Using Consulting Resources Effectively - Part I

You know how it goes...a whiteboard chock full of prioritized strategic initiatives and projects that all need to be implemented this year.  Annual spending budgets may have increased slightly year over year, but certainly not significantly and not keeping pace with business demands.

No longer can your internal business customers wait many months for delivered benefits and results.  The Lifesciences compettitive landscape has only become more and more competitive; patent expirations, generic competition, biosimilars, increased regulatory scrutiny and legal burdens and the higher costs associated with bringing new products and devices to market.

A recent 2012 Accenture Lifesciences industry study states, "The revenue forecasts...reveals how starkly the future prospects have changed for several of the companies over the last three years. The four year forecast (2013-2016) remains low for some companies which continue to struggle to navigate a path back to growth after the worst of the patent cliff. A few even face the prospect of a second round of significant patent expiries and are forecasted to have negative growth. However, several companies are forecast to grow in line with the estimated global market growth of 4-5 percent, having articulated a clear path back to growth and making substantial strategic and operational changes.These companies are adjusting to a “new normal” where profitable growth is still attainable, although harder to achieve." 

Do you have a plan? How will you resource strategic projects this year? This buyer’s guide will assist you in navigating the hazardous landscape of buying consulting services.

Let’s first look at defining your project type.

Project Categories:

Strategy - Architecting new business and IT solutions by shifting previous thinking and adopting new approaches.  Here, our categorization of strategy projects is "pure strategy", it does not include the execution or implementation phases which would later fall into one of the below categories. 

Large Scale Transformational - Efforts attempting to deliver benefits across an entire organization, or multiple business functions simultaneously.  High degrees of business and IT complexity, organizational changes and many moving pieces equates to large:  program budgets, project resources and capital expenditures.

Large Divisional - Delivered benefits intended to impact a single large company division e.g. Research and Development or Sales.  Even the most straight forward implementation will be complex due to size and business criticality. 

Departmental - Vertically organized to produce results that impact specific business functions e.g. Legal, Compliance, Regulatory Affairs.  Smaller in scope and complexity of a Large Divisional program.

Ad Hoc or Incremental - The smallest of the project categories, often used to incrementally build upon previously delivered benefits, for example system enhancements or extensions, and continuous improvements to business processes.

In Part II of this series we will show you a behind the scenes "menu of consulting firms" available to fulfill these project types. 

About Us:

At CompassX we know all about strategy implementation and great project execution excellence.

Learn more: kyleh@compassx.com  |  www.compassx.com | © COMPASSX GROUP, 2013 All Rights Reserved.

No B.S. Time Management Book Review

Recently I finished reading Dan Kennedy's "No B.S. Time Management for Entrepreneurs, the Ultimate No Holds Barred Kick Butt, Take No Prisoners, Guide to Time Productivy and Sanity".  The title is quite a mouthful, and a bit flashy, but the author's content is worth the read.

Since many of my clients and friends are not business owners, I wanted to extract the bits most relevant to both leaders, employees, and business owners. 

• Kennedy takes you through a series of steps on how to value your time in dollars.  The punchline...your time is worth a lot more than you think, treat it as your most valuable resource.
• Increase your productivy by "getting lost".  Kennedy provides an example of a businessman who rented a small office neither at his home office or onsite work office.  In this example, the man was not productive in either of the typical settings because of frequent interruptions.  His third office provided him with the opportunity to harnesh his producitvty zone.  Find your "third office", whether this be home, a closed door office, conference room, library or coffee shop.
• Link everything you do to your goals - multiple times per day.  He recommends frequently asking yourself, "Is what I am doing, this minute, moving me measurably closer to my goals"?  A >50% "Yes" rate is your benchmark, strive to constantly push this percentage higher.
• Delegate and then keep yourself out of the way. Kennedy has a little saying when delegating, "Good enough is often good enough", meaning often the delegator will have a better way of doing things or at least believe he does.  By stepping out of the way, and letting the results materialize, you will often find the results are indeed good enough.
• Reasons why a year passes and no meaningful progress is made.  This final chapter is the most poignent.  Write down the 3-5 most important, highest value, daily tasks that will return big dividends.  Make yourself do at least one of these tasks every day without fail.  This may require some serious self-discipline, tossing out old ideas and re-arranging your daily routine, but Kennedy points this single disiplice out as the number one factor of personal and career success.

For more material on Dan Kennedy see www.dankennedy.com

Speaking Bureau: Life Sciences’ New Compliance Normal

Life sciences chief compliance officers are not taking many vacations these days.  Regulations are requiring compliance departments to delve progressively deeper into interactions with health care professionals (HCP’s) and health care institutions (HCI’s).  The physician speaking bureau is one such HCP interaction which has come under increased regulatory scrutiny.

