Watching A Train Wreck

“It’s like watching a train wreck”. I’ve heard this expression several times and repeated it myself often, especially since starting consulting several years ago. And it seems like a few client engagements in 2011 have been train wrecks of sorts.

I usually look forward to these types of engagements. Usually these opportunities present quite a bit of “low hanging fruit” to help the company in question make a few tweaks and modifications to drastically improve outcomes. Many times, this type of scenario works out well, allowing us to establish a strong bond and rapport of trust very quickly.

However, there are those occasions where this type of scenario never pans out. We are nearing the end of one of these engagements now. We’ve been working for the client for several months. From day one, we quickly identified several opportunities to improve the situation. We shared our findings and were ready to start making progress. But the culture of the client wasn’t ready to tackle the solutions quite yet. So we moved on to the next set of issues. Same result.

This cycle repeated itself over and over during the course of the engagement. Now as we prepare to wrap up our engagement, I’m reflecting back on this experience to see what lessons I can take away and what milestones we were actually able to achieve. Finding significant milestones is tough. Yes, we did make a few improvements, albeit very minor in the grand scheme of things. But there are a few lessons I’ve learned:

  • Be sure executive management is on board. If not, it will be a bumpy ride.
  • Determine who the go to people are at the company. Just because someone is in a certain role with a certain title doesn’t mean this person has the necessary knowledge and expertise to be an asset. Just as important, there are people “hidden” within the company who possess a wealth of knowledge. These are the people to seek out and find as early as possible.
  • Give the client a “warm fuzzy” by showing progress sooner, even if what has been requested is a huge nebulous cluster. Figure out a way to deliver some work product for near immediate feedback. Don’t just put your head down and chip away at the big, hairy item requested.
  • Sometimes the client doesn’t know what they want, need, or asked for. Figure out what the client knows and doesn’t know. If there is something the client doesn’t know, help educate them. Use objective evidence, such as FDA regulations, as a reference rather than just sharing your own personal experiences and opinions.
  • Find the people who don’t want you there and who are constantly trying to undermine your efforts. These people often feel threatened by your presence. Try to turn them into allies. Try to help them with their needs.
  • Be firm, yet fair. Rather than try to place the nice guy all the time, be objective. Clients deep down do appreciate truth, even if it might sting a little.
I’m sure we’ll have other challenging client engagements in the future. In fact, we may just be at the beginning of another one now. I’m sure I’ll have more insights to share about this experience sometime very soon.

Big Ideas Winner Starts Her Own Company

As Big Ideas rolls around again this year, we thought we would update you on some of the winners from last year.  Jennifer Blankenship, our second place winner, was inspired to start her own company.  Here is an excerpt from her marketing flyer:

“In the competitive market of rural nonprofit social services and nonprofits engaging in effective development, grant writing, and program delivering can be exhausting.  MAE is here to help!  We can deliver the FAMILY EFFECTIVENESS TRAINING program, GED tutoring, and Self-sufficiency skills building (including employability skills building) that your clients need.  For help with time consuming development projects we are able to offer proven and experienced contracting to get the job done and bring in the dollars to keep your great programs on track.”

When asked about her experiences with Big Ideas and her impressions of the contest, Jennifer stated, “The contest gives people the support from the community that makes a big difference in taking a risk in business.  Knowing that people are hoping that there will be businesses started up and supporting that with dollars is a big incentive to overcome the fear of the mountain of work that can come with making an idea a reality.”

Way to go Jennifer!  What a great example of the entrepreneurial spirit that Big Ideas is attempting to encourage.

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You Have To Read People

As much as I’d like to believe I’m in the medical device industry, I’m really in the people business. More specifically, my job, more than anything else, is to manage and foster relationships. Until this happens, my medical device expertise means very little.

I’ve taken the Myers-Briggs assessment and am an INTJ. But I have my own business. Which means I need to be less “I” (introvert) and more “E” (extrovert). Sometimes, the “I” gets in the way. Once I understand the assignment, I have a tendency to put my head down and get the job done. Even though my clients want me to get the job done, they really want interaction–they want to feel important and valued. I have to “read” clients to understand what they need and when they need it.

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“Mandatory” Is No Longer PC

We are currently working with a medical device company, helping them improve quality systems, documentation, processes, etc. to better align with FDA regulations. Part of the engagement includes training of company personnel. We are working with an internal resource to help us with the inner workings and “landscape” of the company. She offered to help set up training sessions with site personnel.

She sent out an email to all employees with the training schedule, indicating participation in these sessions was mandatory. She was quickly reprimanded by HR because of the use of the word “mandatory”. It was suggested she use softer language, such as “required” or “sure would be a good idea”.

