FAQ on Regulatory Affairs Digitization and DigiLab

At Metecon, we have been dealing with Regulatory Affairs and Compliance for more than 20 years. During this time, many versions of MS Office have come and gone - and our teams still process Word and Excel files from our clients.

The disadvantages are obvious:

• Your RA team is constantly spending a lot of time searching for the right documents and information.
• The information you need may not be available and accessible to each and every employee at every location.
• Your data is likely to be redundantly maintained and perhaps even in a contradictory manner.
• Valuable professional staff are permanently overburdened.
• Your RA processes are lengthy and
• last but not least: you provoke invalid certificates with all this.

This not only costs a lot of frustration - for you and your employees - but also a lot of money. And here comes the good news: It can be done more economically - and above all: it can be done better. Digitization will be the key. Just imagine it: All data - unique data! - in one place. A single source of information! An enormous acceleration of your RA processes! And your employees? They finally have the time to do what they were brought in for as RA experts: to ensure the sales capability of your products in all markets. Doesn't that sound exciting and visionary?

For two years, we tested software for regulatory affairs at our own expense. Our independence and objectivity are very important to us.

There are no obligations whatsoever between the software providers and Metecon; the tools that made it into the DigiLab were tested with a deliberate rejection of commissions in the event of brokerage. Thus, we are completely independent in our recommendations, which creates the basis of trust between DigiLab and our customers, the manufacturers of medical devices, and IVD.

Absolutely! Here is an example calculation:

Let's assume that your RA department consists of five employees. Each of them spends one hour a week searching for the right documents. Let's further assume that they do this - vacation and illness included - 42 weeks of the year. We'll use a standard hourly rate of €90. See how much money that is? 18,900 € that your company invests every year in searching for the right documents.

5 employees x 1 h/week x 42 weeks x 90 EUR = 18.900 EUR

Your team is larger? Under the same conditions - i.e. one hour search per week, 42 working weeks, at 90 € per hour - but now 15 employees instead of five in RA, it costs you an outrageous 56,700 € just to find what could not be filed better.

15 employees x 1 h/week x 42 weeks x 90 EUR = 56.700 EUR

And this year after year! That is not only a lot of money, it is also very annoying because it is avoidable costs. These sums seem frightening, but they are by no means exaggerated. In fact, we are sure that your RA team will have to invest much more time, e.g. when new colleagues have to be trained and/or you have to maintain many products.

Annual costs which DigiLab saves you.

The intended use and your specific expectation of the software is the foundation on which your software selection process is based.

Users usually have very similar expectations of software for standardized application areas, which is why you can assume that these are covered in most software offerings. In a word processing program, for example, they want to select fonts and colors and run a spell check in a language of their choice.

Complex and specialized software solutions are a different story. Medical device manufacturers sometimes use software in their RA processes in completely different manners. Therefore, different companies may have completely different requirements for the software, i.e. INDIVIDUAL aspects are very important when choosing the appropriate software.

Therefore, we recommend that you know your own requirements exactly for the software search. Questions to which you should find answers are the following:

• What features does the software absolutely need to have in order to support our workflows?
• What requirements do we have for the software in terms of usability and performance, and
• Which requirements are essential for IT security?
• In which countries do we want to sell our products and which requirements can be derived from this?
• Who are our stakeholders and what are their expectations?

The requirements for interfaces to other systems are a particularly important topic, because major adjustments are often necessary at this point. Be sure to keep an eye on the cost-benefit ratio here!

One more tip: Try to let your users describe the problem and the task, and avoid thinking too quickly in terms of solutions.

Once you have gained an overview of your requirements in this way, you can start to evaluate available software tools for their suitability.

Most of the time, the following happens: During testing and acceptance of the software - two phases that are often still accompanied by your provider - no serious irregularities become visible yet. However, as soon as your employees are left alone with their new software - i.e., as soon as they really want to work with it - it turns out that not everything fits perfectly, that certain parts should have been configured better, that some things don't work as planned.

