Pharma Checklist for Choosing the Right DTx Partner

The-Ultimate-Guide-to-Choosing-the-Right-Digital-Therapeutics-(DTx)-Partner-v1

If you’ve decided that it’s time to explore the world of Pharma DTx relationships, then you’ll need the right partner.

However, with so many different potential DTx partners out there right now, who’s the best fit for your business?

Introduction

Across healthcare, adoption of digital transformation and technologies has been the norm for almost two decades. With many sectors more progressed in this way than the pharmaceutical industry, now is the perfect time for pharma to jump on the digital bandwagon, and cater to the changing needs of patients across the globe.

Initial signs are good – thanks to the emergence of new technologies, more effective manufacturing and distribution approaches, the pharmaceutical industry is beginning to see the value in digital transformation, with a steady increase in investment that has led to rapid growth.

Manufacturing speed, by way of example, has increased exponentially with the introduction of robotic technology and Artificial Intelligence (AI). However, in order to avoid being left behind by other areas of healthtech, the pharma sector needs to follow the key trends in digital transformation.

Amongst those key trends are:

  • The rise of on-demand healthcare
  • The upcoming big data boom in digital healthcare
  • Treating patients with virtual reality, not just remotely
  • Increased uptake of wearable devices – a sector that’s grown 15x in the last 6 years
  • A boost in predictive healthcare across all areas
  • Increased leverage of Artificial Intelligence (AI) and use of blockchain technology in electronic health records.

Interestingly, digital therapeutics (DTx) is at the crux of most of these digital transformation trends, and will be a key player in how pharma and digital transformation interact in the coming decades. DTx, for those in need of a recap, delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.

What’s the difference between DTx and Digital Health?

An often asked question, and one that’s rarely answered simply. Let’s set the record straight.

Digital therapeutics is a subset of digital medicine, which in turn is a subset of digital health. Digital Health is the umbrella, used to describe all technologies that digitally engage patients for health-related purposes.

DTx exists within the larger digital health space alongside other technologies that assist patients during different phases of their healthcare journey.

Digital health technologies include:

  • Mobile health applications e.g. fitness trackers, nutrition apps, etc. 
  • Health information technology e.g. electronic medical records (EMR) systems
  • Wearable devices and biometric sensors
  • Personalised healthcare e.g. patient-reported outcomes, predictive analytics, clinical decision support etc
  • Telehealth e.g. telemedicine, virtual wards, remote patient monitoring, remote care programs, etc.

Numerous bodies, including the Food and Drug Administration (FDA) in the US have pointed to DTx as a tool that can empower consumers to make better-informed decisions. By utilising DTx patients can,quite literally, take their health into their own hands.

Pharma & DTx

As an industry, pharma has seen a radical shift in the last few years – moving closer to value-based healthcare. This shift reflects the progressive movement of global healthcare systems from fee-for-service models to models that focus on delivering the best possible health outcomes for the lowest possible cost.

Adding DTx to this progression seems to be the next logical step. The depth of data that DTx can deliver can help to complement pharma’s new offerings, which could be used to not only improve existing treatments, but also to create new treatments and lay down new pathways for adjuvant therapies.

There are several examples in the market where pharma has successfully partnered with DTx companies to boost their market access, leverage the digital in monitoring patients in phase II clinical trials and to enhance the user experience of patients thus arriving at the ‘engaged patient’ stage.

As pharma looks for ways to grow, embracing the power of DTx is one of the best ways, especially when there is a clear understanding of the problem/intended use that needs to be solved.

In addition to this, DTx has additional nuances over medication, like taking into account cultural nuances within a market, as well as the different regulatory requirements therein.

The Five Ground Rules 

With any good partnership, ground rules are crucial. We’ve compiled five key ground rules to help you choose the right DTx partner.

  1. Partner-Market Fit

    Has your chosen DTx partner delivered in diverse locations? Exposure to markets where you plan on launching your DTx is critical. Doing so shows that they can overcome the different challenges presented by international health ecosystems and regulatory environments. 

    Are they focused on just one therapeutic area? Or is there room for them to grow? A diverse product portfolio might be desirable for you, in terms of alignment. At the same time, more specialised DTx might be the right move. It’s important to assess your own portfolio, and where it’s moving, to match it to the correct DTx partner.

  2. Reliability

    Everyone wants to accelerate as fast as possible. But not everyone can be the Max Verstappen of DTx. Speed and accuracy are rarely good bedfellows, and reliability stems from accuracy.

    Check out your partner’s track record – do they deliver in time? Are they compliant across all requirements and regulations? When examining this, bear in mind that your current target market is not necessarily the only one you will serve – future proofing your solution by taking into account future target markets is an important consideration at this stage.

