Regulations Archives

Do you need to adjust your HCP marketing and patient marketing campaigns?

Are you wondering if you need to adjust your campaigns depending on whether you’re marketing to patients or HCPs?

Are you looking for tips on the best ways to tailor your campaigns to different audiences?

We specialise in all different areas of Medical Device marketing and one thing our clients often come to us for help with is how their marketing activities should differ when appealing to healthcare professionals versus to patients.

So, we thought we’d write down what we know.

Although medical device marketing is surrounded by regulations, the basic principles of marketing can still be used to create successful campaigns that help businesses meet their objectives. We believe that being in a technical industry doesn’t need to mean that creativity is stifled.

When marketing to different audiences, the same principles still apply, but you need to shift your focus slightly.

1. Knowing your audience

Audience marketing

This is the golden rule of marketing, and one that will not change.

Knowing your audience isn’t as simple as just being able to say who you’re targeting (HCPs or patients), you need to know as much about them as possible.

You need to be able to understand your audience, for instance, what are they interested in? What are their challenges? What questions are they asking? How can you help them? Which platforms do they engage with?

Knowing this will inform you on the best way to reach you audience. Are they more likely to come across your materials on social media or through a search engine? Is the best way of reaching them through live events? You will be able to tailor your efforts to where they’ll be most fruitful.

Furthermore, you will also be in a better position to predict what they will be searching for online, or what will stand out to them when scrolling through social media. You can ensure that the content you create will appeal to them and leave the best impression of your company and device.

2. Multichannel marketing

One of the most prevalent rules of marketing, and one that we firmly believe in when it comes to Medical Device marketing, is that your audience needs to be exposed to your message at least 7 times before they act. With the rise of digital marketing, this number is now more likely to be closer to 15-25 times.

This means that you need to reach your audience as often as possible and with the right content, multichannel marketing can help you do this.

An effective multichannel campaign involves distributing your message consistently across multiple platforms and mediums, reaching your audience on numerous touch points. In Medical Device marketing, this means an approach that involves digital activities, like social media and SEO, as well as offline activities such as event marketing and magazine adverts.

The rule of 7 (or 25) spans across industries and audiences, so whether you’re marketing to HCPs or patients, a multichannel approach is a great way to approach your marketing strategy. Of course, you’ll have to tailor your approach depending on your audience.

For instance, when marketing to patients there may be few opportunities for the in-person contact that HCP conferences present, but you will find that less niche platforms such as magazines or even social media advertising can be used, and never forget SEO, one of the most underrated tactics in Medical Device marketing.

3. Tailoring your content

Again, the importance of knowing your audience cannot be overstated, especially as it enables you to tailor your content, which in turn means that you’re likely to see more success in achieving your business aims. This principle is the same for both HCP and patient audiences.

It’s helpful to understand their challenges and the issues that your Device can help them to overcome. Consider what the top questions your audience are asking and use this as a starting point for creating your content.

By reaching out to them in this way, you’re building more trust than if you were to simply just list the benefits of your Device. Although this type of promotion does have a time and a place, it’s usually when your potential customer is further on their buyer’s journey.

You can also tailor the type of language that you use and the message you present. For instance, when communicating with HCPs you can use more technical language and reference studies and statistics.

On the other hand, when you’re marketing directly to patients, this type of information may not appeal to them as much. You’re more likely to be focusing on lifestyle changes using approachable and open language.

For more tips, check out our podcast on coming up with content ideas.

4. Choosing the correct channels

We briefly mentioned the different channels you may approach for patient marketing and HCP marketing, but it’s important to consider this in detail when planning your strategy.

Generally speaking, you’re likely to find your patients on more casual platforms such as Instagram and Facebook, but again, it entirely depends on your intended audience. You’ll need to research which platforms are most popular among your patients.

On the other hand, HCPs are probably less likely to engage with Medical Device companies on these platforms, simply because they are not necessarily in a professional frame of mind when using them. That is not what they are there for, and as a result you may struggle to engage them.

Marketing distribution channels

Platforms like LinkedIn and YouTube and attendance at events may see better results. In this case, they are more likely to be in the right frame of mind and open to receiving marketing messages.

SEO is an extremely effective tactic, no matter who your audience is. For most people, when they have a problem or a query, their first port of call is likely to be a search engine, meaning they’re actively seeking out your help and your messaging.