When did the word “mandatory” become a taboo word in the workplace?

September 22, 2010 – Your Medical Device Software May Be at Risk

Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.

By applying best practices guidance and process automation, medical device companies can reap the benefits:

  • Get through regulatory approvals faster
  • Lower costs
  • Deliver safer devices

Join Dr. David Vogel, founder and president of Intertech Engineering Associates Inc., and Martin Bakal, Market Manager, IBM, at this Webcast to gain a better understanding of this standard and how best of breed tools help tie IEC 62304 into the development process.

Web event: How to Achieve Compliance with IEC 62304 for Medical Device Software Development
Date: September 22, 2010
Time: 10:00 AM PDT
Duration: 60-minutes

Panelists for the Webcast include:

Dr. David Vogel, Founder and President, Intertech Engineering Associates Inc

Martin Bakal, Market Manager, IBM


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September 28, 2010 – Leveraging Project Management Skills as a Pharma US Regulatory Coordinator

The September public meeting for the Life Sciences Project Management group (LSPM) will take place in Indianapolis on Tuesday, September 28 at Franklin University of Ohio. Franklin University of Ohio is located on the northeast side of Indy at 8415 Allison Pointe Blvd – zip code 46250.

“Leveraging Project Management Skills as a Pharma US Regulatory Coordinator”

Presenter: Jody Roth, Principal Advisor- US Regulatory, MS, PMP, RAC, Eli Lilly and Company
Synopsis: “Developing innovative new drugs for approval requires knowing and using Project Management skills and tools. This skill set is critical for a Regulatory Coordinator who must lead an internal project team to implement a regulatory strategy and interact, negotiate and influence the FDA in order to gain final approval. Please join us as Ms. Jody Roth discusses how a Regulatory Coordinator adopts and implements elements of the PMBOK during drug development.”

Jody Roth is a Principal Advisor in Regulatory, a PMP and has her Regulatory Affairs Certification (RAC). She has more than 7+ years experience in US Regulatory Affairs processes leading internal teams and interacting with FDA reviewers and project managers.

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Regulatory & Quality Services In Demand

During the past few months, we have been in discussions with a half a dozen  or so companies–most early stage–all seeking similar advice. These companies need advice and recommendations on regulatory strategies. What do they need to do to put together FDA submissions? And can Creo Quality help?

Throughout the short history of our business, we’ve found this to be a consistent trend. Of course, it makes perfect sense. Entrepreneurs and inventors trying to develop medical devices need to obtain regulatory clearances before bringing products to market. Entrepreneurs and inventors typically have little to no knowledge of regulatory requirements. Creo Quality does.

I recently came across an article in medtechinsider about this very topic. The article references the Global Life Science Hiring Index report from ZRG Partners. The report states “Regulatory, Quality and Clinical roles were the most in demand hiring roles in the Q2 index with 27.2% of all opportunities in this functional bucket. It appears there is a fight for talent breaking out, with 63% of the opportunities in Regulatory, Quality and Clinical coming from the Outsourcing and Service Sector . . .”

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Pushing The Envelope

2010 has been a fantastic year for Creo Quality, and we still have 3+ months to go! Yes, many of the client engagements have been fairly typical for our business. But we’ve also managed to “push the envelope” a little to explore some new types of projects. And we are currently in some discussions to expand our reach yet a little further.

It might sound like we are straying from our core. No, we are staying true to our expertise in the medical device / life science sector. We are, though, figuring out how to work with new types of clients in this space and projects which are more strategic in nature. We believe we have a formula to stay ahead of the curve.

What are you doing to push the envelope for your business? Does this align with your strategic vision?

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Knowledge of FDA Medical Device Regs Critical

If you have experience with and are knowledgeable of FDA medical device submissions (i.e. 510ks), you are valuable.

If you have experience with and are knowledgeable of FDA medical device product development, you are valuable.

If you have experience with and are knowledgeable of FDA medical device quality systems, you are valuable.

If you have experience with and are knowledgeable of medical device start-ups, you are valuable.

Imagine if you are a medical device entrepreneur and start-up. You need resources in all the above mentioned areas. Where are you going to find answers?

Try Creo Quality. FDA submissions, medical device product development, quality systems, and start-ups are specialties.

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August 25, 2010 – FDA Bootcamp

FDA Boot Camp

Sponsor: ACI
Web Site:

August 25, 2010 – Sheraton Fisherman’s Wharf, San Francisco, CA

ACI’s FDA Boot Camp – the industry standard in providing non-regulatory professionals with a regulatory background – has been designed to give products or patent litigators, a strong working knowledge of core FDA regulatory competencies.


