Transcript Concept Engineering - University of Connecticut

Engineer in Residence Program:
1. Product Development Process
2. FDA for Medical Devices
Beth Contini
Eric Taylor
Covidien
9/19/12
Engineer in Residence Program Topics
 Creativity Tools and Concept Selection
 Product Development Process/FDA for Medical Devices
 Rapid Prototyping/Machining: Methods and Design Guidelines
 CAD Basics
 How to Read Engineering Drawings
 How to Create Engineering Drawings
 Design for Manufacturing/ Design for Assembly
Agenda
 Our background
 Product Development Process - Background
 FDA for Medical Devices
 Classifications
 Failure reporting
 Warning letters
 Recalls
 Medical Device Reform
 Additional info
Beth Contini
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BS Biomedical Engineering (Medical Optics concentration)
University of Rochester, 2007
Interned at Covidien Summer of 2006. Returned to Covidien in 2007.
Biomedical Engineer supporting stapling in the BME/Foundational Research
Group
Eric Taylor
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Engineering Manager – R&D Covidien Surgical Devices
• Prior experience: Design Engineer (Covidien & Welch Allyn)
BS Mechanical Engineering : University of Rochester, 2003
What does the FDA say about product
development?
How does an idea for a new medical device
become a new product?
Device Evolution
Technology Development
Product Development Process
Commercial Product
Technology Development vs.
Product Development
Identify/Develop/Acquire Technology
Identify Customer Needs
Product Development
Brainstorm / Evaluate Solutions
Determine Value Proposition
• Surgeon
• Patient
• Payer
• Company
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Innovation Process
Observation
and Research
Evaluation /
Concept
Narrowing
Brainstorming /
Problem Solving
Observation and Research
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PLANNED research
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Incorporates various approaches to identify customer needs.
 Concept Engineering
 ODI
 Other Traditional VOC Collection Techniques
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Research through field observations and customer interviews.
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Emphasizes human factors, behavior, environment and clinical
needs.
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Output is a set of preliminary prioritized set of customer, clinical,
or technical needs to guide ideation.
Brainstorming / Problem Solving
Brainstorming
Continuous
Feedback
from
Qualified
Resources
Qualified
User
Feedback
(Clinical Partners)
• Iterative process .
• Concepts created to address key technical challenges.
• Concepts combined to create complete solutions
• Prototypes constructed to demonstrate concepts and early stage solutions
• Multiple feedback loops with Clinical Partners used to implement customer feedback
Evaluation / Concept Narrowing
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Customer and Technical requirements from Step One and Two used to
evaluate solutions.
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Perform formal MR activities to gauge market acceptance of concepts.
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Evaluation of prototypes from Step 2 based on test plans / metrics.
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Begin to draft EBM strategy to help lay ground work for any pre-clinical
model development.
Product Development Process
Concept
Feasibility
Development
Qualification
Launch
Product
Launch
Concept
Stage Review
Development
Stage Review
Feasibility
Stage Review
Qualification
Stage Review
PDP Teams
R&D Engineer
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Creates product concepts and then turns those into manufacturable products
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Designs components and assemblies in 3D CAD software
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Builds prototypes to test and analyze from designed parts
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Establishes and verifies technical product specifications
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Design Engineer
• Generates product concepts based on customer inputs and needs.
• Creates detailed designs to ensure function and manufacturability.
• Performs FEA and analytical calculations on designs.
• Builds and tests prototypes to prove function and effectiveness.
• Typical Engineering Majors:
 Mechanical
 Electrical
 Industrial Design
July 7, 2015
Product Development Engineer
• Develops test methods to prove function.
• Iteratively tests prototypes to identify improvements.
• Interfaces with Manufacturing engineers to help move product into
production.
• Identifies and tests materials and assembly methods.
• Analyzes data to prove statistical significance and reliability.
• Typical Engineering Majors:
 Mechanical
 Biomedical
 Electrical
 Chemical
 Optical
 Manufacturing
July 7, 2015
Biomedical Engineer / Biologist / Preclinical Researcher
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Provides anatomical and physiological input to design.
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Organizes and performs pre-clinical in-vitro, in-vivo,
and ex-vivo testing of product.
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Generates data for Clinical and Marketing claims.
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Develops novel test methods for proving function.