Speaking Bureau → Training → Programs → Events.  Great compliance programs will ensure “compliance entry gates” are in place prior to each stage of a speaking bureau.  Long before a HCP has delivered on her speaking engagement, a series of best processes must be in place; they must be enforceable, repeatable and reportable. Not only will these procedures protect a high risk corporate work-stream, but these same procedures will serve as proof of organizational training that is aligned with your company’s compliance policies.

Entry Stage.  A speaking bureau allows for the organization of life sciences marketing objectives, key opinion leaders, speaking events, regions of coverage and all of their associated details.  Much the same as a folder is used to organize paperwork, the bureau is used to group similar topics with a specific purpose.   To maximize the bureau’s effectiveness, acceptance into the speaking bureau should be dependent on the following categories and the proper auditable documentation of the following:

1. Good professional standing. Includes verifying: state and federal licenses to practice, Office of Inspector General excluded individuals, and generally sound existing public relations.
2. Curriculum Vitae.   A potential speaker’s career should illustrate a consistent track record to be given the opportunity to present to highly skilled peer groups, including areas of specialization and clinical experiences.
3. Fair Market Value Compensation. A consistent method or tool used to calculate payment standards for honoraria both within the organization and pan-industry.  Notice should also be taken to ensure payment maximums are not exceeded and, when exceptions do occur, a clear supporting explanation with executive level approvals provided.
4. Contract or Agreement. A fully executed contract with the primary or secondary speakers defining: scope of services, expected dates of program performance and completion, honoraria (gathered through the Fair Market Value process described above), travel and lodging reimbursement policies.
5. Compliance Certification.  An additional but recommended step to clearly presenting your compliance department’s policy to your potential speakers.  This additional certification clause brings special attention to important matters such as: non-approved, or “off label”, questions and answers, mandatory use of pre-approved materials and slide decks, and procedures to ask clarifying questions prior to the actual event occurring.

Training Stage. Once a speaker or HCP has passed the entry criteria for a bureau, proper training is required to meet regulatory training guidelines and ensure the speaker is fully prepared to facilitate speaking sessions on behalf of your Life sciences organization. Proper record keeping and documentation of the following activities is a must have.

1. Attendance & Understanding.  A speaker must attend a training session (either live or web-based) and present an understanding of the materials covered through interactive feedback.
2. Pre-Approved Materials.  The importance of using only pre-approved materials and slide decks should be reinforced during training.  Deviations from pre-approved materials has proven to lead to an increase in speaking infringements.
3. “Off Label” Discussions.  Another priority of your training sessions with speakers will be to reinforce the proper dialogue and communication around non-approved, or “off label” questions and answers during actual events.  It should come as no surprise that this particular area has come under much regulatory scrutiny over the past several years.  The ability or inability to execute controls in this one area should be treated very seriously and given top priority by compliance organizations.

Program & Event Stage.   Only after meeting the above criteria and passing thru the Training Stage should a speaker be allowed to conduct or facilitate an actual event.  Now your policies and processes are put to the test.  This final stage represents a delicate balancing of your organization’s sales and marketing efforts with regulatory and compliance requirements.

1. Aggregated Spend. Spend must be tracked not only on honoraria for the speaking training and program participation but also, due to newly enacted regulation PPACA, expenses such as airfare, lodging, and meals will be reportable for speakers and attendees.
2. Monitoring. Sample or risk based auditing by field compliance team members allow a “boots on the ground” approach to learning about complexities, potential bottlenecks, compliance improvement areas and reporting issues, as necessary.  This monitoring exercise may also extend into other related areas of HCP interactions such as office visits, training and advisory boards.
3. Attendee Lists. In addition to the actual speakers, processes should also capture the participants’ attendance for the proper allocation and recording of items such as #1 above, Aggregate Spend capture.
4. Attestation & Feedback Forms. Your compliance reach will go only so far, and help from your field representatives who will be attending the speaking events provides an opportunity to push your policies to the level of direct daily interactions.  An attestation to the delivered program’s compliance effectiveness provides another level of ownership and buy-in.  This follow-through will enable your organization to react quickly to gaps and facilitates continued improvements in future sessions.

Due to their federal promotional categorization and direct interaction with HCP’s, speaker bureaus lie directly in the crosshairs of regulatory scrutiny, creating a high risk environment for Life sciences compliance departments.  Compliance officers need to orchestrate a symphony of risk mitigating processes with extremely varied departments such as: marketing, commercial, clinical, legal, and information systems in order to produce the elite outcomes necessary for meeting the “New Compliance Normal” of their speaker-physician bureaus.

This article was originally published on March 29, 2013 at Corporate Compliance Insights  http://www.corporatecomplianceinsights.com/speaking-bureau-life-sciences-new-compliance-normal/