Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons.
Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits:
Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development.
All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home.
This informative white paper by Althea covers the challenges of crystallization of proteins for therapeutic use and how to preserve efficiency during crystallization.
World Courier is transporting Zika diagnostic test kits to and from South America.
Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind.
The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending.
Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain.
This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps.
Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:
Exploring Design for Excellence (DFX)
Brian Morrison, from SMTC, took his wealth of knowledge and understanding as the Director of Value Engineering & Technology and presented crucial industry information at the American Medical Device Summit 2016.
Take a look at Morrison’s insightful presentation from the Summit that explores Design for Excellence (DFX) Product Optimization, focusing on these core concepts:
- What is DFX?
- DFX Benefits
- Value Equation
- Product Design Review
- Ability to Impact Product Value
- Early Supplier Involvement (ESI)
- Impact of Design Decisions
- Applying DFX to Product Development
To view the full presentation, click here.
SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and comprehensive testing services, enclosure fabrication, as well as product design, sustaining engineering, and supply chain management services.
In our previous posts we have looked into some of the challenges that documentation can present during a medical device’s development and production stage. In today’s post we wanted to take a closer look at the challenges that commonly arise in the commercialization stage and explore some simple solutions to overcome them.
Seismic, a leading end-to-end content automation solution provider for life sciences firms worldwide, has created the guide below to help organizations overcome 4 common challenges in medical device marketing.
Check out Seismic’s Guide below: 4-simple-solutions-to-common-life-sciences-marketing-challenges
If you are joining the discussion at the American Medical Device Summit this October, don’t forget to stop by Seismic’s booth (# 28) to find out more!
Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare systems and more stringent regulations will have a significant impact on how medical device developers operate and succeed in the years to come.
With the American Medical Device Summit quickly approaching, we wanted to take a closer look at how medical device developers will be able to navigate and thrive in this shifting terrain. Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services, generated the eBook below to help developers address their most pressing challenges and enable a new collaborative model.
Check out the eBook!
With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them.
Check out the Stratos eBook to explore :
- Complications arising from a lack of proper documentation, and how to overcome them.
- Strategies to speed the product development process while effectively managing costs.
- Tactics to make product launches more predictable.
- Regulatory considerations that need to be factored into the medical device development process in the U.S.
- The benefits of outsourcing innovation.
Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of information to ensure device safety and demonstrate that safety in the event of an audit. Given the volume and complexity of information to be tracked, many medical device developers struggle with traceability. We sat down with Seapine Software to better understand the challenges medical device developers face, and how they can be overcome. Check out the Traceability Optimization eBook below!