CE Marking your Medical Device

It’s a hard job but someone’s got to do it!

Obtaining the CE Mark, even for the simplest of medical devices (which may be an app) is not a post-development paper-exercise to ‘get the badge’. The new Medical Device Regulations demand greater and more detailed documented evidence that your device is safe for patients and consistently performs as claim it does. We highlight what we think are the key success factors and tasks to address to gaining the CE Mark quickly and efficiently.

 First-time medical device manufacturers seldom have the in-house capacity and/or capability required to secure the CE Mark for their product. To adequately demonstrate conformity to the applicable medical device regulations and fully address specific elements of them such as risk management, clinical evaluation (trials) and quality management systems requires specialist expertise. However, there are some important steps that you can take to make the process as quick and efficient as possible:

#1 Culture

A positive approach to the Regulations is a key success factor. A company that uses them as a framework and process to ensure their device that is as safe as possible and performs reliably and consistently can enjoy quicker and greater commercial success.

#2 Strategy and Planning

Key strategic questions start with the basics. Is your product actually a medical device as defined in the Regulations? Or is it an in-vitro diagnostic device or indeed neither?

If it is a medical device (or IVD), are there any other Regulations or Directives that might apply? General examples include The Waste Electrical and Electronic Equipment Directive (WEEE), the Low Voltage Directive and The Restriction of Hazardous Substances (RoHS2).

The Medical Device Regulation 2017/745 (MDR) came into force in May 2017 and by May 2020 all medical devices (new and current) must comply with them. Until then it may be possible to still conform to the Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC (MDD) but conversion to the MDR must be complete by May 2020. Will you comply with the MDR straightaway or perhaps comply with the MDD and establish a transition plan?

The route of conformity depends on the classification of your device, some will require involvement of a Notified Body. Linked to the conformity assessment route is the requirement for you as the manufacturer to have a quality management system (QMS). The choice of conformity assessment route and QMS to be implemented will have time and cost implications that need to be factored into your overall development plan and budget.

Early integration of the product development, regulatory and marketing plans helps ensure not only the right product is developed for the right application but that the documentation required for the technical file is prepared concurrently to the development program so reducing time and cost.

#3 Quality Management System

Often overlooked, a Quality Management System (QMS) is an integral requirement of the MDR. Operating within an appropriate quality framework from the start of product development will help demonstrate conformity.

#4 Documented Evidence

Pivotal to securing the CE Mark is the preparation of a technical file of documented evidence to show that you, as the manufacturer, and your device comply with the requirements of the Regulations.

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Document everything you do:  As the FDA say: ‘If it isn’t documented it didn’t happen”

Key tasks to include in your development and regulatory plans include:

#5 Human Factors Engineering

HFE is an increasingly important factor in regulatory conformity and extends way beyond ‘usability’ of the device. Early engagement with intended users and patients is vital to ensure the device design works for both these key stakeholders and addresses environmental factors that could influence safe use of your device.

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Involve prospective users and patients from the early stages of product development and design right through to first use.

#6 Clinical Evaluation

This area has been tightened up immensely under the MDR. Clinical evaluation includes literature review and clinical investigations (studies). It is now a process that continues after CE marking.  You must have sufficient clinical data and evidence to continually

  • Confirm conformity with the general safety and performance requirements of the MDR
  • Evaluate any undesirable side effects
  • Support the acceptability of your benefit/risk analysis.

You must use people with appropriate and demonstrable expertise and competence to undertake the evaluation.

It will now be less possible to meet this requirement by literature review alone. You will now almost always have to have carried out a study to demonstrate safety and performance of your particular device.

A clinical evaluation can only be based just on clinical data (literature review) of another device where equivalence to your device can be demonstrated. In practice this will mean you can only consider devices for which you hold the technical file or possibly where there are other devices already on the market and with a long (published) track record of safe use.  Almost by definition, innovative products will not be directly equivalent to products already on the market and will not have already published appropriate clinical data and so will need a clinical trial to meet the requirements of the MDR.

