Thursday this week, I present at Venture NW and I get to tell Prolifiq’s story in 10 minutes or less (see: Put Me in Coach). Our message, of course, will be heavily weighted to our Life Sciences initiative.

One of the messages I will deliver to this institutional investor conference is the wealth destroying effects of an FDA complaint letter. On average, a Life Sciences company that receives an FDA complaint letter for fraudulent marketing practices suffers a 1% decline in market capitalization. This translates to a median drop of $86 million. (See the study here: http://www.atypon-link.com/AMA/doi/abs/10.1509/jmkg.73.6.227?cookieSet=1&journalCode=jmkg).

I recently outlined Prolifiq’s value proposition in the vernacular commonly used by venture capitalists.  The “Are you a vitamin or an aspirin?” question measures a company by its ability to deliver value based on its impact.   (see: Vitamin. Vicodin®. Vaccine. ).  Prolifiq passes the test given our ability to prevent compliance missteps.    
I don’t know about you, but $86 million is a lot of money--especially when it can be wiped out with the receipt of one letter.

Operators are standing by……

On Thursday October 1, Life Sciences industry trade group AdvaMed is conducting a webinar entitled: “Navigating the Compliance Challenges of Product-Related Communications”.

This educational session is conducted by: Elsa Chi Abruzzo, President and CEO, ARAC, LLC and Steven E. Skwara, Partner, Epstein Becker and Green, P.C.. Side by side, these industry luminaries will discuss and demonstrate how marketers, sellers and compliance officers can safely and successfully do their jobs in this “post-Pfizer Corporate Integrity Agreement” world of FDA regulation.

Prolifiq is sponsoring this webinar in an effort to raise awareness of Good Promotional Practices (GPP) and to help the industry understand how to comply with the increasingly complex web of government regulations in the Life Sciences industry.

Should you, a co-worker, or friend be interested in attending, please let us know and we will see that you get registered.

The US Life Sciences industry employs a small army, approximately 200,000 people, who are on the front-lines of this roughly $400 billion industry. Their job is pretty straightforward – they are charged with educating and informing the health care providers (HCPs) about the latest and greatest tools and techniques in patient care; and, driving the revenue of their companies.

Scattered throughout the country, and clustered around population centers, these reps traditionally work from home-based offices, and from their cars. They typically have 4 year degrees (plus some graduate level work) and are HIGHLY trained by their employers. They must know their product inside and out; they must be able to effectively deliver their pitch in 60 seconds or less – often in less than ideal circumstances; and, they need to advise highly specialized clinicians as to appropriate uses and efficacy – in short, they must be experts in their fields. They also must be businesspeople who can talk contracts, volumes, and value analysis with administrators. And, they need to document all of this on a daily/weekly basis.

The primary task of these reps is to achieve as much “face-time” with the HCP as possible, and to secure their preference for a compound, device or consumable; HCPs need and want these interactions (see: “The needy people”). Because they are so mobile, the reps have large volumes of reporting they need to complete weekly. This includes: fulfilling information requests to HCPs and VACs, call reports, inventory reconciliations, account profiles, etc. This work is often completed at night or on the week-ends.

Charles is a NW Corporate Account Manager for a life sciences company based on the East Coast. Over lunch he told me:

“The two biggest barriers to my success are time and my own company. Time is a challenge because each HCP has between 20 and 60 reps. calling on them—every day. On a good day, I get maybe 2-3 minutes with them. Time is also a challenge because of how much I have to document and communicate. My company is an obstacle because we don’t always move as fast as the market and I am challenged getting what I need, when I need it.”

Their management’s challenge is to have all of these reps operating as uniformly as possible, following the same sales “play book”, getting as much HCP face time as possible, reporting in a consistent manner, and achieving optimal sales revenue. And, did I mention, all of these activities are very closely governed by FDA regulations? The FDA “expansively” classifies anything that “accompanies” a compound or device as labeling, so anything a rep says, does, or distributes as part of their sales process may be considered to be part of the “labeling” process for the company. 

Charles went on to tell me: “I need to follow all of the rules; however, what would make my life so much easier when providing information is if it was quick, timely, accurate, and looks good. My success is dependent on my relationships; my relationships are dependent upon my ability to provide information. In this environment, that is a huge challenge.”

So, the companies spend lots of time developing processes and systems, and train, train, train…all in an effort to ensure the reps are doing the right things; and, if everybody and everything works as planned – all is well.

