sitem-insel AG

Demanding and constantly changing regulatory requirements are a major challenge for translational projects of SMEs and large corporations. With the help of its partners, sitem-insel Promoting Services supports companies in accelerating their path from invention to commercialization.

Contact

Prof. Dr. Rudolf Blankart
+41 31 382 52 77
rudolf.blankart@sitem-insel.ch

Contact

Prof. Dr. Rudolf Blankart
+41 31 382 52 77
rudolf.blankart@sitem-insel.ch

Promoting Services

Collaboration

sitem-insel Promoting Services cooperates with manufacturers, associations, science, and other health care institutions on regulatory issues.

Interconnectedness

sitem-insel Promoting Services works closely with the KPM Center for Public Management of the University of Bern. This cooperation enables a strong network to international top universities, companies and authorities.

Consulting

sitem-insel Promoting Services offers answers to specific questions in the areas of regulatory affairs, intellectual property, and remuneration together with its partners.

Research

sitem-insel Promoting Services conducts research in national and international collaborative projects on current topics in the area of marketing authorization and reimbursement regulation as well as in the area of health services research.

Innovation Management

sitem-insel Promoting Services and its partners provide support in the development of innovations into marketable products. This includes offering an open innovation platform and networking activities with sitem-insel clubees.

Partners

sitem-insel Promoting Services has contacts to a number of authorities, lawyers, consultants, Notified Bodies, investors and other institutions that provide support in the area of administrative and regulatory processes. With the goal of being a one-stop-shop for all regulatory and administrative issues, many of the partners can be found in the sitem-insel AG building.


be-advanced

Impulses for Entrepreneurship & Innovation in the Canton of Berne

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be-advanced AG is the innovation promotion agency for entrepreneurs in the canton of Berne and coaches startups and SME individually in their innovation projects. be-advanced supports companies over the entire life cycle by providing both SME Coaching and a nationally unique startup program. In doing so, the innovation promotion agency actively contributes to strengthening the innovativeness and competitiveness of Bernese companies.

Learn more: www.be-advanced.ch 

Bern Economic Development Agency

Business and the Canton of Berne – an innovative partnership

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The Bern Economic Development Agency supports companies and their activities with a wide range of advice and services. It focuses on the needs of export-oriented and international companies, start-ups, SMEs and multinational groups. The Bern Economic Development Agency helps companies to get in touch with the right administrative authorities.

Their most important services are:

  • Consulting
  • Arranging contacts, real estate, cantonal land and sureties
  • Initial consulting for SMEs and start-ups
  • Financial assistance and tax relief

Learn more: www.berninvest.be.ch

Decomplix

Outsource Your CE Certification

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Decomplix is a compliance network that facilitates market access for medical devices and in-vitro diagnostics. Manufacturers and developers can outsource their entire CE certification process to Decomplix. Decomplix acts as the legal manufacturer in pre- and post-market phases and thus bears responsibility for product safety.

Developers can thus start directly with the product certification and do not need the specific knowledge or company certification. Decomplix brings compliance personnel, a Notified Body and the required ISO 13485-certified quality management system into the partnership. In order to remain in the market, Decomplix maintains the CE certificate and supports the developers in the long term.

Learn more: www.decomplix.com

HGF Intellectual Property Specialists

Your idea is a precious and unique thing. HGF can help you protect it.

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HGF offers the dynamic intellectual property service that every innovative and competitive organization requires, wherever they are and whenever they need it. Our approach, from the inception of ideas to the enforcement of IP rights is truly collaborative. Our unique and successful client relationships come from our strategic teams that fit around each client’s requirements.

Learn more: www.hgf.com

Swiss Medtech

For a strong Swiss medtech industry

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Swiss Medtech is the association that represents the interests of the Swiss medtech industry. The aim is to maintain international competitiveness, innovative capacity, and to strengthen the domestic market.

