10 steps to successful CE marking (+BBQ)

Are you an innovative startup in the medical device industry and feel a bit overwhelmed by the Medical Devices Regulation in Europe?

Do you more or less understand this Regulation, you are aware of the available guidance documentation, but do not know how and where to start?

This workshop can be the answer to the questions you have on where to start, what to do, and also when to do it. In this workshop, you will learn which steps to take in which order, the key issues to address and pitfalls to avoid. You will learn about the intended purpose of a medical device, the choice of Notified Body, device classification, the use of (harmonized) standards, the Technical Documentation, the Quality Management System, and last but not least the clinical evaluation.

Bio trainer Peter Reijntjes

Peter is Principal consultant Quality & Regulatory Affairs and Head of Training within the Qserve Group.

After an extensive career at KEMA Quality (nowadays known as DEKRA Certification) Peter joined the Qserve Group in 2007 to combine his quality system knowledge with the regulations in the medical device industry.Peter uses a pragmatic and practical approach with a strong focus on strategic and operational compliance and excellence. He is well known for his trainings.

Specific topics and questions

If you want to participate in this workshop and have specific questions or topics you would like to know more about, do not hesitate to send them to info@briskr.nl . They will be forwarded to the trainer.

Live event
We organize this workshop in a live setting at Novio Tech Campus in Nijmegen and will take all necessary RIVM/national measures into account. If a physical workshop is not possible, we will reschedule to a later date or convert to online.
 
Good to know
We finish off by joining the great BBQ from Kadans (Kadans Summer Event). This workshop is free of charge and facilitated in English. We welcome new contacts, so feel free to share this invite with your network! Please register upfront! 


SMB-meeting; Patient-driven innovation

Healthcare is a peoples business. Keeping the patient not just in the center of the attention of innovation but also as a co-driver in your development process of is of paramount importance. But still, all too often businesses forget to involve patients in the core of their innovations and pay for this mistake in the end.
 
Our SMB meeting of May 19 focuses on some best practices on how to involve patients.
 
First speaker is Erik Verkaar from Zorgbelang, an organisation helping others to involve patients in their processes. Not just how to deal with empowered patients but also patients with low health and literacy capabilities. Our second speaker, Chris van den Brink, is patient ambassador for Enzyre. Enzyre develops near patient diagnostics for blood coagulation. Chris will talk about the importance of developing from the perspective of how the patient will use the technology in real live. And last but not least, Concha van Rijssel will talk about how Radboudumc Innovation Labs has created an innovation process really incorporating the involvement of the patient view.
 
For those interested, we will conclude the event with networking, drinks & bites. 
   
Live event
This event will be organized in a live setting at Novio Tech Campus in Nijmegen (building M, Mee&Greet area). A few days before the event we will send an email with practical information on directions/parking (sender = smb@radboudumc.nl). You might have to check your spam box.
  
Good to know
Presentations are in English & the entrance is free (registration upfront is needed though). We welcome new guests, so please feel free to pass on this invitation to relevant people in your network!
 
We look forward to meet you! Sign up here.

Webinar: Investor Perspective: The Strategic Venturing Spectrum

Large corporations can use Corporate Venture Capital (CVC) as a vehicle to get early access to new innovations. They strategically look for companies developing assets and technologies that might complement their pipeline in the future. So how do CVCs maximize the value for their company with a balance between capital and strategic objectives?

Join the discussion during this Johnson & Johnson Innovation webinar as corporate investors share their insights. Register here.

Final countdown: Rocket reloaded

After three years of successful cross-border R&D cooperation, the INTERREG VA project ROCKET Reloaded is coming to an end. The German-Dutch collaboration in six highly innovative company-driven innovation projects led to the development of a large number of state-of-the-art products and services.
The ROCKET Reloaded Core Partners would like to invite you to the final project event to join the project partners in celebrating the extraordinary success of this German-Dutch technology partnership on

Tuesday, 17 May 2022 from 13:30 – 17:30h
at the DRU Industriepark, Hutteweg 24, Ulft, The Netherlands.

