This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.

2. What Is It?
Product Management vs. Product Development
Warren M. Gitt
Overlook International Group LLC
Columbia MD
(410) 456-6282
wmgitt@gmail.com

3. Warren Gitt
Overlook International Group LLC
• Background & Experience
• 35 Years in the Medical Device/Healthcare Arena
• Products and Services for the Physician, Hospital, Medical Device, IT,
Pharmaceutical, Consumer, and Managed Care Markets
• Executive Level Roles in Product Management, Marketing and Sales
Management, Business Development and General Management
• Expertise/Experience in International Markets (Bilingual in German)
• Public and Private, Start-Ups, Development Stage, Fortune 500 Cos
• Currently Serving as VP Global Business Development for K2M, Inc.
• Education &Training
• BA Secondary Education and German Language (Hastings College, NE)
• MBA International Business (Thunderbird – now part of ASU)
• US Army Defense Language Institute

4. Key Takeaways
This session will focus on the respective roles and responsibilities of the
Product Manager vs. the Development Engineer from a product’s inception
through its lifecycle maintenance, including:
• Leveraging the Cross-Functional Product Team to Deliver Results
How to manage and direct the organization’s resources to develop a
product that will achieve the financial, market and strategic objectives of the
product’s business.
• Business vs. Technical Aspects of Product Development
If not me, then who is responsible?
• Putting the Customer First
How to avoid developing the perfectly designed product that doesn’t fit the
customer’s needs.
• Navigating the Organization and Getting Things Done
How to manage all that responsibility with little to no authority via
networking, politicking and influencing (situational consultative leadership).

5. OMTEC 2016
PRODUCT DEVELOPMENT
IS A SUBCOMPONENT
OF PRODUCT MANAGEMENT
WHAT IS IT?

6. A Picture Worth A Thousand Words

7. WHAT IS PRODUCT MANAGEMENT?
OMTEC 2016

8. Product Management
What Is It?
Market
TechnologyBusiness

9. What is Product Management?
• Strategic Business and Product Planning
• Global Strategic Business Planning
• Long Term Strategic Growth
• Maintaining a Strategically Healthy Product Range
• Product
• Manage the Product Development Process
• Forecasting and Product Planning
• Augmenting/Culling the Product Line
• Distribution
• Competitive Analysis
• Sales Analysis
• Sales Support
• Product and Customer Education/ Training
• Pricing and Reimbursement
• Promotion
• Sales and Product Promotions
• Marketing Communications
• Trade Shows, Exhibitions, Seminars
UPSTREAMDOWNSTREAMUPSTREAMDOWNSTREAM

10. Upstream - Product Development Model
Develop a collaborative approach
to product development, through
which healthcare providers, opinion
leaders, experienced
biomechanical engineers, and
product management experts
gather at regular product
development meetings, maintaining
constant communication either
in-person or via prescheduled
audio and video conference.
Development
Project

11. Upstream - CEO of the Product Line
Product
Management
Customers:
Distribution
&
End-Users
Engineering
Supply
Chain
Quality and
Regulatory
MarComm
Med Ed
Corp Events
OUS vs US
Finance
Sales
Management
and Field
Specialists
Responsibility but Limited Authority – Requires Leadership from the Middle
Execs
Competitors
Gov’t
Regulatory
User
Preference

12. Downstream Marketing
Medical
Education
(Includes Sales Training)
Marketing
CommunicationsField Activities
Global Sales
Support
Corporate Events
(Trade Shows/ Conferences)
Global Marketing:
Product
Management
functions as product
CEO

13. Sales SupportActivities
• Market and Territory Research and Analysis
• Sales Planning and Review tools for use by Sales
Management
• Territory Planning Tools
• Scorecard Development
• Inventory Planning and Oversight Tools
• Support of National Contracting Activity
• Visits to the Field
• Key End Users
• Case Coverage
• Training
• Feedback Loop – “Voice of the Customer”

14. WHAT IS PRODUCT DEVELOPMENT?
OMTEC 2016

15. Product Development Approach
(Collaborative Teams)
Development
Team
 Project Manager Functions as the CEO for Team
 Develop Business Plan and Market Opportunity,
 Manages Team ‘s Administration and Logistics
 Senior Engineer Functions as the Chief Technical Officer
 Biomechanical Engineering
 Intellectual Property Development
 Regulatory/Clinical Interface
 Global Subject Matter Experts
 Providers (Surgeons, Nurses, Other Clinicians)
 Sub-Segment Expertise
(CEO)
(CTO)
Structure and Process Are Essential

16. Stage Gate Model
A conceptual and operational road
map for moving a new-product
development from idea to launch. It
is a product management
technique in which any product
development process is divided into
various stages separated by gates.
It is an iterative process in which
each stage is unique & independent,
consisting of activities necessary
before moving to the next gate. Gates
serve as quality control
checkpoints with 3 Goals: to ensure
quality of execution, to evaluate the
business rationale and to approve the
project plan and resources.
At each gate the team leadership
determines if more information is
required to move forward or
whether to abort the project. The
Product Manager can switch to
any of the previous stages in
case of failure to qualify through the
appropriate gate.

