Analytics in Medical Devices: 5 Questions with Arta Doci

June 4, 2012

2 Min Read
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1.What is “Analytics”?

Analytics examines raw data through the process of cleaning, preprocessing, modeling, and postprocessing with the goal to highlight useful information, detect patterns, test hypothesis, develop explanations, and support decision making.

2.What are the main applications of Analytics in medical devices?

The main applications include:

  • Monitoring algorithm, application, and system performance

  • Providing integrated information to the healthcare providers from the interface of data from the medical device at the healthcare organization environment at which the device is located

  • Using Bayesian Statistics in Medical Device Clinical Trials [1]

  • Integrating several data sources e.g., Quality Systems, Operations, Technical Services, Supply Chain, and Lab Management data to correct current issues and prevent future problems (CAPA)

3.What are the main tools used in Analytics?

  • Trackwise for CAPA.

  • Lean Six Sigma toolbox.

  • Advanced statistical software packages, including Minitab, Matlab, SAS.

  • Home grown tools.

4. How can companies use training to introduce Analytics?

Companies should organize half-day training sessions where the instructor leads by case studies and introduces a set of tools and provide specific examples of how these tools can be used to discover patterns on data, highlight useful information, point out the root cause(s) and illustrate symptoms. Interactive exercises will help the audience to better understand the tools and their usefulness.

5.Who is the best person to present the training?

An in-house statistician or a Six Sigma Master Black Belt person can develop the curriculum and present the information. The educational experience will be enhanced when the presenter partners with a culture anthropologist to provide case studies on how to use data to enable decision making at different levels, including design thinking and innovation.

Reference: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials


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Arta Doci is an Adjunct Professor, Business School, where she teaches Project and Multi-Project Management. She is passionate about Medical Device industry, where she has been actively contributing on the Analytics and Quality of medical devices via a dozen of conference and journal publications. Also, she served as Program Director for the American Society for Quality, Denver during 2009-2011.
 

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