effective medical device project management (and how to avoid the most common pitfalls)
TRANSCRIPT
“A carelessly planned project will take three times longer to complete than expected.
A carefully planned projectwill only take twice as long.”
Good Project Management
Improved Time-to-MarketLower project costCompetitive productRegulatory compliance
gantus.com / greenlight.guru
A Project has a Goal
Functional Organization Project Team
Steering GroupThe Family
The Construction CompanyContact Person Project Manager
Construction Workers Team Members
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Project management Applying tools, methods and skillsto reach project objectives.
Smorgasbord Don’t taste everything!
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The Design/Project Plan
$30k6 weeks
$170k1 year
MEDICAL DEVICE
DESIGN VALIDATION
DESIGN TRANSFER
DESIGN VERIFICATION
DESIGN OUTPUT
PLANNING(DESIGN INPUT)
INITIATION
gantus.com / greenlight.guru
Project vs Design and Development Plan
Project Plan- Budget & Project Risk= Design and Development Plan
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Late projects - Causes
Over optimistic plan
Poor Project Execution
Miscommunication
Did not get the agreed upon resources
The project manager was not clear about what he/she needed
Low Efficiency
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How to use probability to manage expectations and meet project deadlines!
Featureflash Photo Agency / Shutterstock.com
Estimated project duration12 months
Expected project duration12 months * 3.14 =38 months
Which date should you use?
“If you aim for the stars, you will hit the tree tops.”Swedish idiom
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The Aggressive Schedule
Time saved
The Expected Schedule
What schedule is that?!!
Which date should you use?
Execution Reserve time
The goal20%
Expected50%
Commitment90%
Agree with your team that you all will be referring to “The Goal”.
Agree with the steering group that you work with one internal aggressive goal, and promise delivery at another date.
The project will finish in August!
Great, but help me out, is that your aggresive goal or
something you can really promise?
Well...hum...!?
www.liquidplanner.com
ExecutionCompilation of DHF
(Reserve time)
The goal20%
Expected50%
Commitment90%
Key Takeaways
• Be aware of how wishes becomes expectations and how the can make key stakeholders disappointed
• Have an aggressive plan and a conservative plan that you can commit to
• User probabilities when talking about project or even task completion dates
How project risk management can help you achieve the right budget (and schedule)?
PRODUCTRisk ManagementRiskCombination of the probability of occurence of harm and the severity of that harm.
ISO 14971:2007
RiskEffect of uncertainty on objectives.
ISO 31000:2009
PROJECTRisk Management
The Project Manager’s First Estimated Budget
$100,000Work and
material resource cost
gantus.com / greenlight.guru
$50,000Unforeseen costs
$100,000Work and
material resource cost
Cost overrun
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$100,000Work and
material resource cost
$50,000Risk mngt cost
Cost Performance Baseline
$150,000
gantus.com / greenlight.guru
$50,000Scope changes
$100,000Work and
material resource cost
$50,000Risk mngt cost
Cost Performance Baseline
$150,000
gantus.com / greenlight.guru
Total project budget
$200,000
$50,000Mngt reserve
$100,000Work and
material resource cost
$50,000Risk mngt cost
Cost Performance Baseline
$150,000
gantus.com / greenlight.guru
The Design/Project PlanThe Contractual Perspective
$30k6 weeks
$170k1 year
MEDICAL DEVICE
DESIGN VALIDATION
DESIGN TRANSFER
DESIGN VERIFICATION
DESIGN OUTPUT
PLANNING(DESIGN INPUT)
INITIATION
gantus.com / greenlight.guru
Key Takeaways
• Make sure you work with Project risk management before completing the planning phase
• If there may be changes to scope, make sure there is money allocated to the changes – a management reserve – that goes into the company budget
• Include your project risk management costs in the budget (and schedule)
“If everything is going according to plan, you have overlooked something.”
gantus.com / greenlight.guru
Waterfall / Agile – the Best of Two Worlds?
Religious war
Agile vs Waterfall model
EN ISO 13485:2016
MEDICAL DEVICE
DESIGN VALIDATION
DESIGN TRANSFER
DESIGN VERIFICATION
DESIGN OUTPUT
PLANNING(DESIGN INPUT)
INITIATION
TRAD PM ROLES: StakeholdersUsersTeam membersProject managerProject sponsorSteering group
DR1 DR2 DR3 DR4 DR5
GR1 GR2 GR4 GR5
TRADITIONAL WATERFALL/PM PROCESS
First article in the 50s Popular in recent years Rolling wave planning in PMBOK A Guide to the Project Management Body of Knowledge
Daily stand up meetings– Good communication– Team work– Celebration of completion
Welcomes (late) changesCyclical approach to work
– Regular feedback
Visualization
>
Daily stand up meetings– Good communication– Team work– Celebration of completion
Welcomes (late) changesCyclical approach to work
– Regular feedback
Visualization
>
Daily stand up meetings– Good communication– Team work– Celebration of completion
Welcomes (late) changesCyclical approach to work
– Regular feedback
Visualization
>
Daily stand up meetings– Good communication– Team work– Celebration of completion
Welcomes (late) changesCyclical approach to work
– Regular feedback
Visualization>
Agile Limitations and Challenges
Works best with Software Not the solution to every problem (nor is the waterfall model)Can be challenging to implement while complying with IEC 62304Does not mean that you should not document anything
>
Agile Limitations and Challenges
Works best with Software Not the solution to every problem (nor is the waterfall model)Can be challenging to implement while complying with IEC 62304Does not mean that you should not document anything
>
Agile Limitations and Challenges
Works best with Software Not the solution to every problem (nor is the waterfall model)Can be challenging to implement while complying with IEC 62304Does not mean that you should not document anything
>
Agile Limitations and Challenges
Works best with Software Not the solution to every problem (nor is the waterfall model)Can be challenging to implement while complying with IEC 62304Does not mean that you should not document anything>
15 m
in S
tand
-up
mee
tings
Cards on the wall
Key Takeaways
• Remember the toolbox, use the elements that you like• Be cautious about agile and IEC 62304
How to make schedules visual?
