Launching an orphan drug is the culmination of years of research and investment. As you prepare to bring your therapy to patients, one of the most critical decisions you'll make is selecting a digital health platform to support your launch. This choice will impact everything from patient adherence and data collection to your long-term commercial success.

But with so many vendors, how do you look past the slick demos and choose a true strategic partner?

Before you sign a contract, gather your team and make sure you have clear answers to these five critical questions.

## 1. Is the Platform Truly Integrated, or Just a Collection of Features?

Many platforms are a patchwork of acquired tools or disconnected modules for things like adherence, ePROs, and clinician engagement. This creates data silos and a clunky, disjointed experience for your users.

Ask: "Can you show us how the patient app, clinician portal, and data analytics engine work together on a single, unified platform? How do you ensure a seamless data flow between them?"

A strong partner, like Mahalo, will offer a truly integrated ecosystem where every component is built to work together, providing a single source of truth and a superior user experience.

## 2. How Does the Platform Handle Compliance and Regulation?

In the world of pharma, compliance isn't optional. A platform that treats regulations like HIPAA, GDPR, and GxP as a simple checkbox puts your company and patients at enormous risk. You need a partner who lives and breathes compliance.

Ask: "Describe your Quality Management System (QMS). How do you approach SaMD classification and validation for your software? Can you walk us through your security and data privacy protocols?"

A strong partner will welcome these questions and provide clear, confident answers, demonstrating that their platform is built with "compliance-by-design" as a core principle.

## 3. Is the Platform Built for Long-Term Scalability?

The platform that supports your initial 100 patients must also be able to support 10,000 patients globally. It needs to evolve with your therapy's lifecycle, allowing you to add new features like RTM, new languages, or new country-specific regulations down the road.

Ask: "What is your product roadmap for the next 18 months? How does your architecture support global scalability and the addition of new functionalities post-launch?"

A strong partner will have a clear vision for the future and a modern, scalable architecture designed for growth, ensuring you won't need to switch platforms in a few years.

## 4. Who Owns the Data?

This is a simple question with complex implications. The real-world data generated by your patients is an invaluable strategic asset. Some vendor contracts have vague clauses that can lock you in or, in worst-case scenarios, give them ownership of the aggregated, anonymized data.

Ask: "Can you show us the exact contract language that specifies that we have full ownership of and access to our program's data?"

A strong partner will be completely transparent, with a clear, unambiguous "customer owns the data" policy.

## 5. Are We Buying Software, or Gaining a Strategic Partner?

A software vendor sells you a tool and a user manual. A strategic partner invests in your success. For a rare disease therapy, you need a partner who understands the nuances of biopharma, from patient services to regulatory submissions.

Ask: "What does your customer success and strategic support model look like after we go live? What level of biopharma expertise does your team have?"

A strong partner like Mahalo provides a dedicated team of experts who act as an extension of your own, offering strategic guidance to ensure your digital health program achieves its full potential.

Choosing the right platform is one of the most important decisions you'll make for your therapy. By asking these questions, you can ensure you select a foundational partner that will de-risk your launch and amplify your impact for years to come.

Ready to partner with a platform that has the right answers? Contact Mahalo Health today.

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