US-Japan MedTech Frontiers promotes medical device innovation and American-Japanese collaboration. Voler Systems is pleased to represent Silicon Valley Companies and to foster discussion on important issues regarding the competitiveness of our two regions.
Walt Maclay gave a presentation to an audience of engineers, startup executives, managers, and investors.
Here is an edited transcript of questions from the audience directed at Walt, followed by his answers to questions directed at the full panel:
What types of remote monitoring technologies were being focused on five years ago, and how has that changed today?
In our role as an outsourced partner, we see many new innovative technologies. Over the years systems have moved from benchtop equipment connected to remote sensors to where everything is now connected. Today, wearable devices are hot. Large data sets, such as images and video, are transmitted from all types of equipment, including wearable devices.
What types of technologies do you see enabling better remote patient care five years into the future?
Remote monitoring capabilities are already enabling more convenient care, resulting in better patient outcomes and allowing physicians to effectively serve more patients. We are seeing improvements in bio-sensing to better measure ECG, blood pressure, breathing, sleep, and glucose.
You’ve probably seen a number of great technologies, and technologies that SHOULD have been adopted by medical professionals and patients, but ultimately were not adopted. Why were some of these technologies not widely adopted? What could these startups have done differently? Many startups with good ideas do not execute well.
Innovation very much depends upon the context. Each case is different, and each failed startup has a different reason, but the team is the most common problem. They may have a good idea but team may not be good enough to raise money. Funding is a very common failure point, and it is often difficult because of the team. There is a large gap between an idea and a device ready for approval: the company can be hard to fund if the team does not have a track record and strong capability.
Questions for Full Group:
Remote monitoring is becoming increasingly important for providing the best care to patients. What are the key clinical areas where remote monitoring and sensors are gaining traction or have the most potential?
Cardiovascular is always first, because the market is big and proven, even for wearable devices. Sleep monitoring and sleep apnea treatment is also hot. Home monitoring following a hospital visit has become important in the US. Aging in place is a large and fast growing market, but in the US it is hard for small companies to enter. Any technology that collects more patient data is valuable for data analysis.
One of the challenges we now have with so many remote monitoring technologies is data… and maybe too much data from too many different sources. How are each of you using your data to inform medical professionals? Jim, your data can help professionals “predict” certain medical conditions…For example: a technology that can “proactively” alert medical professionals of a fall or dangerous event at home… how do you serve up that data to the right people to triage care?
We design the device, and our customers use the data. Some of our customers are data companies that are reluctantly developing their own data collection devices. Data is valuable and may be specific for post-op monitoring or general health monitoring a while in the hospital or at home.
FDA / Regulatory
Today, the FDA seems to have a progressive approach to approving remote monitoring technologies and the software / analytics being used. As an example, the Apple Watch received clearance within 30 days for their software algorithm. Have you experienced a change in your discussions with the FDA?
The biggest change was the guidance document from the FDA in 2016 that classified certain apps as not medical devices, while the same function in a single purpose device would be a medical device. The Apple watch, as a generic consumer product, is like a phone, so apparently the guidance applied to it too.
Large Tech Competitors
We hear about new projects from the big technology companies in the US. Google is developing a contact lens that can measure blood glucose and other biomarkers through the eye. Apple has their watch and continues to make progress into healthcare. Amazon has now launched their own brand of at home diabetes testing products. What do startups need to succeed, or even just compete, with these ‘technology’ companies? What types of partnerships should a startup explore to scale their business effectively?
Many of our customers say the large companies are helpful by opening the markets for other innovation. They are good partners for an exit too.