#7 Software and Apps

The growth of mobile apps and web-based healthcare products has been and still is immense. What has been often missed it that these can still fall under the legal definition of a medical device.

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Test the use your app against the definition of a medical device

There is a new rule in the MDR for classifying software whether it is within a device or stand-alone:  Rule 10a means that software intended to “provide information which is used to take decisions with diagnosis or therapeutic purposes or to monitor (vital) physiological processes” may now be a higher-risk, class II device, requiring Notified Body involvement to secure the CE Mark.

#8 UDI/EUDAMED

To facilitate identification and traceability, all devices (other than custom-made and investigational devices) will now have to carry a Unique Device Identification (UDI) number on the device or on its packaging. It will probably take the form of a bar-code.

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Prepare to develop UDIs for your products

There will be a European-wide database of UDI numbers (EUDAMED). The impact of Brexit may affect this, but we consider that if UK manufacturers intend to export to the EU, they will still have to place their UDI numbers on this database.

#9 After the CE Mark

The obligations of the device manufacturer don’t end with securing the CE Mark. The technical file is a ‘living document’. It must be maintained throughout the lifetime of the device.

There are also post-market obligations that includes monitoring the market for information about the device and acting on it if required. You must also have a post-market clinical follow up plan to proactively collect and evaluate clinical data from the use of your CE marked device within its intended purpose.

The new Regulations now call for a ‘suitably qualified’ person to be responsible for these and other regulatory activities.  Micro and small enterprises are not required to have this person employed within their organisation but ‘shall have such person permanently and continuously at their disposal’.

Do you have such a person in your organisation?

Stop thinking USP- think Value Proposition.

Starting or growing your business with the NHS is a difficult and demanding journey.  So, how can you best respond to the challenge? Helping your customer solve their problem is the way to go.

The idea of a unique selling proposition (USP) has been around for a long time. Aimed at the consumer market, it aims to differentiate one product (or service) from its competitors and so influence the buying decision. One definition is

The factor or consideration presented by a seller as the reason that one product or service is different from and better than that of the competition.

I think Clayton Christensen’s concept of the value proposition is a more powerful one for innovative products. He describes the value proposition in terms of the ‘job to be done’- something your customer wants to get done better, quicker, or cheaper or something that they can’t get done at all. Simple example-  if someone wants a hole in their wall (or wherever), the ‘job’ they want done is the hole. A drill is one way but there are many other ways to get the job done.

People have misinterpreted the value proposition for something to do with economics and financial return- probably mistaking value for cost or price. It isn’t. It’s about solving a real problem, it’s about getting a job done. Here’s an example from Christensen’s book, The Innovators Prescription (a great read  by the way about innovation in healthcare and the challenges facing the US healthcare system):

Before digital cameras, we took our roll of film to be developed. Often we got double prints because there was an offer, the prints were good quality and we thought it would be great to share them with family and friends. We took them home, looked at them once and then put them in a drawer, seldom, if ever, to be looked at again.  Few of us ever organised them into an album or actually did send them on. We knew we should and we wanted to but we didn’t. Here’s the key thing: what we do and what we say we (will) do or what we should do are very often different.

The first digital cameras arrived. Initially, companies offered several value propositions; you can click ‘attach’ and instantly e-mail photos to family and friends when something important or interesting or funny happened, you can digitally remove red-eye from those photos you only ever looked at once, (provided you bought and learned how to use the software), you can keep your photos in an online scrapbook, that makes it easy to sort, search and print from the gallery of thousands of photos…..

In reality, very few digital camera users did any of these. The feature most users of the first digital cameras actually made use of was to e-mail images to family and friends at some later date. Why? Because that’s the same job we were trying to do (but seldom did) when we ordered multiple prints. So, the first digital cameras that made this possible was giving the user an easier way to get their important job done and stole a market advantage. Now, there a new jobs need to be done, new value propositions need to be built. Now, digital cameras are in mobile phones.

