Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting

Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting



Kalms Consulting is pleased to announce that it is opening two new American offices in the most vibrant healthcare technology regions of the United States: San Francisco and Minneapolis.

Navigating FDA approval can be a significant investment in time and dollars. Executing a dual pathway strategy via the European market can provide a streamlined opportunity that quickly allows manufacturers to jumpstart revenue gains, develop a strong health economics story, and aggregate additional clinical data needed to successfully gain approval in the U.S. The European market is also an attractive target for well-established companies looking to expand beyond their native country. Kalms Consulting enjoys longstanding relationships with small, mid-cap and large, US-based medical device, biotech, biopharma and life science clients who continue to benefit from broadening their revenue pathways in Europe. Establishing permanent offices in the United States to better serve existing and future clients made perfect sense. The Kalms Consulting team is comprised of experienced and highly qualified experts who deliver affordable, data-driven solutions to clients worldwide. The U.S. division will specifically focus its efforts on market access, strategic business development, technology assessment and market analysis while working in concert with their European counterparts.

Founder & CEO

“It is my pleasure to introduce the American Division of Kalms Consulting. With these offices we’re giving American firms a better opportunity to access the German and European market.” 


Kalms Consulting GmbH
Rheinstrasse 45–46 Aufgang 1
12161 Berlin | GERMANY



San Francisco is the cultural, commercial, and financial center of Northern California.
California has a great history of innovation in life sciences, developing new technologies to solve health problems.

As the birthplace of biotechnology California stands for the innovation in life sciences in particular. Genomic technologies help detect diseases, while new therapies and devices help to treat them. Digital health technologies help prevent diseases and provide patients with better tools to manage their conditions.

Life Sciences is a cornerstone of California’s economy and contributes to a healthier society and advances new medical technologies.
California’s life sciences community continues to grow, with 3,040 life sciences companies – 192 more than the previous year – producing new technologies and boosting the state’s economy. In 2015, the Golden State’s life sciences industry employed more than 287,000 people. This highly trained and diverse workforce helped develop novel drugs, devices and diagnostics, while also exploring other applications, such as leveraging biotechnology to produce sustainable energy. “Life sciences companies have been incredibly successful. As of September 7, 2016, 1,269 drugs from Californian companies were in the FDA pipeline. In 2015, 264 new devices developed by Californian companies were approved. Academic excellence, forward-thinking public policy and the commitment of thousands of entrepreneurs and business leaders has translated into new ways to address some of the world’s most severe medical conditions: cancer, hepatitis, HIV, rare diseases and many others. These efforts help power our economy and provide health for millions around the world.”1

1CLSA California Life Sciences Association/ 2017 California Life Sciences Industry Report 


Business Development U.S.

“Being the center of technological innovation on the West Coast San Francisco is the perfect location for opening a Kalms Consulting office. We are going to provide start ups with easier access to the rich European market.” 


Kalms Consulting US, Inc.
San Francisco Office
101 Montgomery Street Suite 2050
San Francisco | CA 94104



Minneapolis is the county seat of Hennepin County, and the larger of the Twin Cities.
Minneapolis and Saint Paul anchor the second-largest economic center in the Midwest, after Chicago. Minneapolis lies on both banks of the Mississippi River, just north of the river’s con uence with the Minnesota River, and adjoins Saint Paul, the state’s capital. The city is abundantly rich in water, with thirteen lakes, wetlands, the Mississippi River, creeks and waterfalls.

Minneapolis has a great tradition of making an impact on the health eld and continues to do that today. It hosts the University of Minnesota, which ranks in the top three research universities in the USA. Medical device research is robust at the University of Minnesota. One of the most innovative health providers in the nation, Mayo Clinic, is just an hour and a half drive to the south in Rochester.

Multiple Fortune 500 companies in the health eld were founded in Minneapolis, and the impression these companies have left via innovations reverberates throughout the world.
According to the Minnesota-based Medical Alley Association more than two-thirds of last year’s PMAs out of FDA went to applicants out of California and Minnesota. 

Business Development U.S.

“With Minneapolis’ history of Medical Innovation and achievement the founding of the Minneapolis division of Kalms Consulting will provide existing firms and start ups a gateway to the international stage.” 