However, no system involving humans is ever perfect – “outlier” circumstances come in to play. How does a company respond to a request for information about an un-approved use case; how does the company ensure compliance with FDA mandated Good Reprint Practices (GRP)? How does a company ensure the rep is using the latest journal article, labeling disclosure, or price sheet? How does the marketer know who is using what material? How does the rep know what info most interested the HCP? How are these interactions “discoverable” should a compliance officer need to support and defend the actions of a sales rep? And, most importantly, how can a company accomplish all of this without adding to the time and reporting burden of the rep?

So, today’s question is: “what is: quick, timely, accurate and makes the rep look good? Oh, and follows all the rules.

Today, I am going to introduce you to the first, and most important, “persona” in the Prolifiq Life Sciences ecosystem—the Health Care provider (HCP). Typically, this HCP is a physician, however, they may be an executive administrator that is part of a value analysis committee (VAC); but, for the purposes of this post, I use the terms interchangeably.

My good friend and advisor (see: “Virgin Atlantic and Jonathan” ), Dr. Jonathan Sackier, Professor of Surgery, University of Virginia sums up his being with:

“Let’s face it – we physicians are needy people. We need to do well by our patients – we need to help them; we need to make them better; we need the best possible outcomes. We need information. Yes, we read a lot, we use libraries, we use the internet, and we talk amongst ourselves. But – the single greatest source of knowledge about the latest and greatest comes from our interactions with the sales reps. We need to hear from them.”

The HCP is the person whom the life sciences (pharmaceutical, medical devices, or biotechnology) sales people wish to interact with. The HCP is THE person who is on the front-lines of health care delivery in this country, and is often faced with life or death decisions. This person typically has 8+ years of under-graduate and graduate education, has typically received medical board accreditation, and is required to receive continuing medical education (CME) to stay current with their profession.

Over the last several years their lives have changed dramatically. Escalating business operating costs, managed care and federal reimbursement practices have driven the industry to consolidate. Rare is the sole practitioner; specialty groups have emerged and hospitals have come to own many physician practices and clinics. The HCPs need to see and treat increasing numbers of patients in order for their business model to work.

The thing that motivates all HCPs is: to do what is best for the patient – each and every time. They look to achieve the best possible outcome for each patient; these outcomes are often driven by the use of certain compounds (pharmaceutical or biotechnology) or certain products and procedures (medical devices and biotechnology). These compounds, products and procedures are developed through a complex research and development process that combines industry investment, clinical research and governmental oversight and regulation. The HCPs need to be kept up to date through the consumption of scientific, educational and promotional material from the industry in order to understand how to achieve the best outcomes possible.

The challenge for the HCP, and the LS sales representative, is their time to interact is becoming more and more limited. These exchanges may need to take place at a scrub sink; they may take place between patient exams; they may take place walking in the hallway; and they can increasingly take place electronically (increasingly, HCPs are becoming avid computer and smart phone users). In any case, the HCP has: 1) a need for timely relevant information, 2) limited time, and 3) limited attention span. And, most importantly, the HCP wants to be able to consume the information in a way that suits their learning style.

William Greenebaum, Administrator, OHSU Dotter Interventional Institute tells us:

“We pride ourselves on our reputation for innovation.  We value the professional collaboration that exists between industry and our physicians, without which we are less likely to fully accomplish our mission of excellence in patient care, teaching, and research.”

When we identified this market, we studied the HCPs to understand their needs. So, today’s question is: what is the best way to satisfy this need?

Next up:  Feet on the street.

For some, these two words may conjure up images of beer-influenced frat-boys and their merry-making ways; however, for Prolifiq, this means management is going out to meet customers and prospects. Several of my co-workers love to say: “…good things happen when we’re on the road…”. What they are referring to is how well the Prolifiq story sits with people who have the opportunity to hear it.

Starting September 13, Prolifiq is engaging in a series of events to promote the Prolifiq for Life Sciences offerings. This is the culmination of a lot of HARD WORK by the entire company. We have been serving – quite successfully, I might add – several Life Sciences companies for the last 18 months. Earlier this year we consciously decided to focus our attention on this industry because we have helped transform how these companies work.

These events are designed to dramatically increase our awareness in the sector; and, to increase our market penetration. We have great solutions for real-life, day-to-day challenges this industry experiences; and, our market research tells us we’ve nailed it. Maureen has done a fantastic job leading our thinking; and the whole team has performed in bringing it all together. It hasn’t all been pretty; but nothing worthwhile is ever easy or pretty.

My next series of posts will take you through the four personas we impact in the industry (salesperson, marketer, regulatory affairs professional and the healthcare professional), the specific challenges they face, and the activities we are engaged in to serve this industry. I will share with you some of our challenging deliberations, talk about our website machinations, the word-smithing on our messaging, and through it all I’ll really open the door on Prolifiq. This is in keeping with a commitment I made in my first post on the subject (see: “You’re doing what?” ). Through the process you will hopefully learn more of who we are. Good things happen when we’re “on the road”.

