1. Muhammad Fauzi Wibisono Leonard Ochieng Xueyun Zhou Lorenzo Valeriani
Vincintori
Muhammad Fauzi Wibisono
Leonard Ochieng
Xueyun Zhou
Lorenzo Valeriani

2. Fitness Genes
What are they doing?
What is the problem?

3. The current market Internet-Based Direct-to- Consumer Genetic Testing
Business to business model
Small/medium fitness operators:
Personal Trainers
Gyms
Wellness and insurance corporations

4. Legal Perspective of B2C
Legal issues on DTC generic testing
Advertising restriction
The new EU's IVD (In-Vitro Diagnostics) Regulation
Ban on DTC advertising
Its effects on marketing strategy
Option

5. Legal framework issues under discussion
Current legal framework governing the use of DTC genetic testing within UK , EU and USA
The proposed legal framework governing DTC genetic testing within EU .
Its effects to the market strategy
The way forward

6. Legal framework governing the use of DTC genetic testing within UK
Legal framework governing the use of DTC genetic testing within UK.EU and USA
DTC genetic testing has become a popular business model used by companies who are looking for ways of expanding the market for genetic tests. This done by selling genetic testing to consumer directly via the internet.
However there are currently no general restrictions under UK and EU legislation on the marketing of CE marked IVDS directly to consumers.

7. Advertising restrictions
Companies marketing diagnostic screening tests should be very careful with advertising claims to ensure they comply with the applicable rules in the country where consumers will be targeted. For example, in USA, there is a legal framework in place following the decision by the US Federal Drug Administration (FDA) to crack down on misleading claims made for genetic tests in late another example of a country has put restrictions is Germany.
Even if the website advertising the DTC genetic test includes some form of disclaimer , a regulator is likely to regard the provision of the information directly to consumer as de facto provision of medical information and so will treat the testing kits as an IVD .

8. The new EU's IVD (In-Vitro Diagnostics) Regulation
If this new directive is adopted, it will require companies to provide clinical evidence to support the claims they make. This means that they will either have to employ a physician or partner with medical health service provider.

9. Ban on DTC advertising
The directive has propose a ban on the DTC advertising of devices for genetic testing. They are proposing that a device may only be used for the purpose of a genetic test if the indication is given by a person admitted to the medical profession after a personal consultation.
This is a material development and it would serve to seriously constrict markets access for the majority of genetic testing companies who currently offer some form of DTC services

10. Its effects on marketing strategy
This ban mirrors the strict requirement in the EU Pharmaceutical legislation.
If this proposal is carried into legal text then its implication is that companies would have to re- evaluate their commercial approach because they would no longer be able to legally target EU consumers by advertising and selling genetic screening directly to them.

11. The Problems (What? And Why?)
To B2B
Advantages :
Marketing: New partner that have bigger numbers of customer  Brand Awareness increased and minimize the gap from early adopters to the early majority consumer
Finance: Increase the Revenue Stream and Investors trust  Operation and Investment
Product and Service: A lot of data for research activities can be obtained  Improve the quality and accuracy of product and service
Disadvantages: (Involvement in product development, focus will be divided, high risk (marketing) and need more effort)

12. The Problems (Capability of Your Firm)
Finance: Limited
Marketing: Capable
Research and Development: Capable
Team or Human Resources: Limited
Legal Aspect: Limited

13. Solution
Health Insurance Companies

14. Solution
Fitness Organisations

15. Wellness Companies

16. Participants in the Technology Adoption Life Cycle
Revenue growth
Innovators,
Lead Users
Early Adopters, Visionaires
Early Majority, Pragmatists
Late Majority, Conservatives
Laggards, Skeptics LU EA EM LM La
Time

17. Conclusion
The Problems 1: Fitness Genes product and service has a big gap between early adopters and early majority in Technology Adoption Life Cycle
The Problems 2: Whether stay in B2C or try to expand to B2B model? What to prepare?
Solutions: Go expand to B2B model, but set up some preparation first  Because, B2B offer a lot of advantages to the development of your firm, but it come with high risk