[This guest post was written by Alexander Romantschuk, Innovations Leader, Lilly Germany, Alexander studied molecular and surface physics at the University of Bielefeld, Germany. Since November 2005 he has held the position of European Medical Innovations Leader at Eli Lilly. Here he was responsible for numerous prototypes for internal medical clients. Since mid-2009 his team has been working on mobile devices and mobile applications. He is sharing his experience of the development of mHealth apps in a regulated health care environment. ]
To develop a regulated mobile device application for a pharmaceutical company for the first time is a big challenge. It is a very complex project that begins with numerous unknown variables. What are the main success factors? With the first mobile application development at Lilly we had a cross functional, highly motivated and qualified team coming from areas such as Medical, Marketing, IT, IT Quality and this combined perfectly with the external partner. Another important point is strong sponsorship from senior management. When the application launched on the app store it was worth every effort.
Mobile app development – a field report from a pharmaceutical company
The pharmaceutical industry is highly regulated. The main reason for these regulations is to protect the consumer; patients who need to take drugs. Buzzwords like GxP, CRF Part 11, Data Privacy, Compliance, Regulatory and IT Validation are used regularly if an IT application is developed. From an IT process point of view there is no reason to distinguish between the developments of a normal web application or an application for a mobile device but in reality people’s minds make a big difference. Smartphones, mobile broadband and availability are still ‘new’ and especially for the conservative pharmaceutical industry it isn’t that easy to adopt these new concepts.
This blog post is a best-practice report from the viewpoint of an IT professional in how to develop the first regulated application for a pharmaceutical company.
❯ What do you need to consider?
❯ How can you convince your internal customers and stakeholders?
❯ How much time do you need?
❯ What is really different, what is new?
❯ Important deliverables! From the idea to reality!
The project initiation phase is most important. First there is the idea to create an application for a smartphone. Let’s imagine you would like to transform an existing book into an iPhone app. It is possible, but what will it look like? In our case the European Medical Innovations Team has developed a prototype to convince our internal customers and stakeholders that an application is feasible and the user interface is reasonable. Once we had the buy in of our stakeholders, some additional questions needed to be answered. How many customers already possess an iPhone? Do we get the approval from the internal legal, compliance and regulatory department? Who will develop and deploy the application? Remember, this is the first time that you develop this kind of application! Let me answer the questions one after the other.
Based on a market research in Q1 2010 ca. 10% of German physicians had an iPhone, another ca. 30% had a smartphone and the rest owned a ‘normal’ mobile device. With these numbers the sponsor of the project decided to move ahead. Side note: To be able to reach all our customers we developed two applications, the above mentioned iPhone app and a mobile web application. The mobile web application isn’t of interest here. In general the mobile web application is a key part to provide a service to all customers. The mobile web app has been developed with exactly the same requirements and content, only the technical platform and realization is different. If an arbitrary smartphone tries to open the web app, a service running in the background and provided by the vendor detects and determines the smartphone category, it then renders the mobile web page optimized for the device and so the web app will be displayed.
Vendor selection process
Let us look at the development of the application a bit closer. We knew how to develop an iPhone application ourselves. The development of the prototype was realized in-house, but what about the deployment and submission to Apple? Here we had no experience and to be on the safe we minimized risk and decided to work together with a vendor. Here we went through a vendor selection process by asking four companies to come back to us with cost estimation and ideas based on high level requirements we defined beforehand. The process to choose a vendor took us 4 weeks. Once the vendor had been selected, we immediately scheduled a one day workshop with stakeholders from all involved areas to gather and define the exact detailed requirements. The participation of the selected vendor during the workshop is mandatory as they are the technical experts which can consult and decide which requirements make sense and are also feasible. In our case the vendor added many helpful ideas and concepts which have been implemented.
