In the past 21 months since Covid-19 became a public health crisis, the adoption of virtual health solutions has accelerated to reduce risk. Although once regarded as a useful companion for hospital visits, virtual care is becoming more and more common as the default starting point for healthcare provision due to CMS reimbursement. This has not only become the norm for many primary and some emergency care services, but also the norm for professional fields such as behavioral health. National retail chains such as CVS Health and Walgreens have adopted platforms to support Virtual First Care (Virtual1Care). Amazon Care uses Virtual1Care-it has provided the service to employees across the country, and other companies have begun to use it, especially Hilton.
Virtual1Care This is part of the broader trend we are seeing in healthcare restructuring. To benefit from this trend, pharmaceutical and medical technology companies must ensure that their digital health tools around drugs or devices comply with changing regulations. In an interview, CEO and founder Dr. Kal Patel discussed how Virtual1Care is shaping digital healthcare adoption, some of the ongoing regulatory changes in digital healthcare, and how BrightInsight is working with the company to realize this new healthcare vision.
One transaction that emphasizes this trend is the digital health cooperation between the two parties. The virtual clinics of Fitbit and Verily under Google – OnduoThe collaboration will pair Onduo’s chronic disease platform with Fitbit’s devices and Fitbit Premium as part of the company’s holistic health approach. It aims to fully understand how different aspects of health and well-being come together, including activity, sleep and stress, to help participants better manage their health and establish daily activities that suit them. According to the September announcement.
For the same reason, such cooperation is also taking place in the field of life sciences.
“How do you use continuous data sources to drive patient interventions, not just patient interactions that must be face-to-face clinical visits?” Patel asked.
“Our entire product portfolio demonstrates the potential and power of packaging regulated software around traditional medicines and devices.”
In 2021, investment in digital health has soared to new heights, especially for companies developing virtual care technology. As a company that provides infrastructure for the development and expansion of regulated digital health projects for pharmaceutical and medical technology companies, BrightInsight has also benefited from this investment trend.In the first quarter, it closed a $101 million in Series C financing Led by General Catalyst.
Patel’s background in Amgen Pharmaceuticals Digital Health, Doctor on Demand, a telemedicine provider, and most recently as President of Flex Digital Health make him well-suited to lead these collaborations. An example of how BrightInsight can help a life science company achieve its digital care goals is its collaboration with Novo Nordisk to support people with type 2 diabetes.
This pharmaceutical company needs a regulated digital health platform to help it build and operate a set of digital health products and services to improve diabetes care. In addition to an open, device-agnostic platform that can capture data from continuous blood glucose meters and insulin pens, Novo Nordisk also needs a regulated platform designed to meet the strict privacy, safety, and regulatory requirements of U.S. and European healthcare regulators. And quality requirements. One of the challenges the company seeks to solve is to improve the way patients manage chronic diseases. At least 45% of patients with type 2 diabetes have difficulty controlling blood sugar levels, and medication compliance is a contributing factor.
The collaboration with BrightInsight can help diabetics unlock real-world data. By combining the user’s blood glucose data with the insulin dose data automatically recorded by Novo Nordisk’s smart insulin pen, users can better understand how their activity, diet, and insulin intake affect their levels, and make smarter decisions. The decision is to keep their blood glucose levels within safe parameters.
Although there are many companies developing digital health solutions, if they cannot adapt to regulatory changes, they may fall behind or become irrelevant.Earlier this year, EU regulators Enforce a series of changes Instructs companies on how to manage software medical equipment, effective May 26. These changes are designed to ensure high standards of safety and quality, as regulators try to keep up with the pace of health technology innovation while maintaining the demand for safety and health. effect. The FDA shared a draft guideline for pre-market submission of plan changes for digital health technologies-the original version dates back to 2005.
FDA has indicated that it is Update software medical device guide According to a blog post on the BrightInsight website, every software appliance will therefore fall into one of two categories: basic or enhanced. The updated draft guidance is the FDA’s attempt to keep up with the influx of cutting-edge submissions. By focusing on basic risks and enhanced risks, they eliminated the middle ground and simplified the submission process.
“This reflects the FDA’s view of low-risk/high-risk equipment,” said Sonia Nath, a partner at BrightInsight’s Cooley law firm. “This may be announced as a simpler, risk-based way of looking at software equipment in general… The idea behind this guide is that if we tell you more clearly what we need, you can do it faster The approval process, because there will not be so many back and forth. Technology is always faster than laws and guidance documents.”
The new draft guidelines will require more design documents to be attached to the submission of “high-risk” software equipment, detailing the technical design details of the software function, how the software design implements all the requirements of the Software Requirements Specification (SRS) and the Software Design Specification (SDS) How to trace back to SRS in terms of intended use, function, safety and effectiveness.
In the past few years, the integration of pharmaceuticals, medical technology, and suppliers through digital health data has been a fascinating transformation. Pharmaceutical companies such as Takeda and Sanofi are developing professional practices to gain a deeper understanding of market dynamics and patient needs. Patel pointed out that health data has become a key commodity.
“For pharmaceutical and medical device companies, their resources will continue to expand significantly and focus on software,” Patel said. “You will have multiple sources of health data to answer questions from the diagnosis of the disease to matching the correct treatment for the patient.”
He added: “I think all disease areas are suitable for digital solutions.”
Virtual health visits are expected to increase in 2022 The demand for supervised connected devices and software known as medical devices (SaMD) will also monitor the health of patients between medical appointments. Collecting and analyzing data from these devices is not only critical to discovering potential problems with dosage, device usage, and overall patient health; they can also make the interaction between patients and their clinicians more meaningful by providing them with insights. Digital health products in the fields of pharmaceuticals and medical technology will continue to expand and become stronger in specialized fields such as chronic diseases and oncology and rare diseases. It will be interesting to see the form these collaborations take in the new year.
Photo: NicoElNinom, Getty Images
