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Who we are

Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Over 230 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum.

Our clients

The spectrum of our fields of expertise is as broad as the range of clients we work for, enabling us to cater to the varied needs and wishes of the Life Science industry. We bring our palette of services to companies, ranging from start-ups to multi-national organizations, to provide them with robust solutions. Whether they are a (bio)pharmaceutical or medical device company, a hospital or a pharmacy, a manufacturer or a laboratory, we match their colour.

05-12-2017
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#SERIALISATION AND UDI: 4 REASONS TO START TODAY

In recent years, new European legislation on traceability of medicinal products and medical devices was introduced to guarantee patients’ safety and to avoid fraud. Depending on the industry in which you work, you might have heard more of either Serialisation or UDI (Unique Device Identification). Below we will mention the difference between them. Although the terminology is somewhat different for medicinal Products and for medical devices, in both cases, this is about traceability. And to be precise, it is about track (where the product is now) and trace (where the product came from).

In this blog, we will explain why we advise you - as a medical devices supplier, a medicines supplier or as a logistics service provider - not to wait much longer and start implementing unique identification to take advantage of traceability.

The benefits of traceability

Legislation is not the only reason to implement unique device identification. Traceability has a significant impact on the efficiency of your own and your customers’ operational processes. Traceability is actually nothing new. In many other industries, logistical efficiency is crucial and for years, organisations have been ‘tracking and tracing’ their products with unique identifiers.

For healthcare institutions and pharmaceutical wholesalers, working ‘lean’ is becoming the new standard. For example, if your products do not have machine-readable barcodes, institutions might not purchase your products, as being able to scan all products, benefits them in many respects. Think of: having all relevant data available as soon as a product arrives, having insight of your stock levels, constantly knowing where it is or getting an alert when the expiration date is within e.g. a year. With traceable products, you are better prepared for your customers’ requirements and, of course, for your own efficiency improvements.

4 reasons to start today

As the legislation applies as of February 2019 (for medicines) and May 2020 (for medical devices1), you might think you still have time. But consider to start yet for the following reasons:

  1. Efficiency. Just because of the fact that efficiency is of increasing importance to you and your customers, traceability is recommended.
  2. Implementing traceability might require some significant organisational adjustments, think of:
    • Redesign of packaging and labeling
    • Adjustments to packaging lines and automation systems
    • Documentation of adjusted packaging specifications and procedures including getting approval for them
    • Validation of new or modified packaging processes, equipment, and IT systems.
  3. It is better to avoid rushing into (flawed) decisions. In case you need advice or support to design a new or modified process, the farther the deadline, the more time you have to consider your options.
  4. Practice in the United States has shown, that even with a segmented implementation and with a wealth of experience with UDI, manufacturers have difficulty meeting the deadlines.

The difference between Serialisation and UDI

The European Medical Device Regulation (MDR) 2017/745 published in 2017 elaborates on prior traceability regulations and introduces UDI for medical devices, which you should apply as of May 5th, 2020. UDI stands for ‘Unique Device Identification’ and consists of a device identifier (for manufacturer and model) and a product identifier (for packaging unit, batch, production date or expiration date). So, as it is prescribed now, ‘unique’ does not imply traceability of the smallest saleable unit.2

When reviewing Serialisation regulations for medicines, you will find that the identifier prescribed should be unique for every saleable unit, enabling traceability throughout the entire sequence from manufacturer to the last part of the supply chain, in particular cases even up to the individual patient. The Delegated Regulation (EU) 2016/161 published in 2016 introduces two safety features - a unique identifier (two-dimensional barcode) and an anti-tampering device - to be placed on the packaging of medicinal products as of February 9th, 2019. Although this level of identification for medicines is not yet required for medical devices, it is expected that future ‘Implementing Acts’ for the new MDR will include traceability of the smallest saleable unit, up to the patient as well.

