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Medtech Specialist Claims Growing Trend Of Questionable Practices Among Under-Pressure EU Notified Bodies

With EU notified bodies under ever tighter scrutiny, and demand for their services outstripping supply, is there a temptation among smaller operators to adopt practices that could potentially hurt certain medtech clients? One prominent EU legal specialist thinks there is.

Medical Device Europe Policy

Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In

How manufacturers of drug-device combination products set up their quality system depends on various factors, including the primary mode of action – the constituent part of the product that offers the most overall benefit. So say experts from Johnson & Johnson, Eli Lilly and PAREXEL, who offer other tips and advice.

Medtech Tips Combination Products Quality Control

Standards, Not Predicates Emphasized In Finalized Alternative 510(k) Pathway

Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons. 

Medical Device FDA Regulation

Execs On The Move: New CEOs At JenaValve, Foundation Med; New CFO At Natus Medical

Transcatheter aortic valve firm JenaValve and genomic profiling firm Foundation Medicine each announced new CEOs, while endosurgical tool company Medigus said it is looking to fill its top post now that its chief executive has stepped down. And at newborn care, neuro and audio devices and services company Natus Medical, a new CFO is now in place.

Appointments Commercial Medical Device

QUOTED. Jan. 23, 2018. Patty Krantz-Zuppan.

Medtronic's Patty Krantz-Zuppan says when a device-maker implements cybersecurity risk-control measures, it must also consider the impact of those measures on device safety. See her remarks here.

Quoted Risk Management Standards

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Recent Tweets from Medtech Insight

Optimizing Product Lifecycle Management With Real-World Evidence

An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products. Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.

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Policy & Regulation Explore this Topic

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EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDR

There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?

Medical Device Europe Policy

Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says

Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly's David Shore advises. In fact, to be sure it always has the right experts available to answer investigator questions, the firm has restructured its organization to include two new roles to support audits: global product stewards and global process stewards.

Compliance Corner Enforcement Compliance

QUOTED. Jan. 24, 2018. Matt Wetzel.

Device industry trade group AdvaMed has issued a revised version of its broadly used Code of Ethics. The new document, set to take effect on Jan. 1, 2020, discusses how device firms can work with health-care professionals to deliver high-quality, innovative care, without violating ethical principles or anti-bribery laws. See what AdvaMed's Matt Wetzel said about it here.

Quoted Compliance

AdvaMed Urges Medicare Commission To Emphasize Devices As Opioid Alternatives

In a statement to the Medicare Payment Advisory Commission, the medtech industry group bemoans the lack of consideration for medical device alternatives to opioids in treating pain management. The group says the commission should factor in such alternative treatments, per the SUPPORT Act, in their recommendations to Congress in March.

Reimbursement Legislation

Warning Letter Roundup & Recap – Jan. 22, 2019

No device-related warning letters were released by US FDA the week of Jan. 22.

Device Warning Letters FDA

QUOTED. Jan. 21, 2019. Diana DeGette.

Diagnostics regulatory reform is on the agenda of the US House Energy and Commerce Committee this year. See what Rep. Diana DeGette, D-Colo., a senior member of the committee, who helped introduce the 'Verifying Accurate Leading-edge IVCT Development Act' (VALID Act), a proposed diagnostics reform bill, had to say about device safety here.

Quoted Legislation

AdvaMed Code Update Focuses On Compliance Standards

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

Compliance Medical Device

IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

Medical Device Europe

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

AdvaMed Code Update Focuses On Compliance Standards

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

Compliance Medical Device

Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

Compliance Corner Combination Products

Random Checks Now Routine: China To Inspect Your Factories Near And Far

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

China Manufacturing

Commercial Explore this Topic

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Pacts In Medtech: Amarantus And Todos Form Breakthrough Diagnostics Inc.; Edwards Teams Up With Bay Labs To Find Heart Disease

Derived from Strategic Transactions, Informa's premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech feature highlights notable technology alliances, R&D partnerships and commercial collaborations. This edition covers industry pacts that were sealed in November and December 2018.

