Insights for FDA Regulated and HIPAA Compliant Organizations
The Internet of Things (IoT) is getting personal. Wearables, ingestables, even implantables – devices that can monitor and manage disease and its treatment – are right around the corner.
And where the IoT goes, money follows. In this case, Big Pharma smells opportunity, writes Jason Bloomberg , contributing writer in Forbes magazine. Life science companies are looking beyond traditional mergers and acquisitions by acquiring ‘beyond-the-pill’ products and services to bolster their portfolios and pipelines of drugs.”
As an example of companies moving beyond the pill is Teva Pharmaceutical which purchased Gecko Health, a manufacturer of inhalers which empowers children and their parents to better manage their asthma by monitoring medication use, providing reminders and increasing disease awareness.
Changing industry fundamentals has created a new challenge for FDA regulated companies. Pressure to control healthcare spending, a decline in productivity in research and development (R&D), and the rise of emerging markets are major trends affecting the direction of the global pharmaceutical market.
The last few years have seen numerous innovation crossovers as pharma looks towards unconventional partnerships. Biotech, medtech, specialty pharma and particularly big pharma are looking towards innovative partners to fuel growth and move beyond traditional lines of business. A patient centered model in healthcare is driving the need to streamline, innovate and the rise of precision medicine.
At TAGmedica, you’ll find the solutions you need to solve tough FDA regulated supply chain challenges that exceed customer demands and help companies gain competitive edge.
At TAGmedica, our most successful partnerships are those with rapidly growing, biologic companies that have outgrown the ability to kit, warehouse and distribute on their own.
Increased compliance and regulatory protocols require partnering with a vendor who can document, trace and manage outsourcing processes under ISO 13485:2003 certification.
Growth rates for FDA regulated industry manufacturing have been high. The entrance of numerous small, virtual startups into the market that have no manufacturing capacity is a prime reason.
The desired end at TAGMedica is to help you execute your business plans and roll out product. A recent study from The Council of Supply Chain Management Professionals (CSCMP), reports that virtual startups that are outpacing the industry in terms of growth, will need to build better end to end supply chains.
The shift towards outcomes. Trends in the Life Sciences industry are driving pharmaceutical, biotechnology, medical device, and diagnostic companies to rapidly transform their business operations.
These trends in the Life Sciences industry are putting new pressure on companies’ manufacturing and supply chain organizations to simultaneously improve the quality of products, increase the speed of delivery, and lower costs.
We're at the early stages of a fundamental transformation, marking what could be one of the most significant disruptions to the life science and healthcare industry since the Industrial Revolution.
Manufacturers of medical devices and instrumentation are increasingly adding software, sensors, and wireless connectivity to their products, providing a foundation for the Internet of Things (IoT), which IDC defines as a network of uniquely identifiable endpoints (or "things") that communicate without human interaction using IP connectivity.
IDC forecasts that by 2020, there will be 30 billion connected devices / products in use by consumers and businesses. These smart and connected products in turn become critical components in the connected supply chain and smart manufacturing.
Authored by Jon Nugent. The rapid pace of process innovation and technological advancement in the last decade has introduced both significant benefits as well as significant challenges to FDA regulated industries.