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Practical Tips

A top-level sampling of advice we've provided to clients over the years:

• New Product Development
• Compliance
• Business Alignment
• Project Management
• Security & Privacy
• Information Management
• Choosing Consultants & Contractors

 

New Product Development Tips

Communicate Your Competitive Advantage in the "Flat" World In the today's increasingly interconnected global world, your organization's overall cycle time (from product concept to market release) is your true competitive advantage. In order to improve your speed, focus your organization by making the priority of each new product crystal clear across the entire company, from Finance to Human Resources to IT to Shipping & Receiving.

Involve Marketing & Sales Get your Marketing and Sales departments involved as soon as possible. Recent research increasingly shows that the quality of your consumer and market research is one of the very few crucial factors in a new product's level of profitability.

Hidden Inefficiencies in a Regulated Marketplace Because regulations level the playing field, time-to-market is often determined by your organizational level of bureaucracy. Ironically, this is especially true in those areas of your company with little or nothing to do with the specific regulations. Lengthy purchase order processing times, inflexible vendor approval procedures or protracted technology IT evaluation-approval periods can bury your productivity and grind down your bottom-line.

Four Top Technologies to Speed Time-to-Market Within the past 10 years, the top four technologies critical to speeding your new product development cycle are:  3D printing and faxing, 3D computer-aided design/manufacturing software, remote collaboration tools such as videoconferencing and WebEx, and automated molecular modeling systems.

Follow Hewlett-Packard's Ink Trail When Hewlett-Packard engineers discovered inkjet technology, the company immediately assembled a cross-functional team of engineering, sales and marketing, purchasing, finance, manufacturing and early-adopter consumers (both business and personal). This cross-functional team quickly realized the market potential was much better for the personal user rather than the business user, and thus, even today, Hewlett-Packard dominates the inkjet market.

Use "Genenchecks" Pharmaceutical company Genentech set tight development timelines couple with significant financial incentives (a $3,000 "genencheck" for each member of the project team) to focus its  teams. This approach can also help minimize the risk of "rabbit-hole research" (wherein scientists and engineers pursue tangential research or designs that could be followed-up later after the new product is on the market).

"Book-shelve" Your R&D Abandoned or otherwise dead-end product development projects should be catalogued and indexed to allow the research to be recalled easily for review and possible placement into new product ideas over time. Work with your IT department and your records management group to store the research in such a way as to allow for trigger-points and easy searching / browsing.

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Compliance Tips

Vendor Support With a turn-key installation, ask your vendor to perform and document a qualification/acceptance test of their equipment (including hardware and software). Then, setup annual maintenance "health checks" to examine, clean (if appropriate), and recalibrate their equipment. This dual-tact will reduce the man-hours your personnel (or an outsourced provider) will need to expend to complete and maintain validation, and thus reduce the overall compliance lifecycle cost.

Accountability of IT Ensure that your Information Technology department understands its accountability, directly or via its outsourced providers, for the compliance of any system automation or administration. Time spent by product development engineers or scientists on computer system administration  equates to a loss in business productivity and a greater risk of non-compliance.

Procedure Writing, Tip #1 Write procedures so they can be followed by personnel knowledgeable in the field to which the process applies (laboratory science, database administration, etc.), but are not so detailed as to be followed by inexperienced personnel. Processes that are too detailed increase both the risk of non-compliance and the costs of compliance to maintain the document over time.

Procedure Writing, Tip #2 A good target for the level of writing appropriate for procedures that strike the balance between detail and ambiguity is the Flesch-Kincaid Grade Level between 11.00 and 12.99. You can determine this score automatically when checking for spelling and grammar with Microsoft Word.

Three Critical Components of Compliance Initiatives For any compliance initiative make sure to include three components:  get IT involved to automate compliance over the long term; pull in all functional groups touched during the process being reviewed to ensure comprehensive compliance; and use the initiative to streamline the process prior to putting in the compliance checks and balances.

Reliance Upon E-Mail Avoid relying upon e-mail alone to demonstrate compliance intent. First, in reviewing e-mail threads, it is too easy to miss something. Second, e-mails are too easily edited after-the-fact without leaving a trail. And third, the majority of e-mail systems are not designed as stable, long-term storage repositories.

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Business Alignment Tips

Project to Strategy Alignment Establish a direct line of sight between the top 10 business projects and the IT and compliance funds supporting those. Projects not directly supporting these top business objectives do not need to be done.

Two Crucial Business Case Elements A good business case for any proposed project will answer two specific questions:  precisely how the project results will support strategic objectives and precisely how the project will improve the company's operational or strategic effectiveness.

Be a Stockholder First Every IT person - from intern to CIO - every compliance individual must actively be on the lookout for new technology advancements, new processes and method refinements that can save enough company money or increase company productivity enough to offset both the initial implementation and the long-term management and compliance oversight of the new technology / process.

