Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Policy & Regulation

Set Alert for Policy & Regulation

Open Payments: Zimmer, Medtronic Top List Of Spenders

Major medical device companies paid almost $1bn in consulting fees, royalties, research costs and other expenses to physicians in 2017, the most recent data release from the US Open Payments database shows. Zimmer Biomet reported the highest spending on general physician payments, while Roche and Medtronic topped the list of research spending.

Clinical Trials Compliance Policy

Do What You Can, And Do It Now: MDR/IVDR Experts Advise Industry To Move Quickly

There are hurdles to compliance with the EU Medical Device and IVD Regulations –  but companies must jump them now.  A look at why it's time for manufacturers to throw themselves into MDR/IVDR compliance, even if they will sometimes need follow their instinct rather than formal guidance.

Europe Medical Device Policy
Advertisement

Regulation

Set Alert for Regulation

How Kavanaugh High Court Pick Could Increase IUD Sales

A look at what impacts a changed court could have on abortion rights, and related IUD products that device companies Bayer and Allergan make and sell, plus a peek at new contraceptive products on the horizon.

The second of a multi-part Medtech Insight feature series on what a more conservative Supreme Court could mean for future court decisions that impact the medical device industry.

Legal Issues Policy United States

Latest From Regulation

European Parliament To Commission: How Will New Regulations Be Ready On Time?

Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.

Europe Medical Device

EU's New MDR/IVDR Governance Group: What's At The Top Of Its Agenda?

Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device and IVD Regulations. But the current agenda of the Medical Device Coordination Group gives some insight.

Medical Device Europe

QUOTED. July 16, 2018. Seema Verma.

Proposals for the 2019 Medicare physician fee schedule and clinical laboratory fee schedule (CLFS) released July 12 include reforms designed to relax reporting requirements for providers of health services, and take advantage of emerging telemedicine technologies. See what US Centers for Medicare and Medicaid Services Administrator Seema Verma said about it here.

Quoted Reimbursement

CMS Proposes To Cover More Telehealth, And Address Imaging, Lab Pay Matters

The US Medicare agency has proposed several changes to the status quo in its planned 2019 Medicare physician fee schedule and clinical laboratory fee schedule that will impact reimbursements for telehealth services, the advanced imaging industry and clinical laboratories.

Reimbursement Regulation

Localism & Local Languages Make For Better Medtech Business In Russia And EAEU

The probability of a postponed entry-in-force of the single Eurasian Economic Union system of medtech regulation has increased over the course of this year, according to speakers at the 2018 Informa KNect 365 Medtech Summit. But the drive for stronger local medtech industries continues, leaving foreign manufacturers with market-access problems to address.

EAEU Regulation

Message To US Congress: Know What Cybersecurity Tools You Have, Share What You Know, Untie Our Hands

Responding to US lawmakers on how to tackle cybersecurity threats to medical devices and the health-care system, device firms, hospitals, provider groups and other stakeholders listed recommendations on creating inventories, sharing information and amending laws.

Cybersecurity Digital Health
See All

Quality Control & Compliance

Set Alert for Quality Control

Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience

Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Compliance Corner FDA Medical Device

Latest From Quality Control

Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.

Device Week FDA

Inside Toyota's 'Cult': Car-Maker's Quality VP Tells Device-Makers How They Can Adopt 4-Pronged Quality Strategy

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

Quality Safety

With New Initiatives, Case For Quality Embarks On Mission To Create 'Safe Space,' Engage CEOs, #makeCAPAcool

Quality and regulatory officials from Medtronic, Hologic, Baxter Healthcare and Boston Scientific – among others – are working with the joint US FDA/MDIC Case for Quality to fully realize a two-year strategic plan that targets corrective and preventive action (CAPA), CEO engagement in quality activities, career paths in device quality, and more.

Quality Control Manufacturing

New 'Quality Culture Playbook' Aims To Drive An Organization-Wide Quality Mindset, AdvaMed Says

The device industry advocacy group is putting the final touches on its free playbook, which draws from proven quality culture work conducted at high-profile companies like Medtronic and Covidien, among others.

Quality Quality Control

Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience

Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.

The third 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

Compliance Corner: Contract Sterilization Can Be The Bane Of Device-Makers. FDA's Device Expert Sees These 6 Issues

US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.

Compliance Corner FDA
See All

Policy

Set Alert for Policy

Latest From Policy

MassMEDIC Taps Device News Publisher As New Prez

The Massachusetts-focused device industry trade group has appointed journalist Brian Johnson as its new president, replacing long-time leader Tom Sommer.

State News Policy

Who Is Responsible? Congressional Cybersecurity Inquiry Reveals Manufacturer, Provider Rift

Hospitals and clinicians are pushing back against any assertion that they share equal responsibility with product manufacturers for cybersecurity of legacy connected medical devices. Manufacturers should be required to bear more responsibility, health-care provider groups told US House lawmakers. Device-makers, however, argue it is unreasonable to expect them to support security on their products indefinitely.

Cybersecurity Digital Health

European Parliament To Commission: How Will New Regulations Be Ready On Time?

Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.

Europe Medical Device

Medtech Suppliers Still Out Of Pocket As Turkish Hospital Debt Trundles On

Even though the Turkish government has settled some of the sizeable debt owed by hospitals to medical device and pharmaceutical suppliers, industry continues to be disgruntled over not being remunerated for the full amount owed and there continues to be wrangling over how the situation should be resolved.

Turkey Market Access

EU's New MDR/IVDR Governance Group: What's At The Top Of Its Agenda?

Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device and IVD Regulations. But the current agenda of the Medical Device Coordination Group gives some insight.

Medical Device Europe

US Durable Equipment Bidding Restrictions Will Relax, Temporarily, In January

Durable medical equipment suppliers will have the flexibility to provide products to any Medicare beneficiaries without having to win a competitive bidding contract beginning Jan. 1. That state-of-play will last until CMS reinitiates the paused bidding program currently undergoing reforms.

Medicare Reimbursement
See All
UsernamePublicRestriction

Register