Roberta Goode began her career on a path that is rare among other entrepreneurs. After earning her high school diploma at the age of fifteen and entering college at age sixteen, Roberta’s goal was to study pre-med biology, complete medical school, and establish her clinical practice as soon as possible. Upon completing her bachelor’s degree at the University of Miami, which boasts one of the nation’s top medical schools, and with her full-time position as a programmer analyst (to finance her own education), Roberta’s plan was to complement her natural love of medicine with a strong foundation in technology. The best way to do this, she felt, was to pursue an advanced degree in biomedical engineering prior to applying to medical school. Upon earning a Master of Science degree in Biomedical Engineering in 1991, she was recruited by Cordis Corporation (a Johnson & Johnson company) where she gained extensive product development experience and was promoted to senior product development engineer by the age of 28. She quickly earned four US patents for her novel cardiovascular device designs that were eagerly adopted for clinical intervention around the world. In a life-altering moment of insight, Roberta realized that she could benefit many more patients in this role than as a physician in private practice. Thus, when Baxter Healthcare’s Renal Division offered her an opportunity to expand her product development skills to include manufacturing, quality assurance and regulatory affairs in intensive, hands-on assignments with their world-class organization, Roberta didn’t hesitate. Recognized as a talented engineer with business acumen, her career took another leap in responsibility when Baxter's Vice President for New Product Development recruited her to expand Baxter's client base by leveraging new and existing technologies for novel clinical applications. Easily making the transition from product development to partnership development, Roberta Goode’s career really had nowhere to go but up. She didn’t disappoint, championing the commercialization of multiple medical applications for diverse indications ranging from wound sealing in open spinal surgery to an artificial liver bioreactor as a bridge to organ transplant. Additionally, her proximity to and involvement in the contract negotiations and business development activities inherent in nurturing these business relationships provided a complementary element to her skills in science, technology, engineering and mathematics. Equipped with these business development, manufacturing, and regulatory affairs skills, Roberta’s career took another leap forward when she founded Goode Compliance International, an engineering services firm specializing in remediation of compliance actions levied upon medical device manufacturers by global regulatory agencies. Armed with her designation from the American Society for Quality as a Certified Quality Engineer and a Certificate in Management and Leadership from the MIT Sloan School of Management, Roberta built GCI’s corporate compliance division from the ground up. She provided pivotal leadership in building out corporate quality systems and establishing patient-focused risk management and validation practices for her clients, resolving regulatory restrictions and directly impacting patient safety. This stunning success was fueled by Roberta's broad industry and academic networks developed through adjunct faculty appointments at the University of Miami’s College of Engineering and George Washington University’s School of Medicine and Health Sciences. With Roberta’s reputation and her well-managed consulting firm, she grew GCI from a staff of one to a staff of sixty-five engineers in only eighteen months. Roberta and her colleagues at GCI provided expertise on process validation and recertification of legacy medical products, resulting in the resolution of regulatory agency compliance actions for the device manufacturers and more reliable products for the physicians and patients they serve. Word travels quickly in this industry, and GCI’s accomplishments soon earned them the trust of 17 of the 20 largest medical device manufacturers in the world.

Her vision led to an innovative and award-winning business model in which top engineering college graduates are mentored and poised for success in the resolution of technical and regulatory compliance challenges for the world’s largest medical device manufacturers. Roberta takes pride in her clients’ successes, and in the shepherding of young engineering graduates into meaningful careers. She demurs that her team are to be credited with these accomplishments, which enabled GCI to create over 350 engineering jobs in Florida. But most significantly, Roberta finds meaning in the knowledge that these efforts have improved the quality and safety of the lives of the many patients whom they have touched.

After a 6-month hiatus to care for her terminally ill mother, Roberta turned her attention to the challenges patients and their healthcare providers face when attempting to balance quality of life with extension of life at all costs. A published author acclaimed public speaker, and patient advocate, Roberta was inspired to develop and communicate practical toolkits to drive consistent industry best practices in risk management and benefit/risk assessment in healthcare. Founding Altrec, LLC, she launched the Benefit Risk Collaborative Community in partnership with the US FDA and industry leaders, to arm patients and their physicians with practical decision-making tools to balance benefit and risk in treating disease. Recently joining forces with Florida Death with Dignity, Roberta now collaborates with over a dozen other states to allow terminally ill individuals to legally request and obtain medications from their physician to end their life in a peaceful, humane, and dignified manner at a time of their own choosing.