New pilot program could overhaul traditional health FDA practices
With interest from over 100 companies, the Food and Drug Administration is diving into its Digital Health Innovation Action plan, and has named nine companies who will become part of its new pilot plan, Pre-cert.
All companies were chosen on the basis of size, level or risk, high profile and level of quality throughout their operations within the digital industry.
The scheme will look at how technologies approach the area of quality control with regards to a growing healthcare focus, and subsequently streamline its approach towards this growing trend, enabling companies to bring products to market quicker, whilst adopting high levels of quality and safety throughout the process, leading companies to become pre-certified.
Such analysis will also enable the development of performance indicators to enable pre-certification going forward. "We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” commented FDA Commissioner, Dr Gottlieb.
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“This helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
The nine companies are as follows…
- Johnson & Johnson
- Pear Therapeutics
Such developments will see the eradication of traditional blockages and revise current regulations towards current and developing healthcare services and products, which can then be received by the patients in weeks and not months.
Corey McCann, President and Chief Executive Officer of Pear Therapeutics has stated: “We commend the FDA’s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients.
We are honoured to be at the table with these eight other companies and the FDA as we help write the new chapter on digital health and digital therapeutics.”
On the rise: Doktor.se
1. Doktor.se launches as a digital healthcare platform in Sweden in 2016. The company's focus is on the B2B market, with a mission to help members find, book and get access to healthcare services through telehealth and telephone calls.
2. The company offers healthcare services through its app as well as at bricks and mortar clinics. After raising more than €40 million in a funding round in May 2020 to expand its operations both nationally and overseas, CEO and founder Martin Lindman says there are plans to enter new markets at the beginning of 2021.
3. Belgium becomes the fifth market where Doktor.se provides telemedicine, through Belgium's communications company Proximus Group. It becomes the second most downloaded doctor app in Europe, and over 1.2 million patient consultations are carried out, either through the app or at physical clinics in Sweden. Throughout 2020 it administers over 250,000 COVID-19 antibody tests in Sweden.
4. Doktor.se is the most popular digital healthcare in Sweden, used by approximately one-tenth of the country's population. New funds are raised to offer improved services for mental health and chronic illnesses, and to expand digital services and acquire physical services to integrate into its digital platforms with the aim of creating a hybrid model.
5. The company announces €29.5 million in funding from Chinese technology multinational Tencent Holdings. Doktor.se say the funds will be used to make its global healthcare services more efficient, accessible and affordable.
The platform now employs nurses, doctors and specialist doctors, psychologists, and physiotherapists, and is available across Europe and in Brazil.
6. Over 1.5 million people are currently using healthcare apps developed by Doktor.se, either run by the company or through its SaaS licensing business. There are around 900 people employed by the company, and Doktor.se say that the productivity of medical staff using the platform is up to four times greater than those working in traditional services.