And what happens then? Your biggest nightmare comes true: Your RA departments and all the others who now have access to the program find their own, in their opinion, practical solutions: home-made workarounds, updates via e-mail again, individual workarounds that take the idea of a unique database makes no sense at all. And what that costs you, you don't see for a long time, and you can only change that at great additional cost.

This means that your digitization has failed in three aspects:

1. You have no workable and powerful software,
2. Your employees remain trapped in time- and energy-consuming activities that you actually wanted to get rid of, and
3. You've spent valuable budget on software that doesn't work.

Rather, do it right from the start. It will pay off later.

If you have put a lot of energy into the project from BEGINNING to identify your individual requirements (whether with or without DigiLab), then there will be no nasty surprises in the "acceptance" and "operation" phases.

And in addition to cost optimization, requirements engineering has two other key advantages: If requirements are carefully captured, this requires all stakeholders in your company - and thus you automatically actively involve employees* in the decision-making process.

This increases the acceptance of the new software enormously:

• Everyone has participated.
• Everyone identified their own requirements and contributed to the development process.
• Everyone had the opportunity to discuss their needs and fears.

As a result, your employees feel connected and committed to the common cause; the success of the digitization project is not imposed from above, but is a personal concern. The goal, too, is not one ordered from a higher level, but a self-defined and thus effective one: You see the better solution within reach and do everything to achieve it. And you quickly save the costs for the changeover.

The second positive impact is that you can check in discussion with all those involved in the workflow whether your processes are actually being implemented and whether they are appropriate to the tasks and therefore effective.

If you digitize bad processes, you will end up with digitized bad processes.

Discussing at what points data is transferred or shared, where interfaces between different systems are necessary, and who actually uses what data for what purpose, brings the processes and workflows to their attention. This helps in analyzing where these processes can be optimized BEFORE they are implemented with software.

Our goal was to shorten the selection process for our customers. So we did some preliminary work:

First, we worked with our internal RA experts to identify the basic requirements that apply to all medical device manufacturers - and, of course, to you.So we asked ourselves: What do you definitely need? What basic workflows does the software need to support? What information must it always map? Can it manage all submissions for multiple markets? Who are the key stakeholders? And what do they expect?

In the next step, we tested more than 30 softwares and configured the shortlist together with the vendors according to these requirements and then tested them thoroughly. Our tip for this phase: Make sure you are shown all aspects that are interesting and necessary for you. Software vendors naturally like to show what their product can do, and less like to show what it can't do so well ;-)

We took two years for this preparation. With the result that our customers are able to jump on the train at a time when it is already picking up speed: The time-consuming pre-selection is no longer necessary and together we work out the respective individual requirements and scan the software that fits them. These are the first, but essential steps towards successful digitization.

Our ultimate tip: Invest sufficient time and energy in identifying your requirements. Because this is where you lay the foundation for your future project. It's a lot of work, but once you can do it - and it's worth it, we promise!

And one more piece of advice from us: Also take a look at whether the software manufacturer is interested in you as a target group in the long term. A cooperation can be very time-consuming and therefore expensive if you are just "side-catch" and the software is actually designed for a different target market. In this case, assume that you will have to make a lot of adjustments.

We are continuously expanding our software offering: For example, we now also have a selection of PMS software for database searching, literature searching and editing, surveys, PMPF and PMCF. Next additions will be risk management and QM software. So the DigiLab is always looking for software solutions!

The easiest way to get together is to:

1. Contact us; we look forward to getting to know you and your software solution!
2. We provide you with software requirements based on the functionality of your software. You present the software based on the requirements we have provided you with and make a test version available to Metecon. This version can later be used for customer presentations.
3. We test your software according to conformity, usability, flexibility for adaptation to individual processes, authorization concept, willingness and ability to cooperate as well as cyber security.

If your software is convincing, then we warmly welcome you to the DigiLab!