Wounds. Just the term itself evokes unpleasant images for most of us. Lesa Hobright-Turner, however, has dedicated the majority of her career to researching and developing better biocompatible and reinforced materials for the advanced management of wound healing. 

As the Director of Clinical Affairs at Synovis Life Technologies, her focus is on therapeutic wound technologies

How does one become involved in wound management and find it provides them with a challenge?  When Lesa returned to the workforce after beginning her family, she took an administrative position with Augustine Medical to make use of her Communications degree.  Reporting to the VP of Clinical Research, a vascular surgeon, she was asked to proofread a manuscript he was reviewing for an investigator.  He likely expected the document returned with a few spelling errors and grammatical corrections.  Instead, he got the manuscript back with red marks all over it.  Not only did Lesa change and alter the intended areas, she also posed thought provoking questions in the margins regarding the research, and found a few holes in the data. 

Her supervisor took Lesa under his wing, mentoring her and encouraging her potential through her career progression.   Although she did not have a scientific background, she quickly learned about the products and therapeutic areas they were working on.   Her interest was piqued, and she became educated not only in temperature management, airway management, and wound care, but also how to dissect a piece of literature and study design.  Her intent was to become a more valuable employee. 

Lesa’s work included collaboration with the overseas Wound Healing Research Institute located in Wales.  . She decided to begin a master’s degree program medicine at the University of Wales, College of Medicine in Cardiff Wales.  It was a unique program based on 10 modules and a thesis.  Four times a year, Lesa traveled to Cardiff, Wales for classroom lectures and then returned home to write papers to demonstrate her learning.  Not only was the program very conducive to the working professional, it also provided an international forum, as students came from all over the world. In addition to learning different wound healing protocols, Lesa also learned about different regional healthcare systems and that in some countries you had to be on a waiting list just to be seen for a cold or flu.  The end result was a Master’s in wound healing and tissue repair/cellular regeneration, and a very well rounded education with a global perspective.

One highlight Lesa recalls was being invited to the European Tissue Repair Society Meeting in Ireland.  She was asked to present on cost effectiveness.  This seemed like a fairly simple topic, but Lesa spent a great amount of time trying to research comparisons to the US. Lesa felt a need to relate to her audience and the options in their various countries, such as using a pressure offloading cushion for a wheelchair versus a roll of towels to achieve the same affect.  The presentation served two purposes.  First, a culmination of everything she learned in graduate school paired with her hands-on role at Augustine. Secondly, an understanding of how fortunate we are to have the resources we do in the US. 

Lesa spent over 5 years at Augustine in clinical research.  The most valuable skill she learned from her mentor was what she describes as “the underbelly of medicine”.  He taught her the inside workings of the clinical community and how to interact with anyone at any level.  He taught her to manage the medical piece of what they were trying to accomplish.  Most importantly, even though many people have “a sense of both fear and respect” when talking to physicians with expertise in their fields, he taught her to approach collaborative partners in research as their equal.  Over the years, this last skill has been a huge advantage to Lesa as she is able to maintain control of research objectives. 

After Augustine, Lesa joined St. Jude Medical and worked on three IDE heart valve studies.  At the time, the organization chose to contract with a large CRO to complete monitoring in one of the studies.  They learned a very valuable lesson.  They thought the CRO knew exactly what oversight was needed; however in the end the CRO had done something completely different.  Painstakingly, Lesa’s team had to remonitor the 500 patient entire trial, some covering a five year period.

This experience fueled Lesa’s next move to join PPD as Director of Medical Devices.  Her intention was to learn the inner workings of a CRO. If she ever had to outsource again, Lesa would have a better understanding of the CRO's role. She spent three years at PPD on new therapeutic areas in a fast paced environment, learning how to put bids together and managing a team that worked on diverse projects. As a result, Lesa gained the ability to ask difficult questions of CROs to get to the root of their understanding of a project as well as how to uncover hidden costs.  However, there was a lack of personal satisfaction for Lesa as any product had to be returned to the client.  She found she missed having full ownership.

The opportunity to join Synovis and focus on soft tissue technology arose about two years ago.  It was what Lesa needed to  return to using her research skills within a therapeutic area she had a passion for.   Lesa is happily working on 5-7 post-market trials and manages a staff of three people. She loves Synovis as she feels it is the right size and poised for growth in 2010. 

With this growth comes the challenge of finding qualified talent to supplement her team in the coming year.  One thing Lesa has noted over the years is that some in the industry feel the need climb the ladder quickly which can lead to being “promoted to a level of incompetence”.  This is akin to a top salesman being promoted to area manager and failing miserably because their forte is selling and relationship management versus people management.  Lesa has seen individuals promised a higher title and level of responsibility who failed to grow into the role and never developed the skills to succeed. She strongly believes in diligently working up the corporate ladder and achieving a given promotion based upon demonstrated competence.

In talking about her fourteen years within clinical research, Lesa mentioned the uniqueness of beginning in this field without a scientific background.  It could have been a huge obstacle in her path, but her mentor stated it was “mind over matter” and if she really wanted to become a clinical researcher, the only thing that would be stopping her is herself.  Lesa forged on, motivated by seeing well run clinical trials and their effect on improving patient care.  She found that everyone was supportive, even the key leaders and “icons” within wound care.  They went out of their way to help, recognizing Lesa was part of the next generation who would carry the torch to continue their work. Lesa gained further knowledge, challenged herself and motivated her team to complete the best research possible.  As a result, Lesa developed the competencies for each new level of responsibility.

