Five Reasons to Be Bullish on Medical Devices

Five Reasons to Be Bullish on Medical Devices

Kalorama Information has increased our projection of the growth rate for the overall medical device market. From pharmaceutical replacement to advanced pricing, This article summarizes the reasons why, though it's not all upside, and there is greater explanation and data in our 2017 global medical device report.


What is the Size of the Indonesian IVD Market?

What is the Size of the Indonesian IVD Market?

With a combination of hospitals and community health centers, public and private laboratories, the sprawling Southeast asian nation's rising middle class presages a growing IVD market. This article discusses the Indonesian IVD market, including growth factors and multiple segments.


J&J, Hill-Rom, and KCI Leading in Wound Care

J&J, Hill-Rom, and KCI Leading in Wound Care

Our most recent report, Advanced Wound Care Products, finds J&J, Hill-Rom and KCI leading the advanced wound care products market. That doesn't mean there isn't room for other competitors, however, as this article details.


User Fees a Test of New Administration for Device Companies

User Fees a Test of New Administration for Device Companies

One test of the new admin’s stance towards the device industry will be the Medical Device User Fee agreement fee negotiations. It cost over $200,000 for a standard business to launch a new device with the FDA and $4,700 for a “shortcut” or 510 (k) application off a previously approved device. A further reduction or limited/no increase are goals of the industry.


FDA Warning Formalizes Growing Cybersecurity Concerns for Medical Devices

FDA Warning Formalizes Growing Cybersecurity Concerns for Medical Devices

The ground-shaking OPM hack affecting over 20 million Americans and a string of other high-profile hacks in the private sector brought cybersecurity to the public’s attention, but it has become even more intimate of an issue for individuals following the FDA’s first ever medical device warning for IT vulnerabilities. The July 31 FDA warning communicated that an independent researcher and the manufacturer Hospira had found that the company’s Symbiq drug infusion pump could be accessed and control...


Recently Proposed CMS Rules to Shape Opportunities in Advanced Patient Monitoring and Wearable Devices Markets

Recently Proposed CMS Rules to Shape Opportunities in Advanced Patient Monitoring and Wearable Devices Markets

This blog covers markets treated fully in the recently released Kalorama Information market research reports Advanced Remote Patient Monitoring Systems, 8 th Edition and The Market for Wearable Devices.

The Centers for Medicare & Medicaid Services (CMS) released proposed rules and funding changes this month for reimbursement of home health and nursing home care. These actions on the part of the largest payer for home health and nursing care in the United States create both opportunities for ad...


Repeal of Contentious Medical Device Tax Passes in House

As expected, the “Protect Medical Innovation At” (H.R. 160) passed in the U.S. House of Representatives earlier this month. The bill would effectively repeal the medical device excise tax enacted in 2013 as part of the Patient Protection and Affordable Care Act (ACA). Proponents of the repeal contend the added cost has depressed research and development (R&D) within the device industry. Kalorama Information regularly assesses industry R&D trends by tracking related expenditures of the most repre...


Sleep Apnea Far From Slumbering Factor in the Respiratory Device Market

Sleep Apnea Far From Slumbering Factor in the Respiratory Device Market

Respiratory health in populations worldwide has been challenged by numerous factors including worsening air quality, substandard living conditions, other allergenic risk factors, and even economic development. Asthma and chronic obstructive pulmonary disorder (COPD) have been significant factors fueling contemporary market growth in the global respiratory devices market according to Kalorama Information. The majority of the respiratory devices market is represented by inhalers or devices for the...


Checking Up on Patient Monitoring: Medtronic and Covidien

Checking Up on Patient Monitoring: Medtronic and Covidien

Medtronic’s roughly $43 billion acquisition and merger with Covidien created the world’s second-largest medical device company. The deal had significant implications in terms of enhanced market presence and company financials with the Medtronic’s move to Covidien’s Ireland home. The deal also made Medtronic-Covidien a stronger leading player in the advanced remote patient monitoring system market. Together, the two companies will feature a diverse set of solutions spanning inpatient to home care...


Medical Device Start-Up Flight to Europe and its Market Implications

Medical Device Start-Up Flight to Europe and its Market Implications

Future upsides to the global medical device market may increasingly originate in Europe as many start-ups seek initial market approval within the European Union (EU). Recent criticism of the U.S. FDA has been preoccupied with the relative complexity of clinical trial plans in the United States. At a recent conference, Mark Deem, managing partner of medical device incubator The Foundry LLC, noted the FDA’s deficiencies relating to his issue:

Clinical trials are a particularly sore point - the F...