avoca presentation to medical devices conferences

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Trends in Medical Device Clinical Outsourcing: Where are we now as an industry and what does the future hold? Partnerships in Medical Device Trials

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Trends in Medical Device Clinical Outsourcing: Where are we now as an industry and what does the future hold?

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Page 1: Avoca Presentation to Medical Devices Conferences

Trends in Medical Device Clinical Outsourcing:

Where are we now as an

industry and what does the future hold?

Partnerships in Medical Device Trials

Page 2: Avoca Presentation to Medical Devices Conferences

2

Survey Respondent Base

Sponsor: What type of products does your company develop?

Sponsor: In what FDA Class is/are the primary medical device(s) that your company develops?

53

25

7

Therapeutic Medical Devices

Diagnostic Medical Devices

Other

16

46

30

3

Class I

Class II

Class III

N/A

37%

16%

30%

17% Large (>$1.5B)

Mid-sized ($100M-$1.5B)

Small, revenue-generating company ($1-$99M)

Pre-revenue company

Sponsor: How would you characterize your company based on its revenue?

N=70

16%

31%

28%

19%

6% Top 5 CRO

Mid-sized CRO

Small/specialty CRO

Independent contractor

Other

N=32

CRO: How would you describe your company?

Page 3: Avoca Presentation to Medical Devices Conferences

3

Why Outsource?

Q: Sponsor: What is/are the key reason(s) that you outsource clinical research?

39

18

9

6

5

5

4

2

Management of resource capacity gaps

Access to operational expertise/experience

Access to regulatory expertise/experience

Access to scientific expertise/experience

Accelerated time to market

Reduced cost overall

Better cost predictability

Better access to investigators

Page 4: Avoca Presentation to Medical Devices Conferences

4

Which Services?

Q: Sponsor: When you outsource clinical services, which of the following services do you prefer to outsource?

34

33

26

24

15

14

13

8

6

4

4

Clinical Monitoring

Data Management

Biostatistical Analysis

Clinical Trial Management

Safety

Medical Writing

Regulatory Approvals/Activities

Investigator Recruitment

Quality Assurance

Preclinical Development

Protocol Design

Page 5: Avoca Presentation to Medical Devices Conferences

5

What Drives Vendor Selection?

91%

72%

70%

56%

53%

44%

33%

28%

28%

28%

28%

23%

23%

9%

91%

69%

53%

88%

38%

56%

38%

44%

47%

50%

19%

59%

41%

9%

Medical device experience/expertise

Cost-effectiveness

Effective communication

Therapeutic area experience/expertise

Specific staff assigned to project

Geographic reach

Existing relationship with the company

Regulatory expertise

Hands-on attention from a single point of contact

Accurate response to RFP

Partnering/preferred provider benefits

Personalized attention

Operational excellence/innovation

Size of the company Sponsor (N=43) CRO (N=32)

Q: Sponsor: What are the most important attributes you look for in a clinical service provider?

Q: CRO: What do you think are the most important attributes that medical device companies look for when looking for a provider of outsourced clinical research services?

Page 6: Avoca Presentation to Medical Devices Conferences

6

How are CROs Performing?

Q: Have there been significant gaps in terms of services or expertise…

Sponsors: …that you have been able to obtain from clinical service providers in the past 2 years? – 57% said yes

CROs:

…that CROs have been able to provide medical device companies in the past 2 years? – 50% said yes

Page 7: Avoca Presentation to Medical Devices Conferences

7

How are CROs Performing?

Mean Ratings Sponsor CRO Difference

I am satisfied with the overall service… …received from the CROs my company is using on our medical device trials. …my company provides to support clinical trials for medical device and diagnostic companies.

3.3 4.2 -0.9

CROs currently have the requisite regulatory knowledge to successfully design and execute medical device trials.

3.3 3.8 -0.5

CROs currently have the requisite clinical knowledge and capabilities to successfully execute medical device trials.

3.4 3.9 -0.5

There is a significant opportunity for select CROs to differentiate based on their ability to successfully conduct medical device trials.

4.2 4.4 -0.2

N range= 50-65 30-32

Page 8: Avoca Presentation to Medical Devices Conferences

8

Break-Out: How are CROs Performing?

Mean Ratings Sponsor:

Large/ Mid-sized

Sponsor: Small/

Pre-revenue CRO

I am satisfied with the overall service… …received from the CROs my company is using on our medical device trials. …my company provides to support clinical trials for medical device and diagnostic companies.

3.1 3.9 4.2

CROs currently have the requisite regulatory knowledge to successfully design and execute medical device trials.

3.1 3.5 3.8

CROs currently have the requisite clinical knowledge and capabilities to successfully execute medical device trials.

3.2 3.6 3.9

There is a significant opportunity for select CROs to differentiate based on their ability to successfully conduct medical device trials.

4.2 4.4 4.4

N range= 31-35 17-31 30-32

Page 9: Avoca Presentation to Medical Devices Conferences

9

How are Sponsors Performing?

Mean Ratings Sponsor CRO Difference

Specifying the tasks to be performed and all relevant assumptions in RFPs sent to CROs 3.1 2.5 0.6

Specifying realistic project timelines in RFPs sent to CROs 3.0 2.4 0.5

Managing outsourcing relationships overall 3.1 2.6 0.5

Efficient use of internal resources in the management of outsourced studies 3.0 2.5 0.5

Establishing appropriate contracts with CROs 3.1 2.7 0.4

Managing CRO relationships 3.1 2.7 0.4

Managing CRO performance 3.0 2.6 0.3

Identifying the CROs to which RFPs should be sent 2.9 2.7 0.2

Managing CRO costs 2.8 2.8 0.0 N range= 41-43 26-32

Q: How strong do you feel that your company's capabilities / medical device companies are in each of the following areas?

Page 10: Avoca Presentation to Medical Devices Conferences

Future Trends

Page 11: Avoca Presentation to Medical Devices Conferences

11

What percentage of your company's outsourced spend is currently directed toward each of the

following type of outsourcing relationships? Average Values

What percentage of your company's outsourced spend currently falls under each of the following types of outsourcing models? Average Values

53%

20%

13%

4%

Project-by-project outsourcing

Preferred providers

Strategic alliances/partnerships

Other

67%

24%

4%

Functional Service Providers

Full Service Providers

Other

Current Trends in Outsourcing

When you outsource clinical research services, what types of service providers do you prefer?

4

21

30

22

2

Top 5 CROs

Mid-sized CROs

Small/specialty CROs

Independent contractor

Other

Page 12: Avoca Presentation to Medical Devices Conferences

12

32%

13% 7% 13%

35%

1% - 25%

26% - 50%

51% - 75%

76% - 100%

Didn't outsource

68%

11%

21% Yes, an increase

Yes, a decrease

No

In 2013, approximately what percentage of your company’s total spending on clinical research was

outsourced to a clinical services provider?

Do you anticipate a change in your amount of clinical outsourcing in the next three years?

3% 21%

21% 55%

1% - 3%

4% - 6%

7% - 10%

More than 10%

By what percentage do you anticipate an increase in your amount of clinical outsourcing

in the next three years?

N=34

Medical Device Companies Predict Future Trends

N=60

N=56

Page 13: Avoca Presentation to Medical Devices Conferences

Thank you [email protected]

Contact Avoca at: (609) 252-9020

www.theavocagroup.com

[email protected]