There’s never been a better time to be a life sciences startup company seeking regulatory approval, thanks to digital innovations like cloud technology. Take the example of the recent regulatory victory by medical device developer BraveHeart Wireless Inc.
On June 19, 2019, the startup company received U.S. Food and Drug Administration (FDA) clearance for its BraveHeart™ Life Sensor Cardiac Monitoring system, a Class II medical device that features a self-adhesive biometric wearable that attaches to a patient’s skin near the heart. The single-use patch’s built-in sensor captures the patient’s heart rate and EKG data and wirelessly transmits the data via Bluetooth Low Energy (BLE) to an internet of things (IoT) gateway so it can be monitored in real time by health care providers.
Founder and CEO Steve McCalmont described getting the green light from the FDA as “bigger than big” for BraveHeart. “As an entrepreneur, you always want things faster, better and quicker,” he said. “But what we’ve done in a very short period of time is really amazing.”
By securing 510(k) approval for a technologically sophisticated medical device just two years after the company’s founding, BraveHeart is a shining example of a startup achieving early success by adopting a digital-first mentality and leveraging cutting-edge cloud technologies.
The medical device company’s leading-edge monitoring system relies on a cloud-based RESTful API and a modular hardware platform — technology that gives the company remarkable efficiencies and distinct advantages over many of the life sciences’ old guard whose fears of digitization have made them reluctant to embrace the cloud.
But cloud technology isn’t just a critical element of BraveHeart’s monitoring system — it has also been integral to the company’s fast track to regulatory success.
Knowing that a novel medical device would have to meet stringent regulatory standards in order to obtain clearance from the FDA, the company’s forward-thinking yet resource-conscious leaders knew from day one that they would need a fully digital cloud-based solution to streamline quality and compliance processes.
“While you start to grow, you’ve got to make sure that your compliance and regulatory systems are in place so that you can scale,” said Ted McAleer, BraveHeart vice president of business development.
With solid product and business plans in place, BraveHeart chose to implement the MasterControl Spark turnkey solution, which is specifically designed to affordably streamline quality and compliance management for small companies doing business in regulated industries. The fact that BraveHeart went with a digital system from the get-go gave the startup an edge over traditional life sciences companies that are mired in paper-based processes.
“We don’t know what the paper process is like, because we never implemented it,” McAleer said. “All of our controls, policies and procedures, and all the documentation that supports that, has been digital from day one.”
A preconfigured cloud-based solution is the fastest and most efficient option for organizations that need to automate their processes and connect personnel with the systems they need to do their jobs.
“Cloud equals speed in getting to a digital environment,” said MasterControl executive vice president Matt Lowe. “On-premise system installation and configuration takes a lot of time and IT manpower to get going — in the cloud we can get the process going much faster.”
Startups and cloud solutions are the peanut butter and jelly of the life sciences world. Cloud-based software is ideal for smaller companies in life sciences and similar regulatory environments because it eliminates the need for on-site IT personnel or dedicated servers. The cloud allows startups to minimize headcount and headaches, which liberates skilled employees from busywork and lets them focus on their core competencies.
“We’ve done an enormous amount with a few people and it’s really helped us force multiply what they do,” said McCalmont. “Other companies have full teams doing what we have one person doing.”
In addition, while there has been a long-held misconception among compliance-minded organizations that cloud environments are less secure than premise-based environments, just the opposite has proven to be true. A reliable cloud solution provider has far greater capacity to nip security issues in the bud, since they employ dedicated experts who bear the responsibility of monitoring a single application’s threat landscape and updating its security parameters. A startup, on the other hand, typically has limited IT resources, and often can do little more than apply a general security blanket to all applications used throughout the enterprise.
“If you've invested $1 billion in your cybersecurity program, you probably have a pretty secure network,” said cloud expert Kieran Norton of Deloitte Risk and Financial Advisory.1 “But if you don't have that kind of money, there are cloud providers who can dump more resources, technology and R&D into building that base infrastructure and securing it so it can be leveraged in a way that a company alone could never match.”
That being said, enhanced data security may not even be the best feature that the cloud has to offer.
“Not only is data secure in the cloud, it is easily accessible across regions, people and departments in real time,” said Lowe. “This leads to the biggest benefit — leveraging big data, where all the data is there and connected. In this environment, companies can see trends, make predictions and understand how to stop quality events, and create huge time efficiencies.”
The cloud enables BraveHeart’s teams to collaborate more effectively and provides all stakeholders with access to the critical information they need, whenever and wherever they need it. “Working in the cloud helps us work through iterations collectively with people in other offices, as well as consultants,” McAleer said.
As budding enterprises like BraveHeart continue to rack up successes, more and more life sciences companies are migrating to proven cloud solutions to keep from falling behind their more efficient cloud-enabled competitors. The industry is starting to catch up to the rest of the business world where a reported 77% of enterprises have at least one application or a portion of their enterprise computing infrastructure in the cloud.2
Proliferation of the cloud is showing no signs of slowing down, either. Worldwide, the public cloud service market is projected to grow from $182.4 billion in 2018 to $331.2 billion by 2022, according to Gartner research.3
As technology continues to rapidly transform the life sciences, the new best practice for startups is to follow the lead of success stories like BraveHeart’s: digitize from the start and move to the cloud as quickly as possible.
Learn more about the numerous benefits of cloud technology and the transformative power of digitization in MasterControl’s “Architecting for Change: Embracing a Platform Approach” executive brief.
1. “Debunking cloud security myths,” Architecting the Cloud, part of the On Cloud Podcast, May 1, 2019.
2. “State Of Enterprise Cloud Computing, 2018,” by Louis Columbus, Forbes, Aug. 30, 2018.
3. “Public Cloud Soaring To $331B By 2022 According To Gartner,” by Louis Columbus, Forbes, Apr. 7, 2019.
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