With each day; Lesa sees opportunity to improve a patient’s quality of life. She doesn’t just want to care for wounds, she wants to heal them.  Lesa feels that the Synovis products can help heal both acute and chronic wounds and provide patients with a better outcome. Whether she has a good day or a bad day, something she accomplished will make a patient’s life better.  It invigorates her, challenges her to go back the next day and do it all again.

Pamela Wolfe is a Business Strategist and President of Big Bad Wolfe Strategies. She works with healthcare related companies to create solid foundations and develops organizational strategies. For assistance in achieving strategic goals, through growth preparation, market assessments, organizational efficiencies, or operational streamlining, please contact Pamela at wolfestrategies@comcast.net or at 763-258-7027.

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This is the second article to help in your quest to  implement Lean in a regulated industry.   It has been interesting to hear from some of you, and how the last article resonated with you.  One individual commented that they related very well with changing SOP’s to just satisfy auditors.  Thank you and please keep your comments coming.

So what is the magic bullet of lean implementation?  I have found that sheer perseverance and resilience is what you truly need.  These qualities will help you and your organization sustain the elements of the lean system you are implementing.   It is acceptable to alter some lean tools to fit your organization; however, the basic elements of the tools should be kept as is.

Let’s discuss what can be done to ensure that standardized work instructions, standard operating procedures, expendable supplies and raw materials are always ready for an audit from one of the many regulatory agencies that visit us each year.  I had good success as the kaizen facilitator for a continuous improvement event in this area.  Before this, whenever the medical device company heard of a coming audit, everyone would scramble to make sure that the current revisions of documents were being used on the production floor and in the office.  A Kaizen team was formed to determine what could be done to eliminate this wasteful task and to ensure that the proper documents, procedures, and inventory levels were maintained at all times so there was no need to do the “audit scramble dance”.   The team was comprised of the manufacturing manager, product quality supervisor and a production floor lead person.  This team worked for a week to develop a system that would work, be sustainable and have accountability all at the same time.

The assessment process, as it became to be known, (regulatory would not let them use the term audit) consists of several elements.

1. Each work cell has a set of assessment cards created specifically for the cell.
2. Assessment cards are laminated flip cards used as a check list when each cell is assessed
3. Each card is unique.  Create one card for each of the following categories:
   
   1. Personal Protective Equipment and Safety
   2. Tool Calibration
   3. Expiration dates
   4. Maintenance
   5. Work Order, Material Deviation control
   6. SOP revision control
   7. Work cell cleanliness
   8. Use of lean flow
4. The lead person for each work cell uses the cards to assess the cell on a weekly basis.
5. The lead person notes the results on a form located within the cell.
6. Each month all of the production managers are given one or two work cells to assess.  The assessor then completes the form started by the lead person. (Here is the twist)  This time, the manager scores the cell based on each flip card.  One point is given for each card with no errors, a zero if a finding is found.  A perfect score on all cards enters the work cell in a drawing for a free lunch at the company cafeteria.   The assessing manager also lists any findings they have found on the scoring sheet.  Positive comments are encouraged as well.
7. Each manager then turns in any findings to the respective manager responsible for the correction of findings. 

When the assessment process was first implemented it took several months to clean up existing problems, but once done, most assessments have not found any critical problems.  One will always find minor issues, but with each lead person, line supervisor and production manager knowing what problems have been found and corrected, there is now an ongoing accountability to maintain audit ready documentation and facilities.

Using this type of assessment process eliminates the wasteful “audit scramble dance” while providing a leading indicator that shows what needs to be corrected before an auditor finds it.

As we continue this series of articles on lean in regulated companies, your input and comments are welcomed.  If you have something you would like us to discuss, please let us know.

Mike Elbert of Elbert Lean Business Systems provides coaching and implementation support to small and medium size companies wanting to improve their operations and business processes. Mike can be reached at www.elbertleansystems.com, mike@elbertleansystems.com, or 612-845-2912

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Anulex Technologies, Inc. Announces the Launch of the Xclose™ Plus Tissue Repair System and Achieves 7,300 Patients Treated Milestone

Anulex Technologies, Inc., a privately held medical device manufacturer focusing on spinal disc Preservation & Anular Repair^™ products, announced the commercial availability of the Xclose™ Plus Tissue Repair System at the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves meeting in Orlando, Florida.

The Xclose Plus Tissue Repair System incorporates a number of advances that greatly simplify implantation of the device, enhance the mechanical closure of the tissue and allow the surgeon to implant in more challenging tissue. These advances were accomplished with the development of Invisiloc™ Technology, a proprietary locking technology to reduce the total mass of the construct while enabling smooth tensioning of the system. Additionally, the combination of materials provides a more durable implant.

The Xclose system has been used in over 7,300 U.S. procedures to date. Xclose was cleared in September 2006 for use in soft tissue approximation for procedures such as general and orthopedic surgery. Xclose provides a simple, convenient method for treating the compromised soft tissue of the anulus fibrosus.

The Medical Device Alliance includes press releases from local medical device companies every month. Please feel free to send all PR to kirbys@mfrall.com for potential future inclusion.

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