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Becoming a Project Manager within the Medical Device or Pharmaceutical Industries

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in partnership with:

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Table of ContentsWhat’s Different About Working within Life Sciences? .....................................................................................3

Project Management Within the Highly Regulated Medical Device and Pharmaceutical Industries ................4

5 Tips for Breaking into Medical Device or Pharmaceutical Industry Project Management ..............................5

Medical Device Project Manager Compensation ..............................................................................................6

Pharmaceutical & Medical Device Industry Trends ..........................................................................................7

From the Life Sciences Project Management Trenches ....................................................................................9

Is Project Management Right for Me Self-Assessment ..................................................................................11

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A Special Thanks

A special thanks to Project Management in Life Sciences (PMinLS), Dee Suberla, Craig Josephson, Jennifer Erpenbeck, Annette

Johnston, Kevin Grossenbacher, and Karen Zylberman who all contributed meaningfully to this piece. PMinLS is a group of individuals

interested in the pharmaceutical, medical device and biotech world of project management. PMinLS provides an environment to

expand and strengthen life sciences related project management capabilities. If you are interested in learning more about this orga-

nization including membership and our upcoming events, please visit www.pminls.com.

Exploring Project Management Series

Welcome to 180 Engineering’s project management series created in collaboration with Project Management in Life Sciences

(PMinLS). This series will consist of three pieces and will explore the project management function, becoming a project manager

within the medical device or pharmaceutical industries and project management trends within life sciences organizations.

• PM.1 - Is Project Management Right for Me?

• PM.2 - Becoming a Project Manager within the Medical Device or Pharmaceutical Industries

• PM.3 - Optimizing Medical Device & Pharmaceutical Project Management Organizations

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Becoming a Project Manager within the Medical Device orPharmaceutical IndustriesDo you feel drawn to the pharmaceutical and medical products industry? Well, you wouldn’t be the first. There are many

project managers (PMs) wondering how to break into the business of helping to save lives. There are quite a few nurses,

pharmacists, and doctors working for corporations producing pharmaceutical and medical device products, but what if you

don’t have a medical background? Or what if, on top of that, you haven’t racked up a lot of hours as a project manager?

What’s Different About Working in Life Sciences?

The medical device, pharmaceutical, biopharmaceutical, blood and tissue and select other biology-based medical

segments are cumulatively referred to as the life sciences industry. Product development processes for life sciences in

general, and most certainly the pharmaceutical and medical device industries, are typically much longer than in other

technology and product fields.

The amount of testing and the length of time for approvals are the biggest factors that extend the development process.

On the pharmaceutical side, it takes even longer and sometimes includes a series of submissions to regulatory bodies

if clinical trials are involved. These extended timelines can also affect medical device development when working on a

combination product (both drug and device involved). The project manager and others must figure out how the two items

will become one high-functioning product that is both safe and effective for the product’s target patient population.

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Project Management within the Highly Regulated Medical Device and

Pharmaceutical Industries

If you are an experienced project manager looking to get into the medical device or pharmaceutical industry, there are a few

things to consider before you plunge in. First, life science companies are focused on improving the quality of patients’ lives

as well as making the job of those who care for them easier. They are focused on patient outcomes - the product needs to

make a meaningful difference. The end user is the patient, but the patient is generally not the customer. Even if it is a tool

that a lab worker uses to conduct a diagnosis, using those lab products directly impacts the patient’s life.

This explains the criticality of the regulations. In the United States, the Food and Drug Administration (FDA) is the chief regulatory

body. Every country has a regulatory body, and these agencies frequently differ on the information that must be provided to

approve a product for use in the field. It’s important and very complex, so if you are thinking about moving into the life sciences

industry, it’s best if you have experience in other regulated industries such as motor vehicles or telecommunications.