Getting started

So, what now? Start orientating and ask yourself questions like: What is your organisation’s situation at this moment? What is your knowledge of the legal requirements and of the efficiency opportunities? What should be your next step? What do you need for that? How much time will it take? 

It’s well-advised to raise your knowledge level, provide a clear overview of your situation, do a gap analysis and provide solutions, explore different options, share best practices with others in the field, and start drafting an action plan. If you are uncertain about some aspects, don’t hesitate to contact us, we will be happy to talk to you about it.

Blog by: Louis Habets - Sr. Consultant & Trainer at Xendo

 


Footnote 1

If the European Medical Device Database Eudamed not fully functional is on May 26 2020, numerous requirements listed in the MDR and relating to where any information needs to be stored in Eudamed, will apply six months from when the Commission has published a notice declaring that Eudamed has achieved full functionality. While waiting for Eudamed to become fully functional, the corresponding provision regarding the exchange of information in the MDD and AIMDD will continue to apply. This regards particularly Vigilance Reporting, Clinical Investigations, the Registration of Devices and Economic Operators, as well as Certificate Notifications.

Footnote 2

When will UDI carriers really need to be placed on the label of devices and all higher levels of packaging as described in Article 123,3f, depends on the Risk Level of the product:

  • May 26, 2021 for Implantable and Class III devices;
  • May 26, 2023 for Class IIa and IIb devices;
  • May 26, 2025 for Class I devices.
  • How soon the UDI carrier need to be placed on re-usable devices is determined in Article 123,3g as:
  • May 26, 2023 for re-use Implantable and Class III devices;
  • May 26, 2025 for Class IIa and IIb re-usable devices;
  • May 26, 2027 for Class I re-usable devices.

24-11-2017
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#Slide Deck: Changes in the Medical Device Legislation; the day after.

Feel free to download the slide deck of one of our recent talks on the new Medical Device Regulation which was presented by Jan Bart Hak at the autumn meeting of the Pharmacovigilance  Platform Netherlands on November 21st, 2017.


The European Medical Device Regulation 2017/745 (MDR) is published on May 5, 2017, in order to replace the current Medical Device Directive 93/42; it will apply 3 years after this date. Requirements related to the technical file and procedures will be significantly reinforced, without the possibility of grandfathering.

These new requirements will affect the entire medical device (MD) industry with products in the EU. This implies that companies with products on the market within the European Union will need to come up with a transition plan to comply with these new rules and they have until May 25th, 2020 to do so.

A short calculation tells us that the countdown is at two and a half years at this point. As an example, in case the clinical evidence needs to be updated, one must start now. Clinical evidence can be collected in a clinical investigation or via post-marketing surveillance, which includes vigilance and post-marketing clinical follow-up studies. If a medical device company does not start now, it can be too late risking the CE mark and so market access.

Click here for the PDf of the full slide deck.

21-11-2017
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#MDR: Why you should start now or lose money!

Although the new Medical Device Regulation (MDR) is now officially effective (in co-existence with the Medical Device Directive, MDD) we’ve noticed that some companies are well on their way with the transition (mostly EU companies) but there seems to be only a small percentage of US companies that has actually started to transition from MDD to the MDR. Especially for Regulatory Affairs (RA) managers this might be frustrating because they are well aware that from short-term perspective sticking your head in the sand, in the long run, might cost you serious money. Here’s why.


MDD TO MDR


For those who haven’t yet had the time to investigate what (mandatory) changes the future holds in the Medical Device field, we can summarize it as follows: requirements regarding your product are increasing and becoming stricter. Examples are requirements regarding, risk classification, clinical evidence, Economic Operators, and Post-Marketing Surveillance. All currently certified Medical Devices (MDs) must be re-certified in accordance with these new requirements.
First of all, companies are well-advised to perform a GAP-analysis to see how they want to proceed with their product. Three likely outcomes could be:

  1. You find no go GAPs which means ‘no worries’.
  2. Major GAPs meaning there’s a lot of work and you should start rather sooner than later.
  3. So many GAPs that you might consider discontinuing your product and withdraw it.


