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

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

2. 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?

3. 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

4. 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

5. 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?

6. 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

7. 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

8. 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

9. 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?

10. Future Trends

11. 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

12. 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

13. Thank you
Lisa.McKay@theavocagroup.com
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com