Meeting regulatory requirements also means that these companies have very stringent quality requirements. Throughout the

product development process there are quality systems requirements that must be adhered to in order to fulfill regulatory

requirements as well as support the integrity—as in safety and efficacy—of the products themselves.

One example is a hazards analysis. The technical teams (science and engineering, etc.) get together to brainstorm about all

the things that could possibly go wrong. This sounds like project management, but it’s much different. They are focused on

things that could go wrong with the use of the product, creating hazardous conditions, or even causing harm to the patient or

a caregiver. This falls into the category of product risk.

Contrast product risk with project risk. Project risk will focus more on budget, time, and product scope. This is project

management. If a project risk ventures into the arena of a safety or efficacy, it goes straight to the quality systems team to

be managed as a product risk. With U.S.-based products, the FDA is deeply concerned with, and audits for product risk.

Even people with extensive medical product and pharmaceutical experience can get confused when they are first faced with the concept

of product vs. project risk. A good way to differentiate: risks to safety and efficacy (product) vs. risks related to time, money, and scope

(project). Both are critical to success and a project manager must fully understand the difference to help the team get it right.

While there is an incredible diversity of efficacy impact in the pharmaceutical industry depending on the biological system or

disease state in question, within the medical device industry there is a huge range of materials, mechanical, electrical, and

chemical considerations at play. There are laboratories dedicated to testing final product, measuring strength of materials

(alone and when bonded together), molding and thermoforming process development. There are particle analysis labs

looking for foreign bodies or evidence of chemicals leaching into medical solutions from their container.

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Remember that a very large percentage of medical products are used in processing, testing, or delivering pharmaceuticals. Most

people are familiar with the small or large bags hanging on bedside poles that infuse solutions into patients. That bag must be

designed to very exacting specifications and be released for use in testing with the actual drug while it is being developed.

It doesn’t take long for medical products to meet up with a drug. An antibiotic has to be put into some sort of container: a vial, a bag, or an

injection device. Is it a drug or a device? It’s both. There are regulatory frameworks for devices, for drugs, and for combinations of products.

As you can see, there are many areas in which to develop expertise and gain entry into project teams. Here we are talking

primarily about product development, but if that doesn’t interest you, there are other areas that need project management

support. It really depends on you, your experiences, your areas of expertise, and your passions.

5 Tips for Breaking into Medical Device or Pharmaceutical Industry Project

Management

If you lack project management experience but would like to lead projects in the medical product or pharmaceutical industry,

begin in a functional role where you can provide support to product development projects. Engineering is one example of a

function that is always present in project teams. Many medical projects include software and electronics, as well as a myriad of

other materials. Most projects have highly trained experts leading less-experienced engineers and technicians.

Of course, the types of jobs to consider depend on the focus of the particular company or organization and your own areas of

interest. Take a close look at your experience and expertise. Do the research to determine which companies have functions that

need your skills. If you’re working with a recruiter, make these desires known up front. They can help you to align your strengths

and passions with a company in need of your talents.

If you are entirely new to working within regulated industries, consider starting at a lower level. For example, supporting a

project or program manager or working in the PMO in a tracking role gives you an opportunity to become familiar with the

terminology and standard practices within the industry.

Another option is working as a contract project manager to quickly gain an understanding of the landscape. As mentioned, life

science companies are sometimes leery of project managers from other industries because they question their ability to adapt to an

intense regulatory environment.. Contract or contract-to-hire lessens the commitment until you and the company are sure it’s a fit.

Be sure to educate yourself in project management. If you are not already trained in this area, start with the Project

Management Institute at www.PMI.org. Their publication, “A Guide to a Project Management Body of Knowledge,” (PMBOK) is

the foundation of project management. At the very least, learn the basics.

Research the terminology and regulatory constructs that the industry must operate within. FDA.gov is a great resource offering

information about its history, current regulations and guidances under review (insights into where the industry is heading).

Here’s a good one to get you started: 21 CFR 820, “Quality System (QS) Regulation/Medical Device Good Manufacturing

Practices.”