This implies that companies with products on the market within the European Union who find themselves in the second category will need to come up with a transition plan to be compliant with these new rules and they have until May 25th, 2020 to do so. A short calculation tells us that the countdown is at two and a half years at this point.


To assist RA managers eager to start a possible transition we’ve lined up some situations that might motivate all their colleagues to set things in motion. We suggest exploring the three most likely options that could be considered.


1. WHAT IF I DON’T?


Definitely a bad idea. The new MDR does not allow for grandfathering meaning that products that are currently on the market will not automatically be approved to stay on the market. So, if you choose not to transition to the MDR your product will no longer be allowed on the European market and consequently, you will lose income in other countries where turnover is dependent on a valid CE-mark.


2. I’LL DO IT LATER


Tempting, but not a good idea either. To explain this, let’s have a look at the math. To be compliant with the new MDR there are activities that have certain throughput times.
For example, let us assume that your clinical evaluation gap analysis shows that you need to upgrade your clinical data with data from a Post-Marketing Clinical Follow-up study (PMCF). If we pivot these numbers against the time left until you lose your CE-mark, we come to the following:

Activities that would have to be performed against the time it would take and the time that is left in months.

All these activities alone leave you with ‘0‘ months left until your CE mark (read: market approval) expires if you aren’t compliant with the new requirements. So actually, we can say that every moment that companies are delaying the transition to the MDR they will be facing a loss of revenue from the marketed product.


3. START NOW


Yes, we agree. This does not mean that you will be overwhelmed by additional work that can’t be handled.
For instance, your strategy on extending clinical data can be considered via Post Marketing Surveillance while still under the MDD using a PMCF study to gather this data. Under the new MDR, this collection of clinical data without a CE-mark will be considered a clinical investigation, which is subject to far stricter requirements. In that case, you’ll have to set up, for instance, a new randomized controlled clinical study with a 100 patients, a 6-month patient follow-up, and at 10 different sites which is a very costly process with patient insurance, submittal to the Competent Authorities and longer timelines than a PMCF. And also for other issues, a pragmatic approach can often be chosen so that your product’s certification remains valid and continuity of sales is not hampered by regulatory issues.

ARGUMENTS & BUY-IN


We can assure you that securing buy-in from the decision makers and different stakeholders in your company is essential in situations like these. So to pave the way we’ve lined up some arguments to use in persuading that you need to start today.
Since it all usually comes down to commercial considerations, this is likely to be your strongest argument. Here are some examples to paraphrase the money issue:

  • Loss of revenue in all countries where turnover depends on a valid CE-mark
  • Correct expected projections beyond 2020
  • Losing business will eventually result in a loss of qualified staff
  • Increased investments will be required to make up to regain lost market share
  • Investors are very aware of the MDR and usually require a transition plan
  • The company’s reputation is at stake

TRANSITIONING


The implementation of the MDR or the transition, if you will, is most likely an extensive project. And this actual transition is something we’ll get back to in another blog. To put it shortly, all companies are strongly advised to come up with a comprehensive transition plan including:

  • Relevant differences
  • Risk Class Determination
  • Conformity Assessment Procedure
  • Top Management Awareness and Commitment
  • Implementation Plan
  • Assessment Partner
  • Product Documentation
  • Quality Management System
  • Post Market Activities and Reporting

In conclusion, although the deadline of May 2020 seems far away, it really is false security. To ensure continuous compliance of medical device products to the new legislation, i.e. the MDR, a swift start and a solid plan are necessary. This will bring peace of mind to any Medical Device company because business continuity is assured.


So instead of waiting around to see what the future holds, get started and find out where you’re at. And if you’d like some more specific information don’t hesitate to leave us a message.