They’re open and engaged, meaning it’s a great time to get in front of them and encourage conversion.

Are the regulations different for HCP marketing and patient marketing?

One thing to be aware of when tackling the differences in Medical Device marketing strategy for HCPs and patients is the difference in what you can say to still comply with regulations.

The EU MDR contains some differences between the member states with regards to patient marketing and often increased limitations do apply. France, for example, has the strictest rules forbidding marketing to a patient for any device that has a risk classification of IIb or higher.

We have a handy PDF download of EU MDR and local country medical device advertising guidelines.

Follow the basic principles

As you can see, successful marketing comes down to remembering the basic principles and applying them to your campaigns, no matter who they are aimed at.

As long as you’re complying with regulations and you know your audience well, you are sure to see success.

Patient and HCP marketing with Podymos

Do you want to communicate more effectively with HCPs and patients? Do you want to be able to deliver high-quality, multichannel campaigns? You’ve come to the right place.

Podymos is a healthcare marketing agency, specialising in downstream Medical Device marketing.

We’re more expensive than non-specialised agencies and freelance teams because we only work in the Medical Device space so we have specialist knowledge and experience that other agencies may not be able to offer you.

If you want high-quality, compliant campaigns that help achieve your business goals, we’d love to hear from you. Simply leave us your contact details below and we’ll get back to you very soon for a no obligation chat.

GDPR for Medical Device marketers

Although GDPR has been around for a while now, it is still a term that scares marketers and causes them to tread lightly in their marketing activities for fear of not complying. The rules are buried so deep under technical jargon that it can be difficult to really understand what you can and cannot do as a Medical Device marketer.

Luckily, we’re here to clear a few things up and leave you feeling more confident running your marketing campaigns.

GDPR is different to the EU MDR released in May 2021. As a Medical Device marketer, you need to be aware of both sets of regulations, so once you’re finished here, you can visit our incredibly comprehensive EU MDR article and download.

What is GDPR?

The term GDPR refers to the General Data Protection Regulation of 2018. It was put in place to give consumers greater transparency about the collection and use of their personal data.

Although the EU drafted it, it still applies to companies outside the EU collecting data from its citizens. For example, a US-based company would still have to comply with GDPR if collecting data in France or Italy.

Organisations and companies that fail to comply with GDPR leave themselves open to facing vast fines of up to 20 million euros or 4% of annual global turnover, whichever is higher. Not only that, but the damage it can do to a brand’s image can be irreparable as clients and customers lose trust in the company. So, it’s best to get it right!

How to comply with GDPR

The official legal text with all of the regulations on it is lengthy and technical and a lot of it isn’t relevant to you as a Medical Device marketer. Often, the language used is ambiguous, so it is really important to justify everything that you do.

As an organisation that collects personal data of any kind, you must be able to comply with at least one of the six legal bases for processing personal data. These are:

Explicit consent – Someone should agree to have their data collected and stored without being tricked in any way.
Performance of a contract – Sometimes, you must collect data to create a contract
Legitimate interest – This is probably the most obscure basis. In general, this is when you use data because the subject would expect you to. You can find out more about legitimate interest from the ICO.
Vital interest – This might be used in processing health data to save someone’s life.
Legal requirement – This is when there is a legal obligation to collect and process data; for example, employers need specific data on their employees.
Public interest – This is most likely to be used in civil service and governments.

As a marketer, the safest option is probably always to gain informed consent; that way, you can know with certainty that you are collecting and processing the data legally.

personal data

What counts as personal data?

First of all, it is good to clarify what is meant by personal data. It can include the following: names, email addresses, location data, a person’s physiological details, genetic, mental, economic, cultural or social identity. When it comes to online information that you might collect, it includes IP addresses, cookies, devices and search engines used.

It is essential to know that although all of this information could be made available to you, a critical point in the General Data Protection Regulation is that you should only collect the information you need. Storing any data poses a risk, and that risk grows with the more data you hold, so you should only hold the minimum amount that you need.

Website data collection

You probably use an analysis tool like Google Analytics or SEMrush to check how your website is performing. You might look at traffic statistics or bounce rate, but whatever data you’re looking at is collected via cookies.

Cookies are small text files that websites use to collect data on users. If you would like to learn more about what they are, check out our article “What are website cookies?”.

