LIFE SCIENCE INCUBATION

A national platform supporting both incubators and life science start-ups and SMEs.

Sweden’s life science incubators are working together to develop common tools and methodologies to support the development of promising companies. Through working together, we can provide high-quality support for companies and incubators from all over the country, and help connect companies with international investors.

15 mars 2017

FOCUS AREAS


Key Knowledge - Online seminars, courses and workshops designed to help you gain a better understanding of if - and how - regulations will affect your product or service and how risk management strategies can be implemented

Expert help - get access to help and support from larger companies who have the expertise needed to provide key input to help solve your challenges, or to give you an important 'second opinion'

 


F
inancing - national financing events that bring the most promising Swedish companies together to meet relevant national and international investors

Inspiration - find out how other start-up companies have succeeded in taking their ideas and launching their products and services on the market. How have they succeeded and what have they learned on their journey?

Events and Activities - courses and seminars for start-ups, SMEs and incubators

KEY KNOWLEDGE

SHORT ONLINE WEBINARS - FREE

Our free online material will help you understand the life science 'landscape' better. What regulatory demands will be made on your product or service? When is software classified as a 'medical device' and what does this mean in practice? When do you need a CE mark, and how does the process to get one look like?

Each course program is divided into small, short modules that you can view using your computer, pad or phone at a time that suits you. If you have not already done so, you will be asked to register a Learnifier account before accessing the programs (registration is free of charge and only takes a few seconds).

PUBLISHED COURSE

Your road to market for a Medical Device A step-by-step introduction to Regulatory Affairs for Medical Devices and especially what important Decisions and Strategies you need to grasp to succeed in getting your product on the market. Gain an understanding of how Medical Devices are classified and what demands are made on each class

 

Sustainability for Life Science Companies An introduction to the topic of sustainability, and how it impacts life-science companies. In six hshort modules, the course gives you an understanding of why you should work with sustainabiity at an early stage, through to stakeholder engagement and supply chain management. The course has been developed in collaboration with the TEM Foundation

 

COMING SOON...

Software as a Medical Device
When does software get classified as a medical device and what does this mean? What important Decisions and Strategies you need to grasp, and what processes to implement in order to succeed in getting your product on the market. This program will give you a basic understanding of if - and how - regulatory demands will affect your product.

 

 

LONGER COURSES

Courses and seminars organised by our partners. Start-up companies connected to a business incubator can receive a 10% discount on courses organised by Läkemedelsakademin (a part of Apotekarsocieteten). Simply write 'NPLS' in the comments field when you register.

3 APRIL: IVDR training with TUV SUD
@ Wallingatan 26A, Stockholm

An opportunity to learn of requirements, challenges and useful insights directly from one of Europe’s largest and leading notified bodies.

Information and registration


23 APRIL: MDR training with TUV SUD
@ Wallingatan 26A, Stockholm

An opportunity to learn of requirements, challenges and useful insights directly from one of Europe’s largest and leading notified bodies for medical devices.

Information and registration


12-14 MAY: Biologics Drug Development-3 day course
@ Wallingatan 26A / Online

A three-day course coering all aspects of the development of biological drugs, from discovery to product launch, including principles on biologics safety, planning strategy for toxicology and clinical studies as well as key aspects of manufacturing and controls

Information and registration

 

EXPERT HELP

There are a number of established MedTech / HealthTech companies that are passionate about supporting innovative startups and advising the next generation of entrepreneurs.

We can help connect entrepreneurs with companies that are keen to share their expertise and experience in a number of areas from detailed technical advice on specific topics to strategic business development.

The meetings need to be well prepared with clear question(s) to be discussed, so that the most relevant experts are from the larger companies are engaged.

 

For more information, contact Magnus Bergendahl at Sahlgrenska Science Park (Magnus.Bergendahl@sahlgrenskasciencepark.se)

More information on Astra Zeneca's Exchange Monitoring can be found here and here.

 

 

 

INSPIRATION

How have other companies succeeded in taking their projects from idea to a commercial product / service? What have they learned on their journey?

For the recorded seminars, you will need to register on Learnifier if you have not already done so. Registration is free of charge and only takes a few seconds.

Recorded seminar:
Björn Nordlund, Medituner

Björn Nordlund, one of the founders of Medituner and the mobile app Asthmatuner. Björn talks about when he and co-founder Henrik Ljungberg saw a need to simplify and improve care for both for patients and caregivers, and then took his idea all the way from idea to market. Björn shares experiences and lessons learned - how to reach all the way to CE marking and market? What systems and processes need to be created? What experts and advisors do you need to travel with? How to find a business model that fits? What should you simply think about, tough lessons, important tips?

Access a recording of the seminar here.

 

 

 

Recorded seminar: 
Fredrik Dahl, Forskningschef PerkinElmer

 Fredrik Dahl, research director at PerkinElmer is a serial entrepreneur who - together with his colleagues – started, built and exited Halo Genomics. What did they learn, and did their learnings influence the strategies when their next company, Vanadis Diagnostics was built up. What choices did you need to make? What did they take the chance to change when they had to do the trip?

This seminar is in English (introduction in Swedish). Access a recording of the presentation here

Recorded seminar:
Maria Winkvist, Kontigo Care

Maria explains how they took their e-health solution for addiction treatment from idea to market in 18 months. What did they learn through developing medical technology hardware and software, building quality systems, creating clinical data and the conditions for sales to healthcare providers?

This seminar is in Swedish. Access a recording of the presentation here.

EVENTS AND ACTIVITIES

Other seminars and courses that can help your business development. 

11 MARS: Affärsutveckling för medicintekniska produkter 2020
@ World Trade Center, Stockholm
Meeting held in Swedish

Välkommen till 2020 års temadag som genomförs för andra gången! Affärsutveckling såväl som säljstrategi behöver anpassas för att möta det nya medicintekniska landskapet. Vilka regulatoriska strategiska beslut behöver man ta, hur går utvärdering och prövning praktiskt till, vilka olika investeringsvägar finns? Kort sagt, vilka viktiga saker behöver jag känna till för att ta de rätta besluten under resan från idé till produkt på marknad.

Dagen arrangeras av Läkemedelsakademin i samarbete med SwedenBIO, Apotekarsocietetens sektion för Medicinteknik, Swedish Medtech, UIC, Sting och Plastforum

More information and registration

 

 


6 FEBRUARY: Kan AI/ML användas säkert inom medicinteknik? Regulatoriska utmaningar
@Göteborg / Stockholm

Diskussioner om de säkerhetsmässiga och därmed regulatoriska utmaningarna som användningen av AI/ML innebär i medicintekniska tillämpningar. Vad är det som gäller? Vad kan vara svårt? Kan det överhuvudtaget fungera? Teori och praktiska erfarenheter.

More information and registration

useful resources and links

The European Union's latest guidance on qualification and classification of software in medical devices and in vitro diagnostics. Link

TOPRA is the professional organisation for people working in regulatory affairs. They offer a range of courses and meetings, some of which in are located in Sweden. For more information, visit their calendar.


EMERGO provides a large resource of information on market data and regulatory pathways for the major markets in Europe, US and Australasia

 

Läkemedelsakademin is a part of Apotekarsocieteten, a non-profit organisation for professionals in the field of pharmaceuticals. Läkemedelskakademin arranges a wide range of courses and events covering all aspects of pharmaceuticals, medical devices and in vitro diagnostics. The course calendar can be found here.

CONTACT

For more information about the platform and its activities, please contact Andy Browning (andy.browning@uic.se), tel +46 706 181635