Transcript Dreaming Big, Being Small

Dreaming Big, Being Small
Taking a DIY Approach to
Getting a Medical Device to
Market
January Luczak, PhD, PEng
Principal Consultant, JuLise Consulting
Winnipeg Manitoba Canada
Objectives
• To chronicle the progress of a
small company’s path towards a
functioning, effective quality
system for a medical device
technology
• To provide some DIY tips learned
from the experiences, which may
be applied across many industries
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Outline
• Role of a quality system in getting
innovation “from bench to bedside”
• Establishing the quality system
– Phase 1: Ground work
– Phase 2: Implementation
– Phase 3: Approval (for quality system
and product)
– Phase 4: Continual improvement
• DIY tips – denoted by
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Innovative technology Now what?
Role of a quality system in
getting innovation “from
bench to bedside”
Factors in Managing Innovation
• Technological innovation is not
enough to ensure market entry…
Business
Objectives
Protect IP
Customer
Requirements
Regulations
• All factors should be considered
throughout product development
5
Organized Approach to
Innovation
Customers
• A quality
system
incorporates Business
Quality
objectives
System
all
Input
Requirements
requirements
and provides
an organized
approach to
Standards
innovation!
Product/
Service
specifications
Regulations
6
Primary Link between
Technology and Market
Consumers
Quality System:
Technology
•Incorporates requirements of
consumers and regulators into
technology design
•Is itself a requirement of numerous
jurisdictions
Images from: http://medgadget.com/2006/08/forehead_retina_1.html
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You NEED a Quality
System...
• In regions with advanced medical
device regulations – e.g., Canada,
US, Europe, Australia, Japan:
– No quality system = no regulatory
approval
– No regulatory approval = no market
entry
Images of flags from: http://en.wikipedia.org/wiki/Main_Page
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You WANT a Quality
System...
• A quality system is beneficial in
many ways
– Increased safety and effectiveness of
a medical device
– Reduced liability exposure
– Reduced regulatory exposure
– Increased customer satisfaction
– Increased consistency in internal
operations
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Establishing a Quality
System
Phase 1: Ground work
Denotes DIY tip
Case Background
• Case: A small company (< 10
employees) has developed a
medical device technology and
wants to place it on the market
• Being a small company, there is...
– No formal quality system in place
– No documented operating procedures
– No experience with obtaining
regulatory approval
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Where to begin?
• Determine what standards and
regulations apply to the technology
– Key standards for medical devices:
ISO 13485:2003 and 14971:2009
– Regulatory bodies publish lists of
standards to which they require
compliance
– Standards exist for most any
technology – e.g. involving software,
sterilization, electromagnetic
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radiation
Where to begin?
• Take stock:
Standards
Regulations
List all
requirements
Customers
Determine which
requirements are
already met by internal
processes
Business
Product/
objectives
service
Define what must be
done to meet all
requirements
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Where to begin?
• Take advantage of guidances!
– Free and easily accessible
– Exist for most any aspect of quality
system and regulatory requirements
(e.g., FDA, Health Canada)
– Global Harmonization Task Force
(GHTF) guidances incorporate
requirements of several medical
device regulations
Image from: http://www.ghtf.org/
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Where to begin?
• Option: Hire consultation
– Advises on which standards and
regulations the company needs to
follow
– Helps the company define operating
procedures
– Assists with applications for
regulatory approval
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Pros and Cons of Hiring
Consultation
• Pros:
– Provides guidance based on
experience
– Can bring to light “unwritten rules”
– Efficiency
• Cons:
– Costly
– Difficult to find a consultant with
directly relevant experience
– Some may take advantage...
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Developing Core Procedures
• Formalized procedures bring
together requirements of
regulations and standards, and a
company’s operation requirements
• Processes that may already exist:
– Purchasing
– Design and Development
– Production
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Developing Core Procedures
• Processes that may not already
exist:
– Internal Audits
– Corrective Action, Preventive Action
(CAPA)
– Post-market surveillance
– Formal management of records and
documents, and change control
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Quality
System Input
Requirements
Control of
documents and
records
Change control
Design and
Development
Customers
Business
objectives
Quality
System
Input
Requirements
Production
Product/
Service
specifications
Define and
implement CA
NO
All
requirements
met?
YES
Define and
implement PA
YES
Can
improvements
be made?
