Forum MedTech Pharma e.V.
Dr. Jörg Traub
Market Access Pathways
Nov 14, 22 – GTAI @MEDICA

Medical Technology in Bavaria – Best Practice from our Cluster

Bildquelle: Fotolia©gpointstudio_Montage + Aktormed

AKTORMED GMBH : SOLOASSIST - How can we provide the surgeon a 3rd arm?

Forschung & Entwicklung

Technology Management &Innovation Management

technology andmarket screening

innovation
workshops

Research & Development

transfer &technology boards

cooperation
partnerfinancing aidand funding

Technology Marketing &Innovation Marketing

partnerbooths at exhibitions

studies &publications

innovationcongress

Forum MedTech Pharma e.V, Innovation Think Tank in Partnership with Bayern Innovativ

Membership structure of the Forum Medtech Pharma e.V. association
Member locations in Germany
OthersMedical technologies

Patent and lawyer

Number ofmembers in theregion:

Associations

Clinics and doctors

Research institutes

Service provider
Companies

Venture Capital
Sales / Trade
Suppliers

Pharmaceuticals andBiotechnology

IT
Consultant

Further countries
Austria, Belgium, Croatia, Denmark, Greece, India, Japan,Netherlands, Slovenia, Switzerland, United Kingdom, USA

Our team of health & care innovation experts

Dr. Jörg Traub
Managing Director

Raphaela Wallner
Innovation in CareDr. Frank Miermeister
Regulation & Medical Device

Stefanie Brauer
Supplier & Sustainability

Julia Ott
Advanced Therapy & Start-Up

Christine Twete-Dietrich
Member & Office Management

Jürgen Frickinger
Medical Electronics & IT

Jennifer Meschnig
Marketing & Events

Sandra Karakaya
Press & Public Relations

Lena KastnerTechnology & FundingInterested to shape the healthy future together? Your access paths!
Join as a member (registration form)

Shape with us the future (contact to the team)
Networking (our members)Experience innovation (our events)
Realize innovation (news from our network)

Part A
Market Analysis

New to EU? Why you should start in Bavaria?

2h1h12h24h15h30hHealth Care Economy Fact Sheet Bavaria – data from 2018
Health Care

Healthcare Industry

gross valueof overall
economyaverage annual growth
2009-2018

employment

Further Careof overall
economyaverage annual growth
2009-2018

Source: BMWi; GGR, issue 2019; calculations and representation by WifOR;
Details and Report (German only): https://www.bayern-innovativ.de/seite/wie-stark-ist-die-gesundheitswirtschaft-in-Medical Technology in Bavaria – B2B• More than 3% of the world's medical technology products areproduced in Bavaria.
• ~ 1,000 companies are active as manufacturers, suppliers andservice providers for medical technology.
• The export of medical technology products accounts for a highproportion of total sales. Yet the most important target regions
are the EU countries, the USA and China.
• Bavarian medical technology companies are very satisfied with
their location. This is mostly in the area of metropolises withhigh-tech environments (Munich, Nuremberg/Erlangen).

• Advancing digitization and networking are considered
important technological trends.
• The future development of the Bavarian medical technology
industry is considered to be very positive.
Source: Branchenstruktur Medizintechniik in Bayern
https://www.cluster-medizintechnik.de/de/home.aspx

Patient Care Infrastructure in Bavaria – B2C~400
approved acute care
hospitals~11.000~58.000

dentists

physicians~62~285

excellent spas and health resorts

preventive or rehabilitation facilities

Part B
Market Access Pathways

Our Networks to support Health-Tech in Bavaria

Forum Medtech Pharma e.V. Members from University / ScienceMDR / IVDR – partners from our network• experts in strategy and consulting services• test labs and/or specialists on norms• Be on Quality• SGS• Metecon• Eurofins Product Testing• en.co.tec• TÜV Hessen• MedIdee• M3i• Seleon• IT – Testing• Requalite• HWI group• entity that can take over the legal
manufacturing role
• CEYOO• experts on clinical trials / cinicalassessment• Climedo• Novineon• Notified Bodies• MEDICRO• DQS• NAMSA• TÜV SÜD Product Services• MedSURV• Trials24

Reimbursement Pathways
in Germany

NoYesReimburseme
nt with new
EBM-CodeNoNo
Reimburseme
nt

Process according§135 SGB V
successful
Out –patient Trial
initiated byManufacturer

