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Every OEM that was surveyed in the lead up to the creation of 2017’s agenda mentioned regulatory guidelines and compliance as a concern. Right now, compliance becomes more and more critical as the FDA’s current focus is on third party providers and their relationship with OEMs.
Strict guidelines are a necessity that the industry understands. In a life or death setting, there is no time for faulty equipment. There is a reason why OEMs are concerned, however. These very same regulations can also impede innovation. For example, apps built within a CRM that are not “quality certified” get shut down. Due to the sheer number of spare parts, regulatory bodies are forced to cherry pick what, when, and where they are going to enforce. Unless you are a big hospital or facility, JCAHO cannot enforce everything 100% of the time, creating an inconsistency in who is being carefully watched over.
Still, medical device equipment, spare parts, and how the technician fixes the machine have to comply with a multitude of rules. And as long as there is consistency and a quick turnaround process for approval, the OEM can appreciate this.
Despite how much compliance crackdowns may hinder ingenuity, money is continually poured into R&D for new products since the industry is fueled by the moralistic end-goal of improving quality of life. According to MDDI in a telling article entitled American Medtech Market to Grow 6.4% Annually Through 2017, “By 2016 the medical device market is projected to reach $134 billion.” As this industry grows in revenue, there is a bigger focus on after-market service quality to create a brand differentiator, as they are selling to an increasingl