Our Company History

Two colleagues seated at a desk are talking to each other.

Over 20 years of history – what has shaped our company over time

From the vision of a specia­lized master's program to a success­ful and sought-after consul­ting firm in medical technology

2024

  • More experts are striving to join the institute.
     
  • A second cohort of the Fit for Future Program is starting. It enables manufac­turers to automate and optimize their regulatory processes and increase competitiveness​​​​​​​.
     
  • The third World Medical Device Summit​​​​​​​ intensifies cooperation between politics, authorities, notified bodies, and manu­fac­turers. As a result, the FDA is involving us in further developing its data interface (eSTAR program). 
    ​​​​​​​
  • We are supporting a notified body in the development of a REST API (data interface) that will speed up the “approval process” significantly.
     
  • Together with a Notified Body, we are offering a rather unknown conformity assess­ment procedure for manufac­turers of standalone software. This will make it easier to switch to the MDR. 

2023

  • We are strengthening our team with more great colleagues. By the end of the year, we will have over 170 employees.

  • We are turning the market upside down with another product: the Fit for Future Program. For the first time, an offer specifically supports medical device and IVD manufacturers through their digital transfor­mation. From a five-person company to a corporation with billions in revenue.

  • At the second World Medical Device Summit​​​​​​​​​​​​​​, we present the digitali­zation of regulatory processes. Representatives from politics are enthusiastic and plan to involve us in evaluating the MDR and IVDR.

  • The Swiss Ministry of Health commissions us to develop a concept to eliminate impen­ding bottlenecks in the supply of medical devices.

  •  AI is finding its way into the daily work of our consultants. 

  • We are starting to digitalize the first notified body.

2022

  • The institute has continued to grow. Over 140 people work directly or indirectly for our clients. 
     
  • Digitization has taken great leaps forward. The first seven-figure order is received. Post-Market Radar and Regulatory Radar have become important pillars.
     
  • The first World Medical Device Summit​​​​​​​ takes place. Authorities such as the FDA, the EU Commission, ministries, manufac­turers, notified bodies, and medical professionals come together and find specific approaches to counter the looming gap in patient care. The state of Baden-Württemberg is offering funding of over two million euros for this purpose.
     
  • The annual "Institutstag" has now outgrown even the Council of Konstanz. It will take place for the first time in the more spacious Bodenseeforum.
    ​​​​​​​
  • After more than ten years, we are saying goodbye to the Villa Rheinburg. Our new location in the Rheingarten is ten times larger.
Christian Johner at the 15th "Institutstag" of Johner Institute

2021

  • We exceed the 100-employee mark. 
     
  • We hire the first researchers in the field of regulatory science. 
     
  • We start a partnership with Harvard. 
     
  • We move into the new Konstanz location in Rheingarten, which is three times larger. 
     
  • We play a major role in bringing corona tests to market thanks to our usability tests.  
     
  • The Ministry and the German Council of Science and Humanities approve the concept for the university. 
     
  • Digitization of the approval process starts in collabo­ration with TÜV SÜD
     
  • Launch of new English “Auditgarant” in the USA
     
  • Design and launch of “Regulatory Affairs” degree program
    ​​​​​​​
  • We publish the Audit Guideline in English for the first time.

2020

  • Start of cooperation with WHO

  • Decision to found a university

  • Some notified bodies adopt our AI and IT Security Guidelines.

  • Registration of first DiGA app with BfArm

  • Second Medical Device Days​​​​​​​,​​​​​​​ taking into account all regulations – despite Corona

  • Establishment of the subsidiary Johner Medical GmbH: Now, we are also a legal manufacturer and authorized represen­tative for medical device manufac­turers.

  • Over 1,500 free consulta­tions were provided via micro-consulting​​​​​​​ for the first time.

2019

The year begins with a move to Turmstraße 5 in Konstanz. The premises in the technology center were too small. We do not give up our location in Villa Rheinburg, so we are repre­sen­ted at two locations in Konstanz. 

Once again, we expand our range of services:

  • CSV seminar
     
  • Regulatory Affairs Update Service, which will later be name ​​​​​​​Regulatory Radar
     
  • Support for devices that use artificial intelligence​​​​​​​ 

2018

In 2018, our fast-paced develop­ment is demonstrated by the following:

  • Our company grows by 100%.
  • We successfully pass our ISO 13485 certification on the first attempt.
  • We are opening our new location in Berlin.
  • New seminars such as the one on IVDR are comple­men­ting our range.
  • ​​​​​​​Every year, we substantially expand the videos in the Auditgarant. The GDPR, CSV, and clinical evaluations are in focus, as is translating over 100 videos into English.
  • ​​​​​​​The book on IEC 60601-1​​​​​​​ has been written and is ready for publication and printing in 2019.

2017

We are expanding our seminar offerings:

  • “Usability Testing” Seminar
  • MDR Seminar
  • ISO 13485:2016 Upgrade Seminar

We are running out of space again in Konstanz. We are renting two offices in the Technology Center.

Auditgarant is expanded to include 50 video training courses to provide support in implementing MDR requirements and IT security.

The team is growing by five more experts, primarily in the areas of clinical evaluation, CSV, and in vitro diagnostics.

The usability labs in Germany and the U.S. are fully booked, and the first projects on IT security for medical devices are getting underway.

The 12th master’s program has begun, sold out as always.

