Moving away from the document transfer station and regulatory uncertainty towards a regulatory affair that is "fit for future"
The first run of the Fit for Future Program with 15 medical device manufacturers has already started. Please get in touch with us to secure your seat in the next cohort so we can guide you through your digital transformation.
Key findings from the webinar
Over 300 companies gathered important insights into digital transformation at our webinar on October 19:
Insight 1: Digital transformation is not the goal
The goal is not digital transformation, but
- a shorter time-to-market, in order to generate revenues earlier and not fall behind the competition,
- greater regulatory certainty,
- more efficient processes, that relieve employees of routine tasks such as copying, formatting, and checking documents,
- more attractive workplaces, where regulatory affairs teams no longer see themselves as document transfer stations but instead attract young colleagues because they can make a meaningful contribution with modern tools, and
- with all that ensuring endangered competitiveness and job security.
However, digital transformation is a key component in achieving precisely these goals.
Insight 2: The transformation results must meet five principles
A digital transformation makes a company "fit for future" if these five principles are met:
- Processes must be designed and automated end-to-end. In the case of approval processes, this includes the authorities and notified bodies in order to achieve a "global optimum" of efficiency and effectiveness.
- Data-driven rather than document-driven processes are the prerequisite for automation. Because algorithms need data, not documents.
- Common data structures for all processesprocesses are necessary to avoid data silos and, thus, contradictions and inconsistencies. This is because regulatory.
- Regulatory requirements must be translated into algorithms (e.g., test logic) that automate processes and eliminate unnecessary work.
- Until all authorities and documents have switched from document-driven to data-driven processes, the systems and processes must be backward compatible" and able to extract documents.
Most of the IT systems that manufacturers use to digitalize themselves do not or only partially meet these requirements. Therefore, these approaches are not " fit for future".
Insight 3: The right time for digital transformation is now
Professor Fratscher from the German Institute for Economic Research says that "many German companies overslept the [...] transformation in the good 2010s and are now lagging behind. Ultimately, the main responsibility lies with the companies [...]." Therefore, manufacturers should not wait any longer:
- Any delay harms competitiveness.
- For the first time, we know that authorities and notified bodies have also embarked on the path to data-driven processes (as other industries did decades ago). This means that manufacturers know where the journey is heading and can make themselves "fit for future".
- The data models, algorithms, and software systems are available for the first time.
- It has been proven that the efficiency of regulatory processes can be increased by orders of magnitude(!). Even without automation, notified bodies expect productivity to triple or quadruple with systems like the Johner Institute's.
- There is a "Fit for Future Program" in which the Johner Institute will accompany a cohort of companies through their digital transformation.
This is the first time that all the requirements for a successful digital transformation have been met.
Elements of the Fit for Future Program
The Fit for Future Program includes everything manufacturers need to move from a document transfer station with regulatory uncertainty to regulatory processes that ensure the company's competitiveness.
- We create a precise roadmap for the companies to complete their digital transformation in six sprints, each lasting one quarter.
- In weekly expert sessions with personal support, we provide tips, answer questions, and suggest which specific tasks need to be completed in the coming week.
- The Johner Institute's regulatory experts perform a conformity check of the newly recorded parts of the technical documentation so that a complete and compliant TD is digitally transferred.
- The Johner Institute provides software to record and automatically check all this data.
- Participants also receive blueprints on integrating existing and new systems (e.g., Polarion, Jira) and developing connectors for them, for example.
Costs of the Fit for Future Program
Digitalization projects are usually very expensive: implementing RIMS (Regulatory Information Management Systems) alone costs tens of millions in larger companies. The Johner Institute also carries out projects with corporations in the six and seven-figure range.
Because small and medium-sized companies do not have these budgets at their disposal, we have considered how we can substantially reduce these costs. The answer is through automation and standardization. This means that digitalization is also the key to increasing efficiency and cutting costs. We are happy to pass these savings on to you.
| Fit-for-future-Program Professional Version | Fit-for-future-Program Premium Version |
Enterprise-Program | |
| monthly costs in EUR | 4.000 | 10.000 | from 20.000
|
| going through the sprints | together in cohort | together in cohort | individual |
| expert sessions | weekly | weekly | individual |
| support ratio in expert sessions | 1:10 | 1:1 | 1:1 |
| feedback on TD | individual | individual | individual |
| use of software | inclusive (1 device) | inclusive (1 device) | individual |
| connectors | blueprints | blueprints | individual (including development) |
| number of seats available | 10 | 5 | 1 for now |
Please let us know if you would like to take part. We will give you feedback by the next workday as to whether seats are still available and whether your registration was successful.
Guarantees
Guarantee 1: Money-back guarantee
If you are not satisfied with a sprint, let us know by the end, and we will refund your money because we want you to be absolutely satisfied.
Guarantee 2: Free exit after each sprint
If you feel that you have already achieved your objectives before the last sprint or no longer see the need to continue for any other reason, you can drop out after each sprint at no cost. Let us know four weeks in advance so that we can reschedule the next sprint if necessary.
Guarantee 3: No vendor lock-in
We do not want you to become dependent on us. Therefore, you can export your data in a machine-readable format. This format also gives you valuable information about the data structure.
Guarantee 4: One-off price
We want to reward the determination of early adopters. That's why we promise a sensational price we will never offer again.
Guarantee 5: More regulatory certainty
We also guarantee increased regulatory certainty and labor savings. These benefits are for sure:
-
The software inherently increases data quality, and the regulatory experts check the data. This inevitably results in greater regulatory certainty.
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Many tasks, such as reviewing documents or creating and formatting documents for the various target markets, are reduced or even completely eliminated.
Registration for the Fit for Future Program
If you want to be one of the 15 companies that the Johner Institute accompanies through digital transformation, get in touch to book an appointment and clarify any final questions.
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