(7 minute read)
We’re all well aware of how technology has drastically changed the medical industry such as the Da Vinci Surgical System, or the somewhat recent trials of creating artificial organs using 3D printing. We’re aware of the news, but a majority of us may not technically know the application of technology and the amount of work that went into building it.
Alacrity is a MedTech Regulatory, Quality, and Engineering firm that has developed multiple medical device projects. Alacrity’s Founder & CEO, Steve Woodard, was steadfast in protecting the privacy of his clients and their active projects but was candid about development activities in the MedTech industry.
Katie (Breadware): Alacrity has been a leading MedTech development company since 2006 – can you explain how IoT has been incorporated?
Steve (Alacrity): It’s been exciting to combine what Alacrity does well with IoT. We work with medical device companies to get their products developed and approved faster and more cost-effectively. We can already see medical IoT coupled with big data analytics is going to be a prolific source of advancements in human health. And unlike some of the more recent unicorn examples, I think the future unicorns that emerge from this will become sustainable businesses because they’ll be among the first to shift the application of big data analytics from value-displacing to value-creating.
Katie (Breadware): What do you mean by ‘value-displacing’?
Steve (Alacrity): Big data analytics have been largely focused on improving ad-tech. I see the societal value of these consumer influencing efforts as suspect because they tend to be a zero-sum game. This is what I mean by value-displacing. You’re spending resources on influencing, or brainwashing in some cases, a consumer to purchase a product from company X instead of company Y.
Katie (Breadware): So what’s an example of ‘value-creating’ in your space?
Steve (Alacrity): We have projects oriented to the early detection of disease and improving patient non-adherence. This is going to have a pretty significant impact on health outcomes, but what’s to follow are major scientific breakthroughs from the application of these technologies. Medical IoT is mostly the portal for collecting patient data. The companies that use these data with advances in AI to gain a first-principles understanding of disease states like cancer are going to be a big deal. They will be the next Facebooks and Amazons.
Katie (Breadware): You mentioned earlier that big companies like Facebook have driven big data analytics and how they can drive consumer behavior to what seems like a detriment versus how the medical industry could influence behavior for the betterment. Can you elaborate on this topic?
Steve (Alacrity): It’s interesting to see Facebook become infamous in the public dialogue so quickly. I expect benevolent applications will outpace malevolent applications over the next couple decades and human health will be a major beneficiary. An example of a positive behavior shift that comes to mind is from my experience using the Oura sleep tracking ring. As someone who doesn’t struggle with sleep, I was surprised to discover having a coffee in the afternoon was compromising my sleep efficiency. With this insight, I made the obvious adjustment to my behavior and have experienced improvements to my sleep I didn’t even know I needed.
Katie (Breadware): Not meaning to touch on Facebook again, but to collect medical data is an amazing feat in technology; however, it tends to stir up regulations and privacy issues.
Steve (Alacrity): You might be surprised that the majority of medical device start-ups are still using paper-based systems because of data compliance issues. With paper-based systems, a lockable, fireproof filing cabinet goes a long way in terms of compliance. Going with a paper-based Quality Management System seems like a sensible method to start with, but the problem we see over and over is these companies don’t ever have the bandwidth to switch over to an electronic system as they grow. As they progress into the clinical stage, the number of documents needing to be managed under the QMS become exponential. They end up with thousands of physical documents needing to be categorized and instantly accessible.
MedTech is filled with pitfalls and dead ends. It’s not kind to those who take a “fumble forward and figure it out later” approach.
Katie (Breadware): How does your team navigate or otherwise comply with this when creating your products?
Steve (Alacrity): Alacrity has developed an easily scalable electronic QMS called FlightDeck that offers the simplicity and flexibility of a paper system without the inevitable downsides. I didn’t want to have to build our own software solution, but after years of experience with various enterprise-level eQMS offerings, we found they consistently bog down pre-market release start-ups. We optimized FlightDeck for the period between day one and initial market release.
Katie (Breadware): What other issues does your team deal with that are unique to MedTech?
Steve (Alacrity): The amount of effort to make an IoT consumer product is a different magnitude of what it takes to make that same product as a medical device. What gets MedTech innovators into trouble is they unwittingly make mistakes early that get baked into the program. The longer these mistakes go undiscovered, the more expensive they become to remediate. If you bake them in and they’re not compliant, you can’t easily unwind them. Sometimes you essentially have to start over. MedTech is filled with pitfalls and dead ends. It’s not kind to those who take a “fumble forward and figure it out later” approach.
Katie (Breadware): What trends are you seeing in medical IoT?
Steve (Alacrity): There are a lot of companies doing approximately the same thing. For many of them, I feel there is a lack of creative insights into the hypothesis. A lot of it is “yeah, we do big data and heart attack detection.” When you look into it, there’s no fundamental insight. It’s just pursuing the category. My hunch is the future medical IoT unicorns will be the companies that are pursuing scientific insights rather than market categories.
Katie (Breadware): What are you most excited about within the technology field as we approach the end of the year?
Steve (Alacrity): The projects we’re working on that are shiny and interesting are years away from getting to market. Unlike smartphones and electric cars, this is not a good industry to talk about exciting things to come on that short of a time scale! Things are disappointingly slow when it relates to medicine. Alacrity can complete a project in roughly half the time of industry averages, but I still get frustrated by the timelines. It’s a long journey to get a medical product to market.
Editor note: As the conversation drew to a close, Steve mentioned one of his favorite aspects of MedTech.
Steve (Alacrity): Overall, MedTech is a fascinating and rewarding place to be. What I love most about it is the quality of people it attracts.
Steve Woodard will also be our guest speaker at this year’s Interrupt MedTech Event in October.