6/11/14 It is the combination of micro manufacturing technologies and techniques along with material developments that drive much recent product innovation, especially in the medical device sector. When materials in medical devices are designed to come into contact with — or be implanted — in the body, there are numerous biocompatibility issues to consider. To cater for this demand, there are frequent material developments in the area of inert, biodegradable, and bioresorbable polymers. Bioresorbables today are found in numerous medical applications such as fixation devices for orthopaedic applications, stents, screws, and scaffolds for tissue engineering.
MES has considerable experience in dealing with a variety of medical grade polymers. When looking at bioresorbables in particular, there are a whole host of issues that need to be considered when using such materials that are by their very nature subject to degradation. For example, bioresorbables demand extremely precise processing controls, and their high relative cost when compared to nondegradable polymers means that manufacturers must use high-yield, low waste molding technologies. MES is one of only a very few micro molding companies that has the experience and knowledge to deal with bioresorbables efficiently.
The difficulties with bioresobables doesn’t end at the processing step, however, and just as much consideration needs to be focused on the impact of residuals, storage issues, and the effects of sterilization on the mechanical, functional, and chemical properties of the polymers.
For any medical device OEM planning to work with bioresorbables, the devil is in the detail, and while costs and development time will tend to be higher than expected, engaging the right product development partner can limit such risks. MES has at its fingertips an innate understanding of such vital considerations as the chemical and polymer morphology of commercially available bioresorbable plastics, necessary to avoid end-device issues such as the leaching of harmful acids, or perhaps worse, the untimely breakdown of device functionality.
Bioresorbables work due to chemical hydrolysis. As water contacts the material, it breaks the chemical bonds in the polymer apart, which over time leads to the complete break down of the material structure. Simply put, the rate of degradation depends on the precise chemical and structural nature of the original material. Intimate knowledge of such degradation rates are obviously critical to ensure device efficacy when in situ.