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How Much do Medical Device Project Managers Get Paid?

An understanding of typical compensation levels is an important factor for career decision-making. The compensation

data below was mined from CareerBuilder’s Talent Compensation portal. Compensation data within CareerBuilder’s Talent

Compensation portal is sourced from thousands of engineering job listings, data from engineering hiring organizations,

supplied data from engineering professionals, and the U.S. Bureau of Labor Statistics.

While there are ample medical device industry opportunities across the Midwest, CareerBuilder medical device project

manager compensation data was not reliable beyond Chicagoland, and therefore was not included. That said, from our

experience pulling data for many other positions, compensation within the Chicago metro area tends to not be markedly

different (generally only slightly higher) than other metro areas within the Midwest.

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3 - 5 years

6 - 10 years

11 - 15 years

16 - 20 years

21+ years

$84,267

$83,815

$108,680

$111,333

$115,792

$103,000

$111,000

$129,000

$143,000

$140,600

$115,000

$128,000

$172,000

$174,000

$166,000

Medical Device Project Manager Compensation - Chicagoland

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Pharmaceutical & Medical Device Industry Trends

So, you want to work within the medical device or pharmaceutical industry. Knowing some of the trends impacting the field

is important. It is an exciting time within both the pharmaceutical and medical device industries as astounding scientific

discoveries continue to manifest, yet very significant changes are afoot.

Fantastical innovations have entered the market, offering tremendous value to patients, and there is seemingly no end to the

progress. However, the industries continue to be plagued with years-long challenges such as R&D productivity, regulatory

complexity, and quality systems management. Additionally, pressure to contain healthcare costs is a very real issue.

The following are some of the leading factors carving the future course of the medical device and pharmaceutical industries:

Diagnosis to Prevention

The global population is aging, most certainly including the U.S. population. An aging population coupled with increased

prevalence of chronic disease has moved the medical device industry’s focus from diagnosis to prevention. Remote

healthcare, wireless enablement of device control, and devices that reduce or eliminate hospital stays are in very high

demand. This has led to an increased focus on preventative care, remote monitoring, self-monitoring, and telehealth.

Medical Device Cybersecurity

Cyber and data security is becoming a very large issue for the market. As devices become increasingly connected with health

care providers, the associated patient data contained on these devices will need to be secured. The industry and regulators

alike will be struggling to meet these challenges in the coming years.

Medical Device Recalls and Product Safety

The industry must improve management of regulatory and compliance issues to avoid repeating the recent waves of recalls

that have cost the industry money and eroded customer confidence. Some sources cite a 97 percent increase in medical

device recalls over the last few years. Reasons for the recalls vary, but are primarily rooted in human error, packaging/sterility

concerns, and materials failures. It’s become necessary to divert attention from innovation to handling these issues instead.

The industry and FDA are working together to solve this problem.

Big Data and the Internet of Things (IoT)

Hospitals across the world are making significant IT infrastructure upgrades. As IT infrastructures continue to improve, so

will the number of medical devices that are linked to them. These devices will continue to become “smarter” and better at

optimizing treatment. Unquestionably, medical devices will take their place in the broader IoT with connections to health care

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providers, payers, each other, and, of course, patients. Ultimately, this should improve the effectiveness of care, increase

treatment efficiency, and lower costs.

Diagnostics and Biotechnology—Blurring Lines

Pharmaceuticals are becoming increasingly intertwined with medical devices as the number of combination drugs

(combination medical device and drug) continues to increase. Specifically, biopharmaceuticals and diagnostic devices are

becoming especially intertwined. In an effort to increase efficiency and lower costs, many pharmaceutical companies are

incorporating diagnostics early in the R&D process. These diagnostics can help forecast which patients are more likely to

respond favorably to a given treatment before treatment even begins.

