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2014 State Medical Device Development Report
2014 State Medical Device Development Report
2014 State Medical Device Development Report
Medical
Device
Development
2014
2014 State of Medical Device Development | seapine.com
Executive Summary
The demand for smarter, safer, more connected
medical devices has introduced new complexities
to the development process. As medical device
manufacturers race to bring innovative new
products to market, they must overcome the
challenges these complexities createmanaging
product risk, documenting proof of compliance
with industry regulations, and streamlining
development with new methods and tools.
To help manage these challenges, medical
device companies have found new ways to
improve the product development process.
These process improvementsand the
challenges that drive themare what we
sought to understand with the 2014 State
of Medical Device Development Survey.
Managing risk is the first key challenge survey
respondents identified. In order to be effective,
risk mitigation artifacts must be visible to
everyone involved in the development
2014 State of Medical Device Development | seapine.com
Key Challenges
The 2014 State of Medical Device
Development Survey identified three
overall challenge areas:
1. Managing Risk: Teams struggle to
make risk more visible across the
development lifecycle.
2. Working with Documents: Teams spend
far too much time managing, linking,
and reviewing documents.
3. Overcoming Barriers to Improvement:
Budget, validation overhead, and
bureaucracy prevent companies from
making needed improvements.
Senior Executive
What is
your current
level within the
organization?
36%
Professionals
35%
Management
29%
How
long have
you been
working in the
life sciences
Industry?
10+ Years
61%
5-10 Years
18%
Other
2%
What is
your current
role within the
organization?
Research
9%
Regulatory &
Quality
32%
Engineering
57%
How
do you
manage risk
identification,
analysis, and
mitigation?
Documents
on Shared
Network
47%
Methods Used
The top three methods used for mitigating risk in this years survey were Failure
Mode Effects Analysis (FMEA), risk management files, and Root Cause Analysis
(RCA). Nearly 70% of respondents said they also use Corrective and Preventative
Action (CAPA) as part of their quality management system. No distinction was made
between reactive and proactive methods.
FMEA
Risk Management
Files
RCA
What
types of risk
management
methods do
you use?
FTA
PHA
FMECA
Nothing Formal
HACCP
RCCA
HAZOP
Safety Assurance
Cases
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Tracking Risk
Survey results show two-thirds of teams start tracking risk before device
development work is started. This helps teams avoid costly rework by identifying
potential risks early in the development process. The danger is that all of that risk
information can get lost or forgotten once the actual development work begins, if
its locked away in a document control system.
When
do you start
documenting
risk?
31%
Phase
0%
10%
Concept
20%
35%
30%
40%
Feasibility
50%
60%
27% 7%
70%
Development
80%
90%
100%
Verication
Increasing Visibility
Tracking risk alongside design and testing assets
in an integrated product development solution
not only keeps risk visible to the team throughout
development, it also improves visibility into risk
assessment and mitigation efforts across the entire
organization. This heightened visibility helps ensure
risk management work done early in the process is
not lost or forgotten once development begins.
New regulatory requirements and an increased
focus on the cost of care are challenging device
manufacturers to improve visibility across the
development lifecycle in order to meet aggressive
deadlines and prove a devices safety and efficacy.
We asked respondents to identify the top 3 areas
where they need improved visibility.
10
What
are the top
three pieces
of information
you wish you had
better visibility
into?
Impact
Analysis
Risk Controls
Gap Analysis
Related
Requirements
User Needs
Related Defects
Change
Management
Trace
Structure
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
11
What
are your
most timeconsuming
tasks?
Organizing
Work
Data
Analysis
Prioritizing
Work
Objective
Evidence
Researching
Related Items
Seeking
Approvals
Linking Related
Items
Updating Multiple
Systems
Establishing
Risk Controls
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12
13
Between 2011 and 2013, we saw a large jump in the number of companies adopting
these solutions to help them better manage their product development. This
years results show the adoption of product development software solutions has
stagnated a bit.
Use
of artifactcentric vs.
documentcentric
approach
2014
2013
2011
0%
10%
20%
30%
40%
Artifact-Centric
50%
60%
70%
80%
90%
100%
Document-Centric
14
The reason for this slowdown isnt clear, but when we analyzed it demographically,
we noticed a higher adoption rate among respondents who are newer to the
industry. It could be that professionals with more experience are accustomed
to the way weve always done it and are hesitant to change, or that newer
professionals have more knowledge about the latest technologies and methods
being practiced with success in other industries.
100
The use
of documentcentric tools is
high among more
experienced
professionals
75
50
25
Artifact-Centric
15
artifacts.
