Category Archives: qualification & validation

Riding the wave of Software as a Medical Device

For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads, other territories will follow.

It’s probably little surprise, given that software apps rely upon a stable platform to operate effectively.

If, like us, you’ve ever experienced an update to one of the apps on your smartphone either “break” functionality or impact on how another, seemingly unconnected, app performs, then you will appreciate why this is a challenge that needs to be resolved.

FDA publishes and updates guidance documents

Signs of the changes for Software as Medical Devices (SaMD) are mainly found in the activities of the FDA (the US regulator for drugs and medical devices) and forms part of the US government’s drive to bring regulation up to date, by passing the “21st Century Cures Act” into law.

Agency guidances have since been published for a range of topics;

Clearly, FDA view the changes as important to the health of the US populace.  Taking the case of apps used to support drug treatment as just one example, here’s what the FDA commissioner, Scott Gottlieb had to say;

“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge”

International guidance for software as medical devices

The flurry of activity comes on the heels of the last in a series of documents produced in the area by the IMDRF (International Medical Device Regulators Forum).

Perhaps you’re not too familiar with the work of the IMDRF? That’s ok, it is after all a rather niche topic. Regulators from the EU and 9 countries have been working together “to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device”.

Work completed by this IMDRF working group produced a suite of guidance documents relating to SaMD, including;

If you’re considering, or are already a long way down the path to, developing, pure software medical devices or “accessory” apps, such as those used to manage a chronic disease such as diabetes, then you need to be aware of the shift and adjust your approach accordingly.

Help is at hand for software as a medical device

Clearly, there’s a lot to take in with the swathe of documents, before assessing the impact the changes may have upon your development plans.

Over the coming weeks, we’ll be sharing insights for each of the documents mentioned in this article.

Subscribe (add your email to the box on the right of this page), to ensure that you’re alerted as soon as new information is published.

Perhaps you want to get to grips with the changes today?  Get in touch now.

Business Bridge tender success for Three Circles!

We are delighted to have won a tender to supply regulatory guidance, CE marking and support services to companies developing medical technologies, via the Keele University and University Hospitals of North Midlands NHS Trust (UHNM) Business Bridge programme.

Healthcare market access support for Staffordshire businesses

The Business Bridge programme supports businesses based in Staffordshire, UK, currently working within or hoping to access healthcare markets. The partnership between Keele University and UHNM provides fully funded innovation vouchers to the value of £7,000 to eligible companies.

The vouchers can be exchanged for access to an expert panel of specialist advisors within the healthcare and medical markets and/or specialist support such as; support for market access, product design, prototyping and testing and CE marking and other regulatory advice.

Matthew Theobald, New Product Director at Three Circles commented: “We are delighted to have won this tender and to have the opportunity to support businesses in the West Midlands looking to develop innovative products for the healthcare market.”

Click here to visit the Keele University Business Bridge web page.

 

 

Medical device development; look what you could have won…

Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…)

Our inspection lifeboat

Three Circles, the leading medical device development consultancy, have commissioned bespoke research into the industry’s perceptions of best practice, areas of risk, and the causes and impact of delays in the development process for medical devices.

 

 

If you are currently:

  • a director or head of department with responsibility for device development within your organisation (i.e. you manage the team, control the budget and are responsible for the strategic overview and project delivery),
  • A project leader with responsibility for device development projects within your organisation (i.e. you manage the team, manage the budget and are responsible for project delivery),

then we want you to participate in our research.

The research will be conducted by an independent third party who will ensure your participation remains confidential with the results anonymised. The findings will be used to validate our route map for the development process and will be shared with participants.

Along with a copy of the research findings, you will receive our eternal gratitude and a small scale model of a speed boat and we will make a donation to the RNLI for everyone who takes part.

To register your interest in participating, please email me directly (hello(Replace this parenthesis with the @ sign)threecircles.eu) with your contact details.

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.