Biotech MATT GANI My Job Medical Devices Design and develop - - PowerPoint PPT Presentation

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 Idea Product Development Product Released Approval or Clearance

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?