Although they’re helpful to marketers, cookies can store a lot of personal information, and you will need to make that explicitly clear to your website visitors. They will need to opt-in to be tracked by cookies. You can do this through a cookie banner or pop-up box, where you ask users to accept or refuse cookies.

website cookies

You should also allow users to personalise their cookies settings; for example, if they want to allow some cookies but not others, they should be able to update their settings so that they can do that. If you’re not sure how to do this or if you are compliant, you can talk to a developer to work with you and update your website.

Data and privacy policies

As well as including a cookies banner or pop up, you should also ensure that your website has a cookies and privacy policy that clearly lays out what data your website collects and why. This should be written in an easy-to-understand way to ensure that readers have full knowledge of what they’re agreeing to.

Typically, you will find cookie and privacy policies either linked in the cookie banner or pop up or in the website’s footer. This allows users to read about the website’s policies in-depth, but there doesn’t need to be a huge part of the website dedicated to it.

Writing cookie and privacy policies doesn’t have to be complicated; in fact, there are templates available online if you do not feel able to draft it for yourself, such as this template builder from Termly. If using a template, you need to ensure that it is personalised to your website and isn’t giving out any false information. Of course, if in doubt, you should consult a lawyer to ensure that you are 100% compliant.

Email marketing data collection

When the GDPR was first released, marketers feared that it would be the end of email marketing, but that hasn’t been true at all. In fact, the new rules have meant that you will only end up marketing to people who have agreed to be marketed to and are therefore more likely to be an engaged audience, so more likely to convert. This way, you won’t waste time on prospects who have no interest in what you are offering.

If you are looking to build up a mailing list to send out campaigns to, whether it’s monthly newsletters or webinar invites, there are a few rules to follow, which are centred around consent and greater control for the data subject.

Explicit consent

The major rule around email marketing is that you have to gain consent to contact your mailing list. Consent has to be explicit, so you cannot simply tell people they are signing up to join a mailing list in small print at the bottom of the page.

The best way to ensure that people know what they are signing up for you should create a box that users have to tick to join the mailing list, and the copy should state precisely what they are signing up for in no uncertain terms.

By having users complete an action, i.e. ticking a box, you will ensure that you have informed consent and, therefore, a legal basis for storing their data. Again, you should only store the necessary data to carry out your marketing duties, which will probably be their name and email address. As well as being more secure, you don’t risk people dropping out of the signing up questionnaire because they cannot be bothered to answer so many questions.

Opt-out

As well as giving consent, your mailing list, you must allow people to have control of their data. This means that not only must you be transparent about what data you store and for how long, you must also delete people’s data if they ask you to.

Email campaigns should make it easy for people to be removed from your mailing list by having an unsubscribe button. Campaign builders such as MailerLite and Mailchimp make it easy to include unsubscribe functions. You can choose to delete the user’s data immediately or keep it. When you do delete the data, it is your company’s responsibility to ensure that data is destroyed appropriately and cannot be gathered for fraudulent purposes as you will be held accountable.

Regularly review data<

The GDPR states that you shouldn’t keep data for too long, so your company should have policies in place to ensure that data is reviewed frequently to either delete it or regain consent. The amount of time you store data for is debatable as the language surrounding it is ambiguous, stating that you cannot keep data “any longer than you need it”. How long you need to store data probably depends on your purpose for acquiring the data in the first place.

As a Medical Device marketer, your purpose for storing personal data is probably because that person is a customer, or they are a prospect/lead. As long as someone remains a customer, you’ll want to keep their personal data to contact them, but if they stop being a customer, how long will you keep their data before deleting it? Likewise, how long do you store leads data before accepting that they will not convert to becoming a customer? This is up to your company to decide, but it is very important to have clear guidelines on it so that you can justify how long you store the data for.

Our top tips for staying on top of GDPR

Develop a set of policies to cover how you are going to stay on top of adhering to the regulations. This should include how much data it is necessary to store and how frequently you are going to review data.
Having a customer relationship management system (CRM) will help you to keep track of your customers and the data you have stored on them, making it much easier to control.
Review your mailing list sign-up and privacy policy. Make sure that the copy is easy to understand and leaves no room for confusion.
Utilise social media. Information on social media is publicly available, so if you want to reach out to prospects individually, social media is a great way to do it!

