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Reduce Supplier Risk, Reduce Organizational Risk

In compliance, medical device, medtech, quality, regulations by Alicia Cheung1 Comment

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.

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The Medical Internet of Things (MIoT)

In Internet of Things, IoT, medical device, medtech, wearables by Alicia CheungLeave a Comment

The Internet of Things (IoT) has emerged as something of a phenomenon in the last few years. The concept has become so popular that its impact is being felt across many industries. The healthcare industry is no exception. It is playing a leading role in this transformative process. Five years ago, the medical connectivity market was largely insignificant but has caught up rapidly. The market is expected to grow an astounding CAGR of 38% until 2020 by adopting the capabilities of the IoT. This intense growth is due to the increasing connectivity of medical devices and personal health tracking devices on the market, leading to an explosion in healthcare big data. Medical equipment, personal health and fitness trackers collect terabytes of data each day, most of which goes unutilized. In the future, the application of advanced analytics to healthcare ‘big data’ will have far-reaching implications on the industry overall, with the global healthcare analytics market expected to reach $20.8 billion by 2020.

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Case Study: 4 Steps to solving Complex Development Projects

In Generis, generis group, healthcare technology, manufacturing, manufacturing operations by GenerisLeave a Comment

Successful companies are constantly fine-tuning existing products and planning new ones. But even the most ambitious businesses can suffer when critical projects get backed up in the pipeline. Management at Chicago-based Rauland-Borg Corporation realized its good intentions were being subverted by the lack of effective project portfolio management (PPM), and decided to do something about it.   Check out the full case study to discover the four step approach to solving complex development projects. 

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