Blog by: Nick Veringmeier - Xendo

20-11-2017
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#EMA: Welcome to the Netherlands

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

As a fast-growing company, we are ready to support all life sciences companies during the transition of the EMA from London to Amsterdam. With over 240 efficiently cooperating consultants (including QPs, QPPVs, and Auditors) in different fields of expertise, we’re able to offer our customers a complete palette of services. Especially our familiarity with The Netherlands’ Health Authority, the MEB-CBG, will prove to be an asset for all companies that require expertise regarding their upcoming Regulatory Affairs changes that this transition will bring about.

Please contact us to find out more.

14-11-2017
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#Xendo awarded for the third time in a row as FD Gazelle

Xendo was named an FD Gazelle 2017 again, meaning we belong to the fastest growing companies in the Netherlands for the third time in a row. The Gazelle Awards, an initiative of the ‘Financieele Dagblad’ (Dutch Financial Times), are awarded annually to the fastest growing enterprises, where the main criterion is a turnover growth of at least 20% per year during a three-year period.

André van de Sande (CEO, Xendo) says:

Our clients increasingly know how to find us for our expertise and support in all phases of product development and we are very grateful for the trust they place in Xendo.

Based on this trust, we have been able to grow our organization from 60 to over 240 employees. We plan to further expand in the Netherlands as well as internationally and as such we are always open to getting into contact with new potential colleagues. Please visit our website to see an overview of our most recent vacancies.

14-11-2017
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#COMPLETE PV SYSTEM: READY IN 1 MONTH

Bringing new products to the market while managing all pharmacovigilance (PV) requirements within a reasonable timeframe can be challenging, especially now that the technical requirements of a PV system are becoming increasingly complex. Getting it right the first time will help you off to a good start.


A high-quality and cost-effective solution

This is exactly what we can provide you with regarding the necessary support. Our PV experts provide cost-effective solutions in compliance with all regulatory requirements while you focus on what matters to you: the quality and safety of your product.

To assist in achieving a fit-for-purpose PV system and to safeguard your responsibilities as a Marketing Authorisation Holder, we offer an end-to-end solution for small and medium-sized companies who are about to bring a product to the market in the EU and need a fully functional pharmacovigilance system. We can provide the planning, implementation, and maintenance of any or all of the essential parts of your PV system. The complete set-up of your global PV system can be realised in 1 month, which includes:


State-of-the-art Safety Database - Argus

Our dedicated case processing team makes use of the industry acclaimed standard Oracle Argus Safety Database for Adverse Event Management; including Safety Database Hosting & PV Query Tool. By applying a multi-tenant approach and lean processes with a focus on first-time-right we’re able to offer this software as part of a cost-effective solution.  And with this state-of-the-art database, line listings and reports for case processing can be generated independently of the size of a corporation.

Have a look at the schematic overview.


Other PV services

After setting up your basic PV system, we are also fully equipped to provide you with all other PV services like:


Xendo - A trusted advisor

So why Xendo? Taking your product to the market requires experience and solutions beyond pharmacovigilance. This is why we aim to offer a complete spectrum, including all the expertise you’ll need to be successful.

Introducing our palette of services that complements our pharmacovigilance department and sets us apart as a full-service provider:

With many, effectively cooperating consultants in different fields of expertise at your disposal, we’re able to offer you a complete package and peace of mind.

Please contact us to find out more!


10-11-2017
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#Posters ESGCT 2017

At the ESGCT 2017 conference, we presented two posters on CMC development and comparability strategies.  Afterwards, we received several requests for the posters and additional info, so we have decided to put them online! Have a look and leave us a message if you'd like more info as well.

Comparability Exercise

CMC Development

08-11-2017
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#BIO Europe Berlin

Xendo CEO André van de Sande and Xenia Freifrau-von Maltzan brought one of our customized VANMOOF bikes to this years' BIO Europe in Berlin. Several hundred participants showed that the raffle we organised with Berlin Partner was a huge success and attracted a large crowd. We wish to congratulate this years' winner and we are very much looking forward to another successful BIO again next year!