show phone number write email open contact form
Johner Institut – Member of GBA Group
Problem Outcome Method Process Pricing FAQ Book Now
AI Strategy Day for Medical Device Manufacturers

One day to an AI roadmapthat management and departments stand behind.

Together, you determine where your company stands today, where it should be in twelve months, and which decisions you need to make before they become expensive.

1 day on-site or 2 remote sessions · 3 to 10 people · from €9,800 plus VAT See pricing and services
A shared picture instead of individual opinions: five levels, from strategy to day-to-day operations Steps with a KPI, an owner and a deadline Reviewed by the red team before you spend money
ⓘPlease note: the AI Strategy Day is held in German only.
A consultant of the Johner Institute facilitates in front of a screen; participants sit at the meeting table with laptops. 1 day on-site or remote 3 to 10 people Roadmap by the next day
20+years of experience
1,000+companies advised
20,000+seminar participants
AI guidelineAuthor of the notified bodies’ guideline
The Problem

The tools are there. The plan is missing.

Many manufacturers now use AI. Very few know where it should lead and who decides.

The other side is gearing up. Notified bodies and authorities increasingly review with AI. If you deliver more slowly, you lose time with every submission.
The advantage is organisational. Everyone has access to the same models. The winner is whoever aligns their processes to them, not whoever buys the best tool.
Uncontrolled growth or standstill. Some people use AI without rules and without a goal. Others wait for a directive from the top that never comes.
Decisions are made silently. Document formats, data models, tools and contracts become fixed before anyone has consciously decided. Later, that is expensive to reverse.
Projects without a KPI. AI ends up where a task is tedious instead of where it moves one of your company’s KPIs.
The result? Every month without a shared plan locks in decisions that nobody consciously made.
Employee of the Johner Institute wearing a headset at her workstation in an open-plan office.
The Outcome

What You Take Home

You receive your roadmap in digital form no later than one day after the workshop.

01

Your Starting Point

A shared picture on five levels: strategy, organisation, QM & processes, technology & data, operations. Management and departments have agreed on it.

02

Your Target in Twelve Months

For each level: where do you want to be? Ambitious, but achievable.

03

Steps with a KPI

Every step with the KPI it moves, an owner and a deadline. That makes it possible to budget and track.

04

Your Decisions

What you need to decide before it gets expensive: AI policy, document format, make or buy, delivery formats in contracts. Each with a point in time.

05

Your 90-Day Plan

On the Monday after, everyone knows what they are doing.

06

A Reviewed Roadmap

The red team looks for the gaps before you invest: missing levels, transitions without a decision, steps without an owner.

07

Clear Ground Rules

What departments may initiate themselves and what they need management for. That ends uncontrolled growth and standstill at the same time.

08

A Team That Owns the Plan

Because it developed the roadmap itself instead of having it handed over.

The Method

Five Stages, Five Levels, One Plan

We have tested the method with manufacturers of different sizes and product types, most recently in the in-person finale of our AI Lab in October 2026.

1Experimenting2Piloting3Systematising4Integrating5AI-First
Strategy●○
Organisation●○
QM & Processes●○
Technology & Data●○
Operations●○

● today    ○ in twelve months · example of a fictitious manufacturer

Five Stages, Five Levels

From “experimenting” to “AI-First”, separated into strategy, organisation, QM & processes, technology & data, and operations. This shows you where your company is ahead and where it is stuck.

Decisions at the Right Time

Before piloting, before rolling out, before building your own solutions, and with every contract. Decide before volume, contracts or investments make a decision expensive to reverse.

KPI First

You choose initiatives by the KPI they move, such as lead time to submission or effort per review. Not by what is most annoying right now.

Red Team

Groups review each other’s results. Is a level missing? Is there a transition without a decision, a step without an owner?

Contracts: Data Instead of PDF

What you should require from development service providers, suppliers, test laboratories and AI vendors so that their deliveries arrive machine-readable.