Business Development U.S.

“The location of Minneapolis in the midwest region provides easy access to firms in Cleveland, Madison and Milwaukee.” 


Kalms Consulting US, Inc.
Minneapolis Office
701 N. 3rd Street
Suite 202 | North Loop Minneapolis | MN 55401



May 23rd, 2017 | wework Transbay | San Francisco

An expert panel discussion about what challenges healthcare companies will face, but the experts also addressed the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there was a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this. Michael Kauch, Associate Partner Strategy & Public Affairs to Kalms explained in his talk the current situation of “Reimbursement and developments in Health Policy in Germany“. The panel discussed key factors for succeeding and investing in the German market as a starting point for further international expansion.

Organized by: Kalms Consulting, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC 



May 25th, 2017 | Intuitive Headquarter | Sunnyvale

Supported by Kalms Consulting, high level German business delegations have visited our client Intuitive Surgical in the headquarter in Sunnyvale, California. 60 entrepreneurs, VC companies and supporting agencies were part of the Silicon Valley tour of the German start-up association (Bundesverband Deutsche Startups). Also the German Ministry of Economic Affairs had been represented. Furthermore, a delegation of the Vodafone Enterprise Forum, led by a Vodafone Germany board member, came to see the latest technological developments in robotic assisted surgery. Both groups were impressed how Intuitive Surgical has made its way from a start-up to a market leader - and how Intuitive Surgical is constantly improving its technologies for the benefit of surgeons, hospitals and patients. 

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

„Please join us for a panel discussion on how to enter the European market via Germany as a life sciences company. We will discuss key factors for succeeding and investing in the German market as a starting point for further international expansion.

Our experts will discuss what challenges healthcare companies will face, but will also address the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there will be a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this.

After the panel discussion we hope you join us for little bit less of a 'healthy' happy hour with appetizers and drinks. We look forward to seeing you there!“

Organized by:

Kalms Consulting GmbH, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC West

Agenda and more information

Market Access Workshop, 12.05.2017, Berlin

Market Access Workshop, 12.05.2017, Berlin

Von der erfolgreichen Produktentwicklung zur rechtzeitigen Reimbursement-Planung

Powered by Kalms & Partner und NAMSA

Berlin, Rheinstraße 45 – 46, Aufgang 1, 12161 Berlin

Die Teilnahmegebühr beträgt 99 € pro Person und wird in vollem Umfang an Ärzte ohne Grenzen e.V. gespendet
Die Teilnehmerzahl ist begrenzt
Anmeldungen bitte mit Name, Firma und Branche an info [at] kalmsconsult.com
Anmeldeschluss 17.04.2017


9:00 Uhr              Registrierung

9:30 Uhr              Zulassungsstrategie – Wichtige Eckpfeiler für eine erfolgreiche Produktentwicklung und Vermarktung by NAMSA

10:15 Uhr            Frühstückspause

10:45 Uhr             Marktzugang und -akzeptanz in Deutschland: Systeme verstehen und Herausforderungen meistern by Kalms Consulting

11:30 Uhr            Mittagspause mit Zeit zum Networking

13:15 Uhr             Neue Innovationskultur im Gesundheitssystem - Medizintechnischer Fortschritt 2.0. Erwartungen und Angebote der Medizintechnologie-Branche an die Politik by BVMed

Ab 14:00 Uhr      gibt es die Möglichkeit persönliche Face-to-Face Gespräche mit den Referenten zu führen. (Bei Interesse, bitte in der Anmeldung angeben, da es nur sehr begrenzte Plätze gibt.)


Ab Bahnhof Zoologischer Garten mit der U9 bis Walter Schreiber Platz
Ab Hauptbahnhof mit der U55 bis Brandenburger Tor von dort mit der S 1 bis Feuerbachstraße




Olaf Winkler

ist seit 2001 Leiter des Referats Gesundheitssystem im BVMed. In dieser Zeit war er zudem für das BMGS, das DIMDI und für die Deutsche Wirbelsäulengesellschaft in unterschiedlichen Ausschüssen tätig.

Des Weiteren hat er einige Artikel zu den Themen Budgetierung, Marktetablierung und Vergütung von Medizinprodukten verfasst. 