"Desired Business Outcome" Field On every internal form - project proposals, change request forms, and so on - set up an initial field that asks for a non-technical, jargon-free explanation of what the desired business outcome is from the client's point of view; this explanation should be understandable by everyone the project, the change, etc. affects. This simple step will help IT and Compliance professionals to keep in mind the business impacts of their activities.

Business Goal Champions Many organizations have adopted the "project sponsor" concept, someone who champions a project. However, during the project, the sponsor often turns into an evaluator, sitting on project board meetings, reviewing timetables, costs, and so on. A far more powerful role is for the sponsor to have two responsibilities:  [1] keep the project's team focused on reaching the business goal, and not getting distracted with technological tools or compliance targets; and [2] vocally support the project's business goals beyond the project board meeting walls. Business executives gain more time on their schedule, the project gains more focus and support, and the company benefits.

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Project Management Tips

Incentives for Project Teams For approved projects, implement an incentive program for all project members that pays off only if they complete the project early and under-budget and meet or exceed pre-established quality control measures.

Establish Project Team Rapport Successful projects are inevitably completed by people who have some degree of trust for each other's expertise and capabilities. Forget the blind-folded, team-building kumbayah sessions; hold a get-to-know-each-other lunch. Exchange resumes and fifty-word summaries of your career. Hold a virtual luncheon with remote work-teams and have each team or person eat food prevalent in the other team's culture or location.

Brainstorm Your Plan with Sponsors Prior to planning the project, set up a targeted brainstorming session with your project sponsors. Have them imagine the project is complete and then, working backwards, ask them two questions:  "What was one specific action that sticks out in your mind that gave you the confidence we were making progress?" and "What was one specific 'gotcha' you were surprised we overlooked?" Cover these points with your project team and ensure they are tackled in your project plan (and any status reports).

Project Management Software At the risk of offending professional project managers, most project planning does not require the complex tools on the market today. Rather, a simple outline in a word-processor or spreadsheet application is usually sufficient. The key is to capture and organize project ideas, information gathering stages, necessary meetings and decision points, and implementation periods.

Report Project Status Transparently Trouble in projects is often hidden until it is too late and some level of value or cost-control must be sacrificed. Try having other vested parties in your organization, like the project beneficiaries, report on its status to the project board or sponsors rather than the project manager.

New Technology Projects New technology is a relative term. The simple reality is that if a technology is new to your organization, it is unproven for your business. Therefore, adopt a low risk approach and conduct a low-cost, proof-of-concept first with a small, but diverse functional business group.

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Security & Privacy Tips

Reduce Spam, Tip #1 One underused method to reduce the spam in your life, the SpamPlan, is a straightforward four step plan written at a non-technical level:  How you get spam > Create a private e-mail with a registered domain > Create aliases > Give out alias addresses.

Reduce Spam, Tip #2 Set up a free e-mail account through Google, Excite, Yahoo or another internet portal, and use that for all on-line transactions, newsletters, subscriptions, blogs, forum posts, etc. Abandon it when it gets too much spam. Give the ISP address that you pay for only to friends and family.

Reduce Spam, Tip #3 On your website encode your e-mail address so that it displays properly when viewed in an internet browser, but it cannot be harvested by spammers because on the back-end it's all gibberish in decimal character entities. A wonderfully easy site for this (a couple of clicks is all it takes) is the Email Address Encoder.

Surf the Web Safely In addition to virus-scan protection and firewalls, consider using virtual PC tools like GreenBorder to protect your PC in the background or plug-ins like SiteAdvisor that scan sites for adware and annoying pop-ups, warning you with color-codes (green, yellow or red).

Public Wireless "Hot Spots" Assume that public wireless "hot spots" are not secure and that people can see information you see or send over a public wireless network. To protect yourself, ensure that you are using a firewall on your laptop or other portable device, and only log onto pages that have the gold lock of SSL in the lower right-hand corner of your internet browser.

Passwords, PINs and UserIDs, Tip #1 Today, it is unrealistic to memorize all your electronic accounts and their passcodes. One option is for every website or membership program to which you belong, print out a copy of the site's homepage and write your UserID and passcode on it, then file it. For encrypted files, consider printing out the first page and writing the key-code on it.

Passwords, PINS and UserIDs, Tip #2 A second option to manage your UserIDs and passcodes is to create a running "password repository" on your computer of your accounts, your IDs and your passcodes, and then print out a hard-copy once a month. For encrypted files, record the key-codes you utilize.

Consumer Computer Security Consumer Reports has done a good job of synthesizing various security and privacy options, plus tools and nine specific tips for maintaining safe surfing and privacy on its Cyber-Insecurity site. There is also a slide show of their visit to Symantec's Internet Security monitoring center.

