Packaging Must Evolve as MIT & Others Develop More Complex Medical Implantable Devices

Implantable medical devices with sensors can detect, diagnose, or monitor conditions in real time. Some monitor glucose; others monitor the heart. Some devices actively deliver needed medications or stimulate nerves. The possibilities seem endless.

Big players are busy developing and getting approvals for their electronics-laden implantable technologies. For example, Medtronic announced in early 2024 that the US Food and Drug Administration (FDA) approved its novel sensing-enabled Percept RC Deep Brain Stimulation system, a surgically implanted medical device to help control tremors in Parkinson's disease.

MIT scientists develop investigational life-saving device

Implantable technologies are becoming increasingly complex and nuanced. A case in point, Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital scientists have developed a medical device — about the size of a stick of gum — that when implanted under the skin can deliver the opioid antagonist naloxone during an opioid overdose.

This implant under development can monitor vital signs, diagnose an opioid overdose, and reverse it with a dose of naloxone. (Image: MIT researchers)

Using sensors, the investigational implantable system for opioid safety (iSOS) monitors heart rate, breathing, blood pressure, and oxygen saturation. It has been shown to reverse overdoses in a swine model. During the animal study, the researchers developed an algorithm that increases the device’s sensitivity to accurately detect opioid overdose, distinguishing overdose from other conditions in which breathing is decreased, such as during sleep apnea.

Physicians should be able to implant the iSOS during a minimally invasive procedure under local anesthesia. The system’s rechargeable battery can last up to 14 days, and contains an integrated, refillable drug reservoir that holds a 10-mg naloxone payload, according to the study.

Study author Hen-Wei Huang, Ph.D., a former MIT visiting scientist and now assistant professor of electrical and electronic engineering at Nanyang Technological University in Singapore, described the proposed technology in an MIT press release as a “miniaturized robotic implant equipped with multi-sensing modalities, continuous monitoring capabilities, on-board decision making, and an innovative micro-pumping mechanism.”

New packaging implications.

Specific requirements for packaging, shipping, and storage are yet to be determined for this iSOS device, since it’s still in early stages of development, according to study author Giovanni Traverso, Ph.D., M.B., B.Chir., an MIT associate professor of mechanical engineering and a gastroenterologist at Brigham and Women’s Hospital.

“However, as a subcutaneous implant, preventing moisture ingress will be a critical consideration for ensuring the integrity of the electronics,” Traverso told Packaging Digest in an email. “We anticipate that the packaging will need to meet stringent regulatory standards set by bodies such as the FDA and EMA,” the European Medicines Agency.

This will likely involve designing packaging that not only maintains sterility but also provides robust protection against moisture to prevent any compromise to the device's electronics, according to Traverso.

“Tamper-evident and moisture-resistant materials would be key components of the packaging design to safeguard the device during transport and storage,” he said.

Traverso and colleagues are exploring the specific materials and conditions needed for safe and effective transport.

“… we understand the importance of using medical-grade materials that can maintain sterility and protect the device during shipping. This might include sterilized plastic or Tyvek for inner packaging and more robust materials for outer protection,” he said.

Regarding temperature and humidity control, the researchers anticipate that the device would need to be stored within a stable temperature range to preserve its components. More research and development are needed to determine exact parameters.

Nitrogen vacuum/flush packaging?

“We are seeing a bloom of medical device manufacturers opting for nitrogen vacuum/flush packaging systems for their critical devices. This trend is powered by our customers’ aim to keep their devices stable during transportation and to manage the internal environment of the pouch,” said Charlie A. Webb, CPPL, president of sterile packaging sciences at Van der Stähl Scientific in Redlands, California. (Editor's note: Charlie is not to be confused with his twin brother Nicholas Webb, who is also an industry leader and regular Packaging Digest contributor.)

The stability of these advanced devices is in jeopardy when exposed to an ambient environment, making nitrogen gas flush and vacuum packaging systems a valuable tool in device stability. Vacuum packaging holds the product in place during shipping, “helping to thwart unwanted rubbing that could jeopardize the sterile barrier system or the device,” Webb told Packaging Digest.

Webb said that he thinks many medical device companies may be naïve in terms of what the handling pathway truly looks like at the hospital or clinics. That understanding, from a packaging perspective, is important as more complex and sensitive devices enter the marketplace.

“As part of packaging validation, we talk a great deal about ‘worst case scenario assessment,’ yet I wonder, do we truly have enough intel on the handling workflow at the point of care?” he said. “Medical device integrity and sterile delivery are at risk in the final 100 yards from failed device handling policies and systems from nonconforming First Expired First Out (FEFO) workflows to overstuffed bins that can damage both device and package.”