Steering Group – High level conservative schedule
Project Manager
Team Members– High level and detailed aggressive schedule
Not only am I very careful about checking my schedule, it is also very small because we only have an A3 printer
Woman with magnifying glass
Level of detail
All Under Document Control
Day to day Operations
Paper based / or electronically signed schedule
High level
schedule
Level of detail
UnderDocument
control
Cloud basedservices
Paper based / or electronically signed schedule
Day to day Operations
High level
schedule
Level of detail
Take pictures of yourPost-its, print, review andapprove.
Paper based / or electronically signed schedule
Day to day Operations
High level
schedule
All Under Document Control
2016 May Jun Jul Aug Sep Oct Nov Dec
Phase 2 -ElectricalThu 5/19
Material AvailableThu 7/28
Testing CompletedTue 8/9
CertificationFri 9/30
ProductionSun 12/4
Phase 1 -Mechanical
Sat 5/14Units Available
Wed 8/3
Drawing's ReleasedSat 8/13
Build StartThu 8/25
Conditional Release Sat 9/3
Pending Results
Fri 9/16Performance
Results
Wed 10/26
www.officetimeline.com
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec2014
Project Kickoff1/1/2014
Award Announcement7/18/2014
Municipal Approval11/1/2014
Feb 1 Mar 31Engineer Selection
Mar 7 Jun 22Site Survey
Apr 4 May 12Equipment Selection
Apr 15 Jun 1Construction Budget Review
Jun 15 Aug 15Schematic Design
Sep 1 Sep 5Vision review - Offsite A
Sep 10 Sep 15Design review - Offsite B
Sep 25 Sep 30Regulatory - Offsite C
Oct 1 Dec 7Master Plan
Dec 15 Dec 17Final Presentation
www.officetimeline.com
trello.com
www.liquidplanner.com
MS Project
Smartsheet.com
MS Project
High
leve
lSc
hedu
le MS Project
Liquid planner
Trello
Office Timeline
Smartsheet
Low
leve
lSc
hedu
le
Key Takeaways
• Plan to spend quite some time establishing and maintaining your schedule(s)
• Create schedules with different levels of detail and information depending on who is the receiver of the plan
• Don’t print MS Project Gantt charts on paper that can’t be read without magnifying glass (unless you really have to for document control purposes)
How to set up Document Control in Projects?
“When the weight of the project paperwork equals the weight of the project itself, the project can be considered
complete.”
Functional Organization Project Team
The iterations can take weeks/months.
Functional Organization Project Team
The reviewer says ”no”?
Review is not approval!
You decide who should be the reviewers and approvers of documents!Don’t make it unnecessarily difficult!
Project internal reviewand approval is fast.
Functional Organization Project Team
Projectaudit
Who should have the burden of proof that you conform/do not conform to requirements?
Issuer Date Effective date
Reviewer Signature Date
Approver Signature Date
Approver Signature Date
Approver Signature Date
Approver Signature Date
Approver
Sisyfos Rangstrup, R&D DirectorSignature Date
Doc ID Title Revision Pages
pse20131227-1 A 1 (1)
Verification Specification
Peter Sebelius 2013-12-29
Verification specification
Maria Löfdahl, QA
Åsa Johansson, R&D Manager
2014-01-032014-01-05
MLAN
2014-06-15
Karolina Nilsson, QC Manager
Mette Lynge, VP QA
Roger Moore, Test and Verification mgr
2014-01-20KN
ML
RM
SR
2014-01-252014-02-052014-02-21
Value of Signatures
100
1 2 3 4 5 6
Value addedby approvers
Number of approvers
Using TBD and Maintaining Documents
100
1 2 3 4 5 6
% documents complete
Project duration
With Stage-Gate Model
100
1 2 3 4 5 6
% documents complete
Project duration
7
Key Takeaways
• Review is not approval• Put as much as possible of review and approval within the project, and…• …audit the projects• Have fewer approvers, with less signature inflation• Don’t allow approvers to not approve because of spelling errors and
grammar• Allow documents to be approved with TBDs• Make sure management understand QA and RA – they are not ghosts!