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Information Management Tips

Naming Schema The value of information is partly reliant upon its connected nature, so establishing a simple, easily recalled naming scheme for your files is important for productivity. One approach is to use David Allen's Getting Things Done methodology and name your files with the term that means the most. Use standard abbreviations ("mtg" for "meeting") to shorten the names and ease scannability.

Brief, Memorable File Names Regardless of the capabilities of your Electronic Document Management System (EDMS) or other electronic information solution, brief, meaningful names ("FDAmtg_NewProdAlpha") will always be better recalled by you. The goal is to name files in such a way that you will not have to open the document to see what it's about. From a technical standpoint, despite vendor claims to the opposite, any file name over 128-256 characters runs the risk of file corruption over time, particularly on your archival media.

Separate Active from Completed Completed project files, reference material, e-mail over 6-12 months old, etc., should all be stored in a "Reference" or "Completed" folder, preferably by year ("projects_2005"). This will provide you two simple productivity gains:  faster, simpler searches for information and quicker, easier review during corporate records review procedures.

Annual Reviews Beyond the need for compliance with corporate or legislative record-keeping requirements, you should review all the rest of your files and e-mail (don't forget Sent Items) yearly. A good rule of thumb:  for files you do not need to retain for corporate or legal reasons:  if you find yourself thinking, "Someone might need this someday," either identify that specific someone and give it to them, or delete it/throw it away. If you are hesitant about this, review the first five minutes of the movie About Schmidt (2002) to see what will likely happen to your carefully shepherded "someone/someday" files.

Rule of Three If you have not actively referenced a document or file in three years, and it's not required to retain for specific corporate or legal reasons, throw it away/delete it. If it is required, send it to storage and get rid of it cluttering up your physical/electronic workspace.

E-Mail and the CYA List In a political world, the Carbon Copy (CC) list often grows and grows as messages pass back and forth, and becomes a cover-your-___ list. Do not partake of this after three e-mail exchanges. Pick up the phone, go see the person or call a meeting. In over fifteen years, we are not aware of a single argument or "robust discussion" that was satisfactorily resolved via e-mail.

E-Mail and the BCC List In our experience, there is only one legitimate reason for the Blind Carbon Copy (BCC) field, and that's to copy yourself on a message for later filing or tracking. Other uses of the BCC field we've seen are usually bad form and often smack of whispering behind someone's back. If you need to keep someone else in the loop, forward them a separate copy of the original e-mail message.

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Tips for Choosing External Help

Collaboration Capabilities Look closely at a consulting company's ability to collaborate with your team.  Is the consultant in "tell" mode or "listen & understand" mode?  Does the consultant see your unique needs or simply view your company as "another industry example"?  A key giveaway is if his/her recommendations are overly complex or optimistic, or have a templated, cookie-cutter feel.

Avoid Surprise Endings Follow a defined process to manage your expectations, involve all key stakeholders, determine accountabilities and measure performance.  Ask how the consulting firm will handle requests that fall outside the signed contract or what will happen if business circumstances for your company change and you need to renegotiate the contract.  Many companies tack on additional fees simply for dealing with a change, much less solving the new request in the first place.  This can quickly eat up any initial cost savings.

Beyond Reputation Many companies look at a consulting firm's reputation as the deciding factor for engaging one firm over another. Apply a lesson from the investment community and remember that "past performance is no guarantee of future performance." Take stock of the value the firm is providing, its product quality, the key personnel you would work with, the firm's flexibility and its commitment to stand by its work long-term.

Outsource Strategically When deciding upon outsourced providers, determine which providers can perform best at particular capabilities - rarely does one-size-fit-all. For instance, Chrysler outsourced its components to several suppliers to ensure a good mix of competitive costs, high quality and efficient delivery.

Hidden Outsourcing Costs Remember that the further the outsourced provider is from your firm, the more likely logistical glitches, bottlenecks and cultural challenges will occur and drive down the profit returns anticipated. When considering outsourcing costs and savings, a good rule of thumb is to set an unanticipated cost buffer between 10-25% and then re-evaluate if the financials are still positive.

Due Diligence Research One way to review a company's expertise is via LexisNexis® or the Yearbook of Experts. Select a few simple key words central to what you need (such as "compliance" or "innovation" or "FDA") and then perform a search. If the company has personnel known for their expertise in those particular areas, it should show up. Then review the details of their profiles for specifics relevant to you.

Outsource Incentively Preferably, you should only work with vendors, outsourced providers and consultants who will guarantee their work - this provides incentive to do a good job. However, sometimes, the best job is done by vendors who get paid for performance. Imagine a website maintenance and optimization service that was paid more based on the higher your website ranked in the search engines and the greater the number of high quality leads you received.

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