Drug-device combination products associate a drug with a medical device, and hence bridge different regulatory frameworks (drug or device). Drug-device combinations can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged together – e.g. syrup with spoon – or products packaged separately but intended for use only with a specific counterpart – e.g. antitumor drug to be injected with a specific needle to target the tumor in the relevant organ, or insulin pumps designed only for specific insulin formulations.

Determining on which side of the drug/device borderline a product is falling is of strategic importance – whether it will be regulated as a drug or a medical device. Decisions made during the early stages of product development have major impacts on the path to marketing in terms of cost and time. Regulatory definitions and classifications vary across markets, which imply to mix different approaches and timelines in the design of global development plans.

Key challenges encompass:

  • Product positioning and regulatory strategy
  • Preclinical development, animal models and proof of principle study designs
  • Clinical development plan and study designs, including human factor studies
  • Risk and quality management
  • Biological and clinical evaluation, including literature analysis
  • Complex international registration pathways requiring expertise in both drugs and medical devices
  • Bridge device and drug vigilancesLife cycle and change management
  • Market access strategy and value demonstration to payers

VCLS Solutions

  • Advise on product qualification and classification as well as product registration path
  • Assist with claims positioning
  • Advise on combination product co-development plan
  • Prepare for/conduct international regulatory bodies Innovation Meetings (Notified Bodies, EMA, FDA)
  • Develop roadmaps towards international regulatory approvals (EU, US, Australasia, South America)
  • Assist with preclinical and clinical development plans
  • Interact with international regulatory bodies (Notified Bodies, EMA, FDA,)
  • Develop risk analysis and risk management plan
  • Submit international Clinical Trial Application
  • Build/support implementation Quality management system and Good Manufacturing Practices (GMPs)
  • Prepare product international regulatory dossiers (in Europe: CE mark Technical File; FDA: RfD (request for Designation), 510k, PMA; Canada; Australasia; South America)
  • Build/support implementation vigilance system
  • Assist with Post-marketing surveillance (PMS)
  • Advise on labeling and advertising