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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 220 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.

14-02-2017
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#6 essentials to introduce Lean Six Sigma in Life Sciences

6 essentials to introduce Lean Six Sigma in Life Sciences

We have come a long way in lean manufacturing since its introduction by Toyota and we apply it in most industries today. We take into account many relevant factors, such as costs, efficiency, supply reliability, quality, and compliance, and we define, measure, analyse, improve and control them. Our field, the Life Sciences, is as diverse as it is well-regulated, meaning it is most certainly a challenge to comply with ever-changing regulations and guidelines (which may or may not contribute to patient safety, quality and/or efficacy). But though it may be challenging, there are most certainly gains to be made here.

To assist in the first steps of setting up lean manufacturing processes we have some best practices lines up for you to try out in your organisation:

1. Engagement


Make sure that everyone, from CEO to supervisor is engaged. It is like an upside down pyramid where the top enables improvement at the bottom. First of all, demonstrate your commitment. You know about biotech, pharma. Learn about Lean Six Sigma and combine these. It’s not only about the processes, metrics, and the production system, but most of all it’s about mindset and behaviour. We are all very much aware of GMP and compliance in life science. Combine with Lean 6 sigma and integrate. Try to implement it in your daily routines. Do regular walk-throughs in the areas where it all happens. The real improvement doesn’t happen in the manager’s office or a meeting room. Ask questions and listen. Be present at opening and close-outs of improvement workshops (kaizens) and be present at daily stand-up (tier) meetings. In other words, people in the work place have the most extensive knowledge about ongoing processes and experience with daily activities. Don’t come up with solutions by yourself, but make it work with them.


2. Sponsorship


Lack of sponsorship is the most likely reason for failure, so just a few more words on promoting taking responsibilities, the right mindset and behaviour. In the old hierarchical way of doing things the boss knows best and tells you what to do and how to do it. In the inclusive approach, you should ask questions such as ‘What is the problem? Where is the problem? Are you able to solve it? Do you need others? How much time do you need? How can I help you?’ The role of the sponsor is to ask these questions all the time and to make sure they get answered. If we’ve learned anything from programs on badly run restaurants, it’s that 9 out of 10 times the manager (sponsor) is the root cause of the problem. Again, ask integrative questions, e/g what does the change imply for GxP? Have we considered the regulatory impact?


3. Stabilize first


Deviations are symptoms of processes not running smoothly. However, in life sciences, we have made compliant procedures for handling deviations. Make sure to get rid of deviations by searching for and solving true root causes, not just fight the symptoms. A practical approach is a kaizen, a workshop of a couple of days to define the problem exactly, to look for true root causes and solve these. When done properly, they give a lot of positive energy and, of course, annihilate deviation recurrence. The concept is not new, however. Therefore, green and black belts should have the proper background to prepare and facilitate kaizens. In my view, those belts should also have an understanding of life science and the processes at hand. It is the way to connect with people and to gain support for improvement. Again, sponsorship is essential to make a team available and continued support for implementing and sustaining solutions.


4. Activate


Introduce visual management and short (15 min) daily stand-up meetings – and become actionable. In many meetings, we talk about things. You will be amazed that just standing in a meeting rather than sitting will make the mood more actionable. It also allows you to escalate any issues within a day to senior management. Applying visual management enables you to make problems more apparent and once visible you can start solving them. It usually starts with a shift transition at production (tier 1): Are we meeting our production schedule? Are we experiencing any issues with people, safety, quality, delivery, and/or costs? What do the facts and figures show us? Ok or not ok? Can we solve all issues or do we need to escalate? At the next level (tier 2), the supervisor discusses the more substantial problems with the production manager, QA, logistics and others who might be involved. Also, metrics at a higher level are shown. Finally, the production manager meets with the management team at tier 3 for escalation of major issues. And this is all done within one day. And once again, it is the integrated approach that works, not Lean Six Sigma for the sake of saving costs. Lean processes are also more GMP compliant, safer, and yield better quality at lower costs. On top of that, people working in these improved environments are generally experiencing less stress and more satisfaction in their work.


5. Shift the paradigm


Introduce a system where everybody in the organisation focuses on solving problems definitively, not just fire-fighting, tweaking, and fixing. Not just the green and black belts for solving the major issues, but for everybody, at yellow belt level, is continuous improvement part of the DNA and their daily job. Solving many small problems can also add up to a large sum. Again, it is the mindset. In one example, 30,000 A4 paper was saved every year, just by asking the question: Do we need to print all this? And not just: we need to do this to be GMP compliant. In lean companies, everybody is trained as a yellow belt. This the entry level of belt training. And it is also their daily work to improve small things. Link this improvement process with the stand-up meetings to ensure follow-up and to measure success.


6. Continue improving


Always, all the time, everywhere, everybody. And sponsor!

In the next blog, we will show examples of effective deviation reduction, while maintaining GMP.

If you want to learn more about applying Lean Six Sigma principles in the Life Sciences, please contact Xendo or take a look at the courses we provide together with the Biotech Training Facility (Yellow Belt & Green Belt).