One evening over a steak dinner, Jeff Gaus, the CEO of Prolifiq Software, offered me a job. Out of the blue. Without an interview. Did I mention I wasn’t job hunting? And, never mind that I had never worked in the software or IT industry. Or, that the last time I did any software programming was in the mid-80s when I was using Fortran for Fourier analysis. In fact, all I remember about software programming now is receiving extra credit for the inadvertent spillage of perfume on the program print-out I turned in (+3 points for “best scented code” as I recall).

On the other hand, I was a huge believer in Prolifiq. My two most recent companies were Prolifiq’s first and second medical device customers. At AtriCure®, we had been hunting for a solution that provided compliant distribution of promotional materials for the sales force. Coming up empty-handed, we built our own software-validated, digital distribution system. A year later, we found Prolifiq. Prolifiq had a more thoughtful and integrated SaaS solution which allowed a sales rep speaking to a cardiac surgeon to send materials immediately from his mobile phone, all while abiding by the rules. This was exactly what we needed.

As each new rule governing promotion of medical devices emerged (and there were many), I found myself summarizing the key points and emailing it to Jeff as another valuable opportunity for Prolifiq. I knew the rules were changing and wanted to ensure it was robust for the regulatory folks yet easy for sales – so I could focus on what I did best, marketing. 

In retrospect, perhaps I should not have been surprised after all.

Jeff explained that Prolifiq was hunting for deep domain expertise in a new business vertical (tech lingo for focusing on one industry). By now, you must have guessed why he was talking to me.   Their new initiative was medical devices where I had spent the last 20 years comfortably ensconced.

"Two roads diverged in a wood, and I - I took the one less traveled by, and that has made all the difference." (Robert Frost)

Next…My First Day of Kindergarten, at 44.

I like to follow unusual paths.  After four years of hard work earning a biomedical engineering degree at Duke and one year at Cordis in engineering, I lobbied my way into the Marketing department.  Why?  I wanted to be closer to the customer – the physicians, the patients and the clinical aspects of technology. And, I was very lucky that Bill Schwartz and Stan Rowe were willing to take a chance on a young engineer who wanted to use both sides of her brain. 

Over the twenty years since, I stayed the course in medical device marketing. In mid-2008, a friend and former colleague and I started to brainstorm regularly about unmet needs and possible new medical device technologies to develop – he said that he had “one last start up in him”. One day I suggested that there had to be an opportunity in the growing breadth and depth of complex regulatory requirements surrounding promotional (sales) and educational materials in medical device companies, including Advamed Code of Ethics and the new FDA Good Reprint Practices. 

Because of the increasing legislation and its influence on promotions and promotional materials, I started to joke in my last few medical device companies that I didn’t need an MBA to advance; I needed to go to law school. Ultimately, we were unable to conceive of a viable product solution to the increasing legal and regulatory hurdles faced by medical device manufacturers, and we moved on in our thinking. 

Meanwhile, the answer was right in front of me.

Next…The Road Less Traveled

Read more about Maureen
Press release: Prolifiq Further Expands into Medical Markets with New Hire Maureen A. Shaffer

Driving to work this morning, I was listening to an oldies station (yes, I am middle aged) and heard an old Police song, “De do do do, de da da da”. These two lines caught my attention:

“Poets, priests and politicians
Have words to thank for their position”

They reminded me how powerful words really are. Love. Hate. War. Peace. Freedom. Respect. Charity. Kindness. All words that conjure up strong emotional images.

Our founding fathers certainly understood how powerful words are – they guaranteed our right to use them freely in the First Amendment to the Constitution. Advertisers and marketers know the power of words as well – they use them to incite certain behavior.

However, freedom of speech does not give a person the right to yell “fire” in a crowded theater; nor, does it mean a marketer can say “free” or “the best” when either is not true or an un-substantiated claim. So, over the last 230+ years, we have developed cultural norms and codified rules and regulations governing how we say things and when certain words are appropriate. As our culture and language continues to evolve, the rules continue to change.

Sellers are another group who “have words to thank for their position” (see: “Seven words”). We use words to uncover hidden needs; we use words to describe our products; we use words to evoke images; and we use words to elicit behavior – moving prospects to buyers.

Again, the First Amendment does not give us the right to say what we want, whenever we want. Nor will our management let us. There are a myriad of reasons including: truth, safety, consumer protection, and brand to name the most important. These are dictated by government statute, marketers and legal advisors; all for good reason. But the key question is: how does one allow freedom while maintaining control of speech in the selling situation?