Keep it simple and transparent!

As you can see, navigating the world of GDPR is no easy task. Sometimes it can be complicated, and the risk of not getting it right can be monumental. The main thing you can do is keep it simple, always be transparent and get permission. As long as your users know what is happening with their data, you are doing the right thing.

About Podymos

Podymos is a dedicated Medical Device marketing agency. We are passionate about sharing relevant knowledge to expand our clients’ capabilities. If you would like to find out more about what we do, you can visit our services page, or get in contact with us.

And don’t forget to follow us on social media

What are website cookies?

You’ve probably found that over the last few years accessing a website isn’t as easy as it used to be. Now you may be bombarded with messages about privacy policies, and it is very rare to find a website that doesn’t present you with a message about cookies.

Cookie banners on web pages are normal these days, but a study found that a huge of people will choose to ignore the cookie banner altogether, although what actually are cookies?

How can you be expected to agree to allow cookies on a website without knowing what they are or what they do? We’re here to help, so read on to find out everything you need to know about website cookies.

What are website cookies?

Despite what you may have heard, website cookies are not spying mechanisms designed to steal all of your personal information; on the contrary, they actually exist to improve your time browsing.

They are simply small text files that usually contain two key pieces of information: the site name and a unique personal ID. They can collect more personal information, but it is up to you what you are willing to share.

They are created by the website and stored on your computer so that when you revisit the website, it will remember you.

Cookies are able to remember you, which is really convenient, especially if you’re online shopping and you have items saved in your cart – you can leave the website and return, and they will still be there. When you first visit a website, the cookie will be downloaded so that when you revisit it, the website can refer back to the original cookie file to present the pages with your preferences, which might include language settings and colour schemes.

Some website cookies are essential, and certain functions may not be possible without allowing them, such as creating accounts with usernames and passwords.

Why do websites use cookies?

Typically, websites cannot actually track your movements on their pages. They cannot follow you when you click from one page to another, and they cannot follow your behaviours on pages.

Cookies allow sites to keep track of what people are doing on their website. This gives developers a much better understanding of how their website is used and how they can improve it for future and returning users.

The different types of website cookies

Cookies may seem confusing, and when you’re presented with unfamiliar terminology, it might be hard to understand what websites are collecting about you, but here’s what you need to know about the different kinds of cookies there are.

Session cookies

Session cookies are only stored for the duration of the time you are on the website; after that, they are deleted. These cookies are good because they don’t store any personal data, but it may mean a less enjoyable experience in the future. For instance, you may return to an online store and find that your cart items have disappeared, which can be very inconvenient. Cookie banners should allow you to change your settings so that you can only accept these cookies.

Stored cookies

Stored cookies, also known as persistent cookies, are stored on the hard drive until they expire. The expiry date is set by the site owner and can range from a couple of hours to a few years. Stored cookies are likely to be the ones that keep usernames and passwords to make signing in easier. These can be extremely useful for websites that you will visit multiple times.

Third-Party Cookies

Third-party cookies are a type of stored cookie. They are created by a domain other than the website you are on and can record the other websites, pages, or products you visited to inform advertising. These are the cookies that seem to follow you around the web, for instance, when you see the same adverts popping up in multiple places. They can be easily disabled on devices through browsers like Google.

It is important to remember that not all websites automatically use third-party data. If you’re not sure, it is worth reading their cookies policy to find out what they are tracking and how they’re storing any data. Usually, cookies banners will have a link to the website’s cookie policy, but if not then you should be able to find it at the bottom of the site in the footer.

What information can website cookies store?

Aside from the website name and unique personal ID, cookies can store lots of helpful information like how long you spend on the website, what links you click and the pages you visit, your preferences and even shopping carts. They can also collect and store more personal information, such as login information, but this is all to give you the most convenient experience possible.

Are website cookies safe?

Cookies themselves are not harmful, but they can be the target of online hackers. This might sound scary, but it is nothing to worry about as long as you do not sign into any of your online accounts on public WiFi.

Often people are concerned when ads that seem very personalised to them start popping up randomly on the websites they’re browsing. They don’t know that their information is being used by other companies to form a detailed profile about them, but this is only possible with third party cookies. If you are worried about this and don’t want to receive targeted advertising, each browser allows you to block this passing on of information.