Specialty Drugs Lead to Questions

Precision, specialty, and other targeted therapies offer lifesaving and/or life-altering therapies to underserved—and

sometimes unserved—patient populations. While many of these drugs are incredibly beneficial, most are also very expensive.

For example, Sovaldi, the treatment for hepatitis C launched in 2013, costs around $84,000 for an average treatment, or

about $1,000 per pill.

According to Tufts Center for the Study of Drug Development’s 2014 study, it costs $2.6 billion to win final approval for a drug. On

average, actual out-of-pocket costs are approximately $1.4 billion and time costs total $1.2 billion, resulting in the $2.6 billion figure. In

the case of blockbuster drugs that serve large patient populations, these development costs are spread across large patient populations.

Specialty drugs, on the other hand, have much smaller patient populations resulting in very high costs for the finished drugs.

A large portion of pharmaceutical market revenue growth is being generated by a proportionately small number of patients,

which raises questions relating to systemic affordability.

Therapeutic Value and Performance-Based Therapy

Providers, medical device companies, and pharmaceutical companies are increasingly required to prove patient benefit as

courses of treatment are being selected. This is commonly known as ‘patient outcomes’. Although still in early stages of

program development and execution, payers are working diligently to apply performance-based considerations as drugs and

devices are selected and levels of payer coverage are being determined.

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From the Life Sciences ProjectManagement Trenches

While all the information we have shared with you is a culmination of many years of project management, medical device

and pharmaceutical industry experience, we felt it was important to invite project and program management leaders actively

working within the field to share their experiences and insights.

We spoke with the following five project management leaders: Craig Josephson, former Head, Portfolio & Program

Management Office, ICU Medical, Jennifer Erpenbeck, Life Sciences Project Manager Leader, Annette Johnston, Senior Project

Manager, Abbott Laboratories, Diagnostics Division, Kevin Grossenbacher, Principal Program Manager, Leading Medical

Device Organization, and Karen Zylberman, Senior Director, Global Program Management, Takeda.

Their insights are reflected below.

Why did you decide to become a medical device program manager?

Kevin: I spent 18 years at Motorola in a variety of functions and roles, starting in manufacturing and ending up in program

and project management. My last role there was a director of program management for software applications development.

After Google acquired Motorola they started going in some different directions from a software development standpoint and

ultimately decided to eliminate the entire group I was in, which consisted of about 400 application developers.

I had a great career at Motorola, but things change and this was an opportunity to take inventory of what was important to

me. I wanted to stay in the Chicagoland area with a program or project management position and find an industry that was

comparable from a compensation perspective. I settled on medical devices as the target industry to pursue. In addition to

meeting my key criteria, it is an interesting field that offers the opportunity to make a difference in people’s lives.

What was the process of finding your first medical device position?

Kevin: I spent a couple months tuning up my resume and networking. I had a few interviews, but things weren’t quite working

out primarily due to my lack of experience working within the medical device industry, despite my extensive program and project

management experience. As luck would have it, I had a lunch with Joe Coletta, the CEO of 180 Engineering. I brainstormed some ideas

with him about how to best get into the medical device field and he recommended that instead of considering only full-time positions,

I look at a contract position within a medical device company to get some experience under my belt that would open future doors. I

thought that was a great suggestion and started to customize my search for those types of opportunities.

It just so happened that two weeks later, Joe had a contract position at a medical device company for a program manager –

the rest is history.

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Jennifer: I started my career in the automotive industry, then moved to telecommunications. While working within

telecommunications, I became increasingly captivated by the product management side of the business. I also became

fascinated by the pharmaceutical industry, due both to the positive impact I could have on patient populations in need and

the complexity of products and projects within the space.

I found my opportunity as a quality engineer on a drug-device combination product team within a major pharmaceutical

company. Although I was hired as a quality engineer, I quickly began carving out the position I truly wanted by assuming

project management roles.

