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.”

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

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

Smorgasbord Don’t taste everything!

The Design/Project Plan

$30k6 weeks

$170k1 year

MEDICAL DEVICE

DESIGN VALIDATION

DESIGN TRANSFER

DESIGN VERIFICATION

DESIGN OUTPUT

PLANNING(DESIGN INPUT)

INITIATION

Project vs Design and Development Plan

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

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

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

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

$50,000Unforeseen costs

$100,000Work and

Cost overrun

$100,000Work and

$50,000Risk mngt cost

Cost Performance Baseline

$150,000

$50,000Scope changes

$100,000Work and

$150,000

Total project budget

$200,000

$50,000Mngt reserve

$100,000Work and

$150,000

The Design/Project PlanThe Contractual Perspective

$30k6 weeks

$170k1 year

MEDICAL DEVICE

DESIGN VALIDATION

DESIGN TRANSFER

DESIGN VERIFICATION

DESIGN OUTPUT

INITIATION

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.”

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

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

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

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>

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

High level

schedule

Level of detail

Take pictures of yourPost-its, print, review andapprove.

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

le MS Project

Liquid planner

Trello

Office Timeline

Smartsheet

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.”

The iterations can take weeks/months.

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.

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

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

2014-06-15

Karolina Nilsson, QC Manager

Mette Lynge, VP QA

Roger Moore, Test and Verification mgr

2014-01-20KN

2014-01-252014-02-052014-02-21

Value of Signatures

1 2 3 4 5 6

Value addedby approvers

Number of approvers

Using TBD and Maintaining Documents

1 2 3 4 5 6

% documents complete

Project duration

With Stage-Gate Model

1 2 3 4 5 6

% documents complete

Project duration

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!

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

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