaMD Transparency and Reporting
Transparency around AI is the first step to building trust, but we still have some way to go to earning that trust in medical AI.
Navigating EU medical device regulation, with Koios Medical
Hardian supported Koios Medical to help their CEO Chad and this American team to navigate the minefield that is EU medical device regulation, and gain a footing here in Europe with a Class IIa CE mark.
Digital health - Strategy or Fantasy?
The worst person you can fool about your product’s value is yourself. It’s time to take a reality check on the feasibility and risks of your grand idea.