How Medical device companies can meet the new standards of Comparative Effectiveness Research (CER)?

Instructor: Maria Shepherd
Product ID: 701512
Training Level: Advanced
  • Duration: 42 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2010

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This Webinar/training will discuss how companies can adopt the Voice of the Customer (VOC) process in product development to meet the standards of Comparative Effectiveness Research (CER).

Why Should You Attend:
Comparative Effectiveness Research is a part of healthcare reform that is here to stay. $1.1 B has been set aside for CER in the stimulus bill, and Baucus bill funding proposes $150M in annual spend to support it. The current debate is not if CER will exist, but what it will be.

How can you improve the probability of product success and profitability in your company in the face of the new standards CER will impose? Many companies will spend millions of dollars developing products that will provide insufficient clinical utility evidence to meet CER standards. Meeting the standards of CER will require the consensus and commitment of all of the project development functions; Quality, Manufacturing, R&D, Regulatory and Marketing.

In this webinar, a form of Voice of the Customer (VOC) that has been adapted to meet the emerging standards of CER is presented. Almost every medical device or life sciences company has used some form of Voice of the Customer (VOC) for product development, and many have integrated it into their product development processes. This new adaptation of VOC benefits product development by expanding the goal of the team to include clinical improvement of the product.

Learn how to integrate new best practices into your product development programs that will help your teams develop products that are differentiated and achieve higher sales and profits.

Areas Covered in the seminar:

  • Update on the current status of CER.
  • Projected impact of CER on the medical devices and life sciences industries.
  • Why VOC is a best practice product development process for medical device and life sciences companies.
  • Starting from the beginning: How to Integrate CER into the Product Development process.
  • Project Already Started? Integrating CER's Mandate for Clinical Evidence into Existing VOC projects.
  • Reviewing prior VOC for projects that fit the CER standards.
  • An Updated Market Specification to include specific reference to CER clinical evidence.

Who will benefit:

  • Manufacturing, Quality
  • Marketing
  • Regulatory and R&D

Instructor Profile:
Maria Shepherd, has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and top-tier companies. Following a career in senior management positions including Vice President of Marketing for Oridion Medical, Director of Marketing for Philips Medical, and Boston Scientific, she founded Data Decision Group. Data Decision Group provides market research to quantitatively/qualitatively size opportunities, judge new technologies, and perform M&A support. Maria has taught marketing and product development courses in the WPI/MassMEDIC Medical Device Certificate and HCMA Programs.

Follow us :
Medical Device Summit 2018
Medical Device Single Audit Program

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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