Legal, compliance and regulatory approvals
What about legal, compliance and regulatory approvals? As mentioned above the pharmaceutical industry is highly regulated. To answer questions around promotional material, copyright, contracts, disclaimer, data privacy, compliance to laws and regulations you need to get in contact with your legal and compliance department to gain approvals. In the end we have all the necessary approvals to go ahead. An important point for an international company is the understanding of different laws and regulations in different countries. If you desire to replicate an existing regulated app from Germany to Spain for instance, you need to contact your local Compliance, Legal and Regulatory department to answer the same question again based on local laws. That is a cumbersome and time consuming process.
Is the mobile phone a medical device?
One very interesting question we answered as part of the whole approval process I would like to consider more in detail. Imagine you develop an application which is supporting some kind of diagnosis for a patient. Based on the result and additional information the physician determines the therapy for a patient. Does this software change the status of the device you install it on? Is the iPhone (or any other smartphone) a medical device in the case that you install our app on it? We discussed this question extensively with the help of an external lawyer, our medical department, compliance, legal and regulatory department and again the answer of no it isn’t a medical device was provided. In case the answer would have been yes, we would have needed to add an additional certification, the so called and well known CE certificate. For more information on the topic: http://www.cemarking.net/.
Some important parts of the project initiation phase we haven’t looked at in detail. How do you classify an application as GxP relevant? How do you determine the risks, especially when you don’t have the experience for mobile device development in your company? When you work together with an external vendor, how do you define roles and responsibilities? All these questions and some others are important but don’t differ from ‘normal’ IT projects and are different from company to company.
When you create an app for a mobile device first time a range of things need to be considered especially those you have seen above. Some of these tasks, like vendor selection are a one-time effort. Afterwards, these efforts aren’t needed the next time. Others such as regulatory and compliance questions need to be answered and discussed each time once the requirements have been determined and the costs are clear and transparent.
The duration of the development phase strongly depends upon the complexity of the requirements and because it will be mainly executed by the external vendor, upon the vendor itself. In this phase you can easily test if you have chosen the right vendor beforehand. Not only is the price important, criteria for the selection process should include available services, service quality and flexibility, to name only the most important ones. In our case the vendor fulfilled all the above and so the development phase went smoothly and without any delays. Main deliverables have been Design Specifications, Coding/Development, Test Plan and Unit testing.
Once the development has been finalized, the testing of the application begins. Let me emphasize here that the test phase with the project initiation phase are key to success. The preparation of the test started already during the development phase. We created a test plan, test cases and test scripts. At this stage all involved stakeholders need to be involved and review the documents to ensure that the quality of the content is suitable and correct, that the content of the document is reasonable and logical, that the calculated outcome is correct and that all requirements are reflected and tested when executing the test script. The executing of the test itself took place in one room with all those involved at the same time. Participants have been members from Sales & Marketing, Medical and IT. Once we finalized the test we were 100% sure that the main functionality of the app worked 100% correctly.
Submission of the app
The last point I would like to mention is the submission of the app to Apple. Before we were able to do that we needed to complete IT validation and to acquire all necessary approvals in the area of marketing. Imagine for instance that the whole text you can see in the app store as surrounding information for the app might have medical or marketing implications as it represents your company externally. The submission, the whole text and information needed were excellently prepared by the external partner.
Overall the project duration was 6 months. Two to three months of that was needed due to the first time nature of the project. As mentioned above, one-time tasks such as the development of a prototype, vendor selection and market research etc. are time consuming. In our case we needed two months for these preparations.
In that phase only three headcounts were needed for the project team – one developer, one business contact and one project manager. Intensive headcounts occupied the core development phase. Here we needed 8 headcounts but of which not all 100% dedicated. We had three people from IT Quality responsible for the validation package etc. (25% involvement), two headcounts from medical responsible for the content of the app (10% involvement), one headcount from our business partner (50% dedication) and two members from IT responsible for the project management, test coordination and business integration with 75% involvement. Altogether, roughly 3 headcounts for a 4 month project duration. One very interesting question is of course the price of such an iPhone / smartphone application. As you can imagine, it all depends on the complexity and amount of the requirements. If you would like to develop an iPhone / smartphone application you can approximately estimate € 20, 000 – 40, 000 for an app such as this.
Please comment and share your experience on the development of mHealth apps.