17. Overview of Development (Device Market)
• Project Initiation
• Design Inputs
• Design Reviews
• Regulatory Planning
• Design Transfer
• Prototyping
• Supply Chain Activities (Planning
and Ordering Products)
• FDA and CE (Regulatory)
• Quality
• Alpha/Beta Product Evaluation/ Intro
• Changes as result of Alpha/Beta
• Final Marketing Introduction
DEVELOPMENT

18. KEYS TO SUCCESS
Product Management
OMTEC 2016

19. What ConstitutesAn Effective Product Manager?
An effective Product Manager is…
A person whose product decisions over time consistently
result in increasing market share without a detrimental impact
on margins. From the customer’s perspective – it is being
constantly "delighted" with the product offering.
How is it done?
By developing and honing three critical marketing skills:
(1) strategic insight,
(2) near flawless tactical execution of strategies, and
(3) the understanding and use of financial tools effectively.

20. Selection Is Critical
PERSONAL QUALITIES AND ATTRIBUTES
Ability to discern between strategic and tactical issues
Meticulous attention to detail, Strong follow-up capability
Ability to work alone
Self-discipline, Self-starter, Goal oriented
Possesses strong time management skills
Team orientation
Able to build team relationships with other business disciplines (e.g. interfaces continuously with engineering, Clinical,
manufacturing, procurement, finance, sales and executive personnel)
Strong oral and written communications skills
Strong analytical and planning skills
Project management skills
Understanding of basic managerial skills
Ability to plan and organize work efforts to maintain proper focus and output, yet be able to appropriately
prioritize tasks
PRODUCT MANAGERS HAVE RESPONSIBILITY BUT LIMITED AUTHORITY
FIND/RECRUIT THOSE WITH THE ABILITY TO LEAD FROM THE MIDDLE
Thick Skin Is Essential

21. Primary Product Management Responsibilities
• Strategic Business and Product Planning
• Product Development and Maintenance
• Distribution Support and Planning
• Product Promotion and Training
• People Management
• Financial and Business Management

22. • Same Skill Sets Required,
Irrespective of Level Within
Product Management.
• Two Development Tracks
•Management
•Subject Matter Expertise
• Appropriate Balance of Upstream
vs. Downstream Marketing
• Frequent, Periodic Feedback
• Bonus Compensation Tied To
Financial Success
Category
Marketing
Assistant
Associate
Product
Manager
Product
Manager
Senior
Product
Manager
Group
Product
Manager
Education BA/BS
BA/BS, MBA
preferred
BA/BS, MBA preferred
BA/BS, MBA
preferred
BA/BS, MBA preferred
Computer/Database Skills - Working
knowledge of Microsoft Office, Database
Applications, CRM Systems, ERP and
Document Control Systems
X X XX XX XXX
Total Experience Required (Years In
marketing, sales or related business
positions, either internal or, if external,
preferably in the medical device business)
0 to 2 1 to 5 3 to 10 5 or more 5 or more
Marketing Experience Required (Years
In marketing positions, either internal or, if
external, preferably in spine or orthopedics)
0 1 to 3 3 to 5 5 to 10 5 to 10
Global Strategic Business Planning -
Write worldwide strategic business plans in
assigned product areas to insure that
products are consistently managed for
optimum growth and margin revenue, that
products are properly introduced to the
marketplace and to the sales force, that
product management mileposts are set,
prioritized and achieved according to plan,
and that implementation tactics are carefully
thought out and planned in advance of
execution
NA X XX XXX XXX
Long-Term Strategic Growth - Develop
and implement a strategic worldwide
business plan the ensure that long-term (3
or more years) growth objectives are
achieved. Identify and establish ongoing
positive relationships with thought leaders
worldwide. Become knowledgeable on
current clinical trends. Gain strategic
insight for providing product direction.
Establish strong clinical partnerships in
developing new products. Define and
locate ideal products and/or business
acquisitions which strategically fit K2M's
mission and which provide the necessary
growth. Map out tactical programs
essential to achieving long-term business
objectives, both domestic and international.
NA
Assists and
Recommends
XX XXX XXX
Strategically Healthy Product Range -
Provide direction to insure that the product
range remains commercially viable and
strong. Specific strategies include auditing
the product range on a semi-annual basis
for competitiveness and commercial parity,
for completeness vs. product gaps, margin
contribution, leapfrog opportunities (cutting
edge technology for development or
acquisition). Insure that direct reports
remain up-to-date on customer and market
issues. Train direct reports to do reliable
primary market research. Insure
responsiveness among direct reports to
field "noise" on product related issues.
Train direct reports on how to drive new
product introductions.
NA X XX XXX XXX
PRODUCT MANAGEMENT REQUIREMENTS, RESPONSIBILITIES AND
PERSONAL ATTRIBUTES
Education
Training
StrategicBusinessandProductPlanning
Well-Defined/ Monitored Expectations

