Guest Columns

1. Understanding Coding Standards In Medtech Development 5/11/2020

   While the adoption of coding standards in medical device development lags behind other industries focused on functional safety, such standards’ use is progressively increasing as their value in risk mitigation and efficient product development is recognized.

2. How To Adapt To Changing Single Parcel Testing Standards 5/4/2020

   Medtech manufacturers currently following the ISTA 2A package performance testing standard may wish to consider more modern standards that allow customization of some testing criteria to better evaluate real-world conditions of their packaging and distribution environments.

3. Developing A Clinical Trials Strategy For A Post-COVID World 5/4/2020

   It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.

4. Pandemic Prompts Supply Chain Exodus From China — What’s Best For Your Business? 4/27/2020

   Decisions made in panic rarely work out for the best. In lieu of abandoning operations in China completely, consider these alternatives to secure your company’s supply chain.

5. Ensuring Quality In Ventilator Production Scale-Up For COVID-19 4/24/2020

   Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.

6. Medtech Data Analysis: Techniques to Create Business-Building Insights 4/20/2020

   Combining industry expertise with sophisticated data science methodologies offers medtechs a more precise and detailed understanding of market dynamics, enabling better business decision-making.

7. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

   The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

    

8. Implementing Data Quality By Design For Improved Data Integrity 4/1/2020

   We must adopt more planning in our data quality activities. This is data QbD in its simplest explanation, and we must include data integrity planning in those activities (e.g., considering how to meet ALCOA requirements).

9. Medical Device Usability Testing In The Age Of COVID-19 4/1/2020

   Organizations striving to validate their medical devices’ human factors performance have a massive new problem on top of testing programs already under attack for improper testing methods and overzealous risk-mitigation practices.

10. How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials 3/31/2020

    It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.