In addition to looking back on the projects achievements, each ROCKET Reloaded project will showcase its findings and results at a project marketplace. Also highlighted at the project market are a number of innovation projects that were developed in the predecessor program ‘ROCKET’ and that finished 2-3 years ago. You will be able to see what has been accomplished in the years since. This dynamic project market will offer you an excellent opportunity to learn more about innovations made possible by international cooperation. Furthermore, we will also look forward towards future INTERREG Germany-Netherlands opportunties, and will stimulate the possibility to network and to discuss new project ideas for the upcoming funding period.

More information.

Visit JLABS Novio Tech Campus

In the morning of the 10th of May the European director of JLABS Elena Fernandez-Kleinlein is visiting the Nijmegen ecosystem. JLABS is the renowned accelerator of the Johnson&Johnson (J&J) organisation and is a partner of Briskr.

There will a short program on Novio Tech Campus and room for informal meeting with Elena. Startups and scale ups in fields relevant for J&J in the Nijmegen region are invited to visit. In the sheets below you can find more information on the topics J&J is interested in. If you feel meeting JLABS and Elena is of interest to you, please sent an email to Niels Wheeler who is organising the meeting.

Find the presentation here.

Innoboot 2022

Innoboot is the annual seminar organzsed by Briskr, Radboud University, RadboudUMC and the HAN. This year the theme was about the disruptive effects that AI has in the most important economic clusters in the region: Health, High Tech and Energy.

T

The first keynote was from Marcel van Gerven, Professor at Radboud University with the title “Brain inspired computing”. At Donders Institute, a cooperation between Radboud University and RadboudUMC, they try to learn from the human brain and translate this into advanced and more versatile AI approaches. Our brain is not a brute force machine (we would not be able to supply the energy) but has advanced approaches to predict and follow-up on the best paths. This research leads to more promising algorithms as well as better suited hardware, for example devices that help blind people see though a camera and feeding the brain with signals through implants.

For each cluster health, hightech and energy examples have been given. Read the full article.

Workshop Sales

The importance of an excellent Sales- and Go-to-market strategy for startups

Many startups have learned the hard way that developing great products is not enough to be successful. For many startups, and especially for startups with founders with a technical focus, sales is a new area. The realization that specific targeted sales is a key aspect for the business, is important for the success of your startup. Your clients are the basis for your company to succeed or not: “Remember the client is always right..”.

Assuming you’ve done your market validation and know your specific client target group: What strategy will be used to sell the solution in the market, and what does this mean for your sales team, the business model, branding, marketing etc.? Your company is unique. However, it is a fact that sales processes hardly differ from company to company, and that’s where potential can be unlocked!

Briskr, OostNL and Orion have joined forces to support serious startups and their founders by offering this extended workshop series. During this energetic workshop series, consisting of four parts, you will learn what you can do to boost sales in your company. Let’s unlock the full potential of your organization!

What you will learn

  1. The key challenges of many other startups & scaleups with regards to the topic of sales
  2. How you can address those challenges in a pragmatic way
  3. Tips & tricks that you can put to practice immediately

The setup of the workshop
• May 13 Part 1: Deadline online intake questionnaire:
• June 8 Part 2: Group training (one full day @Novio Tech Campus in Nijmegen)
• June 30 or July 1 Part 3: Online sessions for Q&A + shared learning (3 participants/session, 1.5 hours)
• September 6 Part 4: Get-together-again session (afternoon @Novio Tech Campus)

Key aspects
• Hands-on, practical and pragmatic
• With lots of personal attention, to make sure your business gets a booster
• Possibility to connect with peers & to share experiences

Your host: Hans Dirne

Hans is eager to unlock the full potential of companies and individuals. He is owner & founder of “Scale-Up.MBA” and “MyBusinessAdvisor” (www.scale-up.mba) and former Head of Sales of Siemens Building Technologies. He has 13 years (international) corporate sales and 3.5 years of Start-Up & Scale-Up sales experience. His background is in electrical engineering.

Requirements to you as participant
• Active in sales yourself (e.g. as (Co-)Founder, CEO, CCO, …)
• Working in a B2B environment
• Have a proven solution with (some) paying customers already
• Eager to learn & share
• Looking for a serious boost in the structure of your sales activities as well as in your business results

Costs
The costs to participate in this sales workshop series is € 200,- We will send an invoice after you have registered and your participation is confirmed once you have settled the invoice.

