Biotech MATT GANI
My Job Medical Devices • Design and develop products • Organize and run projects • Lead and manage teams of people
What is a Medical Device?
Implantable Brain Stimulator
Wearable Heart Monitor
How Do You Develop a Medical Device? Product Released Product Idea Approval or Clearance Product Development
Product Development Process
Project Phases
Product Needs Communication • Interview potential users, patients, doctors, nurses, etc. • Listen carefully • Take good notes Creativity • Imagine a new way to solve a problem Critical Thinking • Consider other similar products • What are their good elements? • What are their shortcomings? Collaboration • Compare notes and ideas with teammates
Ideas
Requirements Communication • Write down everything the product must do Creativity • Imagine how to do testing Critical Thinking • Is each requirement necessary? • Is the collection of requirements sufficient? Collaboration • Review a teammate’s document • Resolve a teammate’s concerns
Design and Implementation Communication • Mechanical drawings, electrical schematics, software • Design description, Theory of Operation Creativity • Imagine how to use everything you know to solve the problem Critical Thinking • Will your design satisfy all the requirements and pass all the tests? • Can you think of ways to break your design, or a teammate’s? Collaboration • Review a teammate’s design – constructive criticism
Detailed Design
Verification and Testing Communication • Writing test protocols Creativity • Imagine how to test something “on the bench” Critical Thinking • Is it a realistic test method? • Does this test verify the requirement(s)? Collaboration • Understand a teammate’s test approach • Figure out why test results were not what was expected
Validation Communication • Talking with users and patients • Training clinical staff Creativity • Imagine how to design a clinical trial that proves the product is safe, and that it works Critical Thinking • What are the results really telling us? Collaboration • Working with hospital and clinical staff • Comparing experiences with other team members
Brainstorming and Troubleshooting Communication • Expressing your ideas in ways that your teammates understand them Creativity • Imagine how to solve a unique problem • Imagine what might be causing a problem Critical Thinking • Does a troubleshooting theory fit the facts? • Can you think of ways to prove or disprove a theory? Collaboration • Support and build off teammate’s brainstorming ideas
Regular Team Status Meetings Communication • Listen carefully • Provide status update Creativity • Imagine ways for the team to work around setbacks and obstacles Critical Thinking • How can a problem be eliminated? Collaboration • Support your teammates • Celebrate accomplishments
Technologies Communication tools • Phone, cell phone, video conference • Word processing, spreadsheet, visual presentation Design tools • Mechanical design tools • Electrical design tools • Software design tools • Analysis and computer modeling Specialty services • Environmental testing – hot/cold, mechanical shock and vibration • Electromagnetic compatibility testing – interference • Contract manufacturing
Skills Communication • Oral – Listening, Speaking • Written – Reading, Writing • Comprehension / understanding Teamwork • Understand how you impact others, and how they impact you Technical • Be good at what you do Planning and Organization • Everything is a project • What is the objective? • What are the steps to get there? – map it out • Is the project on track?
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