Medical Device Monitor

Payment and Delivery Models, Emerging Markets Affecting Medical Device Industry

Report suggests that greater attention to cost-effectiveness, quality, and regulatory issues will force the industry to demonstrate value and be nimble

Katherine T. Adams

Disruptive change is under way in the medical device industry and its future will change dramatically, according to “Medical Devices: Equipped for the Future?”, a report from A.T. Kearney. The changes could cost medical device companies $34 billion in potential revenue by 2020, forcing device manufacturers to look at new segments, products, and services that address value, customer productivity, and total disease management, according to the report.

Based on interviews with 30 medical device industry executives, the study identifies five disruptive forces that will affect the industry:

  • New health care delivery models, such as pathways and the shift from inpatient to outpatient care
  • A power shift that places payers and providers together in the position of evaluating evidence-based treatments and value
  • Stagnant innovation, referring to low R&D investments in new technologies relative to improvements on existing products
  • Greater Food and Drug Administration regulation and more regulatory scrutiny in the form of audits
  • The need to serve lower socioeconomic classes as market opportunities are shifting to the developing world

The full report is available at

Cost-effectiveness study a plus for CTDR device

The incremental cost-effectiveness ratio of cervical total disc replacement (CTDR) using the two-level Mobi-C Cervical Disc, compared with anterior cervical discectomy and fusion surgery, is $24,594 per quality-adjusted life year, according to a study published in JAMA Surgery. The results, say the authors, suggest that CTDR is a “highly cost-effective option” and that, from a societal perspective, CTDR imparts greater quality of life at lower cost over four years.

The full cost-effectiveness study was published online on October 8. Mobi-C’s maker, LDR Holding Corp., specializes in developing technology for spinal procedures.

New heart valves coming?

Medtronic has initiated the global PERIGON (PERIcardial SurGical AOrtic Valve ReplacemeNt) trial to evaluate an investigational surgical aortic heart valve made from cow heart tissue that could replace a diseased or malfunctioning native or prosthetic aortic valve. The valve has been implanted in the first U.S. patient at ProMedica Toledo Hospital in Ohio and is available only for investigational use. The trial will study up to 650 patients at up to 40 sites in the United States, Canada, and Europe.

FDA OKs urinary valve pump

VisiFlo got FDA approval to market its InFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for adult women who cannot push urine out of the bladder. The condition, impaired detrusor contractility (IDC), is typically managed with various types of catheters, including clean intermittent catheterization (CIC). The FDA reviewed data for InFlow through the de novo classification process, a regulatory pathway for some low-to-moderate-risk medical devices that are not substantially equivalent to a legally marketed device. Approval was based on a clinical trial involving 273 women using CIC. Half of the women in the trial stopped using inFlow because of discomfort or urine leakage, but in the 115 women who continued to use the device, 98% had a comparable amount of urine left in the bladder after voiding as those using CIC.

Available in Europe

Novo Nordisk has launched NovoRapid PumpCart, the first prefilled pump cartridge with an insulin analogue specifically designed for insulin pumps. The device, which contains NovoRapid (insulin aspart), is designed to make insulin pump therapy more convenient for people with diabetes and their caregivers. The 1.6 ml cartridge was developed in partnership with Roche Diabetes Care and is compatible with Roche’s Accu-Chek Insight insulin pump therapy system.

The device is being launched in the United Kingdom, Sweden, and Austria, and is expected to be rolled out in more countries in 2015.

Boston Scientific has European “CE mark” approval for the Accolade pacemaker family and for the Visionist and Valitude cardiac resynchronization therapy (CRT) pacemakers with quadripolar pacing technology. These systems offer options to reach and pace a target location in the left heart ventricle, improving patient response to CRT therapy. CE Mark, or conformité Européenne, is mandatory for certain products sold within the European Economic Area and is similar to the Federal Communications Commission’s Declaration of Conformity used on certain electronic devices sold in the United States.

Research happenings

A team of Harvard scientists and engineers has developed a surface coating for medical devices that could prevent blood clotting and bacterial infection. The coating, using FDA-approved materials, repels blood from more than 20 medically relevant substrates, including plastic, glass, and metal, and also suppresses biofilm formation, a common issue with medical devices used in hospitals. Details were reported in Nature Biotechnology.

The first tear-duct implant to treat inflammation and pain following cataract surgery is a reliable alternative to medicated eye drops, according to findings presented at the American Academy of Ophthalmology 2014 annual meeting. Known as a punctum plug, the device delivers postoperative medication to reduce ocular inflammation. Use of the device may address adherence problems with eye drops. In a phase 2 study, researchers found that the plug reduced inflammation and pain, versus placebo, for up to one month after cataract surgery. A phase 3 trial is planned.

Computer-aided nodule assessment and risk yield, a software tool developed at the Mayo Clinic, can characterize pulmonary adenocarcinoma using high-resolution computed tomography images and stratify non–small-cell lung cancer patients into risk groups with different probable outcomes. Results were published in the Journal of Thoracic Oncology.

Pressure ulcers, or bedsores, could be prevented easily by a wearable patient sensor, says Leaf Healthcare, the maker. Results of a three-month study were presented at the American Nurses Credentialing Center National Magnet Conference, held in Dallas in October. The clinical trial evaluated the technology to improve patient-turning compliance. Bedsores are one of the most common and costly medical errors, costing more than $11 billion a year, according to the U.S. Agency for Healthcare Research and Quality.

A Dartmouth study suggests it may be possible to use Diffuse Optical Spectroscopic Tomographic (DOST) imaging to provide biomarkers to help physicians predict which patients will respond best to chemotherapy for breast cancer. DOST imaging is used to measure tumor tissue for hemoglobin and oxygen-saturation levels.

Selected FDA approvals of medical devices and device products, Oct. 10–Nov. 4, 2014
Date Manufacturer Device name Use Notes
Oct. 10, 2014 Bracco Sciences Sulfur hexafluoride lipid-type A microspheres (Lumason) Contrast agent for suboptimal echocardiograms Safety/efficacy defined in clinical trials of 191 patients with suspected heart disease. Carries a boxed warning about the potential for cardiopulmonary reactions after injection of ultrasound contrast agents.
Oct. 13, 2014 VisionCare Implantable miniature telescope Bilateral end-stage, age-related macular degeneration (AMD) in patients age ≥65 Device is Medicare-eligible and is the only FDA-approved surgical device for end-stage AMD.
Oct. 13, 2014 Lutonix Paclitaxel-coated balloon catheter Restore blood flow in patients with peripheral arterial disease First FDA-approved drug-coated balloon.
Oct. 20, 2014 Dexcom Dexcom SHARE Remote continuous glucose monitoring Allows patients to share their glucose data with others via Apple, iPhone, or iPod devices.
Oct. 27, 2014 St. Jude Medical TactiCath quartz contact force ablation catheter Ablation catheter for atrial fibrillation (AF) Approval based on data from TOCCASTAR trial; 85% of patients were free of paroxysmal AF after 12 months of treatment.
Sources: Bloomberg, FDA, FierceMedical Devices, Forbes, and manufacturers’ news releases

A blueprint for high-volume, high-quality lung cancer screening that is detecting cancer earlier—and helping to save lives

Clinical Brief

Multiple Sclerosis: New Perspectives on the Patient Journey–2019 Update
Summary of an Actuarial Analysis and Report