Clinical Development

A rigorous process of drug/device testing, characterization and regulatory review spanning from research concept to commercial introduction.

Traditional sequential steps in clinical development are:

  • Discovery Research
  • Preclinical studies
  • Investigational New Drug (NDA) or Investigational Device Exemption (IDE) approval
  • Rigorous clinical research with checkpoints in three distinct phases
  • Assembly and submission of a New Drug Application (NDA) or Pre-Market Approval (PMA) application for devices
  • Regulatory review and approval decision
  • Commercial launch and post-launch clinical monitoring

Clinical development for drugs and biologics is lengthy (frequently as long as 10 years). The development timeframe for devices (including software) is still rigorous but frequently much shorter, particularly if the need is simply to prove that the device is “substantially equivalent” to one that has been previously vetted. The development of “combination” drug/device products is complex due as it must address both drug and device requirements.


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