Monday, March 28, 2011

Melissa Rosen, SDM '11: Developing Medical Devices and WiSDM

Melissa Rosen
Photo by Kathy Tarantola Photography
By Ethan Gilsdorf






As a project engineer for the Swiss-based consulting group Helbling Precision Engineering Inc., Melissa Rosen, a first-year student in MIT's System Design and Management (SDM) Program, has been involved in the early stage R&D process for medical devices for nearly five years. She leads development efforts to create devices such as drug delivery systems for diabetes patients and implantables like hearing aids.

But as an "ethical engineer," she does not merely focus on her company's bottom line. She wants to create products that both enter the marketplace at the right time and improve the quality of life for those who suffer. "There is a fine line between medicine and business," Rosen said.

The SDM program is helping Rosen strike that balance.

The professors, courses, and community are widening her view of her industry to include all stages of product development — from conceptual design and market studies through regulatory approval and manufacturing. It was one of her faculty members, Eric Von Hippel, professor of technological innovation, who stressed how crucial user needs are in product design. "A patient carries a device like an injection pen or infusion pump with her every day. But it's not just about the technology. Getting that device in a patient's hands and having them provide feedback is extremely important in the design development process. I remember what Professor Von Hippel said: 'The actual users are the ones who are going to innovate.' The professors here are some of the most notable and respected thinkers in the world."

Rosen, 31, holds a BS in mechanical engineering from Carnegie Mellon University. Before Helbling, she worked as a design engineering supervisor for Thermal Circuits Inc. and as a process engineer for Raytheon. Her initial interest in medical devices sprung from her work at Thermal Circuits, where she was on a design-to-manufacture engineering team that created neonatal incubators and heating systems used to automate hospital pathology.

Unlike other SDM students who come from far-flung lands, Rosen grew up in Marblehead, MA, and now lives in Lynn with her husband, Christopher Ceruolo. As a commuter student, she takes a full course load (36 units), while also continuing to work at Helbling's office in Kendall Square. "In looking for a graduate program, I wanted to stay at my job and not relocate," she said. "SDM has been a perfect fit for my career goals."

Despite matriculating just last fall, Rosen is already seeing how her education impacts her day job. "When I come back to the office after class, I have the ability to apply what I've learned immediately," she said. "I can feel myself developing as a person, becoming more proficient in making strategic decisions."

Melissa Rosen, second row from top, second from left,
with members of Women in SDM (WiSDM).
All are in the SDM '11 cohort.
On top of her demanding schedule, Rosen has also made it a priority to enrich the experience of her fellow students. She was an organizer for the SWIM (Sloan Women in Management) Fashion Forward event, an annual fundraiser benefiting Artists for Humanity (which gives undeserved youth in the Boston area paid employment in the arts) and Dress For Success (which provides disadvantaged women with professional attire). Rosen was also a panel organizer for the recent MIT Sloan BioInnovations Conference 2011, where industry leaders such as Steve Rusckowski, CEO of Philips Healthcare, and Peter Hecht, CEO of Ironwood Pharmaceuticals, spoke about trends in life sciences and arising challenges. "We are lucky to get speakers with such impressive global industry experience to discuss the challenges future leaders will face."

Rosen is now reinvigorating WiSDM (aka Women in SDM, and pronounced "wisdom") and was just elected the group's chairwoman. Via networking events, WiSDM informally recruits prospective female applicants and supports women to enter the male-dominated field of engineering and management. "I want to encourage the younger, upcoming generation of women."

Rosen's academic goal at SDM is to more deeply immerse herself in what she calls the "holistic systems" of her field: biomedical business strategy, FDA regulations, intellectual property management, clinical trials and political decisions. "I've discovered this is an incredibly complex process. Developing a medical device can take 10 years and billions of dollars. It's not like making an iPhone app." She expects the MIT SDM program will help her gain a deeper understanding of that process, and better manage it as she rises to higher positions of authority in her field. Her SDM thesis will likely focus on the challenges facing the processes of commercializing biomedical products.

"Throughout my career, I want to introduce high-value products to the market that have a positive impact on the way people live," said Rosen. "In addition, I want to help reduce time, cost, and risk through developing those products."

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