With every passing day, month and year, leading biopharma and medtech companies have more and more choices in terms of who they partner with to bring their SaMD platform and solution goals to fruition. Yet not all partners are created equal—and experience is paramount. Here are five reasons why choosing an experienced partner is always worth it.
In the hyper-competitive digital healthcare space, speed to market is everything. Every month of delay is investment squandered. And we have many customers who come to us after spending years on a solution without ever getting close to launching. Meanwhile, their competitors are getting closer to the finish line.
Experienced partners know what it takes to successfully launch products—and they know how to do it more efficiently. BrightInsight’s Platform and solutions cover all your core needs out of the box, enabling accelerated time to market for SaMD solutions by months or even years. For example, we launched Roche’s SaMD hemophilia dosing calculator and CSL Behring’s Hizentra app in less than six months, and continued to enhance and improve the app with subsequent releases.
There’s a difference between hiring a vendor and engaging a truly skilled strategic partner. A vendor can “check the boxes” and help you get your solution to market, but it may require a lot of hand-holding on the part of your already busy team.
By hiring a true partner with a cross-disciplinary team that has real-world experience launching SaMD, you can free up your internal team to focus on their core competencies and have meaningful discussions with your partner to build differentiated solutions, instead of having to actively manage a vendor you’re not sure you can count on.
Many biopharma and medtech companies are just beginning to really invest in SaMD, and there’s no singular, tried-and-true roadmap. With a proven partner like BrightInsight on your side, you get not only the executional chops to keep your launch moving forward, but you also get a wealth of knowledge from people who have been there before. Our SaMD team has more than 340 years of combined SaMD experience during their careers on over 240 projects in more than 25 therapy areas. As BrightInsight, we’ve successfully launched more than a dozen SaMD’s—seven of them in 2021 alone—and we have 17 more in the pipeline.
Since SaMD solutions will be used by patients and providers, they need to be safe and effective—and that’s not simply a suggestion. It’s a mandate from the FDA, EU and other regulatory bodies. That means the financial and reputational risks are huge. Failed SaMD launches damage your reputation with patients and providers, while the financial and PR fallout from cybersecurity breaches can bring even the biggest pharma companies to their knees.
BrightInsight’s Compliance Team is made up of true industry experts who can consult on strategies for reducing risk, while delivering vital security, privacy and regulatory compliance. We stake our reputation on each of the 46 regulatory audits we’ve completed to date—13 so far in 2022 alone. We invest more than 500 hours to complete each audit to ensure it meets the highest expectations of the regulatory body.
The future of digital health is global, and when you partner with BrightInsight you future-proof your roadmap for expansion into a myriad of markets. We currently support regulated SaMD solutions in the US, Canada, UK, France, Germany, Italy, Spain and Australia, and we meet privacy/regulatory requirements to support launches in 64+ countries, with more on the horizon.
The team at BrightInsight has a collective 870+ years of biopharma and medtech experience and over 700 medical device projects under our belts. And our SaMD expertise isn’t just limited to one team or discipline area. My co-founders and I started BrightInsight to combine technical expertise, industry-leading innovation, and a passion for helping biopharma and medtech companies launch the groundbreaking digital solutions that can improve patients’ lives around the world. Across the organization, our 220+ employees are true leaders in this dynamic field, leveraging an incredible amount of real-world experience to turn your ideas into powerful digital solutions.