Whitepaper: Why Production Forecast Affects Sterilization Method

A validated sterilization cycle is a requirement for many medical devices, and the appropriate sterilization method will depend on two main factors.  The Phase2Medical Whitepaper below discusses these factors and demonstrates the effect that production forecasts have on the up-front and long-term costs for two of the most common sterilization methods.

Check out the Whitepaper below!


Don’t forget to join Phase2Medical at the American Medical Device Summit 2016 taking place in Chicago next week!

eBook: Product Content Management in a Regulated Environment

In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above.

In the eBook below, Seismic addresses some of the challenges that life sciences companies face and provides some solutions to these challenges.

Check out the eBook below!




What Happens When Life Sciences Messaging Doesn’t Meet FDA Regulations

Medical device organizations face a number of regulatory and compliance challenges ranging from design and development to commercialization.  In preparation for the American Medical Device Summit 2016 we wanted to share the post below to introduce some of the challenges that can arise when life sciences messaging doesn’t meet FDA standards.

The Seismic blog post below discusses some common missteps life sciences marketers make when it comes to FDA compliant messaging, and the consequences to distributing non-compliant medical product promotional content. It also offers some simple solutions for avoiding those missteps.

Check out the post!


How to Build Your Quality Nirvana

Quality management is an integral factor in the development, approval and commercialization of medical devices. With the 2016 American Medical Device Summit quickly approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana.

Check out the eBook below!


eBook: How Quality is Your System?

With the American Medical Device Summit 2016 right around the corner we wanted to take some time to sit down with Clarkston Consulting to gather their insights on quality system management.

Clarkston Consulting are specialists in management, operations, and implementation consulting services for life sciences and consumer products companies.  To help guide medical device developers on their quality journey we asked Clarkston to adress:

  • What to Consider in your Quality System Lifecycle
  • Quality Systems Planning and Priorities
  • What Are the Challenges and How Can You Overcome Them?
  • The Benefits of the Lifecycle Approach
  • Quality Acceleration and Overwatch

Check out the eBook below!




Whitepaper: Risk Management for Modern Medical Device Makers

Medical device developers face an array of regulatory, compliance, quality and risk challenges. Throughout the past couple of months we have examined these different challenges and various solutions to overcome them.

In today’s post we wanted to share the Jama Software whitepaper below which discusses methods to resolve the challenges of connectivity, competition and compliance for medical device developers.

Check out the Whitepaper



Product Cost Management: What does your Software do for you?

Computer-aided design (CAD) is an industrial art that results in lower product development costs and greatly shortened design cycles.  In today’s post we take a closer look aPriori‘s software capabilities to gain a fuller understanding of how 3D CAD Modeling can help developers:

  • Launch new products at or below target cost
  • Avoid overpaying for outsourced parts
  • Maximize cost savings of re-design work
  • Increase the accuracy and speed of RFQ responses

aPriori software and services generate hard-dollar product cost savings for discrete manufacturing organizations. Using aPriori’s real-time product cost assessments, employees in sourcing, manufacturing and design engineering make more-informed decisions that drive costs out of products pre- and post-production.

Check out the video below to learn How aPriori’s product cost management software can rapidly generate detailed cost estimates using any 3D solid CAD model as the primary input. Costs can be generated for a wide array of manufacturing processes, such as: Sheetmetal Fabrication, Plastic Injection Molding, Casting, Machining, Forging, Powdered Metal, Gear Making, etc.


Find out more from aPriori by joining the discussion at the American Aerospace & Defense Summit on December 6-7, 2016, in Scottsdale, AZ!

Wait, is that Clean?

Surface preparation is a critical manufacturing process that enables sealing, bonding, painting, coating, printing and cleaning. By utilizing appropriate surface preparation processes medical device manufacturers can speed production, ensure product safety, and decrease the likelihood of recalls.

Despite the critical nature of this process the majority of manufacturers are still relying upon outdated surface evaluation methods such as dyne and water break. These current methods lack precision, allow for subjective interpretation, and are often destructive.

Check out the BTG Labs infographic below to explore the strengths and weaknesses of different surface preparation methods.

updated-btg-sur_14869554_4f0a506967558b2a323bcf42fed7eb9d67211813 surface-preparation-for-manufacturers-who-bond-seal-coat-paint-clean-or-print

Hear more from BTG Labs by joining the discussion at the American Medical Device Summit on October 5-6 in Chicago. Be sure to stop by Booth #21!!

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!

An Agile Alternative to Document-Centric Methods for Requirements Management

The American Medical Device Summit is less than one month away!  The summit will draw on the knowledge of over 40 industry leaders to explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization.

One of the companies helping developers tackle the challenges in product development and compliance is Jama Software. Jama Software has developed a more agile alternative to document-centric methods for requirements management, creating the optimal environment for defining problem statements, validating cross-functional input and ensuring that what is delivered at each phase of is what was intended.

Check out the Demo Video below to find out how on-boarding this software can help developers navigate complex development cycles and build great products by:

  • Removing the overhead of requirements reviews.
  • Shortening the time between milestones.
  • Mitigating risk and maintaining traceability evidence.
  • Visualizing connections between regulations, requirements and test cases.


for a more in-depth look at the software, try the software yourself by signing up for the Jama Software Free Trial!