Corporate Vision May 2017

38 CORPORATE VISION / May 2017 , so we are always expanding our knowledge. Lastly, I am driven to deliver the best possible solutions to our customers. This might mean working tirelessly to prepare for a regulatory meeting or traveling abroad to support a client during a difficult audit. This focus, passion and drive results in our clients getting 110% when they work with MethodSense. How do you think the industry has changed over the years, and has this affected your business? The life science industry is constantly changing. New regulations are developed and existing regulations are modified, requiring that we regularly monitor evolving compliance requirements. Technology, especially software, has completely changed the medical device landscape, which has required MethodSense to cultivate the skills necessary to guide our clients through various requirements. Working in an industry that changes so frequently means we never get complacent. We are always keeping an eye out for what has recently changed and for what is on the horizon. What advice would you give to other women looking to succeed in your industry? What attributes do you believe are vital to reaching the top of a firm within your sector? I feel very fortunate for my success. The Duke MBA program prepared me for business leadership; and my 10 years of work at Underwriter’s Laboratories helped me understand how and why regulations are developed, giving me tremendous insight for interpreting the regulations and standards required for medical device commercialization. To become successful in the life sciences, it is important to maintain relevance by understanding how the industry changes, not just from the regulatory standpoint, but from the perspective of innovation, as well. For other women looking to succeed in our industry, I would recommend they become actively involved in the topics they are interested in and stay focused on their goals. If they aspire leadership, I highly recommend a good MBA program to develop a foundation of business skills. I also recommend they find a knowledgeable mentor who can guide them through challenges, help them understand the industry and keep them motivated. What are your thoughts on the state of your industry currently? Are there any particular issues/changes that are affecting it? This is an exciting time in the life science industry. Medical devices are getting “smarter,” and the industry is evolving to meet the challenges this creates. The application of new technologies, such as the use of mobile platforms, will alter the medical device landscape. It will be very interesting to be a part of this shift toward personalized healthcare and healthcare that is more distributable and available through technology. How important do you think technology is in your industry, and how do you ensure it is used effectively? Technology is critical in my industry. More and more medical devices are incorporating software, communicating with networked systems and other devices, and connecting to patients using smartphones. Regulations and guidelines related to software are changing to meet the demands of the industry, which, in turn, requires manufacturers to understand what is necessary for them to maintain compliance. As consultants in this field, my team needs to stay on top of these changes in order to guide our clients appropriately through their regulatory pathway. We are well versed in software validation, software development lifecycle requirements and methodologies, and software risk management, and this knowledge is applied to many of our clients. What are your future aspirations regarding your business? Do you have any future plans/projects you would like to share with us? For the future, I see our team growing in knowledge and expertise. We will continue working on complex submission projects that require strategic thinking to bring products to market, such as advanced cancer treatments, radiological devices, combination products that include medical devices and pharmaceuticals, mobile medical devices that deliver more personalized healthcare solutions and many more products that utilize software to control devices and information. I have a positive outlook for the future of the medical device industry, and I am looking forward to the new challenges it will bring. “In this day and age, I feel hard work, dedication and perseverance can bring success to anyone – whether male or female. Because I have never let sexism be an issue, it never has been”