2016

The exponential growth continues:

  1. The consulting team is expanding with five new colleagues.
  2. Thanks to our new office in Frankfurt, we can now reach our German clients even more easily.
  3. We have entered into a strategic partnership with UserWorks and now also offer usability studies in the U.S. and FDA-compliant human factors engineering documentation.
  4. The seminar on risk management and the seminar on IEC 60601-1 complement our training portfolio and have been in high demand since their first run.
  5. The scope of AuditGarant doubles: It now also includes video training and templates for establishing and auditing quality management systems.
  6. The book “Usability as a Success Factor” is published in its first edition. The book “Basic Knowledge of Medical Software” is published in its second edition.
  7. For the first time, we are offering our webinars as live streams. Nearly 200 viewers tune in to the first broadcast.
Participants of a live event

2015

The video training courses on Auditgarant are now also available in English. We are using our professional video studio at our headquarters, Villa Rheinburg, for this as well. Now we can produce even higher-quality video training courses even faster.

The 11th master’s program in “IT in Healthcare” is, as always, sold out.

Our consulting team is also growing: Luca Salvatore joined us in the middle of the year.

For the first time, we are offering the “Internal Auditor” seminar.

2014

The second MBA program is starting. Once again, the curriculum includes a week in Silicon Valley, featuring stops at elite institutions such as Stanford University and the Kaiser Permanente HMO.

A complete relaunch is planned—not only of the website and the shop system, but also of the entire e-learning platform. The new video training product is now called Auditgarant and helps manufacturers create audit-ready technical documentation for medical devices in the shortest possible time.

Johner Institut GmbH was established on January 1 and brings together the various business divisions of the Institute for IT in Healthcare.

2013

The consulting team continues to grow: Robert Dick-Hambeck and Markus Gerhart have joined the team.

It goes without saying that the ninth MBA program is fully booked again. This time, as early as the end of June. The second MBA program, which begins in 2014, sold out within eight hours.

With 400 attendees, an in-house seminar on medical software development sets a new attendance record.

2012

Our “MedPack” and “RiskPack” software packages are proving so successful that we have decided to spin off this business unit into a separate company, Medsoto GmbH, and hire a developer for it.

This year’s Institute Day is described by many as the best yet. With 170 registrations, we have reached the capacity limit of our villa.

As every year, a part-time master’s program in “IT in Healthcare” begins in the fall. This is now the eighth one!

2011

We’re kicking off the new year with a first: the inaugural MBA class, with 17 students, is completely sold out. The study week at Stanford is certainly a highlight of this program. Christian Johner’s connections to this elite university are paying off.

With the book “Basiswissen medizinische Software” (Fundamentals of Medical Software), we also lay the groundwork for the “Certified Professional for Medical Software” seminar, for which we become the first training provider to be accredited.

2010

Just as the previous year ended on a high note, the new year begins just as successfully. In the national competition “Germany – Land of Ideas,” the institute is once again honored as an “excellent site,” following its recognition in 2007. This time, the award is for its “Healthcare IT for Africa” initiative.

Demand for consulting services is also so high that further expansion is both necessary and possible with the addition of ISO 13485 Lead Auditor Alexander Thern.

2009

The fifth master’s program is the first to begin at the new Constance location in Villa Rheinburg. With the addition of Sven Wittorf and Corinna Hartmann, the team continues to grow in order to meet the high demand for program spots and consulting services.

The Institute Club is established, and several companies immediately begin using it to provide structured training for their employees. To distribute the approximately 25 web-based training courses created this year, the audit guide developed at the end of the year, and the practical handbook “IT in Healthcare” published by Hanser Verlag in 2009, the Institute Shop is launched. Thus, 2009 becomes the Institute’s most successful year to date.

2008

Almost all hospital chains, as well as major manufacturers and providers of IT and healthcare products and services, are now our clients.

The product portfolio has expanded significantly to include webinars and seminars. As club members, clients enjoy numerous benefits.

As always, the fourth master’s program is already sold out.

2007

In the “Germany – Land of Ideas” competition, the institute is honored as a “Landmark of Excellence.” The grand ceremony becomes a gathering place for the industry.

The Medical Association recognizes the master's program for the additional qualification in “Medical Informatics.”

The third cohort begins in September—already fully enrolled months in advance.

2006

The second course also sells out quickly. The list of companies represented by the participants includes most of the major providers. The list of speakers reads like a who’s who of IT in the healthcare sector.

Christian Johner says goodbye to graduates

2005

Leading experts in the fields of IT management, law, communication, business administration, health economics, IT systems development and operations, and medical statistics have been recruited.

Among them are the head of the Healthcare Management Institute at the University of Trier, Prof. Dr. Goldschmidt; the director of the Institute of Business Administration at the University of St. Gallen, Prof. Dr. Rüegg-Stürm; the senior official at the Federal Ministry of Health, Dr. Dietzel; and Walter Bachmann, a lawyer specializing in IT law at the law firm Graf von Westphalen, Bappert, and Modest.

The program launched to a full enrollment in September 2005. Enthusiastic students gave the instructors in the first few weeks a perfect grade of 1.1.

2004

As part of the “Pharma and Biotech Management” master’s program at Danube University Krems, it becomes clear how many IT projects—even in the healthcare sector—fail to achieve the desired success.

The idea was born to establish a specialized university program in which experts would work alongside students to develop strategies for efficiently designing and operating IT systems and applying them to improve effectiveness in the healthcare sector.

The curriculum is developed, and the newly founded institute is launched under the name “Calcucare Institute” as a division of Calcucare GmbH (now NephroCare), a subsidiary of Fresenius Medical Care.

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