5 Exciting Innovation Areas at the BIOMEDevice Silicon Valley Conference 2023

Authors: Talia Haller and Kumar Bala

The energy of the Bay Area was palpable at the BIOMEDevice Silicon Valley 2023 Conference: we met so many passionate leaders and entrepreneurs excited to share their ideas, exchange perspectives, and work determinedly toward the future of health. The kind of innovations we knew AI would bring are finally becoming realities in the life science/ health care industries in very impactful and exciting ways. Together, myself and thought leader Kumar Bala (a former exec at Oracle with multi-omics and AI/ML expertise) are excited to share five areas of innovation we saw at the conference and why they’re important.

1) Enhanced Training Experiences

Augmented Reality

There are a lot of organizations that are working on Augmented Reality / Virtual Reality (AR/VR) solutions to provide customized and enhanced training solutions for medical professionals. In the traditional model of training, where information is passed down from one person to another in an on-the-job teaching fashion, the person who knows the technology the best often isn’t there during the training and, like the game of telephone, sometimes key nuances of using the tool get lost in translation over time. Augmented Reality solutions, like the one we demoed from Nakamir with the help of Founder Christoph Leuze , allows the solution expert to easily create a training that feels hands-on – like the expert is right there. This kind of hands-on, direct-from-the-expert training will be very useful, especially with the amount of new technologies coming out.

Bioprinting

We didn’t personally see any companies working on this at the conference (though we didn't make it to every booth) but I kept hearing little snippets about the possibilities of this technology in the future: the use of bioprinting to create realistic medical organs. Bioprinting is a form of 3D printing technology used to create tissue-like structures that mimic natural tissues. This process involves layer-by-layer precise placement of biological materials, bioinks (a combination of cells and biocompatible materials), and growth factors. While there are numerous potential applications for this technology, one of the most apparent and comparatively low-risk uses is employing bioprinted medical organs for educational and training purposes in the medical field. Medical students can have very real, life-like organs to practice on without the need to acquire organs from organ donors.  

Medical Simulation

Medical device approval through clinical trials involves rigorous testing, typically including both animal and human testing. The rigor of the tests depends on the nature of the device – given that implantables go and stay inside the human body, they require some of the most rigorous testing and clinical evaluations. Since the early 1990s, researchers have been exploring various ways to satisfy regulatory requirements without using live animals and instead using synthetic human bodies. 

One company in this space is SynDaver® (named as a play on “Synthetic Cadavers”), which was founded in 2004 to commercialize a novel system of synthetic human body parts for the medical device industry. Today, they have some of the most advanced synthetic models of human and animal anatomy that replicate living tissue in great detail, including individual muscles, tendons, veins, arteries, nerves and organs ― all made from complex composites that mimic the properties of the discrete living tissues they represent. Made from water, salts, and fibers, the synthetic tissues have been validated to replicate the mechanical, chemical, thermal, and dielectric properties of the complementary living tissue. In fact, SynDaver ® maintains the world’s largest database of LIVE tissue properties. This validated technology is being increasingly used to replace live animals, cadavers, and human patients in medical device studies, clinical training, and surgical simulation.

2) Flexible, Customized Manufacturing

Flexible Circuits

Flexible, custom circuits were a big trend at the conference – and represent a rapidly growing market, according to Carey Burkett and Mark Finstad from Flexible Circuit Technologies Inc . In comparison to the more standard, rigid circuits, they often provide superior product design, offering the flexibility and customization necessary to create smaller, more advanced “next generation”  implants/wearables. Based on our conversations, it appears one of the main trade-offs for their superior design is that they're more expensive, though this isn’t necessarily a surprise. 

Nitinol shape setting

Though nitinol has been used in medical implants since the 1970s, medical applications for nitinol, a metal alloy in the same family as nickel and titanium, have increased in recent years. Nitinol is known for its superelasticity and "shape memory", wherein the alloy can be deformed from an originally 'programmed' shape, then return to that predetermined shape when exposed to a specific temperature (such as "body temperature"). This unique alloy is already being used to manufacture catheter tubes, guidewires, filters, etc. and will be leveraged in increasingly advanced medical devices and implants.

Industrial CT Scan for Medical Devices

Industrial Computed Tomography (CT) scanning emerges as a powerful ally in medical device manufacturer’s quest for quality, offering non-destructive, high-resolution imaging to pinpoint defects with unparalleled precision. For example, Lumafield is leveraging the advanced capabilities of CT with their Neptune CT scanner and Voyager analysis software, which is an AI, cloud-based inspection platform that enables engineers to take precise measurements, visualize products, and detect dimensional deviations swiftly. Porosity analysis helps uncover hidden voids within materials, a crucial capability to address issues of material integrity. CAD Comparison and Scan to Scan Comparison enable engineers to compare components with CAD models and other parts to quantify deviations, providing insights to combat misaligned assemblies and ensure seamless fits.