I was able to step into a project management role, even though it wasn’t formally a project management position. I was

an engineer—I didn’t have regulated industry experience at that time, but I came in and was really excited about product

development, and got the opportunity by seeing the organization’s need and making a place for myself.

What advice would you have for someone interested in pursuing a career in life

sciences project management?

Craig: For people interested in pursuing a life sciences project management career, I advise trying it out. An individual on a

functional team can simply proactively pick up chunks of work to coordinate. This is an outstanding way for the team member to get

a feel for whether they would enjoy the work of project management, and whether they have the necessary abilities and disposition.

Starting the journey of project management from within the area of one’s experience and understanding is a great way to do it.

Jennifer: Build strong leadership skills; be passionate about what you do; don’t limit yourself; create high levels of value for

your organization. I think we often hold biases in our head and we hold ourselves back. You just have to go out there and try it

and demonstrate value. I am often asked how I know whether someone will make a good project manager.

Karen: People exploring the possibility of pursuing a project management career need to ask themselves several questions: do they

enjoy working within a team, do they like building teams, do they have excellent communication and problem-solving skills? And

increasingly, the need for some innovative thinkers is being realized. Recently, we did this little exercise among my eight project

managers to determine where we fell on the innovation scale. We asked, ‘Do you like to develop the ideas? Do you like to critique the

ideas? Do you like to implement the ideas?’ Eight out of eight fell on the implementation, including myself. We’re strong implementers.

We’re all skilled implementers, and I think we went into project management because we saw that about ourselves – we like

to make things happen. But I think sometimes we would be well served to have some team members who naturally think

in a more innovative way. I’m looking for people who are open to looking at a bigger picture, building ideas, and thinking

strategically and can also manage complexity and ambiguity.

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Kevin: There is a belief of some in the field that if you don’t have medical device experience, you may not have the right qualifications

to do the job. Unfortunately, I see this attitude quite a bit. However, I recommend finding opportunities to get your foot in the door.

Things like taking short-term contract positions so that you get some familiarity with the industry and some experience under your belt.

Second, start to understand the lexicon of the industry. That way, when you’re in an interview you can at least understand and

communicate using some of the proper verbiage. Design control terminology, DMR, DHR, DHS, and so on. Being able to speak

to the FDA guidances and ISO standards that are common to the industry is also important.

Finally, I recommend networking - it’s good to just talk to people. Ultimately, that’s how I got my chance. I met with Joe to

network and brainstorm ideas and next thing you know, he needed somebody with a skill set that matched mine.

Annette: I would advise them to consider getting a PMP certification and/or a Six Sigma Black Belt. I think the team management

skills are the same regardless of the industry you decide to work in, and with a PMP you will have broader job application possibilities.

Generally speaking, a Six Sigma Black Belt is most useful for people looking for a continuous improvement type of position.

Also, you can’t start early enough. Someone still in school could try taking on the management of a project. If you’re in your local

engineering society, decide to mentor a robotics team, or even Girl Scouts – the sooner you start managing projects, the better.

Is Project Management Right for Me?Self-Assessment

We have talked a great deal about what project management entails, the skills required, and have heard from accomplished

executives within the field. So, the question remains. Is project management right for you?

Let’s have a little fun. We have created an “Is Project Management Right for Me?” self-assessment designed to help you

self-reflect. This assessment is not rooted in scientific study or statistical projection - that’s not its purpose. Rather, its job is

to make you think about your strengths, weaknesses, passions and interests.

We have provided the self-assessment in two different formats. First, a static version requiring you to tally your own score.

Assessment completion and tabulation instructions are below.

Secondly, we created an interactive digital version that will tally your score for you. Take the online self-assessment at:

www.180engineering.com/PM-Assessment

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Never True

TypicallyNot True

OftenTrue

MostlyTrue

x 1 x 2 x 3 x 4

=TotalScore

Project Management Self-Assessment

I can stay flexible, motivated and focused during ambiguous, unstructured, and changing situations.

