Author Archives: Matthew Theobald

Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown.  Having a map for this journey would be an attractive proposition.

To flesh out our map for the journey, we joined around 30 other industry experts for Medilink East Midland’s July 2018 conference “How to get your medical device NHS ready”, held in conjunction with Nottingham University Hospitals NHS Trust.

The day covered a range of subjects, all geared towards giving you the knowledge to best prepare your medical device for a favourable review outcome for the NHS.  Amongst the topics we discussed were;

  • The impact of Human Factors in medical device development,
  • Patient Public Involvement – why it’s so important and how to access it,
  • Regulatory support for medical device development,
  • How to undertake a clinical investigation in the NHS,
  • Using a budget impact assessment to support uptake and adoption,
  • NICE engagement and support for developers.

A number of case studies were also shared, demonstrating the value achieved by considering specific topics of the agenda.

We left the event with a clear picture of how our core disciplines supported, and could be woven throughout, the preparations for NHS “readiness”, over and above regulatory authority approval.  We’re now applying that knowledge to help our clients’ development activities.

Involving patients and the public in medical device development

There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK).

An aspect that was revealed to those attending a recent Medilink East Midlands conference in Nottingham. An aspect known as “Patient Public Involvement” (PPI). There’s lots of activity within the NHS to increase PPI throughout all aspects of health and social care in the UK.

Recognition of the importance of involving patients and public in healthcare has implications for the development of medical devices and combination products. Should you be looking for sources of grant funding for planned research, the UK National Institute for Health Research (NIHR) asks applicants to “… describe how they have involved the public in the design and planning of their study as well as their plans for further involvement throughout the research and if not, to explain why.”

NICE is crystal clear about the importance of PPI, expecting the steps taken by a manufacturer to be included in the information they provide for the decision making process, with the “patient voice” increasingly expected to be heard by review panels.

So, what is Patient Public Involvement in medical device development?

Perhaps unsurprisingly, there are many layers to PPI within the NHS. Lots of the layers revolve around Governance and service provision, with layers relating to delivery of treatment buried deep.

There exists a massive opportunity for the developer of a medical device from interaction with patients and service users. By listening to people, we can understand diverse health needs better, “to improve patient safety, patient experience and health outcomes; supporting people to live healthier lives” (NHS PPI Policy). It is revealing that patients are referred to, within the PPI Policy, as “experts by experience”.

Why should that matter to you as a manufacturer/developer?

Simply put, three reasons:

Firstly, it helps you get access to research funding from NIHR and other bodies; as you can clearly demonstrate involvement of the public at an early stage in development.

Secondly, it supports the case for your medical device to be adopted by NICE and subsequently, Commissioning Groups, as the “patient voice” is clearly listened to.

Thirdly, and by no means least, proper patient involvement massively informs the development of your product.

“No matter how complicated the research, or how brilliant the researcher, patients and the public always offer unique, invaluable insights. Their advice when designing, implementing and evaluating research invariably makes studies more effective, more credible and often more cost efficient as well.”

InvolvProfessor Dame Sally Davies, Chief Medical Officer (Foreword in Staley, 2009)

There are other, ancillary benefits too, such as:

  • Patient stories, testimonials are a useful resource to show the value of a medical device for their quality of life,
  • As a marketing tool, articulating your participation with patients and public, throughout development of products that they and the NHS want and need.

How can I involve patients in development activities?

You may already have sensed some similarities or cross-over between patient involvement and the discipline of Human Factors Engineering / Usability.

There’s a good reason for that.

Usability is a great way of ensuring patient involvement in development of medical devices destined for the NHS; in a planned, documented and well thought out manner. There is a clear link between the drive to demonstrate patient involvement and Usability studies, particularly in the earlier stages of development. Formative Usability studies, involving patients and users, inform the requirements for a medical device, test out concepts and gain valuable feedback that hugely influences the final design. Evidence of all this is looked for by grant funders and regulatory decision makers.

And let’s not forget, that early discovery of what users and patients really need a medical device to do for them, can provide you with a competitive advantage for product development. When you really understand what drives the users / patients, what they are “putting up with”, the work-arounds they (subconsciously) use to improve their quality of life with a device, your product will “just work”.

What next

When you’re writing applications for research funding, or drafting your NICE submission (or ideally much earlier in development), consider how you could weave in some Usability activities and data to make the case for patient and user involvement. If you’ve already undertaken (or plan to) as programme of Usability studies, examine how the results can support your application.

If you’re unsure how to get started, call our team now. We will be happy to explore how we can help you get there sooner.