NO
Standards
Regulations
Monitoring and
Measurement
Release
product/
service
Marketing and
Surveillance
Commitment to
continual
improvement
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Resources
management
Assigning Responsibilities
• Each employee should be delegated
responsibilities for quality system
requirements that pertain to their
positions
– There should be a person dedicated to
managing the quality system
– At least two internal auditors will be
needed
• Training should take precedence
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Assigning Responsibilities
• Take a team approach to
establishing a quality system
– Each employee should be aware of
their contributions to the success of
the quality system
– Employee attitude is the most
important factor that can
assure an effective
quality system!
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Establishing a Quality
System
Phase 2: Implementation
Denotes DIY tip
Implementation of Key
Processes
• In the next slides, focus is on:
– Document and Records Management
– Change Control
– Monitoring and Measurement
• Implementation is the most time
consuming phase
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Document and Record
Management
• Every regulation and standard
contains definitive requirements
for documents and records, such
as
– NB: Design documents and records
– Minutes, reports, filled-out forms
– Records of distribution and feedback
– Documents of external origin, e.g.
correspondence with regulators
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Change Control
• Many types of changes must be
controlled, such as
– Changes to design
– Changes in personnel
• Change control =
recording changes,
reasons for changes,
and approval of changes
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Monitoring and Measurement
• CA must be undertaken when a
nonconformity has occurred
• PA must be undertaken to prevent a
nonconformity from occurring in the
future
• Internal Audits measure processes
effectiveness
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Quality
System Input
Requirements
Control of
documents and
records
Change control
Design and
Development
Production
Define and
implement CA
NO
All
requirements
met?
YES
Define and
implement PA
YES
Can
improvements
be made?
NO
Monitoring and
Measurement
Release
product/
service
Marketing and
Surveillance
Commitment to
continual
improvement
Resources
management
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Establishing a Quality
System
Phase 3: Approval – for the
product AND quality system
Denotes DIY tip
Quality System Certification
• Certification to the ISO
13485:2003 standard is necessary
for certain jurisdictions, including
Canada and the EU
• Certification process incorporates
specific requirements of those
jurisdictions, so that one external
audit process can cover all
requirements
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Quality System Certification
• Several conformity assessment
bodies exist (aka, registrar or
notified body)
http://www.intertek-sc.com/index.htm
http://www.dekra.com/en/home
http://www.saiglobal.com/
http://www.bsiamerica.com/americas/
Regulatory Approval for the
Technology
• Depending on the regulatory
approval sought, approval may
entail:
– Filling out a license application
(Canada) (requires ISO 13485 cert.)
– Undergoing an assessment of the
technical documentation (requires
ISO 13485 cert.)
– Premarket approval (PMA) or 510(k)
submission (US)
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Regulatory Approval for the
Technology
• It is possible to prepare
applications and submissions for
regulatory approval without
consultation
– There are guidances – e.g., FDA
offers several guidances on PMA and
510(k)
• Consultant may expedite the
process
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Stats on Regulatory
Submissions…
• Reported in May 2011: Only 4% of
small medical device companies in
the US seek FDA approval as the
first choice
– Small companies are more likely to
incur costly and time-consuming
difficulties in the 510(k) process
– Process takes longer – 330 days vs.
170 days for large companies
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Establishing a Quality
System
Phase 4: Continual
improvement
Denotes DIY tip
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Continual Improvement
• Certification, regulatory approvals – Don’t “rest on your laurels” – keep up
the good work!
• Improvement of the product AND
quality system should be ongoing
• Use post-market surveillance,
internal audits, and CAPA to identify
and address problems and
opportunities for improvement
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DIY Tips
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Summary of DIY Tips
• Phase 1: Ground work
– Determine what standards and
regulations apply to the technology
– Take stock
– Take advantage of guidances
– Delegate responsibilities for quality
system requirements to all employees
– Training
– Team approach
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Summary of DIY Tips
• Phase 2: Implementation
– Pretty much all DIY; only the
company’s own employees can put
the quality system to work
– Perform internal audits to measure
the effectiveness of implementation
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Summary of DIY Tips
• Phase 3: Approval for product AND
quality system
– Prepare applications and submissions
for regulatory approval without
consultation
• Phase 4: Continual improvement
– Use post-market surveillance, internal
audits, and CAPA to identify and
address problems and opportunities
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for improvement
End Points
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End Points
• Initial consultation may be
beneficial, but beware…
– Consultants should develop
procedures based on the company’s
needs and processes, and NOT
provide generic procedures
– Consultants should have directly
relevant experience
• Guidances are very useful and
widely available
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End Points
• Maintain a positive attitude towards
the quality system
– It should be viewed as a helpful tool for
developing and producing a safe and
effective device, rather than as a
burden
– It should not be implemented just to
service auditors/regulators, but rather,
embraced as an organized approach to
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innovation!
Implementation Timeline
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2
3
4
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