Developing and implementing a digital health solution in real world setting is a daunting task that could require considerable effort, especially when you have a limited experience of medtech and digital worlds Pharmaceutical industry has a broad range of expertise drug discovery, chemistry development and clinical evaluation, regulatory affairs, and market access However, the impact of this expertise changes completely when it comes to designing, developing, clinically and technically validating and bringing to market a digital health solution.
These solutions add value to pharma traditional drug assets they provide a sustainable competitive advantage, improve patient and HCP experience and fits well into outcome based frameworks that are expected to burst in the coming years.

But this is not easy. That is why we put together 8 tips to help you save time and choose the right partner for building a digital therapeutic (DTx).

1. Define a detailed and comprehensive project brief A complete, well defined, and shared project brief is essential to move forward at the right pace To do this, you need to think carefully about the final solution, picture it in the hands of the end users, patients or HCPs, in real world setting You must identify what the DTx can bring to the patient and which technical components are needed for its implementation Identifying the need and formulating it in simple terms is necessary to steer the project in the right direction from day one.

2. Have the will to deliver quickly Picture a feasible project and to give yourself the means to do it in a defined timeframe Several obstacles can put the plan at risk Anticipating them is essential to deliver a solution quickly. The scope must also be realistic and achievable the more clinically and technically complex the solution, the longer the timeline.

3. Widen your field of vision A company that has already developed its own digital therapeutics is aware and knows how to intervene in the entire DTx value chain › Design Medical analysis and patient journey definition › Development Risk assessment, human factors engineering, solution architecture, cybersecurity › Regulatory Quality system, certifications, standards, submission files, contact with notified bodies in concrete terms everything in place to de-risk the project › Market access Market definition, targeted population, knowledge of healthcare systems, reimbursement framework, price definition › Operational Solution maintenance, hosting, data protection › Data collection and analysis API, devices/software integration, data analysis infrastructure, reports This means that your future partner can support you throughout the overall project and is better able to cope with difficulties since it itself faced obstacles during the development of its own DTx.

4. Commit yourself to the project Your commitment is key To make sure that you, the pharma company, and your partner share the same direction, it is important to set up regular meetings to present what have been done and validate each evolution This saves time because you can follow the evolution and growth of the DTx step by step ensures a proper conduct of the project, anticipates new requests or changes in direction It is easier to start from scratch than to start over with something that has already been built and approved.

5. Identify the appropriate regulatory strategy asap Working with a company that has put in place an internal quality system tailored for the development of SaMD that knows the regulations in each territory and has already been confronted with notified bodies is a real time saving advantage because: › All employees are trained and are aware of regulatory issues which creates a regulatory culture within the company and shared by all employees ›. The quality and regulatory documentation is an integral part of the DTx design and development process thus facilitating the tracking of information and interaction with regulatory bodies › The knowledge of regulatory bodies and the ways to get a SaMD approved saves time For example, knowing the criteria for an enforcement discretion submission in the US can save 6 to 9 months In the EU, you can submit a SaMD for the CE Mark without any clinical data if a similar SaMD has already been marked › Experience with institutions gives credibility to the partner company and creates trusted relations, the company is well known by the notified bodies Partnering with a company who has its own certified QMS and internal skillset developed over years of experience also means that it can take on the role of legal manufacturer This allows you to avoid setting up a quality system that meets the SDLC (Software Development Life Cycle) requirements, nor to manage post marketing aspects such as device vigilance or complaint handling, so you can focus on your expertise.

6. Develop a flawless team spirit What do a software engineer and a doctor have in common? A quality engineer and an IT manager? A UX designer and a cybersecurity officer? At first sight, not much However, within a medtech company, all these functions meet and must work together It is very important that a collective mindset grows between them to operate more quickly on projects Medical affairs teams must be sensitized to development issues and developers must grasp the clinical needs. A common language must be established so that they can communicate together and therefore make the project grow.

7. Let the professionals advise you Collaborate with an expert company that will support and advise you on technical but also on strategic issues Marketing a DTx is a totally different approach than for a drug Developing a DTx with a specialized partner can only be beneficial in terms of time, risk and costs Developing a drug versus a digital solution do not require the same expertise and skills These are two distinct worlds with different cultures, codes, and languages The collaboration becomes even more relevant when an advising dimension is created between the pharma and the DTx company This way, the DTx company supports pharma in its digital transformation and saves time by being able to intervenes on the entire DTx value chain.
8. Select THE right partner There are medtech digital health, DTx ePRO and SaMD companies all over the place It is not easy to select the right partner Some companies are very specific, others more general, some are a few years old, and others were born at the beginning of the internet bubble But what must be considered is how well the partnered company can meet your need Hence it is important to include the project team upstream so that the need is well understood to avoid back and forth during the development phase The more accurate information your partner receives, the better it can estimate the time needed to complete the project and therefore generate less frustration thanks to respected schedule and scope.

At Voluntis, an Aptar Pharma company, we work closely with Life Sciences partners to create digital therapeutics that empower people with chronic conditions to self manage their treatment, thus improving real world outcomes. Combining mobile and web apps, our solutions use clinical algorithms to deliver personalized recommendations to patients and their care teams Leveraging our Theraxium technology platform we design digital therapeutics across therapeutic areas, especially in oncology and chronic diseases.

If you would like to know more or if you have a project to develop, please get in touch.