Key learning: Observe what you target customers actually do. Dig deep to find the real job they want done then build your value proposition around it. By determining what ‘job’ healthcare professionals (clinical or management) want to do that they can’t do effectively, efficiently or at all, focuses your mind and energy on whether your product can has a solid and real value proposition.

So where does that leave the USP? For an innovative, new-to-market Med-Tech product (or service), your first goal is to convince the customer that it can help get their job done. It is not to show how your product is better than others (that may or may not be used). You are not aiming to secure a buying decision (yet) so pushing your product’s USP is not the best way to go about securing ‘buy-in’ and interest. It will become relevant later, in procurement, where buyers are comparing all products that could (or claim to) do the same job as yours and are interested in differentiation and price.

Another consideration: The value of a device is no longer solely in the product itself. While clinical efficacy is a must, in today’s climate additional value will come from your ability to help your customers to also solve non-clinical problems such as using resources (including staff) more efficiently, reducing length of hospital stays, delivering care closer to home, and reducing future hospitalisation. There may be more than one ‘job to be done’- clinical and operational. Look for them all and talk about the right one with the right person.

Starting or growing your business with the NHS is a difficult and demanding journey requiring in-depth knowledge, insight and committed resources to address this vital element of your market access strategy. So, how can you best respond to the challenge? A vital first step is spend time understanding what job your customer has to get done and building your value proposition around it.

NEW FUNDING SOURCES NEEDED FOR TRANSFORMATION

In the HSJ of 2nd April, Anita Charlesworth and Richard Murray discuss the difficulties of getting funding for NHS organisations to try out new services whilst still maintaining delivery of existing ones and call for a new transformation fund. Their comments are as applicable to new MedTec
products:

They recognise that current business cases are limited to showing where an investment in a new service (or product) can recoup financial benefitsin the same organisation and not in other organisations or indeed outside health all together.

TO BE NHS READY:
Have you identified and mapped all the stakeholders that can influence the
decision to try and buy your new product or service?

They also identify that there is the problem that certain types of costs
are not supported by any of the existing investment approaches.
In particular, it is difficult to raise funding to manage the process of
change from one model to another. This includes provision for so called
double running costs as the new model is tested is parallel with current
services, or where the benefits of the new model take time to be realised.

TO BE NHS READY:
Have you got a win:win business model to make it easier for your customers
to try your product or service?

COST PRESSURES NOT DEMAND IS THE PRESSURE ON NHS

In a National Health Executive News article of 8th April 2015, its cost pressures and not demand that is putting pressure on the NHS. In it, Anita Charlesworth of the Kings Fund reports
“The big driver of deteriorating finances is growing cost pressures andthe big factor pushing up costs is rising spending on staff, and mostspecifically temporary staff. In 2013/14 the number of temporary staff increased by 16%  resulting in spending on temporary staff growing by £1bn (27.4%) in 2013-14.”

TO BE NHS READY:
Can you improve the productivity of permanent staff to reduce this dependence?

The NHS Five Year Forward View calls for productivity improvements and efficiency savings of 2-3% a year.Rob Webster, chief executive of the NHS Confederation has said “It underlines that the NHS requires a new focus on “allocative” efficiencies – by doing things in new ways that
are better, simpler and more cost effective.  It is vital that the public are involved in this conversation,”

TO BE NHS READY:
How can you help do things in new ways that are better, simpler and more cost effective?
How are you engaging with patients and the public?

The Power of Linked In

I have just completed a campaign where I sent a message to 74 of my Linked In connections asking for their advice and guidance about my business. 35 (56%) replied within 10 days, 13 (17%) offered to either meet or talk on the phone and so far I have 4 new leads. Really pleased and encouraged. Many thanks to my Linked In connections!