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.

Learn more about a pathway forward for protein crystallization in the white paper below! 


Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most

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.

Take a look at the full white paper below!


How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency

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:


SMTC Presentation: Driving Product Optimization Through Early Stage Supplier Engagement

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.

About SMTC


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.

Guide: Medical Device Commercialization

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-challenges4-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!

eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

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!

pilgrim cover

eBook: Medical Device Development Best Practices

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.

stratoseBook, Medical Device Development Best Practices

For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.

eBook: Traceability Optimization for Medical Device Developers

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!

TcovereBook, Traceability Optimization for Medical Device Developers


Point of Care Testing and the Need for Interoperability

Point of Care Testing (POCT) enables rapid diagnostic tests to be performed at or near the site of patient care. This allows for the immediate generation of test results which can then be instantly acted upon, improve decision-making at the time of care and shared with all members of the medical team.

POCT devices are used in both a clinical and non-clinical settings.  Complex clinical tests such as cardiac or coagulation testing are often conducted within a clinical setting, however, a number of devices are used within mobile units, ambulances etc.  POCT devices must therefore plan for device use outside of a clinical setting and must consequently take into account the need for connectivity, portability, longer shelf life of reagents and kits and ensure the device usability.

The digitization of medical health records has resulted in a greater need for connectivity among devices and the ability to aggregate data from multiple devices into a single, central system.  The aggregation of this data in itself can become a major challenge as providers attempt to aggregate information from multiple devices with proprietary interfaces.

Wipro Ltd. advises that POCT1-A2 is the approved standard for point of care device interoperability and recommends that providers adopt a framework-based approach that can help address the challenges of integrating POCT devices by standardizing implementation across devices, leading to ease of maintenance and better ROI for medical device vendors. POCT1-A2 addresses the problems of Point of Care Testing device connectivity and message formats for information exchange between the POC data manager and the device for patient results, operator list, patient list, calibration and QC results, and other scenarios.

Wipro coverInteroperability for Point of Care Testing Devices_Whitepaper_web

Join Wipro and Generis Group at the American Medical Device Summit 2015 taking place next week in Chicago!

Balancing Competing Priorities in Medical Device Manufacturing

Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing.  Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity.  As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life.

Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success.

The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers:

  • Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life.
  • Increase patient safety by reducing the number and severity of recalls and field actions
  • Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements.
  • Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission.
  • Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and renewals through end of life) by geo-global regions.
  • Reduce engineering re-design time and cost through simulation testing that can help expedite clinical trials and reduce product failure recalls.
  • Expedite product design transfer with current released documentation to facilitate the manufacturing process while maintaining end-to-end traceability throughout the product lifecycle.
  • Develop strategic suppliers and partners by bringing supplier quality history into the sourcing process.
  • Balance speed versus control by improving common enterprise processes, then tracking and measuring them as a basis for improvement.
  • Maintain complete product requirement traceability from ideation through development, design verification and validation, to commercialization and product obsolescence.
  • Drive part costs down by publishing part specifications across product lines, brands, and regions to create efficient procurement processes.
  • Achieve cost savings through lean and efficient re-use of Intellectual Property (IP).
  • Enable design and manufacturing outsourcing by creating centrally-managed global work teams and using a single repository to store all product information throughout the product lifecycle.

Dessault Systemes

Join Dassault Systèmes and Generis Group as we explore the challenges and opportunities in product development, quality management, speed to commercialization and manufacturing at the American Medical Device Summit 2015 taking place Next Week in Chicago!