To round up
• I am aware not all (co-)founders appreciate the topic of sales, neither enjoy doing it. Don’t worry, that’s exactly why you should be here!
• Ever heard of a “Sales Playbook”? Google it, could be interesting for your business too
• We have only have limited availability (20 seats). Be quick and reserve your seat before May 6!
• Sales really is essential for the growth of your business

Networking skills: fun and best practices

Yesterday Mercator Launch and Briskr organised the annual Networking Skills workshop with Frank Stofmeel. This is a fun & hands-on workshop which is very useful for both experienced and inexperienced networkers.

We started off with sharpening our introduction. By trying out in 1 minute, 30 seconds and 10 seconds we learned the key words to stand out from the rest. We then learned how to break into a conversation during networking time, and also how to do that when you are an English speaker and the conversation is in Dutch! Of course, we also learned how to assess whether a conversation is really interesting, whether you have something to gain from each other, and if not, how to subtly get out of the conversation. Or to round up a conversation with a follow-up (coffee, call).

It was great to practise in a ‘safe’ setting and receive customized tips from both Frank and the other entrepreneurs! We look back on a very useful and fun workshop. Thank you for your enthusiasm & inspiration Frank Stofmeel! See you next year!

HV TV: The eastern Netherlands most innovative health region in NL?!

From the only real Health Valley studio, our trusted presenter Suzanne Verheijden challenges various guests in 55 minutes. This time we will discuss how we in the East of the Netherlands can ensure that in 2040 we live five years longer in good health and reduce health differences between social classes. The theme and the question: is the East Netherlands the most innovative health region in NL?

What are we doing in the East Netherlands to achieve this goal? Where is our strength? How do we use this strength optimally? What can we expect? And what can you as an entrepreneur, knowledge institution or healthcare organisation do to contribute to this?

Reserve Friday 22 April 2022 10.00 in your agenda for our eleventh HV TV broadcast, your healthy coffee break!

HV TV, the fun coffee break talks, just at your home!

Speakers
Prof. Pim Assendelft, Professor of prevention in healthcare at Radboudumc
Monique Esselbrugge, Alderman at Nijmegen City Council

More information.

New partnership: Brilliant Work

Today, Briskr and Brilliant Work announce a new partnership whereby Brilliant Work will provide support to Briskr start-ups and SMEs towards successful growth. Briskr is a consortium in the Nijmegen area with the aim of helping start-ups and innovative SME’s grow faster and make more impact in the Life Sciences & Health and High Tech sectors. Briskr believes that interaction between knowledge-intensive companies and knowledge institutes, such as universities and government bodies, is essential to realising innovation. Briskr operates in three areas – business support, project and program development for innovation activities and acquisition of innovative companies. In order to support start ups and innovative entrepreneurs, Briskr has brought together a network of companies able and willing to support these innovative companies in their growth.

Brilliant Work is an award winning business coaching, consultancy and training firm, specialised in helping small to medium sized companies grow and professionalise, both on a national and international scale. Most of their coaching engagements are on a subsidised basis, making it very affordable for their clients. Setting up, growing and leading a business is not easy, and Brilliant Work is there to help entrepreneurs and managers to make it easier, more enjoyable and reach their goals faster.

Brilliant Work is a great addition to the list of supporting partners of Briskr. Their expertise and drive in sales and entrepreneurship will help innovative companies in the Nijmegen area. With this addition we expect to further advance the startup eco system in the Nijmegen Area.

Martijn Kriens, program manager of Briskr: “We are happy that Brilliant Work is willing to join our network of services for startups. Broad support in sales and entrepreneurship is often important for startups. Brilliant Work has shown in the past to be able to help focus startups on growth. With the partnership with Brilliant Work we formlize and give shape to our cooperation in this field.”

Lizanne Jakobs, founder of Brilliant Work: “This new partnership is a very positive step foward. For businesses in life science, health and high tech, entrepreneurs have to juggle so many aspects of running a complex company at once. The Dutch eco system is there to help support them, but is not always easy to navigate. By joining forces with Briskr, we are thrilled to fortify the amazing all round support they offer as a consortium, locally, with the right people at the right time.”