Planning for the medical device market: Getting the edge from post-market surveillance

Planning for the medical device market: Getting the edge from post-market surveillance

Pam Weagraff, Director MedTech Regulatory, IQVIA
Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

Robust, predictive post-market surveillance systems that monitor medical device safety after launch, reduce both costs and demands on resources and increase product safety and performance. However, as competition intensifies, could it be time to revisit the approach?

The historical role of post-market surveillance (PMS) of medical devices has been reactive. It has focused on collating and reporting adverse events, such as device malfunctions or patient injuries, in order to trigger product returns, modifications, exchanges and recalls as necessary. However, as medical device complexity increases, PMS approaches will need to be more rigorous, leading to earlier detection of potential product failures in the field. (more…)

Supplier Management Validation: What’s Your Plan?

Supplier Management Validation: What’s Your Plan?

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

To fulfill the needs of trending technologies and Life Science needs, a global supplier management program helps to integrate an appropriate level of assurance that suppliers and vendors are able to consistently supply quality of materials and services that are in compliance with regulatory requirements.

Have you considered whether your integrated supplier management program:

  • Is validated to effectively help your company to asses, manage and monitor supplier qualifications, and risk and compliance across your global supply chain process?
  • Is consistently producing the expected results for the intended use that your company is continuously seeking?

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Exploring Supplier Quality Management for MedTech

Exploring Supplier Quality Management for MedTech

Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out, taking an in-depth look at supplier quality management (SQM) processes for both medical device and in-vitro diagnostic medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.

During this on-demand webinar, I laid out the regulatory drivers for supplier management for medical device manufacturers and the importance of Quality in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s. (more…)

Supplier Quality Management in the Medical Device Industry

Supplier Quality Management in the Medical Device Industry

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:

  • Do you have the proper process in place to evaluate, monitor, track, and rate your suppliers?
  • How confident are you that you can rely on your suppliers or even that you are protected from issues your suppliers encounter at any of their locations?

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Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

Do you have the proper processes in place to evaluate, monitor, track, and rate your suppliers? How confident are you that you can rely on your suppliers, or even that you are protected from issues your suppliers encounter at any of their locations?

As global outsourcing activities increase, manufacturers should be placing additional emphasis on the control/oversight of their suppliers, and paying attention to potential risks. Poor cost of quality results in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, etc., which impact the bottom line. (more…)

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves. Regulators will continue to focus in this area as data shows that scrutiny is warranted. For example, from the FDA for Medical Devices (just a portion of the life science market), 24% of all observations made in the period ending September 30th, 2017, were due to supplier issues. (more…)

Quality Nirvana Revisited

Quality Nirvana Revisited

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

With the pace at which business moves today, we’re not often provided the opportunity to revisit previous blog posts, reflect back on position statements, or re-examine our thoughts from a fresh perspective. However, recently an e-book that I authored two years ago, Finding Your Path to Quality Nirvana, was re-published, giving me the opportunity to reassess some of the questions that were posed within its pages.

In the e-book, I answered the following questions, and I wondered, now that time has passed, what came to be, and how some of the questions would be answered today. (more…)

Operational and IT Challenges to Effective Supplier Management

Operational and IT Challenges to Effective Supplier Management

Justin Smith, Manager, Product Management, Pilgrim Quality Solutions, an IQVIA company

Supply chain complexity has grown from simple domestic sourcing, manufacturing and distribution, to a complex evolution of global sourcing, manufacturing and distribution centers. Maintaining control of your entire supply chain is monumental and maintaining compliance is absolutely essential. If your organization hasn’t already implemented an automated Supplier Management system, you are undoubtedly feeling overwhelmed.

Technology is critical to securing the global supply chain because it is the only way to have visibility into products and assets across the extended supply networks, and the ability to immediately take action. (more…)

Simplifying Today’s Regulatory and Compliance Complexities

Simplifying Today’s Regulatory and Compliance Complexities

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.

In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey). (more…)

Heralding the Era of Human Data Science

Heralding the Era of Human Data Science

Marla Kessler, Senior Vice President, Strategy, Marketing, and Communications, IQVIA

It’s an exciting time in healthcare. We now live in a world of bionic eyes and pills made from 3D printing. We are seeing technology advance health every day providing a glimpse of the potential ahead of us. Sharing this vision, we at IQVIA are exploring a new discipline – Human Data Science – to bring together the advances in data science with the possibilities of human science to improve health. (more…)