The Personal Path

What each person can initiate themselves, even if nothing comes from the top.

The Process

Preparation, One Day, One Follow-Up

The work happens in the workshop. So that you work on your real case from the first minute, we prepare it with you.

1
Before

Preparation

✓Preliminary call (approx. 60 min, online) with your management: goals, products, participants
✓Short questionnaire on products, classes, current AI use, tools and service providers
✓Anonymous self-assessment by all participants. On the workshop day, you see where perceptions differ
✓We tailor the keynote to your products
2
The Day

Workshop

✓Keynote: what AI-First means for medical device manufacturers
✓Starting point and target on five levels
✓Steps, KPIs and decisions in groups
✓Red team and consolidation into the 90-day plan
✓Materials: A1 posters, templates, cards, handout
3
After

Follow-Up

✓Your roadmap in digital form no later than one day after the workshop, plus a photo record of the posters
✓Roadmap prompt you can use to develop the roadmap further with AI yourself
✓Follow-up session no later than 30 days after the workshop (60 min, online): review implementation, clarify open questions
A consultant of the Johner Institute facilitates at a flipchart while the group works along at the meeting table.
The On-Site Workshop Day
09:00Welcome: which decision do you want to take home today?
09:30Keynote: where is your AI strategy heading? What AI-First means, the path in five stages, the decisions along the way
10:45Break
11:00Starting point and target: compare self-assessments, define today and in twelve months
12:00Lunch
13:00Steps, KPIs and decisions, in groups per level
14:15Break
14:30Red team: the groups review each other
15:00Consolidation: 90-day plan, owners, management decisions
16:15Your personal next step, wrap-up
16:30End
Remote: Two Sessions Instead of One Day
Two sessions of about 3.5 hours each within one week
Session 1Keynote: what AI-First means, the path in five stages, the decisions along the way
Starting point and target: compare self-assessments, define today and in twelve months
In BetweenThe groups draft their steps, KPIs and decisions per level
Session 2Red team: the groups review each other
Consolidation: 90-day plan, owners, management decisions
✓Preparation, facilitation and follow-up are the same in both formats.
The Difference

Before and After

BeforeAfter the Strategy Day
✕Everyone has a different picture of where the company stands✓A shared starting point on five levels
✕AI initiatives emerge by chance✓Initiatives selected and prioritised by KPI
✕Decisions are made silently or not at all✓A list of decisions with deadlines
✕Departments wait for management or act without it✓Clear rules on who initiates what
✕Service providers deliver Word and PDF✓Requirements for structured deliveries in your contracts
✕“We should do something with AI.”✓A 90-day plan with names and dates
Is This for You?

Is the Strategy Day Right for You?

This Is for You If …
✓AI is already used in your company, but without a shared plan
✓you sense that competitors, notified bodies and authorities are getting faster
✓you want to decide instead of merely approving or blocking initiatives
✓you manufacture medical devices or IVDs: hardware, software, implants, active or non-active devices
✓you are a start-up and want to set up documentation and contracts to be AI-ready from the start
This Is Not for You If …
✕nobody in the room can decide on budget and implementation. A strategy without the people who decide remains a wish list
✕you are looking for training in using AI tools
✕you expect a finished concept from outside instead of working on it yourselves
ⓘPrerequisite: At least one person in the room decides on implementation, i.e. has budget and authority to give instructions. We recommend management.
For Start-Ups

AI-First from the First Document

Established manufacturers are rebuilding. You can build it right from the start. That is an advantage, but only if you make the important decisions now and not on the side.

✓Technical documentation as structured data from the start, not as a collection of Word files
✓Define delivery formats in the very first contracts with development service providers
✓Data model and ID convention before the first deliveries arrive
✓Tools that suit a small team
Your Facilitation Team

Consultants Who Know Your Products

You work with experienced consultants of the Johner Institute. After the preliminary call, we select the person who knows your product type and your starting situation best.