23. Category
Marketing
Assistant
Associate
Product
Manager
Product
Manager
Senior
Product
Manager
Group
Product
Manager
Manage Product Development Process -
Lead development efforts for new products
by collecting and assessing design inputs,
market needs, design and manufacturing
limitations, financial constraints. Serve as
Project Manager by setting timelines,
financial and design controls, adherence to
regulatory and quality requirements.
Collaborate with production on all
operational requirements. Serve as primary
end-user customer interface (Voice of
Customer) and as feedback loop as
regards design, market and clinical needs.
NA
Assists but has
limited authority for
decision making
XX XXX XXX
Forecasting and Product Planning -
Track sales and market history and project
additional/new product sales so that
accurate production schedules can be
developed monthly to drive manufacturing,
and so that intelligent marketing decisions
can be made to correct sales lags, alter
BOMs, instruments, etc.
Assists X X X X
Augmenting/Culling the Product
Offering - Continuously monitor the
product offering to identify and maintain high
margin vs. low margin contributors, high vs.
low volume usage, make
recommendations for enhancing or
improving the existing product offering,
identify product gaps in order to maintain
competitive parity, make recommendations
for complementary product development or
acquisitions
Assists X XX XXX XXX
Competitive Analysis - Closely monitor
and document competition and competitive
activity, evaluates competitive strategy,
develop strategies to block competitive
activity, insure products are at parity or
above on all "customer perceived" critical
features
Assists
Recommends,
Limited Decision-
Making
X XXX XXX
Sales Analysis - Analyze sales trends and
collate sales data to determine
effectiveness of selling effort, provide
"intelligence" to sales management, identify
weak market areas, identify profitable vs.
unprofitable product lines, identify ASP,
measure effectiveness of promotions,
measure market share gains/losses.
Assists X X XXX XXX
Training
Product Training - Insure that sales reps
and sales management are well-trained so
that surgeon questions about the product
can be answered intelligently and properly.
Insure that sales presentations are
informative and cover all salient product
features/benefits and surgical technique
issues. Provide inservices which are
thorough and which address all relevant
questions and issues. Train sales
managers such that they can answer
virtually all general questions posed to and
by their reps and surgeons. Collaborate
with the training department so that field
personnel have a product profile manual to
refer back to for refresher training. Train
customer service reps so they are
knowledgeable regarding products and
instruments. Develop professional training
aids for use by both surgeons and sales.
X XX XX XXX XXX
PRODUCT MANAGEMENT REQUIREMENTS, RESPONSIBILITIES AND
PERSONAL ATTRIBUTES
ProductDistribution
Category
Marketing
Assistant
Associate
Product
Manager
Product
Manager
Senior
Product
Manager
Group
Product
Manager
Pricing Administration - Manage the
pricing function to insure that all products
and instrumentation are priced to achieve
K2M objectives, new products are priced
appropriately for the market and to meet
margin objectives, price increases are
based on increases in costs, inflation, etc.,
short-term promotions or conversion pricing
does not violate long-term business
objectives, ASP objectives are set for major
products on an annual basis and are closely
monitored.
NA X X XXX XXX
Reimbursement - Research, document
and communicate reimbursement
strategies so as to ensure market
acceptance and reimbursement for
products sold (DRGs) and procedures
performed (CPT Code)
NA X X X X
Sales and Product Promotions -
Develops sales promotional concepts that
stimulate short term demand, combat
competitive tactics as required, secure
sales attention and time when needed.
Creates promotional programs that are
easy to understand and implement,
attractive to customers and sales reps,
easy to accept and advantageous to use,
limited in time to preserve premium
margins, professional in all aspects,
consistent with overall K2M strategic
business objectives
NA X XX XXX XXX
Marketing Communications - Collaborate
with Marcom Manager to interface with ad
agencies, graphic designers, printers, etc.
in the development of promotional and sales
support materials.
XX XX X X X
Trade Shows, Exhibitions, Seminars -
Plan and manage activities in collaboration
with other marketing departments. Attend
as required. Provide necessary equipment
and staffing
X X X X X
PRODUCT MANAGEMENT REQUIREMENTS, RESPONSIBILITIES AND
PERSONAL ATTRIBUTES
PromotionPricing
Performance Reviews Tied To
The Product Management Matrix
Well-Defined/ Monitored Expectations

