Medical Design and Outsourcing
July 26, 2022 By
[Image from Unsplash]Dr. Kal Patel, BrightInsight
It’s hard to overstate the importance of the global in vitro diagnostics market.
Fortune Business Insights projects the global IVD market will grow from $71 billion today to $107 billion by 2029 – a 50% increase. The National Institutes of Health estimates that 60– 70% of all healthcare decisions are influenced by IVD testing results.
According to a Deloitte report, 100% of medical technology companies reported investing in device connectivity; 77% said that integrating data from new technologies is a key challenge; and 82% said they plan to collaborate with external partners to advance their digital programs.
As with their peers in the medical device space, IVD manufacturers must manage their devices, and the data they produce, securely and reliably to stay competitive. With new, digital disrupters entering the sector, IVD companies that want to maintain or gain market share will need to have strong digital capabilities. Medical device companies have long recognized that the skill sets required to develop effective, cloud-based software in a regulated environment is often outside of their core competencies.
This is a common question in the digital health space, but it’s actually more useful to think of it as build vs. build, with companies developing some digital capabilities in-house, and partnering on others. IVD companies can take greatest advantage of this by creating a small team to liaise with their external partner.
On average, it takes three times as long and costs five times as much to build Software as a Medical Device (SaMD) in house. Engaging a partner with experience and expertise, who understands regulatory and security requirements and is able to scale efficiently across geographies and products, can greatly reduce these costs and time to market.
There are significant advantages to engaging with an outside provider for a digital solution:
Ideally, IVD companies should seek an external partner that provides four critical elements: compliant cloud storage; device management and analytics; lab workflow (LIS); and middleware — an end-to-end solution that accelerates time to market and addresses compliance and security requirements.
Our research on the IVD market in developing our digital Connected Diagnostics Platform, and our recent work with a major IVD manufacturer, revealed a few key considerations in developing a digital platform for the diagnostics industry.
Not surprisingly, quality and regulatory issues top the list. A quality digital solutions provider will be able to support Class II/III Medical Devices with software designed to meet these classifications via a compliant platform engine, automated solution testing and documentation.
Another key consideration is cybersecurity, ensuring privacy and security across multiple regulatory jurisdictions. A good provider will enable global scalability with compliance for launch in scores of countries.
Last, but perhaps most important, is trust. There are a lot of startups out there making claims they can’t back up. Put your faith in a partner with a proven platform and team.
Kal Patel, M.D., is co-founder and CEO of BrightInsight, provider of the leading global platform for biopharma and medtech regulated digital health solutions. Kal Patel is an MD and MBA with more than 20 years of experience in pharma, medtech and digital health. Since its founding, Kal has led three successful financing rounds totaling $186M, bringing the company’s valuation to ~$750M. Previously, he founded and built Amgen’s Digital Health business unit and was the Global Marketing Lead for Enbrel, Amgen’s leading drug with multi-billion dollars in annual sales. Kal spent several years at Novartis after beginning his career at Boston Consulting Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
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Medical Design and Outsourcing