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Policy & Regulation

Set Alert for Policy & Regulation

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

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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Regulation

Set Alert for Regulation

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

Latest From Regulation

First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised

There's been progress toward designating notified bodies against the EU's medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe's Oliver Bisazza says.

Europe Regulation

FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

Medical Device Regulation

IVDR Notified Body Pulls Applications As The EU System Struggles To Cope

European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?

Europe Regulation

FDA's Speedy Apple Watch De Novos Raise Questions For Industry

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

Digital Health Regulation

Can EU Regulations Be Changed To Allow For More Time? MedTech Europe Says 'Yes'

Huge numbers of products risk failing to comply the new EU regulations in time. Are efforts to extend deadlines legally and practically possible and will they be supported? MedTech Europe's Oliver Bisazza talks with Medtech Insight.

Europe Regulation

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
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Quality Control & Compliance

Set Alert for Quality Control

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

Latest From Quality Control

QUOTED. Sept. 25, 2018. Cisco Vicenty.

US FDA's Voluntary Medical Device Manufacturing and Product Quality Pilot Program has become so popular that both the agency and device-makers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members to assist in appraisals at device firms. See what FDA's Cisco Vicenty said about it here.

Quoted FDA

Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Device Week 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

Device Week, Aug. 22, 2018 – Quality System Regulation + ISO 13485 = ?

On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.

Device Week Regulation
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Policy

Set Alert for Policy

Latest From Policy

QUOTED. Sept. 24, 2018. Joe Grogan.

The Trump administration is prioritizing reforms to improve the reimbursement process for medical devices, and it is willing to spend money to do it. That's according to Joe Grogan, the health program associate director for the White House Office of Management and Budget. See what he said about it here.

Reimbursement Market Access

US Watchdog OKs Ortho Firm's Refund Plan

A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.

Compliance Policy

'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

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

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

QUOTED. Sept. 17, 2018. Kevin Coy.

Many legal threats faced by device and diagnostics companies come from federal law and regulations, but a growing class of strict state privacy laws protecting consumer data could open the door to new risks. See what attorney Kevin Coy said about it here.

Quoted Legal Issues
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