Why choosing the right platform partner to launch software as a medical device is crucial

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It’s not a surprise to anyone in biopharma and medtech that business is booming in the regulated digital health space. Between January 2019 and October 2021 the top five pharmaceutical companies invested some $270 million in Software as a Medical Device (SaMD) solutions alone.

Companies competing for market share in this increasingly crowded field are bringing on platform partners to help accelerate time to market and free up crucial internal resources. It’s a smart move, as the right partner can not only help your team stand up individual solutions to differentiate therapies quickly, but also give you the underlying infrastructure to expand and scale over time.

Yet as the opportunities in regulated digital health solutions continue to grow, more and more consultancies and software companies are springing up along the periphery, positioning themselves as the partner who can stand up your solutions better, faster and cheaper. Yet too often, it’s a “buyer beware” scenario.

Many companies do have some experience building digital health solutions—yet they’ve only built unregulated consumer digital products, so they’re ill-equipped to help you navigate the complex world of global security, privacy and regulatory compliance for SaMD.

We also have seen companies actively mislead potential customers by promising anything and everything, but in actuality, they have unregulated vaporware that they don’t have the knowledge or talent to build. Or, they may claim SaMD expertise when in reality, their Quality Management System (QMS) wouldn’t pass any audit for a biopharma or medtech company.

We have heard enough of these watch-out stories from our clients and prospects, and wanted to create a simple guide to help you find the right digital health partner.

Choosing the wrong platform partner can have broad and long-lasting implications, including:

Financial risk: There are real costs to working with a partner that can’t actually do what they were hired to do. Both failed launches and solutions that launch and then struggle with user adoption are incredibly expensive. Of course, there’s also the opportunity cost of having to start over, while your competitors are busy eating up market share.

Reputational risk: When a solution launches and doesn’t work as intended, your company’s reputation is at stake—with patients, providers, payers, industry partners and investors. And regaining the trust of these vital groups is an uphill battle.

Security risk: Security breaches are a worst-case scenario for biopharma and medtech companies. The cost of healthcare breaches hit a record high this year—they are the most costly of any industry and take the longest to identify and contain. When a platform partner doesn’t have the expertise to build your solution according to the latest security, privacy and regulatory practices, patient data is at risk, and the fallout of a security breach affects every part of your business—for years.

Do your due diligence when researching potential partners

Once you’ve decided you’re going to work with a partner to build your SaMD solution, it’s important to take the time to do your research as you narrow down your options. Here are some tips:

Ask detailed questions

It can be hard to know where to start when interviewing potential platform partners. Our new handout, 10 Questions to Ask Your Potential SaMD Platform Partner, guides you through the most crucial questions to ask, including those that determine:

See what people are saying

Recognize that there are companies in the digital health industry that are exaggerating their expertise. Do more than just a cursory online search—dig deep into every potential partner’s reputation in the industry and find out who is on their leadership team and/or board. See what current and past employees are saying.

Don’t be swayed by freebies

This is the classic “if it seems too good to be true, it probably is.” Watch out for unbelievable discounts, especially from a platform and software partner that will support regulated SaMD. As with any software, you typically get what you pay for.

Dig deeper into the stats

Beware of companies that promise millions of current users on their platform and solutions. Less reputable companies can get pretty creative with their math, and often count users of non-regulated solutions among their totals. Instead, ask for proof of actual recent launches.

Go with the partner trusted by leading companies

BrightInsight is the launch partner and underlying platform for the world’s leading biopharma and medtech companies. We completed seven SaMDs in 2021 alone. We’re backed by leading healthcare and technology VCs and our leadership team brings over 100 years of combined digital health experience.

We invite you to ask us the hard questions, check out our certifications and review our case studies to learn how we’ve accelerated time to market for our customers’ regulated digital health products.

Read 10 Questions to Ask Your Potential SaMD Platform Partner for more.

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