Blog by: Marc Stegeman - Principal Consultant & Black Belt 

01-02-2017
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#XENDO IN TOP 250 GROWING COMPANIES

We are pleased to announce that after being named an FD Gazelle two times in a row (Dutch Financial Times award), we are now also in the Top 250 Fastest Growing companies in the Netherlands; an initiative by the Erasmus Center for Entrepreneurship (ECE) and 'NL Groeit' (NL Grows).

A place in the Top 250 is awarded to companies who were economically active on January 1st 2012 and have realised a turnover and/or employee growth of over 20% a year.

Link

24-01-2017
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#Outdated facilities – bring back the ‘c’ in cGMP

New rules, old facilities. How do these two meet? Is it a big black hole or is there light at the end of the tunnel?


When you work in an older facility, you are probably acquainted with one-liners like:

“We have been doing it for years, how can this be wrong”, “never change a winning concept”, “the Agencies approved this before, they cannot suddenly disapprove it”.

Maybe you already faced an inspection, resulting in observations due to aging facilities, processes or procedures. It is a known fact that legislation can change, new developments change the expected ‘state of the art’ solutions. This evolution takes place faster than your facilities do. You probably already experienced that the ‘c’ in the GMP status needs to be brought back into your facility, processes or procedures and it looks like a big hurdle to overcome.
Quality Risk Management
With every recent change in Legislation, the term “Quality Risk management” (QRM) was introduced. Therefore, every Inspector takes it into account during inspections, and they should, because they are looking for evidence that their trust in you is valid. A good understanding of your processes enables you to base your quality-related decisions on solid risk assessments, which is usually beneficial regarding the outcome of an inspection.

Should you also apply this approach in regard to (older) facilities? Should you bother assessing the risks of a facility that you know by heart? Yes, you probably should! Not just to please the inspection, but because it is a useful instrument to assess if your aging facility is in compliance with the current GMP.

Use QRM to answer the question “Is my facility still suitable to my current activities”. How do you start? How do you organize a process like this? The best idea is to take it step by step. Take the time to learn, take the time to assess. Use the knowledge available across your organisation, it is one of your biggest assets. Most likely many risks have already been assessed, but you just never realised, nor documented it. You will definitely face hurdles, but also realise they can be overcome.

Potential hurdles – don’t let them scare you
Bad archiving practices (in the past and present) of both paper-based and electronic information are major bottlenecks in this process. Staff changes mean that some knowledge gets lost and this is usually regarding process history and where to find available information. The archiving bottlenecks can become enormous in these cases, trying to find information in old archives. But that shouldn’t keep you from accomplishing your goals, every outdated facility is facing similar issues.

Identification of gaps and opportunities
First of all, you need to assess your current gaps against cGMP. Ask yourself “What is required for my current activity?”, “What control mechanisms do I have in my process?”. Use QRM to assess the gaps in your facility’s design and its cleanability. Bring in a pair of ‘fresh eyes’ during the assessment, take a step back and dare to re-assess why you do it the way you do. During this process, unnecessary practices may become known. It’s possible that time-consuming activities can be replaced by more efficient practices or can become obsolete altogether. Maybe you can shorten process times because you realise that you overdo your controls. You will certainly gain some opportunities from these assessments. You will lose some, but you will definitely learn things that went unnoticed before.

Define potential risks and wins
Translate gaps into risks. Quantify problems, issues and potential risks. Include, amongst others, the qualified status of equipment, process robustness, knowledge from e.g. deviations, maintenance records, periodic equipment and utility reviews, environmental monitoring program and results. But please also, document why certain gaps are no risk at all!

Translate opportunities into wins. In lean six sigma terms, define the waste!

Analysis of identified risks
Next, you use QRM and you can apply lean six sigma techniques to identify what you really need to do to run your current activities. Define what is causing the biggest problems and wins, rank potential risks and wins in order to focus on the right points. Dare to break with traditions.

Risk Mitigation
Third, come up with a plan to get back into compliance. Even though GMP changed over the years, the fundamental principles have not. Outdated facilities are mostly engineered and commissioned using common sense, but rationales have not always been properly documented. Based on the outcome of your assessments, you can define your risk mitigation actions and this forms the rationale of what to repair or redo.

Set a realistic horizon. Document your thoughts and doings. Make sure you do what is needed and don’t overdo. Also, don’t be afraid to discuss your findings and plan with your inspectorate. Showing progress and willingness to improve can increase the understanding of your current situation.

Considerations


Legislation changes, though not as fast as it sometimes seems, because it follows the industry. Best practices are gathered over time and form a new baseline. Quality Risk Management is not something new and fancy, but an instrument, applied for ages, just not always formally documented. Make the change and assess your facilities with risk management principles and start to focus on repairs. This is the moment to diminish waste, lower costs, enhance process robustness and stay compliant.
The above exemplifies the risks involved with an ageing facility. When assessed with the right knowledge of legislation, inspections, and manufacturing, these risks can be remediated with a lean six sigma focus, observations can be prevented, and the ‘c’ can be brought back into your GMP status.

