This paper elucidates the history, the design philosophy of innovation and the transformation of an old process-technology into a breakthrough, evidence-based therapy with international medical acceptance, verification of effectiveness as well as the strategic business model employed. Pulsed electromagnetic field therapy (PEMFT) was not medically acceptable and was, until recently in disrepute, professionally speaking. A revisiting of the technology with reference to the partially inconsistent, yet positive anecdotal results obtained, gave rise to in-depth analysis as well as scientific research conducted by independent institutions which resulted in the identification of the key physiological parameters which in turn could be related to a significant improvement of pathologies. By applying and promoting a systems approach as practiced by engineers who were involved in complex multidisciplinary projects for many years, a different perspective on the innovative development of PEMF therapy was established. The innovative process-based therapy working mainly at cellular and self-regulation level was a paradigmatic departure from the indication-based therapy as applied to pharmaceutical therapy. Over the past 10 years exceptional breakthroughs of the nonsymptom based therapy have been documented through clinical trials, scientific medical investigations and the publication of relevant literature. The turn-around of the old and insufficiently understood technology into an innovative, significant, scientific breakthrough-technology, requires a paradigm shift which is analogous to working in a different culture. It is surmised that this paradigm shift will strongly influence medical schools and practitioners over the next 5–10 years. The authors, as “outsiders” to the medical discipline, bring an engineering perspective to bear on the development of innovative but system-integrated medical devices which can promote the medical device industry and bring system engineering approaches into the realm of medical technology and therapy. Both authors have presented a number of papers at international conferences individually and in partnership on the topics of strategic business leadership and business transformation, system thinking and holistic management model development for high technology companies.