Tag Archives: medical devices

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”.

FDA Finalises Human Factors Guidance – summative testing – Part 3

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”.
We have already taken a look at the first three in this list of the key topics covered by the Center:

  • Human Factors Engineering processFDA HF guidance FINAL
  • 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 3, we’ll look at how the topic of Human Factors testing (both formative and summative) may impact what you’re either already doing, or plan to do.

Formative Human Factors testing

Look upon this stage of testing as providing a toolkit to identify potential use-related hazards and hazardous situations. The agency emphasises the value of testing with participants who are representative of your intended users, as this yields early data on how your eventual users cope (or don’t) when using your prototype device.

The agency recognise that formative evaluations provide information about;

  • Design of the user interface (those parts of the device that are manipulated by the user, provide them with information or indicate function)
  • The effectiveness of features or changes implemented to reduce or eliminate use errors (otherwise known as mitigations)
  • The the need for training of users and inform the design of training materials
  • The design and content of labelling such as the Instructions For Use, product labelling, packaging.
  • The content and design of your summative testing.

In the guidance, the Center talk about the value of effective formative testing in preventing very costly errors in the design of your validation test protocol that render it just another formative study.

In a departure from previous guidance, there is information on the expected content of formative test protocols, which creates a coherent and building picture that results in the information now expected for your HF validation test protocol. It’s very much a case of using formative studies as building blocks that provide a robust foundation for your validation test.

Summative Human Factors testing

Summative testing is still in place. However, testing that demonstrates the “user requirements” or User Needs have been met will henceforth be referred to as “Human Factors Validation Testing”. One could perhaps see this as coming into line with the philosophy applied to validation of processes, test methods, production lines, etc

No longer does guidance expect you to just include critical tasks within your test design. Rather, the testing needs to be comprehensive, so that the results can be related to actual use.

Test participants

If your device is intended to treat patients with a condition that can cause them to have functional limitations, these conditions must be represented during both the formative evaluations and your HFE validation study. If you choose not to design your device to accommodate needs of those likely to use your device, then labelling should clearly explain the capabilities that users must have to use the device safely and effectively. You should, therefore, ensure that you’ve understood your Users’ needs thoroughly and scoped out the Usability Specification appropriately to know what capabilities/limitations are to be included in study participant groups.

Participant Training

If you anticipate that most users of your device would receive minimal or no training, the Center now expect that participants in your validation study do not receive training.

A period of time between training and participation in your validation study should be built in to the study design. How long that is will vary, depending upon what would happen in real life and the impact of training decay on the use-related risks that you’ve identified for your device. The important thing is to consider this topic and document your rationale for the chosen approach.

Study protocol

Manufacturers are now formally encouraged to submit draft HF Validation Test protocols for agency review, to ensure that the methods you plan to use are acceptable (via the pre-submission programme). We’ve been fortunate to have supported several clients in developing and submitting draft protocols to CDRH, so have benefited from a “heads up” about many of the changes that are now embodied in this final guidance document. The review can be a great way to confirm that your approach to HF Validation will satisfy expectations.

If testing of labelling formed part of the validation study, the agency now require this to be conducted separately after simulated use testing.

The test protocol must provide a rationale for the extent of device use and the number of times that participants will use the device. This means frequency of device use must be considered; for devices that are used frequently and have a learning curve that requires repeated use to establish reasonable proficiency, testing should allow participants to use the device multiple times, if appropriate.

Data collection should include capture of observational and knowledge task data and should be supplemented with subjective data through the use of de-brief interviews with the participants after the use scenarios are completed. The purpose of the de-brief is to assist with understanding of possible root cause of use errors detected during testing.

Study location

It has long been understood that there is an expectation for the validation testing to be performed in the US. It is an expectation that hasn’t been removed, as the results of studies performed in other countries may be skewed by differences between healthcare practices, cultural and language differences. However, the agency are open to considering exceptions, on a case by case basis, where there is a sound rationale that addresses the differences. In any case, as you might expect, the device, labelling and training must be those that would be used in the US. So, in the vast majority of cases, it is likely that testing in the US would be more straightforward.

When is the guidance effective?

You will have some time to assimilate the requirements…
 
A whole 5 weeks, 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”.