The goeverment of Indonesia is implemntening atransition in the sustainability of the health system that includes, among other things, the development of medical devices made in the country to reduce its reliance to imported medical devices. Through The Regulation of The President of Republic of Indonesia Number 12 of 2021, the ministries/institutions/regional apparatuses are obligated to use domestic products, including national design and engineering. The obligation to use domestic products is performed if there are domestic products that have the sum of National Contribution Value (Tingkat Komponen Dalam Negeri, TKDN) plus the Corporate Contribution Value (Bobot Manfaat Perusahaan, BMP) of a minimum of 40% (forthy percent). The change of new regulation ompacted PT XYZ, a company supplying medical davices mostly to goverment institution experienced turbulence, sales performance 2020 drop more than 50% compared with 2021. New bussines strategy is needed to adapt, develop distincitive value to set apart from rivals and at the end optimized the revenue. The study uses of a thorough research technique performed in June-October 2024 that comprises busniess model canvas, stakeholders analysis, TOWS matrix, Porter's Five Force Analysis. The Medical devices industry is highly regulated segment, shere some requirement like TKDN is mandatory to fulfilled. PT XYZ experienced challenges in the bussiness due to late of adaption to new regulation. The firm sholud assign resources to ensure all legal compliance is in place. The opportunity in the segment is quite attractive however the rivalry among competitor is categorized as high due to similarity of the product offered. PT XYZ has to strengthen the 9 branch office to reach more customer and deliver its value proposition, focusing on hospital which have note engaged with BPJS and hospital in district level where product substitutes is exist. By implementing the reccommended strategies, PT XYZ can enhance its competitivesness, adapt to market changes, and achieve sustainble and profitable growth.