The Journal of Medical Device Regulation helps you understand global regulatory developments and find your path through international medical device regulations.
By delivering in-depth discussion articles and news updates from around the world, the Journal provides you with essential tools for your everyday work as a regulatory professional.

All participants of the MedFIT Conference receive a 25% discount on any type of subscription to the JMDR.

This offer is valid for new subscribers. Existing subscribers may use it to renew their current subscription.

Place your order here.

Quote promo code “MedFIT2020” to receive this discount.

Free sample copy available.

If you have any questions about subscribing, please email us.

Many thanks to Medtronic for joining MedFIT 2020 as a Silver Sponsor !

Medtronic is a global healthcare solutions company committed to improving the lives of people through medical technologies, services, and solutions.

Join key MedFIT 2020 Sponsors such as ICOSA, Medtronic, EIT Health and World Trade Center Twente to have the opportunity to:

  • Identify your organisation with the main partnering event in Europe dedicated to innovation partnerships in the fields of medical technologies and diagnostics.
  • Highlight your interest in innovation
  • Present your ideas and technologies to key innovation players in MedTech
  • Enhance your visibility on an european scale and be recognised as a key innovative actor
  • Show your expertise thanks to specific communication tools

SepTec, elected as the most innovative Start-up of MedFIT 2019

Among 80 applications, 30 start-ups were selected to pitch during the Start-up Slams at MedFIT in different categories such as cardiovascular, AI/Big data, cancer, generic tools, diagnostic, monitoring and coating / implants / wound. SepTec, an Irish start-up represented by Dr. Elaine Spain, co-founder and co-inventor, is the winner of MedFIT 2019’s edition of the Start-up Slams, from the diagnostic category.

Please introduce yourself and SepTec – How the start-up is born?

Elaine Spain: SepTec is a MedTech company with focus on microfluidic diagnostic sensors. It has a clear mission to enable timely, optimal treatment of critically ill patients by providing novel, low-cost, rapid, reliable diagnostic solutions. The company is an SME based in Dublin, where the core innovation underpinning the SepTec technology was developed as part of post-doctoral research at Dublin City University (DCU), Ireland, 2014-2019. The electrochemical and biomaterials experts, namely Drs Elaine Spain and Kellie Adamson are the founders of the company, have since created a patent, built a highly capable team to develop the technology and created validation data. The highly experienced businessman Robert Perryman joined the team as CEO in May 2020.

SepTec has a highly experienced award-winning research team with a strong scientific, engineering background. The core team has extensive technical, industry and sensor diagnostics experience such as generating superior electrochemical sensors, assay development, manufacturing, project management and business development. This is demonstrated by our combined >100 high impact publications, patents and >$2 million in operating grants as PI/Co-PI and clinical lead. The know-how of designing, developing and manufacturing products based on our core technologies lies completely in our current team. They are joined by experienced commercial and clinical advisors and a strong board of advisors of global opinion leaders.

They have created a dynamic and experienced team, who have been involved in pathogen detection, microfluidics, electrochemical sensors, research, patenting, publishing papers, product development, commercialisation, cloud infrastructure, finance and EU grant funding. The senior team have vast experience in developing strategy, networking and dissemination activities. We are strongly supported by our scientific and strategic advisors and in addition to our multidisciplinary technical expertise, our clinical collaborators are experts in sepsis in critically ill patients and active members/chairs of multiple global sepsis organizations including the Severe Sepsis and Septic Shock Working Group and Surviving Sepsis Campaign who provide strategic mentorship and advice. The team has also won the support of leading clinicians and opinion leaders worldwide as well as earning several innovation and research awards. SepTec will continue to draw on the support of current clinical and industry KOL advisors.

Why did you apply to the Start-up Slams? What was your expectations?

E. S.: I attended MedFIT as an attendee the year before and I thought the calibre of the pitches were excellent as well as the exposure to industrial leaders.  We applied to the start-up slams to showcase SepTec to international industrial players with the aim of creating strategic partnerships and network with health partners.  The opportunity to have a stall at the conference for us to have one to one meetings was an added bonus.  This allowed us to interact with Industrial leaders, Investors and strategic partners in a more professional manner.

What did this victory as the Most Innovative Start-up in Europe bring to you and to SepTec?