Swiss Medtech is committed to promoting Switzerland as a leading scientific workplace and center of research by providing targeted training and further education programs, symposiums, export-promoting services, and supportive measures for entrepreneurship. The Association also contributes significantly to ensuring quality-oriented health care with fair reimbursement rates and advanced innovation funding for patient well-being.

Learn more: www.swiss-medtech.ch

Innovation Management

Open Innovation Platform

Introduction

The „Open Innovation Platform“ is a central tool of sitem-insel's innovation management. It will allow to unite different and diverse internal and external partners around one specific topic during an OI campaign.

Access to unused or hidden potential  

The internet based OI platform allows its users to exchange faster and smarter on a specific topic and to extend their access to knowldege and competence outside of traditional stakeholders. Topics can be diverse: from idea generation or improvement to search for innovative solutions for a technical problem, sharing or discussing specific methodologies, access to ressources (e.g. lab instrument, 3D bioprinter) or to specialized staff for a challenging research project or generation of novel grant opportunities. 

We will run our own campaigns on the OI platform and welcome campaigns from our internal and external partners. OI platforms are already used successfully in Swiss industry ( e.g. Post, Swisscom), as well as in Swiss pharma and biotech (e.g. Roche, Ypsomed). An established OI platform at the interface between academia and industry is uncommon and hence represents an incredible potential.

Activities to date

Further to predefined selection criteria and the help of some of our existing partners from academia and industry, we carried out a proof-of-concept phase. As a result, we selected an international and experienced provider for our pilot phase. Beginning of 2019, we will start the first campaign of the pilot phase. It will focus on collaborative work within sitem-insel partner network.

sitem-insel clubees

"The Spirit of sitem-insel" and sitem-insel clubees 

sitem-insel clubees can be considered as a "virtual" club. Its purpose is to connect internal and external stakeholders of sitem-insel into a network, the sitem-insel community. Through targeted events, the members of the sitem-insel community can rapidly improve the optimal translation of their projects.  

During 2019, sitem-insel clubees will focus on organising selected networking events that will feature the different sitem-insel departments and the internal partners that will be located on the sitem-insel campus in Berne, Freiburgstrasse 3. 

Stay Curious

Further exciting topics to follow ! Check in regularly.

Chair of Regulatory Affairs

Teaching

Veranstaltungsnr.

Semester

Typ

Titel

Zeitraster

433876

Herbstsemester

Vorlesung (3 ECTS)

Management in Medizin und Industrie

Dienstags, 8.15-10.00 Uhr

433882

Herbstsemester

Seminar (6 ETCS)

Aktuelle Themen im Management in Medizin und Industrie

Kick-off am Mittwoch 26.09.2018, 18.15-20.00 Uhr

433895

Frühlingssemester

Vorlesung (3 ECTS)

Regulierung im Gesundheitswesen

Dienstags, 8.15-10.00 Uhr

433894

Frühlingssemester

Seminar (6 ECTS)

Regulierung im Gesundheitswesen

Kick-off am Mittwoch 27.02.2019, 18.15-20.00 Uhr

Bachelors' and Masters' Theses

Please contact Florian Dams (florian.dams@kpm.unibe.ch) for more details and registration.

Spitalmanagement:

  • Marktanalyse: Welche Strategien verfolgen Spitalgruppen in der Schweiz
  • Fördert Pay-for-performance (P4P) Ungleichheiten in der Gesundheitsversorgung?
  • Kaizen im Gesundheitswesen: Was sind die Erfolgsfaktoren dieses ganzheitlichen Managementansatzes im Spital?
  • Economic burden of bacteremia and sepsis in Switzerland: analysis of potential benefits of precise, targeted and timely antibiotic treatment for patients and hospitals

 

Gesundheitspolitik und -ausgaben:

  • Leben wir immer länger in Gesundheit: die Medikalisierungs- und die Kompressionsthese im Vergleich
  • Gesundheitsausgaben an der Schwelle des Todes: auf der Suche nach einem gesellschaftlichen Optimum

 

Organisation und Regulation:

  • Das Zusammenspiel von Innovation und Regulierung am Beispiel der Pharmaindustrie in den USA und/oder Europa
  • Organisatorischer Wandel: Analyse von Auslöse- und Befähigungsfaktoren

 

Project Antibiotika Round Table

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The "Round Table Antibiotika" is an interdisciplinary group of experts from medicine, research and economics of almost all Swiss universities as well as committed personalities from industry.

