Medical Device Development

Your medical device CRO partner

For medical devices, good engineering does not necessarily guarantee clinical or commercial success. At times, regulators and device manufacturers seem to be on opposing sides of the playing field. Regulators often contend with pressure to fast-track approvals while at the same time ensuring product safety and efficacy. On the other hand, manufacturers risk spending time and resources to develop a device, only to not receive approval to go to market. This is further complicated when a device also has a drug component attached (e.g., drug eluding stents) which can lead to a debate about the reviewing agency responsible within the agency. The Combination Products division, which was created in the past few years, has helped with this, but it remains a challenge layered upon what has always been a historically challenging development pathway.

Executing a successful market entry strategy involves navigating the complex regulatory approval process, designing and conducting efficient clinical trials, and adeptly evaluating the existing marketplace.

Whether it is augmenting internal staff with a functional outsourcing approach, or managing your entire medical device development program from beginning to end, we can do it, and do it more efficiently.

  • Clinical events committee management
  • Regulatory and strategic consultancy
  • Regulatory submissions and filings
  • Biostatistics
  • Clinical monitoring
  • Data management
  • Device accountability
  • Project management
  • Site selection and management
  • TEMPO™ eClinical platform
  • Global study feasibility
  • Patient recruitment
  • Safety surveillance

Clinipace medical device experts provide the following advisory and operational services:

  • Be design-intelligent
  • Protocol considerations
  • Use of technology
  • Run a transparent, efficient study
  • Establishing clinical efficacy
  • Premarket Notification 510(k) and Premarket Approval
  • Investigational device exemption
  • Importance of seeking feedback
  • Navigating regulatory pathways
  • Running an efficient development program

Looking for Medical Device Development Help?

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