Some challenges that In Vitro Diagnostic products face and how to deal with them. A Guideline for sourcing and purchasing of biologic raw materials.

1. In Vitro
Diagnostics
on the
AdvEntUre
Market
Maria Seriakov
Founder / Managing Director
M bioserviceS GmbH

2. manufactures equipment and Reagents in order to provide
THE IVD INDUSTRY
CONSTANT and RELIABLE test results…
In Vitro Diagnostics on the AdvEntUre Market

3. In Vitro Diagnostics on the AdvEntUre Market
…in a continuously changing
Market environment :
• Raw materials are subject to Availability
and Price Fluctuations
• Legislation Changes in the EU and
worldwide create hurdles and roadblocks

4. IVD expenditure is less than 1% of the European Healthcare
spending …. but 60 – 70% of all medical decisions
are influenced by IVD test results
THE IMPORTANCE
OF IVD PRODUCTS
In Vitro Diagnostics on the AdvEntUre Market

5. Thousands of IVD reagents contain biologic components:
• because of their specific function
• some coming from one single source only
• used from several tons to a few grams per year
• may cost more than gold
Changing components or source may change
diagnostic results and performance!
THE IMPORTANCE OF BIOLOGIC
COMPONENTS
In Vitro Diagnostics on the AdvEntUre Market

6. In Vitro Diagnostics on the AdvEntUre Market
Adventure #1: WHY
are there Shortages and Price Fluctuations of raw
materials like Fetal Bovine Serum, Hemin, Human Serum
Albumin, Fetuin?
- They are by-products of other industries
- Their production can be discontinued
- Nature has an influence
- Political and economic changes
impact production
WHAT can we do?

7. In Vitro Diagnostics on the AdvEntUre Market
Adventure #2: WHO
is the Real manufacturer of my raw materials?
- Many biologic raw materials have only very few
manufacturers worldwide
- Most suppliers claim they are a manufacturer –
are they?
- Historical purchasing data add to the confusion
- There is lack of control and transparency
HOW do we know?

8. In Vitro Diagnostics on the AdvEntUre Market
Adventure #3: WHEN
Legislation Changes are passed without consulting the
industry:
 Sourcing countries or markets become
inaccessible
 Changes of customs duties and taxes impact end
user prices
WHAT to do when it happens?
HOW prepare or prevent?

9. In Vitro Diagnostics on the AdvEntUre Market
Seven Ways to a Happy End
1. Audit suppliers frequently and personally
2. Check and update old sourcing database
3. Caution when your supplier gets acquired
4. Get contractual supply guarantees
5. Rely on a Second Supplier policy – not on a Just-in-
Time inventory
6. Involve Industry Associations
7. Consult an Expert
and don‘t forget…

10. In Vitro Diagnostics on the AdvEntUre Market
“Every challenge is a chance
to become a champion.”
Ifeanyi Enoch Onuoha

11. 20 years of experience in the field
of Biotechnology
Past positions:
Global Regulatory Affairs Manager
at GE Healthcare
Global Sera Business Director
at PAA Laboratories GmbH
Procurement, Import und
Material Management
at PAA Laboratories GmbH
Member of BOD at the
International Serum Industry
Association (ISIA)
Member of the Animal
By-Products Task Force Group
at the European Diagnostics
Manufacturers Association (EDMA)
www.mbioservices.com
The author: Maria Seriakov
Founder / Managing Director of M bioserviceS GmbH