Its aim is to drive Switzerland's contribution to innovation, research and development of new active substances. The development in this area, which has been stagnating for decades, shows that previous approaches and research programmes do not work well enough at national and international level. A better coordination and expansion of the activities supported by Switzerland for the development of market-ready antibiotics and diagnostics is needed.

Download appeal

Project COMED

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Pushing the boundaries of Cost and Outcome analysis of Medical Technologies (COMED)

International joint project with six international partners (Università Commerciale Bocconi (IT), University of Hamburg (DE), University of Exeter (UK), Erasmus Universiteit Rotterdam (NL) Syreon Research Institute (HU)) with the overall aim of shifting the limits of existing methods for cost and outcome analysis of health technologies both within the framework of Health Technology Assessment (HTA) and Health System Performance (HSP) and developing instruments to promote economic evaluation in policy-making. The project is funded by the European Commission within the framework of Horizon2020 (funding number 779306).

Project MARANO

Multidimensional estimation of regulatory effort and identification of optimization needs (MARANO) | Multidimensionale Abschätzung des Regulatorischen Aufwandes und Identifikation von Optimierungsbedarf (MARANO)

The MARANO project is supported by the "Bonny Stiftung für die Freiheit" in order to disseminate research findings from the field of regulatory affairs into practice. In particular, policy recommendations are to be derived that lead to regulatory improvements or simplifications. In this context, the MDR Solution Panel (formerly Swiss MDR/IVDR Forum) was established with the industry association Swissmedtech to discuss the new regulatory requirements of the new medical device and in-vitro diagnostics regulation with consultants, SMEs, representatives from the authorities and the scientific community. Furthermore, the project tries to quantify the regulatory effort due to the new regulations.

Project HNHC

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Managing High-Need, High-Cost Patients: An International Perspective (HNHC)

International collaborative project led by Harvard T.H. Chan School of Public Health with 10 other international partners (The Commonwealth Fund (USA), Dutch Ministry of Health (NL), Institut de recherche et documentation en économie de la santé (FR), London School of Economics (UK), Health Foundation (UK), University of Technology Sydney (AU), OECD, Otago Business School (NZ), University of Bern (CH), University of Toronto (CAN), Unidad de Investigación en Políticas y Servicios de Salud (ES)) to assess the costs and resource consumption of certain patient groups, compare them internationally and derive political implications.

Publications

Blankart, C., R., A. Foster, & V. Mor 2018. The Effect of Political Control on Financial Performance, Structure, and Outcomes of US Nursing Homes. Health Services Research, accepted.

Dams, F., J. L. Gonzalez Rodriguez, K. L. Cheung, B. F. Wijnen, & M. Hiligsmann 2018. Relevance of barriers and facilitators in the use of health technology assessment in Colombia. Journal of medical economics, 21(5), 510-517. DOI: 10.1080/13696998.2018.1449751.

Blankart, C., R., A. Foster, & V. Mor 2017. The Effect of Political Control on Financial Performance and Structure of US Nursing Homes. Acad Manage Proc 2017DOI: 10.5465/ambpp.2017.7.

Hatz, M. H. M., Sonnenschein, T., & Blankart, C. R. 2017. The PMA Scale: A Measure of Physicians’ Motivation to Adopt Medical Devices. Value in Health, 20(4): 533-541. DOI: 10.1016/j.jval.2016.12.002.

Varabyova, Y., Blankart, C. R., Greer, A. L., & Schreyögg, J. 2017. The determinants of medical technology adoption in different decisional systems: A systematic literature review. Health Policy, 121(3): 230-242. DOI: 10.1016/j.healthpol.2017.01.005.

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