Do I have to accept cookie policies?

When the General Data Protection Regulations (GDPR) came into effect in May of 2018, the new set of rules aimed to give internet users greater control of how their data was being collected and used. This meant that websites had to start informing their users of the cookies used to track them, hence why you didn’t notice cookie banners or pop-ups until the last couple of years. The GDPR also set out to give users more control of their personal data, which means that you are under no obligation to accept cookies.

Cookie banners, although often annoying, are there to give you greater freedom and choice. So, no, you don’t have to accept cookies.

website cookies

Some websites require you to accept them, and sometimes you won’t be able to use all of a website’s functionalities unless you accept them, but it is still your choice whether or not you agree to proceed on that site.

It is worth remembering why cookies are there when deciding whether or not to click ‘agree’. Although they may be tracking you, it is only to improve your experience online, and you can personalise which cookies you choose to accept. As well as that, they can’t store any of your personal information unless you provide them with it.

How to clear cookies

At some point, you may decide that you want to start afresh and clear out all of the cookies saved on your device. You should only do this if you are happy to lose information such as login details because when you next go to log in to a website, you’ll have to re-enter your username and password. Similarly, you will lose any preference settings or cart items you have.

Clearing cookies doesn’t require any technical knowledge and can be done quickly in just a few clicks through your chosen browser, usually under history or tools. This is also how you would disable third party cookies and stop targeted advertising.

You can find out more about clearing cookies on different devices and browsers in this article from Norton.

Cookies… not just tasty treats!

Hopefully, you are now prepared to go out and face cookie banners head on! Remember that they aren’t always a bad thing, and they aren’t there to spy on your every movement, just to help give you a more pleasant browsing experience! If you are interested in learning more about websites, check out the website guides in our Knowledge Hub.

8 interesting facts about cookies

1. Website cookies are just small text files that are stored on your computer to help websites remember you
2. Cookies exist in place of storing large amounts of data on external servers, making them much more convenient.
3. Certain functions, like setting up user accounts, aren’t possible without accepting cookies
4. Cookies help website owners to improve their website, to make the experience better for you
5. You can personalise what cookies to choose to accept or block
6. Some cookies naturally expire when you don’t visit a website in a while
7. You can block third-party cookies through your browser
8. Websites cannot follow your movements from page to page without the use of cookies

About Podymos

Podymos is a dedicated healthcare marketing agency. We are passionate about sharing relevant knowledge to expand our clients’ capabilities. If you would like to find out more about what we do, you can visit our services page, or get in contact with us.

And don’t forget to follow us on social media

The EU MDR: Medical Device advertising and promotion in Europe and the UK

What you need to know as a Medical Device marketer, including Medical Device regulations in the UK.

Following a delayed transition, the new European Medical Device Regulation (EU MDR) is finally here after 4 years of industry, regulator and Notified Body preparation.

You’ve likely heard your regulatory, clinical, and post-market surveillance teams discussing these requirements, but how does it impact Medical Device advertising and promotion in Europe? And how does it affect you as a Medical Device marketer?

The EU MDR applies to all 27 EU member countries, but does it override country regulations? The simple answer is not in all instances; whilst from a technical perspective, the regulation is directly and uniformly applicable, you will still need to also comply with each Member State’s regulations and guidelines in addition to the EU MDR when advertising and promoting your device in the EU.

Download the full 12 page document now

EU MDR and local country Medical Device advertising

guidelines

What is the EU MDR?

The Europe-wide MDR came into force on the 26th of May 2021, with the primary aim to ensure the quality, safety and performance of Medical Devices through a robust, state-of-the-art regulatory framework.

It improves on the previous Medical Device Directive by bringing requirements into line with new technically demanding products and patient demands, including particularly more demanding ongoing clinical data requirements for a device’s intended purpose.

What is the intended purpose?

The intended purpose outlines a device’s medical use, information about its mode of action and the patients and medical conditions it treats. Put simply it’s the information your company provides to the regulatory authorities to receive its CE mark.

Any uses identified in your intended purpose must be backed up with clinical and safety evidence but features or specifications of the device are not included. This means in your marketing, you can only reference the uses mentioned in your intended purpose, but you can reference any device features, as long as this doesn’t mislead your audience about your device’s intended use.