I find that people naturally follow my recommendations and advice when I present a logical business case.

When I see a problem, I dive right in to find a solution.

I am a good listener.

I am comfortable working with different personality types and am able to see situations from others’ perspectives.

People trust me, feel comfortable sharing information with me and discussing challenges.

I get excited when the team succeeds.

Effective verbal and written communications come naturally to me.

I can analyze details while keeping the big picture in mind.

I have strong planning skills.

I feel very comfortable leading meetings with my peers.

I feel comfortable delegating tasks.

I feel comfortable communicating with senior executives including hosting meetings and delivering bad news.

I am good at prioritizing in dynamic situations.

Subtotal of checks for each column:

Multiply your subtotals by:

Add all together for total score:

Instructions: For each statement, check the column that best describes you. Please answer questions as you actually are (rather than how

you think you should be). When finished, refer to the tabulation instructions on the following page.

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Project Management Self-Assessment

Tabulation Instructions:

• For every “mostly true” answer, give yourself 4 points.

• For every “often true” answer, give yourself 3 points.

• For every “typically not true” answer, give yourself 2 points.

• For every “never true” answer, give yourself 1 points.

Score Interpretation:

46-56You were born to be a project manager. While everyone, no matter how well they fit a given role, has areas that can use

improvement, you have everything it takes to succeed in a project management career. Go for it!

35-45You have strong project management abilities. While you will likely need to work on some skillsets if you pursue a project

management career, you have a strong base of required skills. Simply be honest with yourself about your areas of weakness

and focus on either improving or compensating for those areas.

24-34You have some of the core disposition and skills required of project managers, but you may need to consider the organization

and the specific roles you pursue. Perhaps your strong technical skills are what is needed for some projects giving you time

and opportunity to improve project management skills.

Below 23You likely have strong functional position skills, you may be happier leading functional initiatives as a core team member.

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About 180 Engineering180 Engineering is exclusively focused on identifying and engaging top engineering and technical talent either with specific job opportunities or simply building our talent network so that we can quickly and effectively fill positions for our clients when the need arises. Project and

program management positions, both direct hire and contract placements, are one of 180’s select areas of specialization.

Why hiring organizations work with 180 Engineering:

• Fast time to fill for direct hire and contract talent - 53 days compared to 90+ days

• High percentage of placements per job order - 39% compared to 24% national average

• High percentage of fills per contract - 42% compared to 24% national average

• Low candidate introductions to hire ratios - 27% candidate submittals to hire compared to 16% national average

• High contractor retention rates - 98% contractor retention rates compared to 70% national average

Why candidates work with 180 Engineering:

• Deep matching of candidates’ skills and personalities to opportunities

• High direct hire and contractor retention rates reflect attention to both the needs of candidates and hiring organizations

• Individualized coaching and interview preparation

• Dedication to the engineering and technical fields offers a robust ongoing career management resource

180 Engineering

4300 Commerce Court, Ste 315, Lisle, IL 60532

info@180recruiting.com

© 2017 copyright 180 Engineering. All rights reserved.

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Seeking new engineering opportunities or seeking an engineeringtalent recruitment partner?

Contact 180 Engineering. We’re looking forward toworking with you for mutual success.

About Project Management in Life Sciences (PMinLS) PMinLS is a group of individuals working in, or interested in the pharmaceutical, medical device and biotech world of project management providing an environment to expand and strengthen life sciences related project management capabilities.

The face-to-face quarterly meetings are free and are hosted by life science companies in Northern Illinois. PMinLS is a membership organization. The annual fee gives members access to additional benefits such as free webinars and other members-only benefits.

Dee G. Suberla, PMP, MBA is the Founder and President of Project Management in Life Science. She is also the author of Poof! You’re a Project Manager and Other Delusions of Grandeur.

For more information about PMinLS including membership information and upcoming events, please visit: www.pminls.com