16
Managing Requirements
When a product development effort reaches design control, the need increases to
move from working in Excel and Word to a more specialized solution. This years
survey results show teams continuing to move into specialized commercial tools to
manage the creation, review, and implementation of product requirements during
design control.
When you factor in the complexity of todays products and the number of teams
required to bring a product to market, its not surprising that more are choosing to
move away from documents and into commercial tools built specifically to manage
the product development lifecycle.
Other
8%
How do
you manage
requirements?
Commercial
Tool
20%
Documents
on Shared
Network
40%
Documents
Under
Document
Control
32%
17
Verifying Change
In 2011, only 32% of respondents were using electronic signatures in their approval
and audit processes. Last year, that number grew to 40%, and this year e-signature
usage equals the use of manual signatures to verify requirements changes.
We expect this trend to continue as more regulatory teams embrace electronic
signatures and adopt tools to support this functionality.
How
do you
verify approved
or changed
requirements?
50%
2014
50%
40%
2013
60%
32%
2011
0%
10%
20%
30%
68%
40%
50%
Electronic Signatures
60%
70%
80%
90%
100%
Manual Signatures
18
Do Not Manage
Test Cases
8%
How do you
manage your
testing efforts?
Completely
Electronic
(Software
designed to
manage test
cases)
Manual
(Printed documents)
20%
25%
Electronic
(Static
documents in a
document or
quality control
system)
Somewhat
Electronic
(Word or Excel
documents
managed in
directories)
26%
21%
19
How do you
verify completed
test cases?
39%
2014
61%
35%
2013
0%
10%
20%
30%
65%
40%
50%
Electronic Signatures
60%
70%
80%
90%
100%
Manual Signatures
20
Improving Traceability
Traceability not only connects the entire product development process, but also is
key to gaining regulatory approval for medical devices. Teams using a documentcentric approach spend an inordinate amount of time digging through documents
to ensure accurate traceability from design through code and testing. Teams are
slowly finding ways to reduce the time spent on traceability, but almost half still
waste a days effort or more each time they need to update the trace matrix.
100
How
long does
it take to update
the traceability
matrix?
75
50
25
Minutes
Hours
2011
Days
2013
Weeks
Dont Know
2014
21
Product
Reqs
User
Reqs
Test
Cases
Risk
Artifacts
System
Specs
Test
Runs
Marketing
Reqs
Defects
Development
Tasks
Feature
Requests
User Stories
Code
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
22
Adding to the problem is the fact that more teams are creating the trace matrix
early, so it will be more complete and accurate. These teams are likely balancing
that benefit with the reality that creating the trace matrix early also means much
more time spent updating it.
At what
point in the
project is the
traceability
matrix
created?
19%
Phase
0%
10%
43%
20%
30%
During Concept/Feasibility
40%
50%
Start of Design
60%
25%
70%
80%
Start of Verication
13%
90%
100%
Right Before
23
What are
the top three
issues that prevent
you from improving
your product
development
processes?
Validation
Overhead
Bureaucracy
Consensus
Decision
Integrating Existing
Tech Investments
Lack of Good
Existing Processes
Interpreting
Regulatory
Guidelines
Lack of
Tools
No Support
From IT
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
24
Budget
Budget is once again the top issue that organizations perceive to be preventing
them from improving their product development processes. This should come as no
surprise, given the economic issues that continue to challenge the industry. Teams
struggle under increasing pressure to reduce costs and get products to market
faster, yet they may get pushback from upper management when they request
new tools that will help them meet these demands. Fewer companies embrace the
spend money to make money philosophy, leaving their teams handicapped with
outdated development tools.
Validation Overhead
Its interesting to note that the cost and time spent validating new and upgraded
systems jumped to second on the list in this years results. Only 27% reported it
as a top barrier to preventing improvement last year. This year, nearly half say it is
keeping them from improving their product development processes.
Bureaucracy
Managers were the only respondents for whom bureaucracy remained the second
biggest barrier to improvement, but it was still high on the list for non-management
respondents. Its clear that companies need to simplify the complicated rules and
processes that stand in the way of improvements their development processes.
25
Almost half of the respondents said they are either successfully using Agile or hybrid
methods or are planning to adopt them within the next 12 months. Another third
of respondents are working to understand how or if Agile practices can help their
development efforts.
Are you
using Agile
or some hybrid
methodology?
Planning To
Adopt Agile Or
Hybrid Practices
In The Next
12 Months
28%
Successfully
Using Agile
Or Hybrid
Practices
20%
Working to
Understand
How Agile Fits
with Regulatory
Requirements
30%
Dont Believe
Agile Fits With
Regulatory
Requirements
22%
Electroni
(Stati
document
management in
a document o
quality contro
system
21%
26
27
28