Tag Archives: medical device

15 things you need to know about MHRA Human Factors expectations

We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.

19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.

While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?

So, here are 15 things you need to know about the MHRA guidance:
Thing 1.

MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.

Thing 2.

Content of the guidance appears closely aligned with FDA guidance and international standards, with some useful additional information to that discussed by FDA.

Thing 3.

MHRA provide a great tool for anyone making the case for usability activities within their organisation; the guidance spells out exactly the essential requirements in the Medical Devices Regulation (MDR) and In-Vitro Diagnostic medical devices Regulation (IVDR) that mandate usability activities, along with a helpful annex mapping the MDD and IVD to the new regulations.

These breadcrumbs will also help manufacturers who are working to prepare their devices for the end of the MDR and IVDR transition periods.

Thing 4.

Clearing the once muddy waters surrounding drug-device combination products, MHRA establishes that the Essential Requirements enshrined in the MDR and IVDR are equally applicable to the device components of drug-device combination products.

Thing 5.

The document provides a helpful compendium of regulations, standards and guidances that should be referred to for development. The information can be seen as a signpost for those just venturing in to this arena, and serves as a reminder for the seasoned manufacturer.

Thing 6.

MHRA appear to have adopted a more realistic approach to the guidance on risk analysis, pulling back from the previous stance of expecting documentation of all possible use errors to a more realistic approach of capturing “reasonably foreseeable” use errors. This sits well with FDA expectations. A gift for usability professionals battling to influence sensible and design oriented risk management, MHRA have included an expectation of a rationale for the prioritisation of risk mitigations, often overlooked by development teams.

Thing 7.

Thankfully, the finalised guidance requires the development of a user interface specification and a usability plan at an early stage in development, aiding the inclusion of usability activities within project timelines, resourcing and budgeting, rather than as a last minute “add-on”.

Thing 8.

The value of formative usability studies is enhanced by closing the loop from risk analysis informing formative study design through to feeding back into the risk analysis the results of a formative test (unforeseen use errors, occurrence levels, etc.).

Thing 9.

Rightly, there’s now heavy emphasis on the ethics dimension of formative testing and manufacturers responsibility to ensure appropriate ethical consideration is given to the design and execution of formative and summative studies.

Thing 10.

Summative testing (called validation by FDA) now explicitly includes training that may be needed, and sets the realistic expectation for inclusion of users who are unfamiliar with the particular device.

Thing 11.

The HF Summary Report, whilst a very useful document to describe the usability journey, does not achieve all FDA expectations (in particular a greater focus on risk), so manufacturers will need to determine how best to fulfil both sets of guidance, if they intend to market their device(s) in both the EU and US.

Thing 12.

Helpfully, the section on Post Market Surveillance identifies some potential data sources, that will help manufacturers get more out of these activities for both existing products and future development projects.

Thing 13.

Guidance is now given about what to do for older products, of particular relevance as their manufacturers gear up to ensuring compliance with the MDR in the near future.

Thing 14.

The whole topic of simulation, which previously gave rise to concern amongst manufacturers, has now been removed from the guidance. Instead, the reader is pointed towards information covered in ISO 62366 (parts 1 and 2).

Thing 15.

With regard to drug/device combination products, the guidance points to changes in the MDR that require an assessment of device components with the Essential Requirements (including those related to human factors / usability). Helpfully, the MHRA document also references EU guidance relating to drug-delivery devices and specific products.
 
What next?

Now that you’ve read all 15 things, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, and existing products.

Pick up the phone today, or write an email to our team right now.

Self-certification, what’s the Medical Device Regulation done with it?

There’s a heart stopping moment in store for manufacturers of low risk, non-invasive medical devices!

The EU Medical Device Directive contained a number of Annexes that mapped out the various routes to demonstrating Conformity with its provisions.  These ranged from the self-certification for Class I, non-measuring, non-sterile devices, through to certification of both your Quality Management System and the medical device by a Notified Body, coupled with regular surveillance visits and re-certification.