Blog by:

Maud Breitbarth - Consultant at Xendo


If you have any questions don't hesitate to contact us, we can be your pair of ‘fresh eyes’!

19-01-2017
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#I4H 2017

XENDO BIKE RAFFLE

Like last year, we will also be organising a raffle for one of our customized Xendo VANMOOF bikes! We are looking forward to meeting you there and don't forget to hand in your ticket at our booth (no. 34)!

INNOVATION FOR HEALTH 2017

Innovation for Health is the premier event on healthcare innovations in the Netherlands. It provides a unique opportunity to meet leading innovators, to catch up on the latest trends, to present cutting-edge innovations and to engage leaders and decision makers in healthcare innovation. Innovation for Health features renowned speakers, displays high impact innovations, highlights best practices and demonstrates inspiring developments in healthcare. By bringing together key players and stakeholders across the healthcare & Life Sciences spectrum, and fostering dialogue between research, markets, and policy makers, the event aims to contribute to the future of sustainable healthcare.

16-01-2017
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#Xendo BV acquires Sofus Regulatory Affairs AB

Xendo, the Life Sciences consultancy company, is pleased to announce that it has acquired the Swedish consultancy company Sofus Regulatory Affairs AB. Sofus is based in Stockholm and provides regulatory affairs services for all phases of the pharma and biotech development, from early development projects to post-approval services including pricing and reimbursement issues, and has a strong position in the Nordic countries. This acquisition will strengthen the two companies to continue providing the highest levels of consultancy services within the Life Sciences industry. Through this collaboration, both companies will be able to offer new services to their customers in an expanded region.

Xendo was founded in 1990 and is now a leading, independent consultancy and project management organization in the (bio)pharmaceutical, medical devices, and healthcare fields. Xendo currently employs over 150 experienced and highly educated professionals. The areas of expertise include a.o. Regulatory Affairs, Pharmacovigilance, Compliance & Validation, and Engineering & Technical Support.

Sofus was founded in 2002 and is the leading Nordic regulatory consultancy, supplying comprehensive regulatory, quality and safety solutions, to both multinational corporations and small businesses in the Nordics and in Europe. Sofus currently employs around 55 people.

André van de Sande, CEO, Xendo comments: “I am delighted to be leading Xendo in this next phase of growth. The addition of Sofus to Xendo will strengthen our position as a trusted advisor in Life Sciences. We operate in an exciting market and this acquisition offers a real opportunity to further develop Xendo’s services and extend our geographic reach. I am looking forward to working with Linda Thunell and her team.”

Linda Thunell, CEO, Sofus added: “This was a natural step for us in the further development of our business. As part of the Xendo group we will be able to strengthen our presence on the international market and at the same time offer a broader range of services to our clients. Our companies are a good match and together we will be able to offer more of the very best services to our clients.”

For further information, contact:


André van de Sande – CEO Xendo
T: + 31 (0) 71 524 4000
E:
W: www.xendo.com
W: www.sofus.se

06-01-2017
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#IVD & MD CLASSIFICATION

How to classify your Medical Device or In Vitro Diagnostic under the new regulation

Medical Devices have been classified under the Medical Device Directive as 1, 1m, 1s, 2a, 2b and 3. With the increase of the class, the inherent risk increases too. As a result, the regulatory requirements will increase too, not only in number but also in nature. Under the new Medical Device Regulation this approach remains.

For In Vitro Diagnostics the new IVD Regulation will also apply a risk-based approach, which could be regarded as a paradigm shift with respect to the IVD Directive. The classes for IVDs range from A to D, with D the highest risk class. Also for IVDs the new approach will result in stricter regulatory requirements for higher class IVDs.

To assist you in your efforts to classify your IVD or Medical Device we have put the criteria according to these novel regulations in a flowchart.

Feel free to contact us in case of additional questions!

View chart here.

Contact: Marc Klinkhamer - Principal Consultant at Xendo

Email:

13-12-2016
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#Xendo announces management buy-out supported by Sovereign Capital

The investment will strengthen the company’s position as a leading consultant and it will have a positive effect on the continuity of business. Current customers will continue to seamlessly enjoy existing services, and Xendo will be able to seek to expand its services and geographical reach, both through organic growth and complementary acquisitions. With a strong track-record as a ‘Buy & Build’ specialist, Sovereign Capital will provide the financial support to grow, develop and expand Xendo.

Under the new ownership the business will continue to operate under its own name. We are also delighted to welcome CFO, Arjen Huijs (previously Jacobs Douwe Egberts) to the current management team.

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13-12-2016
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#Xendo makes the Dutch Financial Times (Financieel Dagblad)

BIO International Convention 2016

Xendo CEO, André van de Sande, brought one of our customized VANMOOF bikes to this years' BIO International Convention in San Francisco.

BIO International Convention 2016

Approximately 400 participants showed that the raffle was a huge succes and attracted a large crowd. We wish to congratulate this years' winner, Ruud Smits of NautaDutilh. We are very much looking forward to another succesful BIO again next year!

Biotechbedrijven dromen zich rijk na megadeal Acerta