As the digital transformation of healthcare continues to gather pace, the explosion of digital health solutions is hard to ignore. One area of interest is the rise of mobile apps which help chronic disease patients to monitor symptoms and manage therapies.
Companion apps are a form of ‘software as a medical device’ (SaMD), which work in conjunction with a conventional pharmaceutical or medical product. Pharma companies often use companion apps to increase a patient’s adherence to medication, while medtech firms are exploring how apps can remotely monitor someone’s surgical readiness and recovery.
With an increasing number of life sciences firms evaluating the role of digital companion apps, they often run into a familiar conundrum at the start of their projects: whether to build in-house or partner a specialist platform provider?
Build versus partner
Building offers the advantage of maintaining full control over everything, from the software to the content, IP and branding. It might also be less risky, as there is no chance of being locked into a long-term relationship with a poorly chosen partner.
Handling the project in-house means you don’t pay for unwanted features that may be bundled into a partnered solution, and in some instances it may simply make more sense. For example, provided the company has the skills and capacity, using a basic app to record manually inputted measurements for one physiological parameter may be quicker and more efficient to deliver independently.
But there are obvious drawbacks to going it alone. Life sciences companies do not tend to be experts in software design and development can be slow, with endless approval cycles, when speed to market and constant iteration is required. The average price of building a health app typically runs into millions and that doesn’t take into account the ongoing cost of maintenance.
Partnering is often viewed as the more efficient pathway for bringing a digital product to patients, since you can leverage the off-the-shelf components of a platform that has already demonstrated its clinical effectiveness, helping you to deliver the project significantly faster and potentially at a lower price.
Further arguments make partnering a digital health company the more appealing choice in many instances. Significant resources are needed to tackle the regulatory compliance journey, yet until you’ve satisfied all of the requirements, the product goes nowhere. Working with a firm that has already secured the necessary certifications for their platform streamlines the filing process, helping you get to market faster. The partner also takes on the responsibility of data hosting and app updates, maintenance and bug fixes.
Analysis of GlobalData’s deals database reveals a growing number of life sciences firms forming partnerships on mobile app projects. While medical device manufacturers represent the majority of the deals in the database, there has been a sharp rise in the number of partnerships formed by pharmaceutical companies since the pandemic.
Your digital partner checklist
Whether you’re leaning more towards building or partnering, here are the six questions you should always consider before making a decision:
How much control do you need across the app-development process?
While partnering means you can leverage the various modules that an existing platform has to offer, it is not the right approach for companies that already have a strong vision for the app’s branding and functionality, and wish to hold the intellectual property as well.
Are you confident you have the internal capability and capacity to execute the project? Successfully delivering a large-scale software engineering project will require significant resources. Any problems can lead to projects exceeding their deadlines and budgets.
Can you deliver the infrastructure and processes required to maintain data security and privacy?
Ensuring an appropriate and compliant level of patient data privacy and security is critical when developing a mobile health solution.
Do you have the internal expertise to secure regulatory approval for the product?
Regulatory approval will be required for every country in which you wish to roll out the app. Satisfying all these requirements needs substantial resources as well as internal expertise.
Do you have the ability to roll out the product at scale?
Digital health companies not only provide the infrastructure but can also offer experience, resources and insights that prove invaluable in the commercialisation of a new digital health product.
Are you prepared to make the continued, long-term financial investment to keep the app running?
Apps require ongoing development and upkeep, which demands continued financial investment.
How to choose a partner
Choosing to team up on a companion app project is just the first step in the journey. Next comes the process of evaluating companies and selecting one that is the best fit for your business needs. If you value flexibility and scalability, look for a company with a disease-agnostic platform, meaning one that can cater to the exact data requirements of a wide range of therapeutic areas, including higher-acuity comorbid patients.
This gives the option to use the same infrastructure to expand into other indications as you scale your digital health strategy. You should also consider whether the platform can be localised for a range of different markets, enabling you to adapt it to various countries and languages as you grow.
A modular approach from your software provider is equally essential, as this enables you to mix and match components that make up the perfect solution. Additional requirements for the platform include a strong user experience, which helps to keep patients engaged along their care journey, and a wealth of clinical and real-world evidence demonstrating a strong track record. Even better is a platform that has already received regulatory clearance, as this can reduce your own speed to market significantly.
But don’t only focus on the infrastructure; also consider the team behind it – do they have in-house experts who can assist clients with regulatory filings? Can they share insights to help launch the product across international markets?
Huma’s remote patient monitoring platform currently supports a growing network of 27 million patients across a wide range of SaMD, clinical trial and healthcare applications. In June, Huma received US Food and Drug Administration (FDA) Class II clearance for its SaMD platform – just three months after it achieved the world’s first and only multi-condition EU Medical Device Regulation (MDR) Class IIb approval.
With Huma, you can choose from modules such as clinician-to-patient messaging, connected devices and smart notifications. The award-winning, disease-agnostic software has powered more than 450 deployments across 60 countries.
To find out how medical device firms can generate revenue from digital health, download the whitepaper below.
[1] GlobalData Pharmaceutical Intelligence Centre, Deals database.