E. S.: Being ‘ Most Innovative Start-up in Europe” was an extremely valuable marketing tool for SepTec.  This award also highlighted the benefit of SepTec technology and provided entry to specific entities and people such as global manufacturers, payers, providers, service providers and investors that we otherwise would not have connected with.

What’s next for SepTec now?

E. S.: SepTec is ready to spinout from Dublin City University in the next couple of months. We are closing a funding round to take the product through further design validation and regulatory. We expanded the team earlier this year and hired Robert Perryman as the company’s CEO. We are looking to further expand the team to include further engineering and quality/regulatory expertise. We will be expanding our clinical trial sites across Dublin as well as initiating a Cleveland Clinic Study.

SepTec is developing a sample-to-answer IVD test that can rapidly detect sepsis causing pathogens in whole blood within 15 minutes. SepTec is composed of highly accomplished, aspiring entrepreneurial scientists, engineers and clinical key opinion leaders with a clear focus to address unmet clinical needs, such as empowering an ICU Consultant to rapidly detect infection in a seriously ill patient. In collaboration with Science foundation Ireland, Enterprise Ireland, Dublin City University, Business Experts and International Manufacturers, SepTec has created a powerful microfluidic device that can address the specific unmet clinical needs as expressed by their network of clinicians. SepTec is currently completing clinical device validation using suspected sepsis patient samples in collaboration with two Dublin based hospital locations and is determinedly working to accelerate the SepTec device to the next stage of commercialisation.

More information: www.septec.ie

Innovation in Regenerative Medicine

Regenerative medicine seeks to promote the natural reconstruction of injured tissues in order to avoid the long-term drawback of the synthetic implants’ deterioration. This need is growing steadily as the implants’ service lifespan is increasing due to the worldwide population ageing.

To reach this goal, Bioregenerative implants must combine numerous properties (biological, mechanical, functional, bio-resorptive, bio integrative…) allowing the cells colonization and tissue reconstruction.

In addition to the bioimplant intrinsic properties, it must also be considered the other practical requirements regarding implants’ production and distribution process, regulatory rules, and ultimately its deployment in the clinical field.

During this webinar*, speakers will present their experience in the very demanding field of bioregenerative implant research & development:

  • “Development of a 3D printed bioabsorbable and tissue  bio colonizable matrix for breast reconstruction “, Kévin ROUX, R&D Process engineer for Lattice Medical
  • “Additive manufacturing benefit for personnalized impants . Application for hand reconstruction surgery. , Professeur Christophe EGLES, BMBI Laboratory, Université de Technologie de Compiègne

* The webinar will be held in French

Contact:

Maximilien VANLEENE
Chargé de Projets Collaboratifs
mvanleene@clubster-nsl.com
+33 (0)3 28 55 50 14

 

18 months to accelerate your company and penetrate the European health market

Do you foresee clinical development and scientific collaboration in France and Europe? Is European commercialization a key factor for your company’s growth and development?

Located at the center of a busy crossroads for European business activity, Eurasante Accelerator aims to jump start medical startups and young companies looking to develop in Europe. Whether you innovate in software, hardware, a service, or a combination of these, our program will equip you to what you need to more effectively tackle the significant challenges specific to the MedTech/Digital Health industry. Our team of experts and partners will guide you through key topics such as value propositions, business modeling, reimbursement, IP, regulatory requirements, and many more.

The first project selected will have its entry into the acceleration program sponsored and will benefit from a €30,000 voucher (to be spent within the French entity*) :

  • Voucher : €10,000
  • Acceleration offered : €15,000
  • Soft landing package : €5,000

>> Apply before September 30th, 2020 <<

In the unique context of this year, and to answer the organisation challenges we are facing, MedFIT and BioFIT organisers and their respective Steering Committees have made the decision to postpone MedFIT (the European partnering event for innovation partnerships and investment rounds in the MedTechDiagnostic and Digital Health sectors) and BioFIT (the leading European partnering event for early-stage deals and investment rounds in the Pharma/Biotech field), and to organise them together.

NEW DATES AND PLACE! The upcoming editions of MedFIT and BioFIT will therefore be held on December 7th and 8th, 2020 in Lille, France.

Interested in attending both MedFIT and BioFIT 2020?

Reduced rates are offered to attend both events. Do not hesitate to come with your colleagues to optimise your return on investment!