9 Steps to right first time regulatory compliance

It can be a scary thought, regulatory compliance.  So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.

1. The right regulation?

May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.

  • Be clear about the primary purpose for your medical device, and the mode of action.
  • Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
  • Does your product fit the description of a medical device? If, yes, then the MDD applies.
  • Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
  • Does your product clearly not fit with any of the descriptions?  You can get advice (in the UK) from MHRA on borderline cases.  Similarly, you can access EU wide borderline device decisions, and the reasoning.

Remember to also consider other EU legislation that your product may need to comply with.  And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.

2. Are you setting out to solve the right problem?

What is the problem or clinical need that your product is intended to resolve?  Is the problem widespread or isolated to a small aspect of healthcare in one country?

Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used.  Your focus is then narrowed onto developing a product to address a specific need.  You can always expand into other clinical pathways or markets with a future version of the product.

Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests.  Get this right, and the foundation is secure.

3. Put a Quality Management System in place

Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.

The difference between the lowest risk medical devices and the higher classes is one of QMS certification.  For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine.  Otherwise, a Notified Body certification is needed.  Make sure you adopt the correct QMS certification route for your device.

4. Good Development Practice

“Begin with the end in mind” as Steven Covey said.  As you develop your device, picture how the documentation will come together for the submitted device.

The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.

The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.

Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development.  Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.

Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting.  If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development.  You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.

5. Use Harmonised Standards

Check the most recent update to the European Commission’s list of Harmonised Standards, to see which are relevant for your medical device.  Manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation.  So following the content of a Harmonised Standard is usually the straightforward route to demonstrating compliance.

6. Take care constructing your Technical File

Make it easy for the reviewer to navigate your Technical File, from a high level overview through to the detailed content that they’ll want to read through.  Adopt a logical layout to presentation of information.  There’s a handy template for the content of your Technical File provided by IMDRF (for a medical device, and for an in vitro diagnostic device).  The IMDRF documents are a few years old now, however the MDR contains a detailed description of Technical File content in Annex 2.

7. Your Clinical Evaluation Report

It won’t have escaped your notice that the MDR includes explicit requirements for Clinical Evaluation and its reporting.  There are two major benefits to getting underway with your Clinical Evaluation early in development:

1. The results of your research feed directly into the definition of Design Inputs (what the device needs to be able to do for the user / patient),

2. You have a clear picture of any Clinical testing that is required for the device, permitting realistic budgeting and planning of the project.

8. Post-market Surveillance Plan

Ensure that your QMS incorporates a good system for Post-Market Surveillance (PMS), covering vigilance activities, steps taken for pro-active PMS as well as reactive PMS (i.e. when you’re alerted of a problem, perhaps via a complaint), post-market clinical follow-up.  Naturally, all this is supported by a plan for PMS, that pulls all these threads together and demonstrates how information will be used to instigate or confirm design changes, how PMS information feeds into CAPA, Change Control and Complaint Handling processes.

9.  Managing Devices in the field

Remember to include activities to provide for CE Marking of your medical device prior to placing it on the market (for Class I non-measuring, non-sterile, this can be self-managed, for all other Classes, a Notified Body must be involved).

Consider what requirements you have for any servicing, maintenance and performance verification while the device is in service, and across its in-use life.  These will need to be documented and tested to verify their effectiveness in ensuring continued device performance and safety.

Getting it right, first time

There can be a lot to take in, working through these 9 steps.  Rest assured, help is at hand, should you wish for some guidance or support along the way.  Get in touch today, so we can explore how best to ensure you reach your goal of regulatory compliance, right first time.

Improving Paediatric oral medicine delivery – workshop

Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

11th September 2018, London, United Kingdom

The workshop is likely to be of interest to many of our readers, so here’s information provided by the organisers:

The European Paediatric Initiative (EuPFI) is inviting expressions of interest in a workshop organised to identify and discuss challenges and potential improvements in the development, control and utilization of oral dosing syringes and enteral accessories for paediatric liquid medicines.

The workshop which will be held at University College London (UCL) School of Pharmacy premises in London, is a crucial step to find the optimal path towards correct dosing to all paediatric patients using these oral administration devices. A broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia, are invited to the workshop to share current practices and issues regarding the development and handling of oral dosing syringes and enteral accessories, to facilitate awareness and identify areas for improvement. Representatives from national competent authorities, EU institutions and other stakeholders will also attend.

Completed forms for expression of interest to attend the workshop should be submitted by 20th July 2018.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.

Further details are available at http://www.eupfi.org/devices-workshop/

We have submitted our expression of interest in attending, and hope to see you at the workshop.