Neat-o!  I don’t say this too much.  Ok, maybe it’s because it’s a dated phrase from my childhood.  But also, because sometimes with so much happening in our daily lives, we forget to appreciate the wonders that are created in science.

Last week, I had such an experience. I attended the Rosenman Symposium at UCSF and encountered a wonderful overview of the collision of scientific worlds.  Nanotechnology met cardiovascular treatments and 3D printing came together with drug delivery.  Here are a few of the talks and topics that sparked my excitement.

Dr. Tejal Desai is a professor in the Department of  Bioengineering and Therapeutic Sciences. She presented how micro and nano structures and the textures they create can interface with cells to create therapeutic materials.  For example, structured microrods injected into cardiac tissue can decrease scarring that occurs after myocardial infarction.  The structures provide the surrounding cells with physical cues that result in a down regulation of collagen and a change in cellular morphology.  In another example, nanotubes engineered on the surfaces of stents can interface with surrounding cellular tissue and even interdigitate with the local endothelial cells  to create a more efficacious therapy.

Carbon, a company located in Redwood City, specializes in 3D fabrication using a liquid UV-curable polymer resin.  The large number of resin possibilities provides a wide variation in shapes, textures and latticing that can be applied in diverse areas such as printing sneakers, dentistry implants and diagnostic devices.  Additional applications presented for life sciences include pediatric tracheal stents, drug delivery devices for cancer therapeutics and microneedles for transdermal drug delivery. The high speed of printing allows for a speedy timeline between design and field testing, and permits serial iterations without major retooling for production.

Proteus has already garnered quite a bit of attention after its pill, designed in conjunction with the active ingredient from Otsuka, gained FDA approval.  But it was the thought process of what the digital pill technology brings, that marries the world of wearables, sensors and biology together. The system addresses both how the patient uses the drug and how each individual responds to the therapeutic.  The technology enables a business value for therapeutics based on value: Did the patient take the drug (as opposed to simply have it prescribed and/or picking it up at the pharmacy but not complying with the prescribed regime)? And for both value per se, and personalized medicine, did the medication work in the particular individual?

The challenges

The influx of new technologies to MedTech, as well as to other areas of healthcare, has created some major hurdles for the industry.  The first of these, the regulatory framework for review and approval, has made strides.  As presented by Dr. Jeffrey Shuren from FDA CDRH, and acknowledged by many attending industry members, the FDA is revamping its processes to streamline and accelerate approvals.  Some changes discussed:

  • Use of real-world data in addition to traditional clinical trial data
  • Consideration of patient preferences
  • Applying the appropriate level of uncertainty that can be tolerated depending on the type and use of the technology
  • Approvals for digital health and diagnostic tests by firm, rather than by individual app or test (see here)

The remaining looming challenge is reimbursement  The FDA is working with CMS (Centers for Medicare and Medicaid Services) to coordinate reimbursement processes with the timing of approvals.  This will hopefully avoid situations where companies enter commercialization with no mechanism to get paid.  But even with government reimbursement in the works, the private payer network will remain a huge hurdle.  Many networks are not incentivized to look towards new technologies, especially if it would increase the number of patients accessing medical devices (and thus using more funds).

It seems as if technology is moving much faster than the processes necessary for the healthcare system to ingest and benefit from the new innovations.  Not clear how or when the technology and the systems it is design to benefit will sync up.  In the meanwhile, there is plenty to watch in what seem like disparate fields coming together.  Some recent announcements related to this topic that caught my attention:  Senseomics implantable glucose monitor and Prellis 3D printing of organs. Bringing different fields of science together is not unheard of, but seeing it in action with some tangible examples really brings home the excitement.