Interested in attending MedFIT 2020 exclusively?

Interested in attending BioFIT 2020 exclusively?

Now more than ever, our industry needs a framework to meet and interact with international key innovators in order to accelerate innovation in healthcare.
You can count on our commitment to prepare the next editions of MedFIT and BioFIT in the best conditions and to guide you through this new configuration. You can feel fully confident about registering and we look forward to seeing you in Lille in December.

Many thanks to EIT-Health for joining MedFIT 2020 as a Contributing Sponsor !

EIT Health is a network of best-in-class health innovators backed by the EU. We deliver solutions to enable European citizens to live longer, healthier lives by promoting innovation. We connect the right people and the right topics across European borders, so that innovation can happen at the intersection of research, education and business – for the benefit of citizens.

Join key MedFIT 2020 Sponsors such as ICOSA, Innov’Health, EIT Health and World Trade Center Twente to have the opportunity to:

  • Identify your organisation with the main partnering event in Europe dedicated to innovation partnerships in the fields of medical technologies and diagnostics.
  • Highlight your interest in innovation
  • Present your ideas and technologies to key innovation players in MedTech
  • Enhance your visibility on an european scale and be recognised as a key innovative actor
  • Show your expertise thanks to specific communication tools

Many thanks to Innov’Health for joining MedFIT 2020 as a Contributing Sponsor!

The Microtechnology Competitiveness Cluster, approved in 2005, decided, with its industrial members and the public authorities (State, Region, EPCI, etc.), to highlight its market-oriented activities in the health sector. A brand and a “lnnov’Health” cluster were drawn up in 2015, reflecting the last 10 years of the Microtechniques Pole’s health activity, particularly through its expert groups led by business leaders from the medical and healthcare sectors. its “health commission” currently led by Statice and a consortium of companies.

The Bourgogne-Franche-Comté region, represents an industrial ecosystem that relies on historical skills in the field of microtechnology, much of which is dedicated to health. For over 10 years, more than 300 companies in the region have been referenced in the sector, most of them internationally recognized and relying on renowned training and research centers (French Blood Establishment (EFS), ISIFC, Femto , LERMPS, Utinam, Clinical Investigation Center (CIC) …).

Join key MedFIT 2020 Sponsors such as ICOSA, Innov’Health and World Trade Center Twente to have the opportunity to:

  • Identify your organisation with the main partnering event in Europe dedicated to innovation partnerships in the fields of medical technologies and diagnostics.
  • Highlight your interest in innovation
  • Present your ideas and technologies to key innovation players in MedTech
  • Enhance your visibility on an european scale and be recognised as a key innovative actor
  • Show your expertise thanks to specific communication tools

Many thanks to World Trade Center Twente for joining MedFIT 2020 as a Contributing Sponsor!

The World Trade Center Twente supports the development of international trade and business opportunities in the Twente region. The WTC Twente Business Club provides a business support environment to share experience and knowledge from every sector. We offer a range of supports for your business such as trade information, training, coaching, trade mission and our Expat Center assists the individuals as well as companies with highly skilled migrants and scientific researchers during the entire relocation process.

Join key MedFIT 2020 Sponsors such as ICOSA, Innov’Health and World Trade Center Twente to have the opportunity to:

  • Identify your organisation with the main partnering event in Europe dedicated to innovation partnerships in the fields of medical technologies and diagnostics.
  • Highlight your interest in innovation
  • Present your ideas and technologies to key innovation players in MedTech
  • Enhance your visibility on an european scale and be recognised as a key innovative actor
  • Show your expertise thanks to specific communication tools

Many thanks to ICOSA for joining MedFIT 2020 as a Silver Sponsor!

ICOSA is an IP law firm. Besides the regular services of an IP law firm, the specificity of ICOSA is to design IP strategy to serve business purposes.

Promoting IP activities in line with the Corporate Strategy, capturing IP value, leveraging company valuation through IP, is what we do on a daily basis.

Our expertise in IP and our high scientific level are tools to promote value, partnership, development and success.

Join a key MedFIT 2020 sponsor to have the opportunity to get unequalled and targeted visibility and exclusive benefits before, during and after the MedFIT event.

For more information about the sponsorship opportunities, visit the dedicated site page.