Eyeworld

Reporting from the Women in Ophthalmology (WIO) Summer Symposium, August 10–13, San Diego EW MEETING REPORTER 124 September 2017 watch Simon Sinek's "Start With Why" TED Talk. Dr. Curnyn also recommended attendees read "Finite and Infinite Games" by James Carse. "I did not want to play a finite game anymore … I want to play an infinite game," she said, noting that in the latter you have to understand there will be different players, dif- ferent goals, and other changes over time. "I am now putting our doctors back with our technicians and our front desk," Dr. Curnyn continued, adding later that by keeping the "why we are doing what we're do- ing" in front of us, we will be able to roll with the infinite game. Editors' note: Dr. Curnyn has no finan- cial interests related to her presentation. Negotiating your worth WIO Summer Symposium Program Chair Lisa Nijm, MD, Warrenville, Illinois, and Paul Lee, MD, Ann Ar- bor, Michigan, led a discussion and interactive activity in a leadership skills workshop on negotiations. The first thing to understand, Dr. Nijm said, is that negotiations are structured interactions or dia- logue between two groups aimed at resolving a difference to reach an agreement. They are not a battle to the death, she said. Her first tip to improve nego- tiation skills is to prepare ahead of time. "Most of the hard work is done prior to meeting face-to-face," Dr. Nijm said. "You need to have a well-researched plan that you're comfortable with." A good negotiator, she said, is not only prepared but is disciplined, relentless, consistent, and practiced. Negotiating is not an inborn talent. When in the actual negotiation situation, Dr. Nijm said it's im- portant that the discussion be kept conversational, not confrontational. Your responses during this conver- sation might need to vary based on the direction negotiations take. Dr. Nijm said it's helpful to have a "package" plan for your negotiation, perhaps not just focusing on a salary number as your only bargaining point but including other incentives that might benefit you, such as time Leadership in ophthalmology A session focused on leadership skills needed by ophthalmologists with topics including managing work-life balance, mentorship, and how to lead a championship team. Kimberlee Curnyn, MD, Arling- ton Heights, Illinois, drew upon her own practice experience to talk about how to manage a successful team, often using the analogy of the ophthalmologist being the quarter- back of a football team. "I was the quarterback of the winning team," Dr. Curnyn said, explaining that after training she started in private practice and grew the practice to three locations where she handpicked key surgeons and the rest of her team. "The quarter- back is part of the offensive team … and knows that the goal is winning the game. I felt like I knew what the game was in medicine." However, Dr. Curnyn contin- ued, as time went on, she saw the game start to change, her goalpost was moving. It was like people were coming in from the stands, unin- vited, to play on her team, she said. Dr. Curnyn hired a consultant who told her to take her best front desk person, best billing person, best technician, etc., and make them leaders of those sections so she and her fellow physicians could focus on practicing medicine. Three years later, her team was decimated, she said. Some members of her staff were leaving, the culture had changed, and she didn't know why. "The wake-up moment was when I got a call from a patient describing what her experience was with my call center and my tech- nician. I realized my practice no longer reflected my group of doctors and what had brought us together," Dr. Curnyn said. "The minute we separate ourselves from our col- leagues, we're going to lose valuable insight." What's more, Dr. Curnyn said she later realized that she had taken good people in administrative and technical roles and made them leaders without teaching them how to lead. A colleague at a networking event recommended Dr. Curnyn kind of medical product it is—bio- logic, drug, device, or combination product—and how it's regulated in respective countries, Dr. Eydelman said. A drug, for example, is described as anything intended to diagnose, cure, mitigate, treat, or prevent disease. Devices have a similar defi- nition, Dr. Eydelman said, except unlike drugs, they do not work via chemical action nor are they metab- olized by the body. An investigational new drug (IND) application approved by the FDA allows for human studies with unapproved drugs, off-label indica- tions, changes in drug formulations, or changes in administration routes. Once the IND is complete, a new drug application (NDA) is filed. This application goes through medical, biopharmaceutical, statistical, micro- biology, chemistry, pharmacology/ toxicology, and labeling reviews. The basis for NDA approval is whether the benefits of the drug outweigh risk in adequate, well-controlled trials, Dr. Eydelman said. Devices receive what's called risk-based oversight, being assigned to a certain risk class (Class I, II, or III) that determines the level of regulatory control. Premarket application type for devices depends on this classification and the review standard. Combination products are a "hot new entity," Dr. Eydelman said, noting that it could be any combi- nation of medical products, such as a device and drug. The FDA, Dr. Eydelman con- tinued, realizes there is an over- whelming amount of information regarding the pathway for approval of medical products and, as such, has created several learning modules and educational tutorials available online. She recommended interested parties reach out to the FDA early in their development process as it could save them time and resources in the long run. Editors' note: Dr. Eydelman has no financial interests related to her presentation.

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