Skip to : [Content] [Navigation]
 

MX

 
 
Email article link Print article

Originally Published MX September/October 2006

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Differing Needs

Multiple departments within a device manufacturing firm can reap the benefit of data produced during clinical studies. Reasons to perform clinical studies include the following.

  • Regulatory: To gather safety and efficacy data to obtain clearance or approval to market a
         device via a PMA application or 510(k) notification with clinical data.
  • Commercial: To engage key opinion leaders, seed the market, produce publications, effect
         label changes, support pricing and reimbursement, expand claims, and keep the
         competition at bay.
  • Corporate: To achieve milestones for fundraising and feed the positive news pipeline.
  • Manufacturing: To ensure the initial design and subsequent design iterations support the
         utility of the device in clinical use.

    Copyright ©2006 MX
    •