It's an exciting time in the medical device industry, with new “cloud-connected” systems emerging every day that offer significant new value to patients and medical service providers. These new device systems—and even some implanted systems—do more than collect and display sensor and patient data; increasingly, they reach out wirelessly to the cloud for data storage, computation, and directed alerts. Read more about the areas to consider when developing a medical device system using the cloud connectivity model at MD+DI.
The WBBA recently hosted an interesting (and at times terrifying) panel titled “Superheroes Fighting Superbugs: Washington State on the Forefront of Antibiotic Resistance.”
The panel included moderator Lisa Cohen, Executive Director of the Washington Global Health Alliance; John Lynch, MD, Associated Professor in Medicine, Allergy and Infectious Diseases at Harborview Medical Center; Bruce Montgomery, MD, Chief Executive Officer of Cardeas Pharma; Michael Gluck, MD, Chief of Medicine at Virginia Mason Medical Center; Scott Weissman, MD, Assistant Professor, Pediatric Infectious Diseases at Seattle Children’s; and Anita Zaidi, Director of Enteric and Diarrheal Diseases for the Bill & Melinda Gates Foundation. The panel was an impressive representation of the work being done in Washington to combat the alarming and growing problem of multiple drug resistance.
Stratos Product Development announced today that it has been recommended for certification to ISO 13485:2003, the internationally recognized quality standard for medical devices.
The recommendation is a result of an extensive assessment performed by BSI Group, and indicates that Stratos’ Quality Management System has been effectively implemented to the requirements of ISO 13485.
This month the Washington Biotechnology & Biomedical Association (WBBA) held its 26th annual Governor's Life Sciences Summit and Annual Meeting at Bellevue’s Meydenbauer Center. The event offered a diverse group of speakers, including Jay Inslee, Governor of Washington State; Dow Constantine, King County Executive; Scott Palmer, Ernst & Young’s VP of Life Science Strategy Services; and Aaron Martin, Providence Health & Services’ Senior VP of Strategy and Innovation.
When granting regulatory approvals for medical devices, both IEC 62366 and the FDA have emphasized the importance of applying human factors and user-centered design activities to the development process to ensure medical device safety and improve usability. The development of mobile medical apps (MMAs) is no exception. Developers of an MMA aren’t just building another Angry Birds or Candy Crush app, they are building a medical device in the form of a mobile app that keeps up with a user’s health, perhaps even diagnosing symptoms and preparing users for unforeseen medical emergencies. Read the whole thing here.
With the increasing occurrences of high-profiles security breaches including identity theft, phishing scams and hacking attempts on internet users not to mention the news of NSA surveillance, we’ve all become very aware that we need to keep our information safe. As more complicated Internet-connected appliances evolve into the Internet of Things, embedded device security has become critical to a product’s viability.
In August, 2014, consulting firm, PriceWaterouse Coopers released a report “Digital accelerators for a new innovation era”. In it, the authors note, “Drug and device companies need the right mix of digital tools and processes to accelerate innovation, or they risk displacement and missed growth opportunities in a New Health Economy that is demanding technologies to support measurable, value-driven care.”