CEMarkYes

Options for
Manufacturer* from book chapter Traub:„HealthTec Networks and Clusters(Global) – Innovation Clusters inMedtech In Europe” in Friebe“Purpose Oriented Health InnovationDesign”,
NOV 2022

In-patient
SectorOut –patient Trial
initiated by
Manufacturer

Yes

Reimbursementwith new EBMCodeYes

Yes

In-Patient

New
MedicalDevice

Out-patientSector

Out-Patient

No Market Access toEU (Optional forResearch only)

Reimbursementwith existing
EBM-Code

Successfulprogess accordingto §137e SGB V?

benefit

BenefitAnalysis §137hSGB VYes

no benefit

NUB initiated byhospital

Process according§137c SGB V
successful
Reimbursementwith existing
DRG

Yes

No

Reimburseme
nt with newDRG
No
Reimburseme
ntNo

Reimbursementwith new DRG

No
Reimburseme
nt

NoNUB
submission
successful

Yes

Reimbursementwith NUB andpotential transfer toDRG

Reimbursement Pathways
1.

Define your reimbursement strategy• Do we need new reimbursement codes or can we use existing ones
• Are we addressing the stationary or ambulatory segment• What is the best location and network

2. Understand your reimbursement requirement and associated investment• Do we understand the user, payer and buyer• Do we have the right partners• Do we have an investment plan
• Are all shareholders (SME) or management (corporate) aligned

3. Work with experts in the field i.e. partners, coaches and/or consultants• Creating files e.g. for G-BA
• Have a sound portfolio for insurance companies (103 stationary with ~73 mio members + ~50 private with < 10 miomembers)• Find the entry door and direct accessPart C
Market EntryExcellent Clinical Research & Medical Education in Bavaria
Würzburg
Klinikum der Julius-MaximiliansUniversität Würzburg(Universitätsklinikum Würzburg)

Regensburg
Klinikum der Universität Regensburg(Universitätsklinikum Regensburg)

Erlangen
Klinikum der Friedrich-AlexanderUniversität Erlangen-Nürnberg(Universitätsklinikum Erlangen)

Munich•Klinikum der Ludwig-MaximiliansUniversität München (Klinikum derUniversität München)•Klinikum rechts der Isar derTechnischen Universität München

Augsburg
Klinikum der Universität Augsburg(Universitätsklinikum Augsburg)Source: https://www.stmwk.bayern.de/wissenschaftler/forschung/gesundheit.html

Start with a Key Opinion Leader…
… selection from our network

Prof. Dr. Dirk Willhelm & Daniel Oster
Klinikum rechts der Isar & MITI InstituteVisceral Surgeon / General Surgery

Prof. Dr. Jürgen Schüttler
FAU Klinikum Erlangen
Internal Medicine& Clinical Director
Medical Valley
Prof. Dr. Philipp Patrottka
Klinikum rechts der Isar,
MunichProf. Dr. Wolfgang BöckerLMU Klinikum Munich
Trauma & Orthopedic Surgeon& Chairman Cluster Medtech Bavaria

Forum Medtech Pharma e.V. Members from Medical Facilities

Find your way for best model for distribution
model

advantage

disadvantage

direct sales

direct feedback, highest control,
highest margin

expensive and partly not possible from a
regulatory point of view

local branch/subsidiarydirect control, partial disclaimer,
positive image of the company

very expensive and complex, very highupfront costs and high risk

agentsinexpensive, no obligations and usually no control, agent commission due after
no exclusivity, no fixed costs, goodproject completion, liability risk remains,market knowledge and regionallots of support from application
network
specialists, high costs for market
introduction

distributors/resellers

no fixed costs, long-term exclusivecommitment, partial disclaimer,
existing network, and regional market
knowledge

no control, high distributors margin on
project realization, A lot of support fromapplication specialists* from book chapter Traub:„Global Health markets and their different needs” from Friebe “Purpose Oriented Health Innovation Design”, NOV 2022

Find a Distribution fit …
… with complementary interest!

Find the needle in the haystack!

„If I’m selling to you,
I speak your language.
If I’m buying,dann müssen Sie Deutsch sprechen!“Willy Brand – German Chancellor 1969-1974

Dr. Jörg Traub
traub@medtechpharma.de24