Pricing

Two Formats, One Goal: Your Roadmap

In both formats, you develop your roadmap with the same method. On-site, the travel expense allowance is added.

Recommended

On-Site

One day at your premises or in Konstanz
€10,300
incl. €500 travel expense allowance (at your premises and in Konstanz) · plus VAT
✓One workshop day, approx. 09:00 to 16:30
✓Preliminary call, questionnaire and anonymous self-assessment
✓3 to 10 participants from your company
✓Facilitation by an experienced consulting team
✓Your roadmap in digital form and the roadmap prompt
✓Follow-up session no later than 30 days after
✓A1 posters, templates, cards and handout in print
✓Photo record of the posters
Book On-Site →

Remote

Two online sessions
€9,800
plus VAT
✓Two sessions of approx. 3.5 hours each within one week
✓Preliminary call, questionnaire and anonymous self-assessment
✓3 to 10 participants from your company
✓Facilitation by an experienced consulting team
✓Your roadmap in digital form and the roadmap prompt
✓Follow-up session no later than 30 days after
✓Digital posters and templates
Book Remote →
ⓘThe AI Strategy Day is held in German only – this applies to the workshop and all materials, on-site and remote.

More than 10 participants or several sites? Get in touch.

For Your Internal Approval

Documents for Your Management

You are driving the topic, but someone else signs off? These documents help.

Decision Paper

One page for your management: goal, outcome, effort, cost

Service Description

What is included and what you contribute

Terms and Privacy Policy

Terms of contract and the Johner Institute’s privacy policy (in German)

Frequently Asked Questions

Questions and Answers

In which language is the Strategy Day held?›
In German only. The preliminary call, questionnaire, self-assessment, workshop and all materials are in German.
We don’t have an AI strategy yet. Isn’t this too early?›
No, this is the best time. The day starts with determining where you stand, and “experimenting” is one of the five stages. The earlier you set the direction, the less you have to rebuild later.
Our management doesn’t have a whole day. Can it be shorter?›
Remotely, we split the workshop into two sessions of about 3.5 hours each. Without anyone who decides on budget and implementation, however, the day makes no sense.
Do participants need prior knowledge of AI?›
No. More important than prior knowledge is that the right people are in the room: those who decide and those who know the work.
Who should attend?›
Management or another person with budget and authority to give instructions, plus typically regulatory affairs, quality management, development and IT. Depending on the situation, also production and purchasing.
Do you work with our documents?›
We don’t need any documents. We work with your starting situation from the preliminary call, questionnaire and self-assessment, and with your team’s knowledge.
What happens to our confidential information?›
What we learn in the preliminary call and the workshop stays within the project. On request, we sign a non-disclosure agreement in advance.
Is the roadmap relevant for audits or the notified body?›
The roadmap is a strategy document, not evidence. It does, however, show where you will need evidence, for example for software validation under ISO 13485, section 4.1.6, or for the AI literacy of your staff under Article 4 of the AI Act.
How does the Strategy Day differ from Zero to Hero?›
The Strategy Day is aimed at executives. They set the direction and make the decisions. Zero to Hero is aimed at the specialists who do the work.
Why does on-site cost more than remote?›
Preparation, facilitation and follow-up are the same. The difference of €500 is the travel expense allowance; it applies at your premises and in Konstanz.
We are more than 10 people. Is that possible?›
Get in touch. For larger groups, two of us facilitate.
What happens after booking?›
We get back to you within two working days, agree on the date and schedule the preliminary call. You then receive the questionnaire and the link to the self-assessment.
Can we postpone or cancel the date?›
Dates, postponements and cancellations are governed by our General Terms and Conditions (in German).
★ from €9,800 plus VAT · on-site or remote

One day. One plan. Yours.

The decisions you make now determine how fast you will be in two years. Make them together and consciously.

Book On-Site → Book Remote →

Any questions? Get in touch. · All prices plus VAT.

X

Privacy settings

We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.