In times of digitalization, people nowadays talk about the fourth industrial revolution, also called Industry 4.0. Unlike the third industrial revolution, which was characterized by the „[…] increasing productivity by multiplying and accelerating the mental capacity of human beings with the help of electronic computing systems and memories“, Industry 4.0 is rather characterized by „[…] individualization or hybridization of products and integration of customers and business partners into business processes […].“
This is accompanied, among other things, by the increasing complexity in the industry  driven by shorter product life cycles, for example. Continuous and digital adaptation, also called digital continuity, to this dynamic environment in every single phase of the product life cycle is seen as a solution to these challenges.
But what can this digital continuity in product development and the integration of business partners into business processes look like while taking regulatory requirements into account? This will be illustrated using an example from the medical industry:
Among other things, the medical device manufacturer Ltd. develops insulin pumps. Such an insulin pump consists of several components that not only act as individual components, but must also exhibit error-free behavior in the overall environment of the insulin pump. Some components are developed by medical device manufacturer Ltd. itself, while others, such as the motor, are purchased from an external service provider.
Let’s imagine that this supplier cancels the engine component and the medical device manufacturer Ltd. has to hire a new service provider.
Here, the medical device manufacturer Ltd. faces the following challenges:
- The external pressure of the ever shorter time-to-market and potential revenue losses due to non-compliance with agreed customer delivery dates require a tendering process that is as short and automated as possible.
- The decision-making process is influenced by regulatory requirements, which must not only be formally fulfilled, but must also be tested in the overall environment and documented in a way that is comprehensible to notified bodies.
Medical device manufacturer Ltd. recently chose Polarion as its development platform to cover the entire conformity assessment process, from intended use until product surveillance. An introduction for Polarion newcomers can be found here: https://youtu.be/xTnbYxpc5qU
Now the medical device manufacturer Ltd. is asking itself whether these emerging challenges can also be solved in its development platform. A Polarion enthusiast demonstrates the following possibilities in this regard:
The tendering process can be orchestrated and automated through the integrated, collaborative and reusable document management in Polarion. The development manager compiles the requirements for the engine component in a new specification in Polarion. Here, the requirements are transformed into individual information elements (small blue symbols on the left side of the document) with a uniquely identifiable ID.
The advantages of these information elements with an independent ID is the reusability of these elements in other documents, an independent life cycle for necessary approval processes and audit-compliant documentation security of changes as well as the establishment of dependencies to other elements.
After completion of the specifications with all requirements for the new engine supplier, this document can be reproduced in a traceable manner for the tender process. As a result, each individual supplier receives a dedicated document with the same requirements:
This document can then be edited by suppliers in two possible ways:
1.) Supplier A and B want a Word export to be able to edit and fill in the tender document locally. Polarion as a digital and collaborative platform enables an automated document export, where the medical device manufacturer Ltd. can set which fields may be filled in by the supplier and which are read-only. After exporting and sending the tender document, suppliers A and B fill in the document and provide further technical indications of their engine component.
The medical device manufacturer Ltd. then receives the completed documents back and reimports the responses from the service providers into the dedicated document on the platform – without any additional manual effort:
2.) Supplier C would like to enter his responses directly via the platform. Using a role-based concept in Polarion, the medical device manufacturer Ltd. can provide supplier C with separate access with restricted rights and views, so that service provider C can only edit and view the RFP document on the platform:
As soon as all answers are available in the system, a tender comparison in the form of a dynamic report can be generated for the purchaser of the medical device manufacturer Ltd. The traceability of the individual documents through the atomic requirements per document enable this individual report by one-click:
This approach enables the medical device manufacturer Ltd. to automate and fully orchestrate its tender process to a certain extent. The formal decision-making process can thus also be mapped in the development platform and supports a faster time-to-market.
However, the medical industry is subject to a large number of regulatory requirements, so that the medical device manufacturer Ltd. must also test the motor component in the overall environment of the insulin pump for notified bodies in a comprehensible and traceable manner. The results additionally influence the decision and selection process of the service provider.
For this purpose, the Polarion enthusiast uses the integrated test area in the development platform and derives dedicated test cases per supplier with all necessary parameters for the regulatory motor requirements. These test cases are then combined in a so-called test run per service provider.
Based on these predefined test runs and an existing Jenkins integration (for the execution of a job from the development platform), this test run can then be started automatically in a simulation environment (e.g. Simcenter Amesim) via the “Execute Button”:
The simulation environment with the physical model of the insulin pump receives all the necessary parameters per supplier from the test runs for the simulation of the motor in the overall environment of the insulin pump. The simulation is started and a reference model is used to test the three motor components with their parameters in the overall environment:
From the simulation, it becomes clear that service provider C does not meet the regulatory requirements in the overall context and is therefore eliminated as a new engine supplier.
The results of the simulation are then transferred back into the development environment in an automated manner so that the traceability of these results back to the regulatory requirements can be ensured.
The simulation results can additionally be integrated for the purchaser in the tender overview.
This means that the tendering process for the medical device manufacturer Ltd. can not only be automated and orchestrated for a faster time-to-market, but at the same time the selection of the new motor supplier can be made simulation-based and thus in compliance with the rules.
The medical device manufacturer Ltd. therefore decides in favor of supplier B as the new motor supplier for its insulin pump.
For German please open the attached document:
Peter F. Drucker was an American economist and is considered a pioneer of modern management theory. Citation above found in: Parker, L. (o.D.), Change of Drive https://cdn2.hubspot.net/hubfs/375601/DYK_6.0_Change_to_Thrive_White_Paper.pdf?t=1532464726090 (30.07.2019).
 Warnecke, H.-J. (1993). Die fraktale Fabrik. Revolution der Unternehmenskultur, 2. Aufl. Berlin, Heidelberg [u.a.]: Springer. S. 34.
 Bendel, O. (2019). Definition: Industrie 4.0. Gabler Wirtschaftslexikon. https://wirtschaftslexikon.gabler.de/definition/industrie-40-54032/version-368841 (23.02.2019).
 vgl. Schwab, K. (2016). Die Vierte Industrielle Revolution, 4. Aufl. München: Pantheon Verlag. S. 9.
 vgl. Warnecke, H.-J. (1993), S. 24.