24. MAJOR RESPONSIBILITIES OR TASKS DURING THIS REVIEW PERIOD AND RESULTS
DURING THIS REVIEW PERIOD
List in order of importance, what this employee was supposed to do (This is not a job description)
What did this employee accomplish based on job assignment above, and any goals agreed upon?
List significant results achieved. Explain any Major Lack of results
Pricing
Price list update and analysis of competitor
pricing
Maintain accurate tables of
competitor pricing, develop
updated Plates, Biologics,
Motion, Interbody and
Accesss pricing for price
list.
Update as
needed, minimum
of 1 time per year
– Achieved,
Worked on 2012
Pricing and on
OUS Pricing/BOM
Protocol
Development
Reimbursement
Work with pricing team as
needed to address any
reimbursement issues
As needed – None
Required at this
time
Training
Create training material and support HCIR
trainings and VIP's for Plates, biologics,
Motion, Interbody and Access as
needed
Training presentations and
quizzes complete.
Coordination of product for
trainings and VIP visits.
Update/support as
needed –
Prepared on time
and as required,
additional
products added
Attend and support Global Sales Meeting
Attendance and preparation
for 2012 meeting.
Complete by date
of GSM – On time,
responsible for 1/3
of content
Support Plates, Interbody and Access
cadaver workshops. Provide product
management support, logistical support,
follow up with all surgeon and sales
attendees, track usage after training.
trainings in 2011 and in
2012. Complete analysis of
ROI of trainings. (Qty
Training TBD by MedEd)
As scheduled;
Completed as
required
Support Plates, Interbody, Biologics,
Motion and Access product demos. Keep
accurate feedback of meetings; follow up
with all surgeons and sales agents within
an appropriate timeframe after meeting.
Maintenance of feedback,
trip reports, completion of
follow up activities.
Monthly –
completed as
required
• Weekly/Bi-Weekly 1:1s with
the Manager
• Quarterly Product Reviews
with Sales and Executive
Management
• Annual Performance
Review Tied to Specific
Tasks Associated with the
Matrix Responsibilities
Well-Defined/ Monitored Expectations

25. Tactical Marketing – “Downstream”
Objectives – Teach skills for immediate on-the-job application in five product
management areas:
1. Sales Database Analysis Understanding what the numbers mean from a marketing
perspective.
2. Field Sales Support Providing materials so effective they significantly enhance the reps
ability to close a sale.
3. Time Management Gaining control of the most precious resource T-I-M-E.
4. Battlefield Competition Dealing with competitors on a day-to-day basis.
5. Market Research Learning the fundamentals of effective market research methods on a
shoe-string budget.
Training seminars are available from such organizations as “The Medical
Product Management Institute”, “Sequent Learning Systems” and others
and can be tailored to your specific company and products
Develop Specific Product Management Skills via Training

26. Training - Strategic Marketing – “Upstream”
Objectives – Provide insight into basic requirements for establishing and
maintaining an effective business strategy.
1. Situation Analysis Comparative analysis of we versus they…product, distribution,
market, and corporate culture.
2. Issues and Opportunities Using efficiency prioritization tools to rank issues and
challenges, as well as strategic opportunities and initiatives.
3. Strategic Array What is your strategy? What are the four critical requirements for
sustainable competitive advantage?
4. Voice-of-the-Customer How do you use VOC to identify and translate genuine
customer needs into superior strategic products? What is your customer's "landscape
of demand"? How do you achieve sustainable "customer advantage“?
5. Weighing Strategy Evaluating strategic initiatives: Using Tools such as Kano,
conjoint, competency analysis, Go/No-Go decisions tools.
6. Positioning Brands Brand building and brand maintenance: How to get products
firmly positioned in the mind of customers.
7. Business Plan Fundamentals How does one put together a long-term
(3-5 years out) strategic business plan?
Develop Specific Product Management Skills via Training
Training seminars are available from such organizations as “The Medical
Product Management Institute”, “Sequent Learning Systems” and others
and can be tailored to your specific company and products