    Reliability should be the starting point for your relationship, especially when it comes to delivering a safe, effective product and achieving credibility from both patients and healthcare professionals.

  3. User Experience & Reach

    How have your partner’s existing products been received and utilised by patients? What are their satisfaction ratings like? How much time elapses from product release to usage? And how are patients reacting to DTx? Without trust in the product, adherence will remain low amongst the adoption cohort. Finally, have they cracked the cultural nuances of a particular geography? Without this, adoption will suffer. 

    These are the key questions to ask yourself when looking at your DTx engagement metrics.

  4. Clinical Alliance

    How does the DTx company collaborate with clinical experts and health care providers? DTx is designed to prevent, treat or manage a health condition and collaboration and integration of healthcare provider work-flows into the product is crucial to ensure success.  It is important not to underestimate the impact of clinical trust in your product. Without trust, adoption simply won’t occur. If you look closely at the Rx velocity of solutions that have achieved adoption, this clinical trust is key.

    Does the company use a B2B model or a B2C? DTx is a prescription product and hence the ideal route is to go via HCPs.

  5. Criticalities

    How does your potential partner deal with critical issues like  IP, product ownership and product design/development?

    Knowing what you want, and what your partner can offer early-doors will be key to selecting a partner whose values are aligned with your own.

Being an End to End Partner (300)

If you’ve followed these ground rules, you’ll be ready to select the right partner for your company.

Once selected, it’s important to ensure that operations run smoothly, end-to-end, in order to achieve scalable growth.

The process starts with defining your need. What is the use case you need to solve? It is important that this decision is not siloed. You will need to engage in wide and deep pan organisational collaboration between your product, clinical and design teams to create a tight scope of work.

Once you’ve decided on a use case, the next stage is design – developing software by utilising a close knit group of patients, providers, and pharma partners. In doing so, it’s important to utilise industry best practice and to understand that these processes are always iterative. 

This phase is resource intensive, but crucial to the success of the overall project.

Once a design has been decided upon, DTx moves to the development phase. It helps if your DTx partner is already regulatory approved, as you’ll need to be both agile and quality compliant to develop something that can be validated.

Wherever you’re based in the world, in healthtech, validation is king. Not only in terms of regulatory approval and compliance, but also to establish safety, efficacy, acceptance, usability and quality of the product.

If you’ve designed, developed and validated your product, then the chances are the next step is regulatory approval. This can be the time consuming part, and a strategy to overcome it in advance is recommended. Regulation is a time-consuming process and the intricacies of applying and submitting to regulatory bodies is better off with a partner who recognizes the nuances of the minefield that is compliance. The key checklist for compliance is:

  • ISO-13485(Quality Management compliance)
  • IEC-62034 (medical device software development) 
  • ISO-14971 (medical device risk management) 
  • Class I/II/II FDA(US) SaMD compliance as per intended use
  • Class I/II/II CE (Europe) compliance as per the intended use

Once the clinical results are submitted for validation, both the DTx provider and pharma organisation should work together to file for reimbursement for future commercialisation. Depending on the reimbursement policy or framework in the target market, you should almost be ready for deployment.

Following a successful reimbursement, it’s time to look at commercialization, and how the ongoing relationship will factor in things like maintenance and updates.

Successful commercialization is not just a pricing strategy aligned to strong marketing. DTx sales cycles are not the same as traditional pharmaceutical go-to-market strategies, and it is important not only to have the right team in place, but also the right communication strategy.

Neither the pharma organisation nor the DTx pattern can own commercialization alone. It must be a joint process. Your DTx partner will have good experience of commercialising DTx products in other markets, and pharma organisations have the network to make it happen. The combining of these two, and one final critical step, will determine the level of success the partnership achieves.

The crucial, final, step to commercialization strategy is training. Pharmaceutical sales reps do a phenomenal job in their core market, but in order to pitch DTx strategy, an element of retraining is required. This can be led by your DTx partner, in collaboration with your sales teams. Getting the pitch right, when communicating the value to clinicians is not a simple process, and it is important to ensure that the messaging is spot on before starting.

So you’ve designed, tested, built, developed, and regulated your DTx product. With a commercialisation strategy in place, it’s now time to deploy. 

In order for it to be the success it should be, you’ll need to connect with thousands of HCPs and patients across diverse geographies to achieve an economy of scale.

You will also need to put in place real-world data collection mechanisms to monitor the usage of your DTx product. It’s important to ensure compliance at this stages GDPR certification would be a plus.

In order to hit each of the milestones above, you’ll need a partner with great expertise in the DTx space.

DTx journeys are not easy, or short, but a true partner walks with you from the very start to the final destination. If you are interested in our work in Europe and across the globe, or looking to scope out your next DTx partner, please get in touch at: [email protected]