Biodesign - Study guides, Class notes & Summaries

Biodesign quizzes with Answers What branch of the US government is responsible for the regulation of medical devices? - Answer-Department of Health and Human Services What class of medical devices does an adhesive bandage belong to? - Answer-Class I What class of medical devices does a surgical drape belong to? - Answer-Class II True or False? All medical devices are subject to general controls. - Answer-True Which of the following are considered to be the minimal requirements for ...

What are the 3 pillars of development within industry - correct answer 1. expansion of proven programs 2. comprehensive skills gap analysis and support for new programs 3. industry placements, internships and fellowships What is the biodesign methodology? - correct answer IDENTIFY an unmet clinical need, INVENT a medical technology and plan to IMPLEMENT a business strategy Name 2 pharmaceutical ...

The biodesign process for developing medical technologies can be summarized in the diagram below by Paul Yock (Biodesign, Cambridge University Press, 2015): Design P At which stage in the process are you too far along to go backwards? a. After inventing a prototype b. Never - you can go backwards at any point and start over c. After interviewing stakeholders to determine the need d. After selecting the final project e. After writing the Need Statement f. After making observations and/o...