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Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA Manufacturing

FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot

US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.

Quality Control FDA Manufacturing

AdvaMed's Top Hill Strategist JC Scott Departs; Greg Crist Will Fill Role

Greg Crist, the top public affairs executive at AdvaMed, is stepping in to head the trade group's government affairs operations, as JC Scott departs to lead the Pharmaceutical Care Management Association.

Appointments Policy Medical Device

'The Sky's The Limit' When It Comes To Device Reimbursement Reforms, White House Official Says

The top health official at the White House Office of Management and Budget says the Trump administration is committed to clearing barriers that stand in the way of reimbursement for new medical technology. “We’re doing a lot of work on medical device stuff that nobody knows about, trying to figure out how America can maintain our dominance," Joe Grogan said Sept. 20.

Reimbursement Market Access Policy

Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies

The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?

Europe Policy & Regulation Policy

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Getting The Words Right: Device Documentation And Translation in Asia

Oracle Health Sciences

Although the medical device sector has seen increasing harmonization of regulations both globally and regionally, market-entry requirements in Asia still retain a significant degree of localization, particularly as they relate to product labeling and documentation.

Download the article to learn more about the challenges and potential rewards of device documentation and translation in Asia.

The article reviews:

  • New regulatory reforms and their impact
  • The role and limitations of localizing software
  • Opportunities to translate for growth

Read Article

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Policy & Regulation Explore this Topic

Set Alert for Policy

French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

Medtech notified body TÜV Rheinland has been recognized as a victim of large-scale fraud in a final-instance ruling in the French criminal case that has led to the conviction and sentencing of the executives at the center of the EU PIP breast implant scandal.

Legal Issues Europe Safety

Payment 'Sunshine' Requirements Would Expand For Industry Under Senate-Passed Opioid Bill

A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.

Legislation Regulation United States

QUOTED. Sept. 21, 2018. Paula Cofer.

A patient advocacy group recently met with US FDA officials to ask for new safety measures, if not a total ban, around LASIK eye surgery. See what the group's coleader, Paula Cofer, said about the dangers of LASIK here.

Quoted Safety

FDA Finalizes Guidance On Products Containing Heparin

US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.

Medical Device Surgical Procedures

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Clinical Trials Compliance

FDA Disputes Study On Breast Implant Safety

US FDA has taken the rare step of publicly disputing a study that seemed to show elevated risks of long-term adverse events associated with silicone breast implants.

Safety Medical Device

House-Passed Tax Bill Would Support Medtech Innovation, Lobbyists Say

The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.

Legislation Policy

Warning Letter Roundup & Recap – Sept. 18, 2018

The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

FDA Enforcement

Zimmer Warning Letter Confirms Ongoing Issues With CAPA, Process Validation

US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.

Compliance Enforcement

TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties  and it looks like SMEs will be hardest hit.

Clinical Trials Regulation

Commercial Explore this Topic

Set Alert for Commercial

Market Intel: Robotic Pills And The Future Of Painless Drug Delivery

Robotic pill technology, which is already being used for diagnostic purposes, will likely be embraced for the oral delivery of biologic drugs as well. Biologic therapies currently require injections in most cases, but some are exploring specialized robotic pills as a pain-free approach that could increase convenience and compliance, and thus efficacy, of medicines. Several established companies and research centers are working on both diagnostic and biologic therapeutic applications of pill-based technologies.

Gastrointestinal Diagnostics Commercial

QUOTED. Sept. 20, 2018. Benita Pearson.

A lawsuit over negative pressure wound-therapy devices ended in a win for plaintiff KCI Medical Services after an Ohio federal judge ordered Healthcare Essentials Inc. to pay $645m for alleged theft. See what Judge Benita Pearson wrote about the case here.

Quoted Legal Issues

Execs On The Move: Change At Codiak Biosciences, And On Qualigen, Sectra AB Boards

A new executive VP and head of research and development is joining the management team at Codiak Biosciences. In addition, new directors joined at Qualigen and Sectra AB.

Appointments Commercial

KCI Awarded $645M In Stolen Device Case

An Ohio federal judge recently awarded $645m to Acelity subsidiary KCI Inc. The company sued Healthcare Essentials Inc. for allegedly stealing wound-therapy units for resale.

Legal Issues Commercial

QUOTED. Sept. 19, 2018. Martha Murray.

An anterior cruciate ligament (ACL) repair technology developed by MIACH Orthopedics has secured backing from investors, including the union for National Football League players, in a new round of financing. See what MIACH founder Martha Murray said about it here.

Quoted Financing

MIACH Orthopedics Score NFLPA Investment For ACL Repair Tech

MIACH Orthopedics, has secured $22.5m from investors including the NFL Players Association to continue US clinical trials for its Bridge-Enhanced ACL Repair (BEAR) technology.

Financing Orthopedics

Israeli Robotics System Steers Closer To European Market

XACT Robotics has secured a CE mark for its XACT image-guided robotic needle steering system for CT-guided percutaneous procedures in the abdomen. The company is hoping to formally launch XACT by 2019 while expanding the system to additional clinical indications, including spine, and lung procedures.

Approvals Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Sept. 10-16, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 10 through Sept. 16, including trial announcements from Medtronic, NovoCure, Gore, LivaNova, and BioSig.

Starts & Stops Tracking Trials Cardiovascular

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Clinical Trials Compliance

Results Recap: Sept. 7-13, 2018

Results Recap is a new regular feature in Medtech Insight providing a summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition includes trial announcements from NeuroMetrix, Vertos, LivaNova, and Boston Scientific.

Tracking Trials Clinical Trials

NICE Endorses Sutureless Aortic Valves While LivaNova Reaches Study Milestone

A new guidance from the UK's National Institute for Health and Care Excellence (NICE) concludes that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The NICE guidance came as LivaNova announced completed enrollment in the 900-patient, randomized PERSIST-AVR trial of its Perceval sutureless aortic valv.

Clinical Trials Companies

QUOTED. Sept. 13, 2018. Deb Houry.

The US Centers for Disease Control and Prevention's new clinical recommendations for health-care providers treating children with concussions or mild traumatic brain injury (mTBI) advise physicians against using advanced imaging for diagnosis. See what the CDC's Deb Houry said about the guidelines here.

Quoted Research & Development

Turkey’s Top Defense Company Sets Sights On Medical Technology

Aselsan, Turkey's leading defense company, is increasing its focus on medical technology to support localization of medical devices. The company has started projects to develop and produce mobile X-ray and MRI systems, as well as defibrillators.

Turkey Diagnostic Imaging

US Agency Advises Against Use Of Advanced Imaging To Diagnose Kids’ Mild Traumatic Brain Injury

The US Centers for Disease Control and Prevention (CDC) has issued a guidance on diagnosing and treating pediatric mild traumatic brain injury, that advises health care providers to avoid use of computed tomography, MRI, single photo-emission CTs, and skull radiographs in diagnosing kids 18 years and younger.

Diagnostic Imaging Neurology
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