Tag Archives: medical devices

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.

Navigating the transition

The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017.

Understanding the changes, let alone navigating them successfully to prepare for compliance in May 2020 is no small task.

Thankfully, the UK regulatory agency (MHRA) has produced a guide to help you get to grips with what has changed and what you may need to do to get ready for a smooth transition in 2020.  After a detailed review of the MDR, we published the 15 things you need to know.

Unlike many other regulatory changes in the EU and US, there will be no “grandfathering” of existing medical devices under the MDR, so we strongly recommend starting your preparations sooner rather than later.  If you’re developing or marketing a Class 1 medical device, you should read about what’s happened with the self certification route too.

And with the ever decreasing pool of Notified Bodies available to work with for the higher risk devices, you’ll probably need some guidance and help before you reach out to one of the few remaining bodies to assess your product against the MDR and (re)certify your CE marking.

We’re always here to provide reassurance, guidance and a helping hand, to ensure you don’t do too much, or too little. We ensure you only do what you need to.

Get in touch today, make the most of the time you have left on that clock.

Additional Resources:

Read more on this topic with these related posts:

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.

FDA finalises Human Factors Guidance – Existing products – Part 4

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

The document, published on 3 February, is the result of nearly 5 years of consultation with industry since releasing a draft guidance back in 2011.

FDA HF guidance FINALWe have covered a lot of ground already. In the first 3 parts, we heard about four of this list of the key topics covered by the Center:

  • Human Factors Engineering process
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Changes to products already on the market
  • Human Factors Engineering Summary report

In part 4, we’ll look at the Human Factors Engineering Summary report and submission of your HFE data. You may then want to think about how this may impact what you’re either already doing, or plan to do.

Changes to products already on the market

You may be wondering how this relates to devices that are already on the market? The agency has provided some guidance to help you understand when modifications to a device mean that it should undergo validation testing. The need for additional human factors validation testing should be based on risk management planning and risk analysis for the modified User Interface or Tasks, to determine the scope and nature of testing required and should focus on those hazard-related use scenarios and critical tasks. The test may, however, be limited to assessment of those aspects of users’ interactions and tasks that have only been affected by the design modifications.

The agency also recommend that for any further human factors validation testing consideration should be given to user’s comparison of the design modification to the previous design.

Human Factors Engineering Summary report

It’s often seen as the culmination of your HFE programme.

Expectations for content of the report have expanded, to require far greater information about analysis and elimination/reduction of risks and hazards associated with use of the device, critical tasks and use scenarios. Far greater detail is needed about the validation study, discussing test environments, training correspondence to real-life, data collection methods, test results, feedback, analysis of use errors, difficulties, root causes of problems and implications for risk elimination/reduction.

The Center are proposing to require submission of HFE data with your PMA or 510-K, for those devices where users performing tasks incorrectly or failing to perform tasks could result in serious harm. There’s a separately issued, draft, guidance that outlines current thinking on which devices would need this as a matter of course, which may well change between now and the final version of that document.

However, the agency has not removed the expectation that a human factors programme is present as an integral part of a robust design control system.

So you still have to do it, you just may not always need to include an HFE Summary report in your submission dossier.

When is the guidance effective?

You will have some time to assimilate the requirements…
A whole month, as they go live on 3 April 2016.
How will these changes will affect your product development?

What impact they will have upon your Human Factors Engineering programme?
Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.