Innovation challenges in healthcare/ Health Challenge Hub

Healthcare professionals know what problems need fixing. Our entrepreneurs know how to create the right innovative solutions. At the Briskr Health Challenge Hub, we bring both perspectives together to boost innovation in healthcare.

Defining the right challenges

Too often, we see innovations in healthcare for problems that do not exist. This leads to expensive pilots and insufficient impact. In the Nijmegen area, we believe that healthcare innovations should start with professionals and patients defining their needs. Based on those needs, we can define the right challenges for innovative entrepreneurs, stimulating them to come up with solutions for important problems in healthcare.

Think of solutions such as start-ups developing new technologies, but also scale-ups and grown-ups tailoring existing solutions to specific healthcare problems. By defining challenges and scouting innovative solutions, Briskr stimulates the right matches.

For entrepreneurs

Validation and implementation are important challenges for innovative start-ups, scale-ups and grown-ups in healthcare. At the Health Challenge Hub, we bring together entrepreneurs and healthcare professionals who are looking for specific innovations and are willing to aid in validating and implementing these solutions. By letting healthcare professionals present their needs first, entrepreneurs will know for sure that their solutions will be welcomed.

For healthcare professionals

In your daily practice, you see clear opportunities for innovation. But who is going to help you create the solution? The Briskr Health Challenge Hub will help you find entrepreneurs who are able and willing to develop the innovative solutions you have been looking for.

Alone you go faster, but together, we go further.

Consult Regulations

Entrepreneurs in Health and High Tech face many challenges when launching their product or service in the healthcare industry. One of the biggest challenges is complying with regulations. Especially in the field of medical devices and pharmaceutical products, companies have to be compliant to an enormous set of regulations.

It takes a lot of effort and manpower, but it’s all the more important. Without a product license you can’t produce and without a market license you can’t sell. Getting all the licenses you need is a lengthy process: it can take up to 3 years. That’s why it’s smart for a start-up to start thinking about this right away, so that by the time you reach the clinical phases of a study, you’ll be ready to go.

Do you want to know what specific regulations your health start-up has to comply with? Or would you like to consult with one of our experts? Plan a free consult! 

Medical Device Directive (MDR)

The European Union has recently put forward a set of rules for medical devices and accessories for such devices. As a start-up in this field you will have to set up a Quality Management System to comply with these rules and to be audited, in order to get your product license and market license. After you receive your license, you will be undergoing yearly audits in which everything gets checked. Not only your company itself, but all other companies you work with as well. The Medical Device Regulation (MDR EU) entered into application on 26 May 2021.

Without a product license you are not allowed to produce, and without a market license you can’t bring your product to the market. The process for receiving these licenses takes at least 3 years, so as a start-up it’s wise to start working on these requirements immediately. Preferably you will have your QMS ready when your product enters the clinical studies phase.

Need help?

Not sure whether your business needs to comply with the MDR? Or could you use some support in establishing your QMS or the Technical Documentation of your devices? At Briskr we can help you with every step in this process. Our experienced supporting partners offer free consults and workshops on this topic. The experts we work with know all ISO, GMP and MDR rules by heart.  So whatever questions you have, our network has the answers.

One of our main experts is Anja Wiersma, a medical biologist with 8 years of experience at a multinational pharmaceutical company (Organon) and 6.5 years at a Notified Body of Medical Devices and In Vitro Diagnostic Medical Devices. Since 2010 she is a RA/QA consultant at mi-CE consultancy for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.

Check our upcoming events to see if there are MDR workshops (presented by Wiersma) you can register for, or contact us if you’re interested in a one-on-one meeting with one of our partners.

Briskr Validate!

Entrepreneurs in Health and High Tech face many challenges when launching their product or service in the healthcare industry. That’s why, Briskr set up a new program: Briskr Validate! Its goal is to create impact for citizens and patients by connecting the needs of healthcare to innovations from entrepreneurs.

Briskr Validate! is a consortium of nine partners: Radboudumc, Novio Tech Campus, BCSEMI NL, Rijnstate, The Economic Board, Oost NL, Health Valley, and Science Meets Business. Together, these partners can help you validate your innovation.

With Briskr Validate!, we offer companies with innovative ideas the opportunity to test and validate their solutions in real life settings. Briskr Validate! is – among other things – all about speeding up the implementation process by involving end-users in the designing of a product, in the technology and with user-oriented advice. We also offer access to health & High Tech facilities, like field labs.

Quality Systems

Any start-up that develops a new product in the field of medicine or medical devices has to comply with a lot of rules and regulations. Therefore, they have to set up a quality system: a formalized system that documents processes, procedures and responsibilities. A quality system helps coordinate and direct your organization’s activities to meet regulatory requirements.

In order to obtain both a product license and a market license, your medical start-up will be audited. Once you’ve obtained your licenses, your company will be audited every year. And this involves not only your own organization, but also the companies you work with: from your packaging company,  the raw materials, the transport company, the wholesaler all the way up to the hospital that uses your products.

Complying with all these regulations takes a lot of effort and manpower, but it’s all the more important. Without product license you can’t produce and without market license you can’t sell. Getting al the licenses you need is a lengthy process: it can take up to 3 years. That’s why it’s smart for a start-up to start thinking about this right away, so that by the time you reach the clinical phases of a study, you’ll be ready to go.