Pacts in Medtech Deals Companies

Medtech Money Flow: M&A & VC Deals, Jan. 14-19, 2019

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Jan. 14 -19, 2019.

M & A Deals

Device Week, Jan. 18, 2019 – Key Topics At This Year's JP Morgan Healthcare Conference

On this week's podcast, Medtech Insight's Catherine Longworth chats with Marion Webb about some key takeaways from this year's JP Morgan Healthcare Conference. That includes a Q&A with Smith & Nephew's new CEO Namal Nawana on his growth strategy for the British medtech giant, new partnership announcements between medtech and tech companies, and trends in digital health.

Device Week Deals

QUOTED. Jan. 18, 2019. George Savage.

Proteus Digital Health announced a new partnership with Minneapolis-based Fairview Health Services and the University of Minnesota Health to prescribe "digital capecitabine," encapsulating the common chemotherapy drug with Proteus' sensor, to colorectal cancer patients. The goal is to achieve medication adherence, leading to enhanced treatment and outcomes, through home-based monitoring. See what George Savage, Proteus' co-founder and chief medical officer, had to say about the new digital oncology program here.

Quoted Commercial

Bringing A Digital Pill To Oncology: Proteus Partners With Health System To Prescribe Sensor-Enabled Chemotherapy

Proteus Digital Health announced a new partnership with Fairview Health Services and the University of Minnesota Health to prescribe capecitabine, a common chemotherapy drug, encapsulated with a sensor to colorectal cancer patients. Under the program, patients are prescribed the "digital capecitabine" and will be monitored remotely to see when they take their meds and for other health data. The goal is to improve patients' treatment adherence and improve outcomes.

Commercial Digital Health

Complaints From Local Industry Reach New Heights In Turkey As Medtech Tender Gets Fourth Postponement

The planned $10bn medical device tender in Turkey, closely watched by multinational and local companies alike, has been postponed, again, until April 16. Local Turkish device companies are objecting strongly to the government’s approach to the tender, arguing that it is adding more pressure on local industry as it is already under serious financial distress.

Turkey Commercial

Edwards Pays Boston Scientific $180M In TAVR Patent Settlement

Edwards Lifesciences and Boston Scientific announced this week that the firms had resolved an ongoing global patent dispute.

Medical Device Cardiology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Device Approvals, Weekly Snapshot: A Quiet Period

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker.

Approvals Research & Development Personalized Medicine

Otsuka, Click ‘Digital Therapeutic’ Alliance Aims At Novel Depression Option

The new alliance is focused on developing a "digital therapeutic" for the treatment of depression. They hope it will take its place as an effective option among current drug and other cognitive therapies.

Digital Health Business Strategies

2018 US Device Approvals: The Year Of De Novos And Digital Health

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

Approvals FDA

2018 Global Approvals Analysis: Emerging-Market Regulators And Companies Make Their Presence Felt

The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.

Approvals Emerging Markets

Results Recap: Pulse Biosciences Announces Results Of Sebaceous Hyperplasia Study

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from, includes just one entry as the 2019 is off to a slow start for trial results announcements. Pulse Biosciences announced encouraging results from the clinical efficacy study of its Nano-Pulse Stimulation technology to treat patients with sebaceous hyperplasia.

Tracking Trials Research & Development

Bruin Lands De Novo On Pressure Ulcer Assessment Tool

US FDA has granted a de novo clearance to Bruin Biometrics’ SEM Scanner, which is the first device cleared to assess parts of a patient’s body that may be at risk for pressure ulcers.

Approvals Wound Management

Global Device Approvals, Weekly Snapshot: Endovascular Entries

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Terumo and Cook each nabbed US FDA approvals for endovascular devices.

Approvals Research & Development