Developers and manufacturers have become accustomed to simply checking the Annexes to establish which route to Conformity made sense for their medical device and business.

Everything changes with the Medical Device Regulation?

Then, along came the Medical Device Regulation (MDR).  In case you’re not already aware, the MDR becomes effective on 25 May this year, with a 3 year transition that finishes on 25 May 2020.  Yes, there are some the major changes to the content, and closer alignment of the MDR with similar regulations for pharmaceutical products.

But, when you reach for the MDR Annexes to check Conformity for that device you have in development, you may notice that one Annex is missing!

The Annex formerly known as “Annex VII EC Declaration of Conformity” has gone!

Yep, the route for self-certification of low risk Class I devices by their manufacturers has disappeared.

What the Medical Device Regulation changes mean

We had calls from several clients recently, panicked that their low risk devices would in future need a Notified Body to certify their QMS and Technical File.  In some cases, this could sound the death knell for their device.

Fortunately, our team were ready to calm these troubled waters.  And here’s what we shared with our worried clients:

  • Yes, the previous content of Annex VII has gone from the MDR.  However, the main body of the MDR reveals the following provision in Article 52:

“7.  Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.”

  • So, the self-certification route to Conformity still exists, for those low risk Class I, non-measuring, non-sterile medical devices.  The requirements for documentation of your Technical File and Post Market Surveillance are detailed in Annexes II and III, rather than being buried elsewhere.

The team went on to outline how the documentation will need to be structured and typical contents that our clients would be required to develop.  Naturally, we will be there to help them through this.

Perhaps you’d like to have a similar conversation with our team?  Get in touch today.

 

Making a difference to medical device users for 10 years

10-years-banner

This week (28th November – 4th December) marks our 10th anniversary at Three Circles.

Over those ten years we have grown, changed and added to our capabilities and knowledge base.  Initially established as a project management consultancy, we quickly expanded to support may aspects of medical device and combination product development, from; human factors, quality management, risk management, regulatory compliance; complemented by lectures and training in those areas.

Throughout our first ten years we have always strived to make a positive difference, both for our clients with the products they develop and launch, and for their end users. Our aims are to help make devices and processes more usable for users, and to help and support the development teams we work with.

We are proud of our team, their expertise and professionalism; they are the foundation for the strong relationships we build with our clients and our network of partners. We now look forward to the new challenges the next ten years will bring.

Here’s a taster of what we have helped clients achieve:

10 years suppporting better healthcare

 

Getting to grips with managing a medical technology project

With increasing pressures on healthcare businesses to get to market quicker, with lower development costs, managing your projects effectively has never been more important.

However, regulatory expectations folots of signpostsr medical technology development are continuously evolving.

There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development.

Following a project management process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

Perhaps you want to understand the crucial steps that need to be taken to ensure successful project completion? Then clear your diary for Tuesday 27th September 2016. We have collaborated with Medilink South West in delivering a one day seminar to outline the common pitfalls and how to avoid them, as well as providing implementable strategies to apply to existing and new projects.

“Great insight into the detail involved and how I can get started”

img_20150917_123707740-croppedThe day is will cover topics like:

  • Why projects fail
  • Why project management makes business sense
  • Project leadership and project management
  • Navigating the complexities of medical device development
  • Key strands of medical technology development:
    • Defining your project
    • Development
    • Industrialisation
    • Product Launch
  • Working with project management methodologies

“Very good, in depth project management tools”

extremely useful, very interesting and well structured.  My interest was held all day which given that it was an all day session is extremely difficult to do.”

At the end of our time together, you will have

  • Gained a thorough understanding of the latest principles of project management
  • Learned how to plan effectively, identifying and mitigating significant risks to your product’s development
  • Created a toolkit for adopting and implementing practical steps and measures at each stage of the process

“Workshops were very energetic and welcomed”

“I know now what we should be doing, and who to call for expert help”

Get started with resolving your project issues by clicking here to book your seat right now.