Stephan Buttron

ist seit 2016 Principal Medical Research Manager bei NAMSA. Er hat über 20 Jahre Berufserfahrung in EU-US-FDA und Weltweiter Zulassung von Produkten aus dem Bereich Medizintechnik und leitete bereits einige Workshops und Trainings im Bereich des Risikomanagements und Marktzugangs.


Dr.Benjamin Schulz
Kalms Consulting

 ist bei Kalms Consulting der Experte für bio-physikalische- und medizinische Technologie sowie für Marktanalyse und strategisches Business Development.

Er hat sowohl im Sektor der erneuerbaren Energien wie auch in dem der Medizintechnik als Strategie- und Technologischer Berater gearbeitet. 

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

Kalms & Partner Consulting will participate in the J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco. At this event, investors and executives from all over the world meet with companies presenting their latest innovations and new partnerships are decided.

35th Annual J.P. Morgan Healthcare Conference
Monday, January 9 - Friday, January 13, 2017

For more information visit https://www.jpmorgan.com/country/US/en/jpmorgan

Kalms & Partner Consulting Newsletter 03/2016

Kalms & Partner Consulting Newsletter 03/2016



In outpatient medical care, the direct contract is the counterpart of the collective contract. Collective contracts are agreed on the national level by the associations of physicians and the association of health insurance companies. Collective contracts are binding for doctors and health funds. The direct contract, on the other hand, offers individual agreements of health funds with service providers and producers of medical devices.

This enables contractual partners to flexibly respond to needs that exist in specific types of care or when treating particular illnesses. The areas in which direct contracts can be used have been widened considerably in the past few years. For patients this results in better care from one provider. The implementation of the new law for strengthening the provision in statutory healthcare insurance (Versorgungsstärkungsgesetz) in 2015 created new opportunities for direct contract arrangements. 

It also simplified existing forms of contractual arrangements. The new law envisages a systematic continued development of opportunities for direct contracts for all service providers. So far, the types of contracts were regulated by different sections of the health code (Sozialgesetzbuch V). They have now been condensed in a new clause (§ 140a SGB V) as ‘special care provision’. 

These contracts can cover matters such as services for early diagnosis, specialized outpatient care, as well as new examination and treatment methods whose applications follow medical good practice.

Content of the new article of law

§ 140a SGB V Special Care Provision

Health funds may enter contracts concerning special care provision for insured persons with service providers shown in Illustration 1.

It enables a cross-sector care concepts or an interdisciplinary approach (integrated care). These are legal prerequisites and not negotiable. It also allows contracts for special medical outpatient care involving approved contracted medical service providers or their associations. Insured persons who want to benefit from the special care of their health fund have to submit their voluntary participation in writing to their health fund. Insured persons can revoke their consent with the health fund within two weeks of submission either in written form or as a written transcript without giving a reason. It needs to be stressed that treatments already rejected by the Joint Government Committee (Gemeinsamer Bundesausschuss) may not be part of the contracts. The contractual parties also have to prove within a certain fixed timeframe (usually four years) that the treatment specified in the contract constitutes an improvement with regard to quality and cost effectiveness for the community.

The number of direct contracts will rise

We are aware of approximately 800 contracts in 2012. In 2014 the Association of Statutory Health Insurance Physicians reported 1,850 direct contracts. This trend points towards a considerable rise in the coming years.

Great opportunities for medical device companies

It is an aim to promote competition for members between health funds as well as competition between service providers. Direct contracts should therefore increase the efficiency and quality of patient treatment and also facilitate innovation. Kalms and Partner have excellent contacts in the German healthcare sector, also in the health funds. We would be pleased to support our customers with initiating contacts with individual health funds to initiative contracts – if the legal prerequisites.

