Industry Insights

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Can Your Laser Micro Drilling System Do all This?

    The recent introduction of 5-axis laser micro drill system expands the limits of micrometer range drilling. Canon’s unique technology creates flexible hole shapes and wider angles at significantly higher processing speeds. Stent production, injector hole drilling and micromachining will benefit.

  7. How To Uncover The Hidden Value Of Culture In Supplier Selection

    W. Edwards Deming once noted that it is management’s role to establish systems and processes that enable employees to be successful.  By working that process continuously throughout the entire organization, employees will have a consistent approach to solve problems. In turn, that approach will enable a company to attain a highly consistent level of quality in its products.

  8. Can Drug Device Manufacturers Achieve Operational Excellence Through A Digital Facility?

    Today’s technology, particularly smartphones, has changed both the way we receive data and the way we communicate. In what is referred to as the Internet of Things (IoT), this instantaneous procurement of data makes life simpler and allows people to connect in ways that used to be impossible.

  9. Remove Headaches By Choosing The Right Medial Plastics Molder

    Today’s medical device and components manufacturers contend with many competing demands. With the growing demand for healthcare-related products, there is increasing pressure to provide a steady stream of innovative products and get them through regulatory approvals as quickly as possible. Meanwhile, medical product developers are constantly looking for ways to save money without compromising a product’s performance. In addition, the medical industry is under increased scrutiny in terms of quality, regulatory requirements, and environmental sustainability for not just the finished product, but the entire supply chain. All these factors require greater attention to detail and a stronger reliance on suppliers.

  10. 3 Key Elements To Consider When Designing Injection-Molded Parts With Rapid Overmolding

    Injection molding is a parts manufacturing process used for a wide range of products including medical devices, children’s toys, household appliances, and automobile parts. Sometimes a second molded part is added as a grip, handle, cover, or sleeve to cover vibration resistance, slippery surfaces, poor ergonomics, and cosmetic concerns. Instead of trying to assemble two different molded parts together, manufacturers can use a rapid overmolding process as an alternative solution. This article touches on three key elements to consider when designing injection molded parts with rapid overmolding.