Typical majors:
• Biomedical Engineering
• Biology
July 7, 2015
Quality Engineer
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Develops and implements quality assurance systems
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Uses six sigma tools such as failure modes effects and
analyses (FMEAs) and statistical tools such as capability
analyses to ensure the safety and efficacy of end-user
products
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Ensures usability of product
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Tests devices and validates processes to ensure products
meet specifications and FDA regulations
Manufacturing Engineer
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Responsible for manufacturability and product
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Establishes product Bill of Materials (BOM)
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Creates process flow map of production line.
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Develops necessary assembly equipment
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Refines process for efficiency and cost effectiveness.
Non-Engineering Functions
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Marketing
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Determines commercial needs for products / Specifies customer requirements
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Sales forecasting
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Develops promotional literature
Regulatory Affairs
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Determines pathway to FDA approval
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Submits data for approval to market
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Works with governing bodies in global regions
Clinical Affairs
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Researches clinical literature related to project
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Plans and executes clinical studies in support of products
Finance

Develops project “Proforma”
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Tracks project spending
Logistics
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Distribution strategy
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Tracks inventory levels and demand
Legal .
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Files patent applications to protect company inventions
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Ensures products do not infringe on existing patents
Product Development Process
Concept
Feasibility
Development
Qualification
Launch
Product
Launch
Concept
Stage Review
Development
Stage Review
Feasibility
Stage Review
Qualification
Stage Review
Concept Stage – Generate Ideas
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“Voice of the Customer”
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Concept Generation
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Legal search
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Preliminary project Plan
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Submit patent applications
Feasibility Stage – Prove you can and want to do it
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Choose a concept(s)
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Generate functional prototypes
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Create product specifications
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Generate sales forecast and financial
analysis
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Create Regulatory strategy
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Formalize business case
Development Stage – Make it a reality
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Detailed design of product
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Optimize function
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Design for assembly and manufacturability
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Legal “Right to Use”
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Identify supply chain / vendor selection
Qualification Stage – Ensure safety and reliability
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Verify and Validate processes
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Production scale up plan
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Regulatory approval to market
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Quality testing
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Design Validation / Primary customer
release
Launch Stage – Get it to the customers
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Build launch quantities
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Monitor performance
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“Lessons Learned”
Class I
Low risk
Otoscope, opthalmoscope
Class II
Thermometer, blood pressure cuff
Most Covidien devices
Class III
Most stents & pharmaceutical products
High risk
Device Classification
The Food and Drug Administration (FDA) has established classifications for
approximately 1,700
different generic types of devices and grouped them
into 16 medical specialties referred to as panels. Each of these generic types of
devices is assigned to one of three regulatory classes based on the level
of control necessary to assure the safety and effectiveness of the device.
(www.fda.gov)
Regulatory Class
Exempt
Non-exempt
Class I
Limitations
510k
Class II
Limitations
510k
Class III
510k
PMA
Failure reporting
- Consumer
- Industry
- Serious adverse events
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Suspect counterfeit product
Product contamination
Defective components
Poor packaging or product mix-up
Questionable stability
Device malfunctions
Labeling concerns
Death
Life-threatening
Hospitalization (initial or prolonged)
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent
Impairment or Damage (Devices)
• Other Serious (Important Medical Events)
When something isn’t right…
Warning letter
- FDA sends to manufacturer when regulations are violated
- Gives guidelines and timeline for plan of correcting issues
- Reasons
- Poor manufacturing practices
- Incorrect claims or instructions for use (IFU)
Audit
- FDA examines all documentation and internal testing
- Reasons
- Voluntary recall
- Concerns about facility / products
Recalls
- ALL medical device recalls are
posted on the FDA website
- Voluntary recalls
Medical Device Reform
A Health Care Reform Law For The FDA
“Food and Drug Administration Safety and Innovation Act”
History:
- Since 1992, pharma companies pay FDA to review applications
- FDA ↑ new hires = ↓ time to review
- NEW ACT
- ↑ fees for medical device companies
- Implement fees for generic drug companies (=28% of all new fees)
- Inspection changes: making it easier to inspect factories overseas
- Removing requirements that plants in the U.S. be inspected twice a year
- CONCERNS
- medical device companies will be able to appeal reviewers’ decisions to a
supervisor → pressure on reviewers can result in bad decisions
http://www.forbes.com/sites/matthewherper/2012/06/27/a-health-care-reform-law-for-the-fda/
More info
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FDA struggles
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Timing vs. Safety
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Usability / Human Factors
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“FDA of Europe”
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TUV & CE mark
www.fda.gov
Any questions?