According to the new law healthcare insurance companies may enter contracts with the following entities:

  1. Individual medical suppliers or associations of suppliers e.g. physicians, practices.
  2. Boards of institutions offering special treatments for insured persons on the basis of Chapter 4 of the law
  3. Statutory nursing care insurers and approved care institutions on the basis of §92b Book 11
  4. Healthcare centres on the basis of §115 Section 2 Sentence 1 Number 1
  5. Pharmaceutical companies
  6. Medical device companies as de ned by the law for medical devices
  7. Associations of Statutory Health Insurance Physicians in order to support members taking part in special care provision 

Author | Barbara Senger
Market Access & PR




Project Management & Reimbursement

Ellen Holtmann is our team member for Quality Management, Quali cation for market access (incl. national and international requirements for the development and manufacture of medical products also in respect to product liability), national and international requirements for clinical assessment and approval of medical products, national and international aspects of the bringing to market and monitoring of products during the product life cycle. Ellen Holtmann holds a University certification being a qualified Manager Regulatory Affairs Medical Devices International.

During her work in the Medical Device Market since 2000 and besides collecting multiple experiences in the field of Customer Service, Customer Relation Management, Office Management, Marketing, Healthcare Compliance, Quality Management , International Sales Management (Austria and Switzerland) and Business Development. Ellen Holtmann is looking back on a working partnership with Marco Kalms for more than 14 years. She is a native speaker in German and fluent in English. 

Market Access & Reimbursement

Dr. Holger Schaffrath has 25 years of experience in sales, marketing, operations and General management for entities of primarily US based medical device companies in Central European markets. This has included working for Boston Scientific for 5 years and in aggregate for Medtronic and AVE 13 years, acquired by Medtronic in 2000. In recent years he has focused on managing startups launching vascular intervention and neurostimulation products, and has steered related therapies through the phases of market access and adoption in Germany, including clinical, reimbursement related and commercialization aspects. As a Senior Consultant he provides our clients with a broad portfolio of profound knowledge of the German health care system combined with insider knowledge of the medical device industry and related markets.

Holger received a diploma in information sciences and holds a Ph.D. degree in biomedical engineering. To round his professional skills off he is a certified psychological adviser and management coach. 




Intuitive Surgical is the leading company in robotic assisted surgery and has developed the DaVinci surgical system. Kalms & Partner Consulting is supporting Intuitive Surgical in the field of Public Affairs. To demonstrate the impact of the technology for high quality surgery, we have initiated a visit by Dr. Georg Kippels, Member of the German federal Parliament, to the St. Antonius Gronau hospital - the leading center for robotic surgery in Europe. Dr. Kippels was able to take part in a 3D live transmission of a minimally invasive prostate surgery - an impressive experience for a policy dialogue on quality medicine. 



Curing severe forms of incontinence - this is the aim of the Botox injection to the overactive bladder. Kalms & Partner Consulting is supporting Allergan, the producer of Botox, in regard to the application of the method to the outpatient sector. One instrument are contracts with major health funds. Allergan and Kalms & Partner Consulting can now report further progress in the efforts to improve access of patients in ambulatory surgeries. 

After a DAK contract in the region of Westphalia-Lippe two more contracts have included the Botox injection to the overactive bladder: DAK in Bavaria and AOK in Baden-Württemberg. 

This is good news for the patients and for the physicians who nally get a much better reimbursement than before. 



Taking place in Düsseldorf November 14th – 17th,  MEDICA is the world’s largest event for the medical sector with more than 5,500 exhibitors (including more than 500 U.S. exhibitors) in 19 exhibit halls and expected and 130,000 trade-only visitors from 120 countries. 

The CEO program was developed by theU.S. Commercial Service in order to offer US companies a unique opportunity to promote their exports and to meet customers and qualified distributors from all over Europe and the world at affordable cost.

Kalms & Partner Consulting is happy to participate in this event in order to continue our activities in successfully supporting US based companies with their German and European activities.



In July 2016, Kalms & Partner Consulting successfully gave an expert workshop on the New Benefit Assessment (NUB) implemented in the German reimbursement system. It applies to certain methods with medical devices provided an NUB application is submitted by a hospital.

In the workshop, Kalms & Partner consultants explained details of the new law, its implications for the medtech companies and strategy recommendations for our clients. Additionally, participants had the opportunity to discuss the matter with high-level representatives of the Association of German University Hospitals and of the Joint Federal Committee, the most important self-administration body of the German health system.

If you missed the workshop, but are planning an NUB application in 2017, please contact your Kalms & Partner consultant as early as possible, as applications that may be subject to a benefit assessment have to be carefully prepared several months ahead of the deadline.