FEATURED EDITORIAL

Ambulatory ECG Monitoring Players: A Competitive Analysis
Ambulatory ECG Monitoring Players: A Competitive Analysis

Physicians have the benefit of a variety of monitoring options, with several companies competing to offer devices and services. These companies can be classified into five distinct types, and the key to choosing your ideal solution is determining which type of partner works best for you. 

  • Do You Make These 8 Big Mistakes In Your Deviation Investigations?
    Do You Make These 8 Big Mistakes In Your Deviation Investigations?

    Deviation investigations are one of the most important quality activities in any GMP (good manufacturing practice) organization. They are also perennially near the top of the list of most frequently cited issues in observations, warning letters, and consent decrees from the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

  • How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans
    How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans

    The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.

  • Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4
    Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4

    The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.  

More Featured Editorial

INDUSTRY INSIGHTS

  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
    How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

Validation: A Key Stage In Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

Segmentation Of The Diagnostics Market

The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

More Industry Insights

SOLUTIONS

Medical Device Supply Chain Management (Metals, Electronics) Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

Detergent 8: Low-Foaming Ion-Free Detergent Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

Solenoid Valves Solenoid Valves

Bürkert systematically follows the principle of maximum customer benefit when developing efficient solenoid valve technology. Regardless of whether you require a single component or a complex system solution, we always focus on optimum process reliability, efficiency, and economy.

Wearable Solutions For Continuous Health Monitoring Wearable Solutions For Continuous Health Monitoring

Wearable medical technologies allow for continuous health monitoring in the home so that patients can conveniently chart their wellness or progress electronically. Designers and engineers of high-tech medical devices have to consider the human skin interface during product development, not just as the last step before market. 3M has the expertise available to assist wearable medical technology manufacturers with selecting the right materials that work well with the human skin interface.

Rapid Tooling And Medical Device Prototyping Rapid Tooling And Medical Device Prototyping

Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.

mHealth Solution For Clinical Trials mHealth Solution For Clinical Trials

Mobile health momentum is building as new technologies emerge. The first steps in your journey — including regulatory strategy and device/data validation —can be challenging.

More Products & Services

FEATURED SUPPLIERS

Donatelle Donatelle

Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products. 

LATEST HEADLINES

  • “Neural Tourniquet” Uses Electrical Signals To Staunch Bleeding
    “Neural Tourniquet” Uses Electrical Signals To Staunch Bleeding

    A recent advance in bioelectronic medicine may be able to stop internal or external bleeding by stimulating certain nerves in the brain using a “neural tourniquet.” Researchers from the Feinstein Institute for Medical Research (FIMR) believe the treatment could be used in battlefield medicine, emergency care, surgery, or post-partum treatments to treat or prevent hemorrhaging.

  • Buyer's Remorse: Abbott Files Suit To Nix Proposed Alere Merger
    Buyer's Remorse: Abbott Files Suit To Nix Proposed Alere Merger

    Abbott says it has filed a complaint with the Delaware Court of Chancery to end its proposed deal to buy point-of-care (POC) diagnostics company Alere, which Abbott believes has lost "significant value due to numerous damaging business developments" since their $5.8 billion merger agreement was announced in late January.

  • St. Jude’s Spinal Cord Stimulation System Deemed Full-Body MRI-Safe In EU

    St. Jude Medical, Inc., a global medical device company, recently announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim Elite Spinal Cord Stimulation (SCS) System.

  • Exact Imaging’s Micro-Ultrasound System Gains FDA Clearance

    Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced it has received FDA 510(k) Clearance for its ExactVu™ micro-ultrasound system.

  • Senate Ends Debate Over “Cures;” Bill Expected To Pass This Week
    Senate Ends Debate Over “Cures;” Bill Expected To Pass This Week

    A cloture vote by the U.S. Senate on Tuesday has ended debate in the Senate over the 21st Century Cures Act and paved the way for a vote on passage of the bill, which could happen as soon as today. Under cloture, a procedure intended to break filibusters, the Senate may limit consideration of a pending matter to 30 additional hours of debate.

  • J&J, S&N Lead $7 Million Financing Into OrthoSpace
    J&J, S&N Lead $7 Million Financing Into OrthoSpace

    Johnson & Johnson (J&J) and Smith & Nephew (S&N) led investors pouring $7 million in equity funding into OrthoSpace, which intends to use the money to support its ongoing U.S. Investigational Device Exemption (IDE) trial and commercialization activities.

  • Series 9.5 ADPs With Enhanced NIR Sensitivity Up To 950 nm
    Series 9.5 ADPs With Enhanced NIR Sensitivity Up To 950 nm

    The new Series 9.5 avalanche photodiodes from First Sensor feature an increased sensitivity in the near infrared (NIR) wavelength range up to 950 nm. Due to its fast rise time and very low dark current the photodiodes are ideal for applications with low light intensities and high modulation frequencies such as laser rangefinding and laser scanning.

  • How Should We Deal With Internet Of Things Cybersecurity Threats?
    How Should We Deal With Internet Of Things Cybersecurity Threats?

    The rapid proliferation of insecure internet-connected devices and systems is threatening critical healthcare, financial, transportation, energy and other infrastructure, to the extent that government and industry should be working together more closely than ever to mitigate risks.

More News