Key Issues in Clinical Development for Interventional CV Devices | Page 7

Key Issue #5: Operational Considerations »

> Predict potential road blocks and how to avoid them;

One of the most challenging operational aspects of medical device trials

> Offer insights on protocol development based on previous

is the timelines. Device studies start faster, end sooner, and usually have

interactions with relevant regulatory authorities;

a steeper learning curve than drug trials. Product/technology cycles for

> Make recommendations for investigators;

devices are typically short,3 so any delays in approval may render

> Provide “on-the-ground” personnel who speak the local

a device obsolete in a particular market.

language, understand the customs, and know the ins and
outs of obtaining regulatory and ethical approval for trials.

Sponsors can mitigate these pressures, at least in part, by:
• Designing straightforward protocols with very specifically

Summary »

delineated requirements for patient inclusion/exclusion,

CV devices are a $50 billion industry characterized by fast cycle

data collection, and AE reporting;

times and significant competition. While regulatory standards are

• Including health outcomes endpoints and economic data early

evolving, under current processes interventional CV devices are

in the development processes to ensure that enough data are

usually approved in the EU in less time and with less clinical data

available for payers to make reimbursement decisions when the

than is needed in the US. However, even in the US, approval

device is approved for sale;

processes – and, thus, clinical development needs – are quite

• Streamlining case report forms, whether paper-based or

different for devices and pharmaceuticals.

electronic, to avoid repetition and unnecessary information;
• Choosing sites early and planning for any necessary import/

Successful device development programs require a myriad of

export permits or material transfer agreements for the device

expertise in protocol design, site management, and the regulatory

and clinical samples;

requirements of each country in which a trial will be conducted or

the device registered. Sponsors without these skills in-house may

• Partnering with a clinical research organization (CRO) with

proven expertise in medical device trials in the countries of

find it beneficial to partner with an experienced CRO who can

interest who can:

provide the knowledge needed to bring a device to market.

Much of the recent criticism of the US medical device approval process centers on the 510(k) applications, which
usually do not require clinical data.12 In an investigation of the 35 CV devices recalled by the FDA from 2005 to 2009
for posing a significant risk to patient health, 23 (66%) of the devices (including 13 Class III devices) had been cleared
via a 510(k).13 The assumption is that many of these recalls could have been prevented if the device was subject to
the more stringent PMA process, and stakeholders have begun to question, “At what point does a modification
of a device warrant an entirely new approval process? And who should make that decision?” 12

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