effective medical device project management (and how to avoid the most common pitfalls)

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“A carelessly planned project will take three times longer to complete than expected. A carefully planned project will only take twice as long.”

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Page 1: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

“A carelessly planned project will take three times longer to complete than expected.

A carefully planned projectwill only take twice as long.”

Page 2: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Good Project Management

Improved Time-to-MarketLower project costCompetitive productRegulatory compliance

gantus.com / greenlight.guru

Page 3: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

A Project has a Goal

Page 4: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Functional Organization Project Team

Page 5: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Steering GroupThe Family

The Construction CompanyContact Person Project Manager

Construction Workers Team Members

gantus.com / greenlight.guru

Page 6: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Project management Applying tools, methods and skillsto reach project objectives.

Page 7: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Smorgasbord Don’t taste everything!

gantus.com / greenlight.guru

Page 8: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 9: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Project vs Design and Development Plan

Project Plan- Budget & Project Risk= Design and Development Plan

gantus.com / greenlight.guru

Page 10: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

gantus.com / greenlight.guru

Page 11: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

How to use probability to manage expectations and meet project deadlines!

Page 12: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 13: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 14: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 15: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 16: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Featureflash Photo Agency / Shutterstock.com

Page 17: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 18: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 19: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Estimated project duration12 months

Expected project duration12 months * 3.14 =38 months

Page 20: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 21: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 22: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Which date should you use?

Page 23: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

“If you aim for the stars, you will hit the tree tops.”Swedish idiom

gantus.com / greenlight.guru

Page 24: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

The Aggressive Schedule

Time saved

The Expected Schedule

Page 25: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

What schedule is that?!!

Page 26: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 27: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Which date should you use?

Page 28: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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.

Page 29: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

The project will finish in August!

Great, but help me out, is that your aggresive goal or

something you can really promise?

Well...hum...!?

Page 30: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

www.liquidplanner.com

Page 31: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

ExecutionCompilation of DHF

(Reserve time)

The goal20%

Expected50%

Commitment90%

Page 32: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 33: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

How project risk management can help you achieve the right budget (and schedule)?

Page 34: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 35: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

The Project Manager’s First Estimated Budget

$100,000Work and

material resource cost

gantus.com / greenlight.guru

Page 36: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

$50,000Unforeseen costs

$100,000Work and

material resource cost

Cost overrun

gantus.com / greenlight.guru

Page 37: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

$100,000Work and

material resource cost

$50,000Risk mngt cost

Cost Performance Baseline

$150,000

gantus.com / greenlight.guru

Page 38: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

$50,000Scope changes

$100,000Work and

material resource cost

$50,000Risk mngt cost

Cost Performance Baseline

$150,000

gantus.com / greenlight.guru

Page 39: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 40: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 41: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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)

Page 42: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

“If everything is going according to plan, you have overlooked something.”

gantus.com / greenlight.guru

Page 43: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Waterfall / Agile – the Best of Two Worlds?

Page 44: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Religious war

Agile vs Waterfall model

Page 45: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 46: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

EN ISO 13485:2016

Page 47: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 48: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 49: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

First article in the 50s Popular in recent years Rolling wave planning in PMBOK A Guide to the Project Management Body of Knowledge

Page 50: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Daily stand up meetings– Good communication– Team work– Celebration of completion

Welcomes (late) changesCyclical approach to work

– Regular feedback

Visualization

>

Page 51: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Daily stand up meetings– Good communication– Team work– Celebration of completion

Welcomes (late) changesCyclical approach to work

– Regular feedback

Visualization

>

Page 52: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Daily stand up meetings– Good communication– Team work– Celebration of completion

Welcomes (late) changesCyclical approach to work

– Regular feedback

Visualization

>

Page 53: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Daily stand up meetings– Good communication– Team work– Celebration of completion

Welcomes (late) changesCyclical approach to work

– Regular feedback

Visualization>

Page 54: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

>

Page 55: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

>

Page 56: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

>

Page 57: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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>

Page 58: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

15 m

in S

tand

-up

mee

tings

Cards on the wall

Page 59: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Key Takeaways

• Remember the toolbox, use the elements that you like• Be cautious about agile and IEC 62304

Page 60: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

How to make schedules visual?

Page 61: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Steering Group – High level conservative schedule

Project Manager

Team Members– High level and detailed aggressive schedule

Page 62: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 63: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)
Page 64: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Level of detail

All Under Document Control

Day to day Operations

Paper based / or electronically signed schedule

High level

schedule

Page 65: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Level of detail

UnderDocument

control

Cloud basedservices

Paper based / or electronically signed schedule

Day to day Operations

High level

schedule

Page 66: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 67: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 68: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 69: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

trello.com

Page 70: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

www.liquidplanner.com

Page 71: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

MS Project

Page 72: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Smartsheet.com

Page 73: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

MS Project

High

leve

lSc

hedu

le MS Project

Liquid planner

Trello

Office Timeline

Smartsheet

Low

leve

lSc

hedu

le

Page 74: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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)

Page 75: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

How to set up Document Control in Projects?

Page 76: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

“When the weight of the project paperwork equals the weight of the project itself, the project can be considered

complete.”

Page 77: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Functional Organization Project Team

Page 78: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

The iterations can take weeks/months.

Functional Organization Project Team

Page 79: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

The reviewer says ”no”?

Review is not approval!

Page 80: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

You decide who should be the reviewers and approvers of documents!Don’t make it unnecessarily difficult!

Page 81: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Project internal reviewand approval is fast.

Functional Organization Project Team

Projectaudit

Page 82: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Who should have the burden of proof that you conform/do not conform to requirements?

Page 83: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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

Page 84: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Value of Signatures

100

1 2 3 4 5 6

Value addedby approvers

Number of approvers

Page 85: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

Using TBD and Maintaining Documents

100

1 2 3 4 5 6

% documents complete

Project duration

Page 86: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

With Stage-Gate Model

100

1 2 3 4 5 6

% documents complete

Project duration

7

Page 87: Effective Medical Device Project Management (And How To Avoid the Most Common Pitfalls)

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!