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August 24, 2010 – Global Pharmaceutical & Biotechnology R&D

Global Pharmaceutical & Biotechnology R&D – Challenges, Opportunities & Pathways

Sponsor: BioPharmaPM
Web Site:
Time: 1:00:00 PM
Location:Online EST
The pharmaceutical and biotech industries have entered an era of unprecedented change and Action for Results, Inc. (AfR) consultant Thomas J. Schulze, PhD, PMP, plans to guide industry professionals through it in a complimentary webinar. Schulze will address the issues that arise from threats to the industry’s current business model including profitability challenges, patent expirations, cost constrained healthcare systems and demanding regulatory requirements. Additionally, he will help attendees understand the objectives and outcomes necessary for successful drug discovery research, development and commercialization.

Patrick J. Riley

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July 27, 2010 – Free Webinar: Redefining Success for Life Science Projects

Free Webinar: Redefining Success for Life Science Projects

Starts: Tuesday July 27, 2010, 01:00PM EDT
Ends: Tuesday July 27, 2010, 02:00PM EDT
Event Type: Training/Seminar
Location: This is a virtual event.
Industry: pharmaceuticals
Keywords: project management, risk management, PMP, CAPM, biotechnology, medical device, life science, pharmaceuticals
Intended For: project managers, project team members

How should life science companies define program and project success? How can project managers and teams take targeted action to make their project succeed – on every level? How do we change behaviors to ensure sustainability for the longer term, including the metrics that drive critical decisions affecting the pipeline of projects?

We all know what it means to have a project fail in the traditional sense. But what about the project that has been completed, appears to do well on the surface, but has given no real value to the business? Is it still “successful”?

This webinar will introduce a foundation for redefining project success criteria for pharmaceutical, medical device and biotech companies that balances short- and longer term business needs, and allows project teams to set their project on the path to success from the start. Participants will not only learn how to build their project for the right outcomes, but also what the most important factors are that help us know, along the way, whether those outcomes are still the right ones and still achievable. We’ll explore the role of the team in making success happen, and how to get every team member focused on the right results rather than just completing a set of activities.

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May 26, 2010 – IMDMC’s Annual FDA Regulatory 101 Course

IMDMC’s Annual FDA Regulatory 101 Course

Wednesday May 26, 2010

Approved for 7.0 Hours of CLE

Presented by a host of Indiana Medical Device Manufacturing Sector Experts


Maetrics, LLC

3 More Sponsorships Available
(Sign up Through the Registration Form)

Register Online Now!

Registration:  8:00 am
Program: 8:30 – 4:30 pm
Location:  Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250

Members: $195 per person (Member discounts when registering more than 4 attendees)
Non-Members: $275 per person

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May 27, 2010 – MWDG Meeting with Scott Willis

Please register on Acteva below before end of the business day 5/25/10.

Welcome to final MWDG topic until the summer break.  Given that we have some members caught up in the downturn of the economy over the past year, we are pleased to have Scott Willis facilitating our May 27 meeting on networking.  Please join us for our last meeting of the 2009/2010 year and the MWDG Leadership Team wishes you a safe and happy summer until we meet again in the Fall.

Do you think about your career differently given the new world economy? Would you like to build better understanding of your own strengths and weaknesses? Learn to talk to other people and help them find connections and ask them to help you? Embrace the reality that life is about learning everyday and no one no matter how smart they are doesn’t need to sharpen his/her saw somewhere.

Join us as Scott Willis facilitates us through a night of Branding! Networking! And other tools to build your career!

Scott’s focus has been in sales and business development for over 25 years. He has held Director and VP roles in Sales and Business Development with such companies as Reebok, Sara Lee, Lowell Shoe, Kenra Hair Care, Product Action International and currently with Telamon Corporation.

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June 14-15, 2010 – Overview Of FDA Regulatory Compliance For Med Devices

Overview Of FDA Regulatory Compliance For Medical Devices

Who Should Attend
This course was developed for those who are involved with ensuring regulatory compliance for medical devices.  Typical attendees include those in:

  • Manufacturing
  • Regulatory Affairs
  • Product Design
  • Research and Development
  • Quality Assurance & Control
  • Development and Preparation of Submission Material
  • Laboratory Operations

This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.  The course content is continually updated by our expert Course Directors.  When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.

Learning Objectives

This course is specifically focused on the law, regulations and policies set down by the FDA for the manufacture of medical devices.  It will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to pre-marketing approval processes and compliance issues for medical devices.  The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval, how the FDA performs inspections, the type of information they are looking to see in place and the variety of outcomes from each inspection.  The course also covers the remedies available to satisfy inspectors that manufacturing processes are fully in compliance with quality system requirements.

Get more info.

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