This is the “mountain range” we claimed when we conceived our platform. After we built and released the product, we sought the appropriate word to name our company – one that would evoke the right image in our customers’ and prospects’ minds. This was one of the most challenging exercises we have ever embarked on.

“Don’t think me unkind
Words are hard to find”

Luckily, Neil had an inspiration while on his morning run, and the creative agency agreed. Thus, Prolifiq was born. Over the last several years, we have used the platform to create a space of “controlled freedom” that ensures digital media is used appropriately on the front lines of the seller-customer interaction. One customer told us: “Prolifiq is a 1400+ SAT word!” Bingo. We evoked the right image. We make sellers better, faster, smarter communicators; in doing so, we make them more effective.

Recently the value of this was made abundantly clear – salespeople are going to jail. One of their offences: making their own marketing material. This offence is something the FDA and DOJ take very seriously, for good reason.

This should give you an idea of how we are applying our expertise to the healthcare industry with our entry into medical devices. Salespeople should be able to practice their profession; but, they have to follow the rules. Marketers need to provide the means to do so. Maureen has done it; and, she is going to share exactly how to go about it. Her first post publishes tomorrow.

“When their eloquence escapes you…..”

In the 1970’s Victor Kiam became famous because he liked the Remington Razor so much he bought the company. I don’t think there is a higher testament to a company’s products or services than when its customers want to work there, or in Victor’s case, to own the company.

Maureen Shaffer is a lot like Kiam – she joined Prolifiq at 8:30 Monday morning as our VP of Healthcare, see press release here. Maureen has an extensive and impressive resume in the Healthcare industry. It includes: a degree from Duke in Biomedical Engineering, and stints with US Surgical (now part of Tyco Healthcare ), Cordis (now part of Johnson & Johnson ), Heartport (now part of Johnson & Johnson), and Prolifiq customer AtriCure. In all of her industry roles, Maureen was responsible for managing new product introductions and marketing for some major players in the HUGE US healthcare industry.

Maureen first recognized the value of Prolifiq to a Medical Device sales and marketing team (see blog entry: Virgin Atlantic and Jonathan) after reading an article about what we were doing for GE (see: “Follow The Lead….Fast!” ). Thus began a three-year relationship that moved to the next level on Monday.

When we first started discussing having Maureen lead our efforts in Healthcare, I asked her if her career goals were to impact 5-7 more companies (the likely number of “gigs” she would complete before retirement) or whether she wanted to transform an entire industry. She chose the latter (evidence that she is motivated and has ambition—traits we covet). So, here we are.

Under Maureen’s direction, we will transform the lives of the 250,000 plus sellers and marketers of the US medical device, pharmaceutical and biotech companies. I am going to let Maureen tell you what we have (it’s BIG and transformative) and I am going to let her tell you how we are doing it. She starts blogging here within a week.

The key to why Maureen will be successful is because she has lived the life of our target customers and has the battle scars to prove it. Also, she has already deployed a solution (twice) that has solved the key issues. In this age of social media and peer experience, there is nothing like working with somebody who has DONE IT to help you solve the problem.

So, what’s next on MY list; stay tuned, I’ll be telling you all about it.

I had the honor of having dinner with Charlene Li, co-author of Groundswell last Thursday night. I heard Charlene speak 3 weeks ago at a conference held by one of our customers; she had provided the audience her email address, and I wrote her a note. That’s how we ended up meeting face to face.

Charlene, and her co-author Josh Bernoff, had much to do with this blog and for the transparency we have as we approach the medical device market. We had been talking about blogging for over a year; but, Groundswell gave us the courage to embark on what some have construed to be a very risky strategy (see: “You’re doing what?”). There are many other things we have incorporated into our daily lives and operations that are discussed in the book; so, Charlene—THANK YOU!

The food was excellent; however, I hardly remember eating. Charlene indulged me for almost two hours allowing me to tell the Prolifiq story. It was fun to remember the last 8.5 years—both the good and the bad. What a gracious listener; at the conclusion of dinner, Charlene thanked me for MY time and then asked: “What can I do to help you?”

I said, “You can tell me what I am doing wrong.” Charlene leaned forward and said: “Well, with your legacy of rich media, I am quite surprised you don’t have any video in your blog.” Talk about the proverbial “duh” moment. Of course─why wouldn’t we use video in our blog? Very simply, because we are the barefoot cobbler’s kids; the toothless dentist, etc. Point made; point taken. We need to eat our own dog food. Charlene – look for video posts very soon.

If you are a Prolifiq customer, when I pull out my flip™ video camera and ask you to repeat something—give Charlene all of the credit.