In recent years, a range of factors, including increasing budget pressures, requirements for real-world data, the availability of more innovative medical devices and technologies, and the shift toward value-based care are driving the development of new pricing and reimbursement models in the medical device sector. What are the four medtech contracting agreements that have emerged?
Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions
In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.
Digital Health Apps In Europe — The Road To Reimbursement Goes Through Security
In September, Spain’s National Cryptologic Center issued a road map to minimum security requirements for digital health applications and e-health mobile apps. This article highlights important recommendations from the 11 sections of the publication, serving as a preliminary checklist when preparing for market entry in Germany and/or Spain.
Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions
By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.
Improving Health Outcomes With Personalized Apps
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
MED DEVICE ONLINE CONTENT COLLECTIONS
Each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.More Content Collections
2021 Regulations! What Should Be Included in Your Employee Handbook to be Compliant!
November 30, 2020
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
December 1, 2020
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
December 3, 2020
INCOTERMS 2020 Made Easy - Decoding your Shipment
December 3, 2020
Medical Device Manufacturing & R&D Summit
December 3 - 4, 2020
San Diego, CA
VIRTUAL MEDICALL - INTERNATIONAL MEDICAL EQUIPMENT VIRTUAL EXHIBITION
December 10 - 13, 2020
Physician Employment Agreements: Items to Consider
December 14, 2020
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
December 15, 2020
The Healthcare Quality Improvement Act: The Quest for Immunity in Your Peer Review Process
December 15, 2020
Designing Compliant Physician Compensation Models With Stark Law Reform on the Horizon
December 16, 2020
Structuring and Auditing Physician Medical Director and Administrative Arrangements: Key Stark Law Considerations
December 17, 2020
De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties
December 18, 2020
Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements
January 8, 2021
Personal Protective Equipment Requirements
January 18, 2021