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Latest From Omnyx LLC
From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish
Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warning that things "can easily become out of control. You need to find a good ringmaster." Yet a back room isn't the only place manufacturers should be careful about using the right people. Present in the front room – where investigators traditionally work when onsite at a firm – should be helpful, reliable facilitators that aid investigators with requests and answer an array of questions.
Noteworthy news from medtech start-ups. This month we profile Ibris, which is developing prognostics to identify breast cancer patients in need of chemotherapy, and Delphinus Medical Technologies, whose platform enables 3-D full breast ultrasound.
Patients with aggressive estrogen receptor-positive breast cancer need chemotherapy in addition to treatment with anti-estrogen therapies. The question for physicians: how to determine how aggressive a cancer is going to be? Ibris Inc. is working to provide that information with a rapid, predictive, prognostic test that can identify ER-positive breast cancer patients requiring chemotherapy.
GE is buying Clarient, which provides molecular cancer tests. It intends to make Clarient the cornerstone around which it builds out a molecular in vitro diagnostics business, combining Clarient with its own diagnostic imaging expertise to give it a full suite of triage and cancer diagnostic capabilities. In some ways, it could solve GE's long-standing issue of how to innovate in healthcare and move into high-value businesses without taking on the risks and timelines of pharma-style R&D.
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