27. Training – Provide an understanding of the fundamentals of accounting and
financial measurements used within your business environment and within
your market (e.g. general finance, reimbursement, coding, currency exchange).
1. Your Company’s Finances –Understanding the financial nuances of your company,
your market and your customers. Balance Sheet, Income Statements, Cash Flow,
Operational vs. Capital Expense, Impact of Currency Exchange.
2. How does money move within your market – Understand the complexity of your
market, where complicated marketing and financial issues exist. Recognize the
interaction and sensitivity of volume, costs, and financials (In the medical market,
where reimbursement issues control payment it is critical to understand the
interaction between payers, physicians and hospitals).
3. Planning for New Product Introductions – Forecasting and working through the
financials in a product introduction scenario where risk alternatives must be correctly
determined and prioritized.
4. Measuring Success – the Right Metrics – Different kinds of measuring tools and
the attributes of each. Understand how different metrics work. Putting it all together –
comfort in understanding the financial management of your company.
Financial Management Skills
Understand “FINANCE” and how to “FOLLOW THE MONEY”

28. • Microsoft Office Suite
• Excel
• Word
• Powerpoint
• Training Specific to ERP System
• Microsoft Access
• Microsoft Project
• Document Control System
• Presentation Skills
• Clinical Applications
• DATA, DATA, DATA - Learn how to transform “Data” first into
“Information” and then into “Actionable Intelligence”
Additional “Skill-Specific” Training

29. LESSONS I HAVE LEARNED
Product Management Vs. Product Development
OMTEC 2016

30. Bad Product Manager
• Always makes lots of excuses.
• A bad product manager is not the product's CEO.
• Lacks in communication skills. Bad product managers don't communicate well
with the engineering team and others, and tend to blame others when things go
wrong.
• Puts out fires all day and complains about being swamped by questions and
interruptions.
• Bad product managers focus the team on the feature that the competition is
building.
• Bad product managers get confused about how to position their products.
• Bad product managers always want to be told what to do.
• Bad product managers don't adhere to schedules or process.
• Bad product managers don't take responsibility and tend to blame others.
Good VS. Bad Product Managers

31. Good Product Manager
• Knows the product, the market and the competition really well.
• Is the CEO of the product.
• Takes responsibility for all aspects of the product.
• Manages him/herself based on the product's performance on the market.
• Takes responsibility for devising and executing a winning plan.
• Good product managers manage the product team and not every detail of every
aspect of everyone's work. He/she knows how to delegate and manage the
team effectively.
• Good product managers are focused on strategic decisions, ensuring that the
product is flexible and adaptable to a changing business environment.
• Good product managers create materials to support the day-to-day operations
of the team. He/she is not swamped by questions about the product and
ensures that the product manager is not the only one that can answer questions
about the product.
• Good product managers focus the team on revenue and customers.
• Good product managers focus on delivering value to the market place and not
on just matching the competition.
• Good product managers are disciplined and maintain schedules.
Good VS. Bad Product Managers

32. • To some degree, Product Managers are born, not made…
leadership skills are a prerequisite
• Draft well – don’t skimp on training (its about process, the product can be learned)
• Some Engineers can be successful Product Managers (Must be “out of box” thinkers and an
MBA is recommended. Beware the Engineer with no creativity!)
• A good Salesman will not necessarily become a good Product Manager but a good Product
Manager must be a good Salesman
• If unable to “Multi-Task”, forget about Product Management
• Product Managers must be expert communicators, have exceptional interpersonal
skills and be “comfortable in their own skin” (and the skin better be thick).
• “Good” Product Managers are not necessarily “Good” People Managers –
Don’t make the mistake of promoting someone to a position managing others just
because they are Subject Matter Experts.
• Product Management activities should create a “One to Many” effect –
There should be leverage in everything a Product Manager does.
• Sales, Engineering and Marketing must share an integrated approach and must not
operate independently
• Empowerment is essential – Product Managers have limited authority, others in
leadership must not undermine their efforts
• Unfortunately, great Product Managers move on to leadership positions or get lured
away (always have a succession plan)
• Product Management is a terrific training ground for General Management
MyAdvice To You

33. QUESTIONS/DISCUSSION
What Is It?
Product Management vs. Product Development
Special Thanks to Sequent Learning Systems and to the Medical
Product Management Institute whose training materials and
practical experience are the basis for much of this presentation and
whose approach to Product Management is quite similar to mine.
OMTEC 2016

34. THANKS!
Overlook International Group LLC
8732 Sage Brush Way
Columbia MD 21045
410-456-6282
wmgitt@gmail.com
WARREN GITT