Specific examples include:

• EpiPen: Voyager allowed for the inspection of the complex assembly of EpiPens, including the needle, spring alignment, plastic support structures, and the plunge mechanism.

• Insulin Pump: Voyage monitors mechanical assembly of springs and actuators inside the insulin pump to help prevent harm to patients and costly recalls for device manufacturers.

3) Focus on Women’s Health Solutions

My favorite (and most entertaining) presentation at the conference was from Surbhi Sarna , a partner at Y Combinator and the founder and former CEO of nVision Medical , which sold to Boston Scientific for $275M. nVision developed a first-in-kind microcatheter for the detection of ovarian cancer. Now as a partner at Y-Combinator, Sarna focuses on investing in and mentoring start-ups in the healthcare and biotech space, specifically startups focused on solutions for women’s health. In her presentation, Sarna called out that the “women’s health” market in the U.S. was once considered a “small” or “niche” subset of healthcare (even though women represent over 50% of the US population alone). However, it has now become one of the fastest growing markets in the medical space. A report from Future Market Insights estimates that the global Women Digital Health Solutions Market was US$2.3B in 2022 and has a projected valuation of $20.1B by 2032 (almost 10x increase in the next 10 years).

4) Decentralized Next Generation Sequencing (The "Third" Generation of NGS)

While Next Generation Sequencing (NGS) has gained massive adoption in research and molecular diagnostics over the past decade, the entire process requires the transportation of samples to centralized facilities, advanced/expensive machinery, and personnel with trained expertise to interpret the results. Cost reduction is only available with pooling of several hundred samples together on very expensive equipment. This laborious process causes delays in drug development and diagnostics.

Decentralized 3rd generation NGS platforms change this paradigm by focusing on creating a small, easy-to-use, low-cost, and highly accessible sequencer that can output results faster with short and long-read flexibility to meet the customer’s needs. Though the company working on this wishes to remain anonymous in this article, they’ve shared that their "3rd generation" NGS sequencer technology is capable of reading 1000 base pairs within an hour, as opposed to 2nd generation sequencers that take 8 hours to analyze 300 base pairs. Their technology leverages a novel detection method that enables low cost DNA and direct-RNA sequencing in real-time. The system’s distinct sequencing chemistry, optimized to the detection system, allows for fluidics-free instrument and very low reagent use. This can support applications in clinical diagnostics and pandemic control, agriculture, food safety, and environmental monitoring. The outcome from the long-read sequencing will be of value in detecting rare and complex genetic variants, relevant for understanding disease susceptibility, drug response, and adverse reactions. Beyond this, it can also offer value for personalized medicine, and pharmacogenomics.

5) Development of Next, Next Generation Technologies

Oral Biologic Drug Delivery

One major hurdle in drug development is ensuring targeted delivery within the body, where the drug can effectively perform its function. Overcoming the stomach's acidic environment, which breaks down most substances, is particularly challenging. BioDrive is addressing this by leveraging the natural protective qualities of edible plants, specifically lettuce. They are developing a system where essential drug proteins (peptides) are incorporated into lettuce, then administered in a controlled pill format. The cellulose in the plants “bio-encapsulates” and shields the peptides from the stomach's harsh conditions, enhancing absorption in the digestive tract and allowing for oral delivery (current delivery for this kind of drug is typically done through local injection). BioDrive's pioneering application of this approach is a weight loss drug: lettuce will be modified to have peptides that are antagonists to incretin receptors, which regulate hunger and, when blocked, can reduce appetite, thereby facilitating weight loss.

AI-Driven Multiomics Software (AIMS) for Biomarker Discovery

In the current state, the discovery of biomarkers for diagnostics and therapeutic applications takes years, costs millions of dollars, and is also beset with a high rate of failure during validation. Pharma and biotech companies are focused on addressing these issues by adopting new and innovative discovery tools to cut costs and time to market. Recently, Artificial Intelligence (AI) based Software as a Service (SaaS) tools have been developed to improve and accelerate the biomarker discovery workflow, generate insights from data analysis, and help automate the entire process.

For example, GeneGenieDx Corp has created an AI-driven Multiomics Software (AIMS) platform for biomarker discovery to provide insights into biological processes, identify biomarkers, and discover disease pathways. This platform is a Cloud-native SaaS solution that enables researchers to cost-effectively apply bioinformatics to a wide variety of validated pipelines and analyses, differential gene expression, variant calling, and AI-driven predictions. It also provides interactive visualizations and data science software plugins to explore and interpret complex datasets. Finally, its integrated discovery workflow is powered by domain-specific/specialized large language models built from curated research literature and biomarkers. Platforms like this have the potential to revolutionize biomedical research by enabling a more effective approach to understanding complex biological systems, ultimately leading to the development of new diagnostic tools and therapies.

As always please reach out with any question, comments, or ideas!