FDA Breakthrough Devices Program: Getting technology into the hands of the user

The Medical Device Manufacturers Association estimates that it can take up to five years and more than $30 million to obtain FDA approval of a new device. The extended timeframe and high cost have limited patients’ and providers’ access to leading-edge technology.

In Q4 of 2017 the FDA published the plan for its Breakthrough Devices program, which expands on the FDA’s Expedited Access Pathway program. The goal is to make it easier for new technologies to be considered for review for 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), and De Novo applications.

Need to demonstrate superiority to existing devices

A key factor of this directive is the expansion of what are considered clinically meaningful advantages over existing alternatives. These include a reduction or elimination of the need for hospitalization, improvement in the patient’s quality of life, and facilitation of a patient’s ability to manage his or her own care.

According to the FDA to qualify to this program technologies must meet the following requirements:

  • The device delivers more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
  • The device represents breakthrough technologies
  • No approved or cleared alternative device is currently marketed in the U.S.
  • The device provides significant advantages versus currently available alternative products

Coming soon

The good news is that providers and patients will have access to a new stream of technologies in the coming year. Still, the challenge remains in determining how these leading-edge technologies will fit with their individual providers’ markets.

Here’s a sampling of what’s in the pipeline:

  • Aethlon Hemopurifier® – to treat life-threatening viruses.
  • Guardant360® – liquid biopsy
  • Second Sight Medical Products – Orion Cortical Visual Prosthesis System
  • MaxQ-AI (formerly, MedyMatch) – intracranial hemorrhage (ICH) detection application
  • AngioDynamics NanoKnife® System – surgical ablation of soft tissue
  • NeoTherma Oncology Vectron TTx – thermal device to treat pancreatic cancer
  • Polyganics – liver and pancreas sealant patch
  • IDx – detection of diabetic retinopathy
  • LimFlow – Percutaneous Deep Vein Arterialization (PDVA) system
  • N8 Medical – CeraShield™ Endotracheal Tube
  • 3i Diagnostics – Biospectrix (blood infection test)
  • Banyan Biomarkers – Brain Trauma Indicator for concussion diagnosis

James Laskaris, Senior Clinical Strategist

James Laskaris joined MD Buyline in 1994 with more than 30 years’ experience in the healthcare field.