The medical device manufacturing industry has gone through tremendous upheaval the last few years, prompted by many factors including the Great Recession, the Affordable Care Act, the Protecting Access to Medicare Act, Clinical Lab Fee Schedule reforms and even changing consumer sentiment. These factors forced many device manufacturers, including much of the In Vitro Diagnostics (IVD) industry, into cutting internal and external plastic injection molding costs to make up for tepid growth in the US and European markets. During that time many larger healthcare companies turned to manufacturing design houses for assistance — not just for the medical plastic parts but the entire consumables themselves.
This forced plastic medical device makers to dive deeper into the go-to market strategies, regulatory burdens and day-to-day rigors of their healthcare partners.
When there are many molders who have the technical prowess to manufacture medical / IVD plastic consumables, medical device manufacturers need to find those companies which can engage at the concept stage. This early engagement makes all the difference to how successful those manufacturers are in the market. Healthcare device manufacturers need plastic molders with the right combination of results-driven talent and technology to help them reach their profit goals in the shortest time possible.
To better serve the medical device industry, there are three “F”s which should guide all decisions about any given plastic part: form, fit and function. Whether it’s a leak-proof bottle or a plastic medical tray, any reputable plastic medical device maker should support the OEM by providing a product that meets the specified user requirements with zero defects. This can only be accomplished through early-concept collaborative design review and component prototyping.
The final step, of course, is quality-driven production molding. Only by partnering with a molder who can put them into direct contact with their top-notch molding engineers can OEMs ensure a smooth process from concept throughout the manufacturing life-cycle.