As the EU MDR has more stringent clinical requirements than the previous Medical Device Directive, some devices may already have streamlined their intended use if unable to provide supporting clinical evidence. It’s vital you are aware of the current intended purpose of your device to deliver effective and compliant marketing.

How does the EU MDR affect existing country regulations?

The EU MDR represents the unified European regulatory requirements for Medical Devices that must be followed throughout Europe to secure and maintain your CE mark. Unlike the previous Medical Device Directive, the MDR is directly applicable, without exception, in all European Member States.

The MDR however, only details the quality, safety and performance requirements for products, allowing for local regulations or guidelines to cover aspects such as advertising and promotion. Before meeting the needs of any individual country’s regulations, you need to ensure you’re meeting the EU MDR.

What does the EU MDR say about Medical Device advertising and promotion?

In short, not a considerable amount, but still more than its predecessor, the EU Medical Device Directive. Under Article 7 of the MDR, your advertising and promotion literature must be in line with the intended purpose of your Medical Device as laid out in your technical file and ‘Instructions for Use’ (IFU).

Why is your Medical Device’s intended purpose so important when complying with the EU MDR?

A device’s intended purpose must be adhered to throughout its lifetime, as it is demonstrated and proven in the clinical evidence, safety data and risk reports contained within the CE marking ‘Technical File’.

All communications with patients or healthcare professionals have to be based on these technical details, in order to maintain the product’s CE mark.

Whilst as a marketeer you’ll never need to write an intended purpose, knowing and understanding it will become central to everything you do with your device.

How do local country regulations affect how I advertise a Medical Device?

Outside the EU MDR, each country has its own advertising and promotion rules, and most will have specific guidelines for Medical Devices.

A common theme in local guidelines is the importance of advertising and promotional materials is firstly not being misleading, and secondly that it reflects the intended purpose of the device.

These principles include all pictures, logos, text, names, and trademarks. Additionally, countries may specify what can and cannot be said when comparing one device with another.

doctor and patient

HCP vs patient Medical Device advertising

Under the EU MDR, there is no distinction between marketing to HCPs or patients; therefore, all HCP marketing must meet the same EU MDR requirements as a minimum.

Differences between Member States do exist, however. For example, while Germany does not provide additional guidelines for HCP marketing, the remaining Member States address the need to provide clear, unbiased information to allow the HCP to choose the most fit for purpose device. Indeed, in Spain, the requirements are greater still, as all information needs to be provided by a trained professional.

Marketing directly to the patient often comes with more limitations and restrictions, with some countries such as France, Spain and Italy not allowing advertising and promotion for specific device types.

France, for example, has the strictest rules forbidding marketing to a patient for any device that has a risk classification of IIb or higher. At the same time, Spain only allows the marketing of devices not funded by its national health service.

At the bottom of this article, we have created an EU MDR and local country Medical Device advertising guidelines table of what is allowed in major European countries.

Can I advertise a Medical Device on social media in the EU?

There has been heightened concern in the Medical Device community about what is permissible in digital marketing.

The EU MDR doesn’t address online marketing requirements but does require that Medical Device websites be seen as labels. As such, the rules for traditional marketing also apply to social media and digital marketing.

In summary, this means that so long as your post, article, or content aligns with your intended purpose, is supported by the correct clinical data, and your content is not misleading in any posts, images or trademarks you will comply with the EU MDR.

In specific Member States, you will need to meet local advertising and promotion requirements for all online advertisements: for example, in the Netherlands, as in many other territories, you will need to consider language requirements. As the internet is available to everyone, online advertisements will need to be aligned with patient marketing requirements. This is not always the case however, as in France and Denmark, Healthcare Professional marketing can only be undertaken if the specific sections are password-protected, whereas in Italy, it same information can be provided online with disclaimers.

Concluding thoughts

Medical Devices, in most cases, can be marketed to patients and HCPs provided the EU MDR and country guidelines are followed. Ensure you have a firm understanding of your device’s intended purpose and relevant country guidelines, and you are not misleading your audience in any way, including through text, pictures, logos or trademarks.

To help with individual country guidelines, we have created the following guide highlighting the differences in marketing Medical Devices for both HCPs and patients throughout Europe.

Download our EU MDR and local country Medical Device advertising and promotion guidelines.

About Podymos

And don’t forget to follow us on social media