The term Secure Product Development Framework (SPDF) was introduced by FDA in the draft guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of ...

We live in a world obsessed with products. Metrics, milestones, and achievements dominate our measures of progress. Promotions, grades, fitness goals, likes, followers, sales figures—you name it. In ...

Tangential Flow Filtration (TFF) is a crucial technology for manufacturing monoclonal antibodies (mAb), adeno-associated viruses (AAVs), and other biopharmaceuticals. However, challenges with ...

The pace of product design, development, and manufacturing is accelerating like never before, and consumers are demanding more from their products. Many products, like coffee makers and even doorbells ...

Back in 2022, I wrote about the triple threat of additive, agility and automation—three forces that were already reshaping manufacturing and product development. Fast forward to 2025, and these trends ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

With all AI related to New Product Development & Marketing, it’s early days full of experimentation & important learnings. To explore the latest and most promising use cases, I spoke with cutting-edge ...