Do you want to know whether or not your health start-up has to comply with certain regulations or how you can arrange the best quality system? Take a look at our workshops or plan a free consult with one of our experts!

Regulatory Affairs

Entrepreneurs in Health and High tech face many challenges when launching their product or service in the healthcare industry. One of the biggest challenges is complying with legislation, especially if you’re a company in the field of medical devices or pharmaceutical products. If you want to be competitive in the market, manufacturers need to be equipped with profound knowledge of all applicable rules and standards. And even more important: you must apply them all appropriately and traceably.

There are many rules and regulations you might need to comply with. Legislation for medical devices is particularly elaborate. Some examples: Medical Device Regulation (MDR), additional CE Directives, US Food and Drug Administration (FDA) and the Medical Device Single Audit Programs (MDSAP) for instance. In Europe Good Manufacturing Practice (GMP) compliance is required for all steps in the manufacture of prescription medicines.

It is crucial – even in the start-up phase – to equip yourself with sufficient knowledge about regulatory affairs. Our Briskr experts can help you with that. Contact us or register for one of our workshops to find out more!

Briskr Support Meetings

At Briskr, we offer professional Business Support to meet your company’s specific needs. We have a network of experts with extensive knowledge and expertise on subjects such as intellectual property, developing your business case and access to funding. You can find an overview of all subjects in which we offer support in the menu above.

There are three ways in which we can offer support on a personal level: an intake, coaching and expert meetings. In addition, we organize all kinds of interesting events at Briskr Academy.

Intake (Scout and Screen)

In our intake meetings, we would like to learn everything there is to know about you and your company. You’ll have the opportunity to pitch your ideas and tell us about your company’s current situation. After our talk, we will make a preliminary report about your company’s strengths and the challenges you may need to face. Based on this intake, we will advise you to take one of the two following steps:

Coaching

Our start-up coaching course aims to improve your entrepreneurial skills. Members of our Business Support Team will set up business challenges specifically tailored to you and your company. For instance, they could focus on developing a business case, or on the search for funding opportunities or help you protect your intellectual property. In this project-based course, we briefly cover subjects like these. And we determine whether you would benefit from the help of experts in one or more specific subjects. The coaching course is free of charge.

Expert meeting

This is a one-on-one meeting with an expert on a specific subject. Think about a patent attorney, or a financial banking expert. Depending on the subject that is most important for the further development of your business, we get you in a room with the right professional. You will be charged for these types of meetings, but our Business Support Team will be happy to help you find vouchers or funding to get the support you need.

Briskr Academy

Our academy offers a wide variety of master classes, workshops, and other activities aimed at common entrepreneurial challenges in Health and High Tech. In addition to speakers and teachers sharing their knowledge, these events provide great opportunities for networking with likeminded entrepreneurs. Click here to find an overview of all Briskr academy activities.

Interested?

Are you an innovative entrepreneur in the fields of Life Sciences, Health or High Tech? Is your company located in the Nijmegen/Gelderland are or are you willing to move your company here? Contact Martijn Kriens to see what we can do for you!

Market Readiness Program

Do you know who your early adopters are? Is your solution the best solution to the problem they are experiencing? Those are the type of questions you will work with in the Market Readiness Program (MRP) of OostNL. In this part-time, ten-week long program you will test your customer assumptions aiming to define and validate your solution, find early adopters for it within a specific customer’s segment, develop a potential business-model and gain commitment of a launching customer.

The MRP is similar to the Discovery Track of Mercator’s IMPROVE Program. The most important difference is that it goes further than problem-solution-fit. You can follow the MRP for free, but it does require a significant portion of your time. In some of the weeks, we expect you to invest 20 or even 30 hours of your time in this program. On the other hand, we have learned that in many cases this investment pays off in the long run.

OostNL has fresh MRP classes starting several times each year. So if you’re interested, make sure to check the upcoming registration dates!

Design Thinking

Are you sitting on a great innovative idea, but not sure how to make it relevant for end users? Do you need to convince potential stakeholders with a powerful pitch to get them on board? Or do you need to validate your idea to make sure it will succeed? The principles of Design Thinking might just be what you need!

Why design thinking?

Design Thinking methods are incredibly useful if you need to transform ideas and technological innovations into relevant and practical solutions. In the past, we’ve had inspiring sessions with Bassam Jabry from Chemistry, a company that evolved from a classic product and graphic design studio to the experienced Design thinktank it is today. Be sure to keep an eye on our upcoming events for future sessions on Design Thinking!

If you would like some information on how Design Thinking could help you with your business, feel free to schedule a one-on-one meeting with us to discuss the possibilities.

Matchmaking events

Bringing companies together to create development and growth opportunities lies at the heart of what we at Briskr do. For example, by connecting relevant start-ups and SMEs to corporate organizations. Either through one-on-one meetings or by organizing matchmaking events.

We bring together businesses from the same sector and with similar interests. The main goal of these meetings and events is to create strategic and financial partnerships between corporates and start-ups and SMEs. Would you like to attend a matchmaking event? Then be sure to check out our upcoming events and find the ones that are relevant to your company!

Would you like some input on potential partner organizations for your business? Feel free to schedule a one-on-one meeting with us to discuss your options.