Designing Biologic Device Hybrid Therapies In Collaboration

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An image of a pacemaker, one of the first implantable device therapies. Taken by Gregory Marcus, MD, MAS, FACC via [CC BY 3.0], via Wikimedia Commons.
What’s more difficult than designing a new drug product or medical device? What about designing a new medical device designed to dispense a new class of drugs that will soon hit the market? This new challenge has prompted new research which is raising the call for additional design controls in medical devices which utilize biological products.1

According to the new research, these new design controls would have to account for the increasing sophistication of drug products and implantable devices in light of ubiquitous digitization of medicine and wider biocybersecurity concerns.2 While the new research cites one of the primary challenges to developing biologic-dispensing medical devices as seeing eye to eye between the medical and engineering communities, it’s safe to say that new efforts producing biologic dispensing medical devices won’t get very far without a software platform to share to enable their collaboration in the first place.

What’s So Challenging About the Future Generations of Medical Devices and Drug Products?

Advances in biocompatible-materials have eased a few of the technological obstacles between implantable biologic dispensing devices.3 There are still a substantial number of obstacles that need to be overcome, however. The new research outlines that cultural and organizational differences between scientists and engineers must be resolved in order to move the field of biologic dispensing medical devices forward any further.

A new synthesis-forming perspective is required, according to the new research. Rather than viewing receptor based drug development and injector based medical devices as two separate parts of the same pipeline that eventually treats a patient, researchers and engineers must come to understand that delivery of drug cargo is more inseparable from the drug cargo the more complex that cargo becomes. While the former perspective of “engineer makes the delivery mechanism and scientist makes the drug that goes in it” may have held true for prior solved issues like insulin pumps, new delivery devices like microfluidics chips may prove to be more finicky.4

Finally, though it’s hard to call it a challenge as far as most scientists will be concerned, there is the question of which problem to address first. Advanced medical devices–potentially themselves made out of biological materials– with the capability to dispense engineered biologic therapies could address issues ranging from wound repair to successful organ implantation.5 6

Integrating Network Medicine

Newly designed medical devices will be designed with network medicine in mind, which means that looking further, drug products intended for use with implantable medical devices will be designed with network medicine in mind, too.7 This means that future medical device development that’s intended to work with the drug products of the future will require:

  • Adequate in-device assaying of drug product efficacy via microassay8
  • Networked device diagnostic which feeds to a health hub for physician monitoring
  • Remote control of drug dosing for user-controlled dosing in response to symptom flare ups
  • Medical device design more sophisticated than auto-injectors
  • Redundancies to safeguard against malfunctioning

It’s clear that the above list is barely a start to the true design specification that a unified biologic-dispensing implanted medical device would require. Many of these are engineer-centric rather than collaborative endeavors, however. What would the scientific research team working on this kind of project need to manage to make their end of the equation work out in the patient’s favor?

In terms of data that scientists would need to track at the preclinical stage, there are still a number of moving parts that will eventually need to be passed off to the medical device engineers:

  • Drug product stability under the storage conditions possible within a medical device
  • Drug titration for varying users based off disease, disease stage, and other pathology factors
  • Drug pharmacodynamics and pharmacokinetics
  • Drug product optimal method of delivery to avoid damaging sensitive proteins or other similar considerations
  • Consequences of inefficient drug clearance in conditions of disease
  • Consequences of drug underdose or lack of dose in event of device failure
  • Consequences of drug product overdose in event of device failure
  • Hypothetical potential for failsafe reactive measures such as including an anti-drug antibody dispensable in conditions of overdose in the event of device failure

Though the clinicians of the moment may believe that highly sophisticated biologic dispensing medical devices with pluripotentiality are decades away, the fact is that scientists and engineers have had decades to be working on overcoming the challenges associated with medical devices and drug dosing.9 Their most ambitious efforts are starting to come to fruition– this is the crux of the new research’s argument. None of the magic happens without robust collaborations between engineers and scientists, however.

Developing Standards via Collaboration

Engineers and scientists will have to work closer together than before to design the medical devices of the future, especially if the line between biologic dispensing medical device and drug product begins to blur thanks to medical devices constructed with biological materials. The precondition of any collaboration between these two very different groups is a common forum for information exchange that’s accessible by collaborators, no matter where they may be. For this purpose, a powerful information technology solution is needed. Thankfully, such a suite exists and may be able to help bridge the gap between the culture of engineers and the culture of scientists to boot.

BIOVIA Collaborative Science is the comprehensive software solution that the engineers and scientists of the present will use to create the biologic dispensing medical devices for the patients of the future. With BIOVIA’s tools, your laboratory can seamlessly share data with associated engineering teams and annotate data so that it’s mutually intelligible. Contact us today to find out how BIOVIA can catapult your laboratory group’s involvement into the medical device space with the help of collaboration software.

  1. “Design control considerations for biologic-device combination products.” March 2017, http://www.sciencedirect.com/science/article/pii/S0169409X17300121.
  2. “Cyber Security and Confidentiality Concerns with Implants.” December 2015, https://link.springer.com/chapter/10.1007/978-3-319-25448-7_11.
  3. “Micro/nano-structured superhydrophobic surfaces in the biomedical field: part II: applications overview.” January 2015, https://www.futuremedicine.com/doi/abs/10.2217/nnm.14.175.
  4.  “Engineering long shelf life multi-layer biologically active surfaces on microfluidic devices for point of care applications.” January 2016, https://www.nature.com/articles/srep21163?WT.feed_name=subjects_diagnostic-markers
  5. “Application of materials as medical devices with localized drug delivery capabilities for enhanced wound repair.” August 2017, http://www.sciencedirect.com/science/article/pii/S0079642517300695.
  6. “Transplantation of Bioprinted Tissues and Organs: Technical and Clinical Challenges and Future Perspectives.” July 2017, http://journals.lww.com/annalsofsurgery/Citation/2017/07000/Transplantation_of_Bioprinted_Tissues_and_Organs_.9.aspx.
  7.  “Focus on the emerging new fields of network physiology and network medicine.” October 2016, http://iopscience.iop.org/article/10.1088/1367-2630/18/10/100201/meta.
  8. “Medical device for analyte monitoring and drug delivery.” September 15, 2015. https://www.google.com/patents/US9131884.
  9.  “A Preliminary Trial of the Programmable Implantable Medication System for Insulin Delivery.” August 1989, http://www.nejm.org/doi/full/10.1056/NEJM198908313210904.