Mobile phone applications allow people to maintain and improve their health by allowing the user to measure: heart rate, blood pressure, blood glucose; count calories; assess exercise regimes and get details about medications.

Animativ Health article about mobile apps and software as medical devices

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Mobile Apps & Software Medical Devices

**Mobile phone applications allow people to maintain and improve their health by allowing the user to measure: heart rate, blood pressure, blood glucose; count calories; assess exercise regimes and get details about medications.**

Mobile applications are mostly simple to use, still, some of them, if they meet certain medical criteria, can be treated as Software Medical Devices. They can also be regarded as Customer Engagement Programs (CEPs) if they are distributed via online distribution platforms (Google or Apple stores for example).


We all know that a **Mobile App** is a computer program designed to run on mobile devices such as smartphones and tablet computers. This should be distinguished from digital files, like video, PDF document or Excel spreadsheet for example.

When developing mobile apps, it is important to consider the constraints and features of the devices. Mobile devices run on battery and have less powerful processors than personal computers and also have more features such as location detection and cameras. Developers also have to consider a wide array of screen sizes, hardware specifications and configurations because of intense competition in mobile software and changes within each of the platforms. 

When a mobile app is developed, it is first tested within the development environment using emulators and later subjected to field testing. Emulators provide an inexpensive way to test applications on mobile phones to which developers may not have physical access. As part of the development process, mobile user interface (UI) design is also an essential in the creation of mobile apps. Mobile UI considers constraints and contexts, screen, input and mobility as outlines for design. Mobile UIs, or front-ends, rely on mobile back-ends to support access to enterprise systems. The mobile back-end facilitates data routing, security, authentication, authorization, working off-line and service orchestration. So, we need to be aware of all the above when developing a mobile app.


Mobile Applications

Animativ Health's app mTrichoscopy screens

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Software medical devices have a medical purpose and may help in diagnosing, preventing, monitoring, treating or alleviating disease, injury or handicap. Generally, health care providers, clinical trial investigators, patients and caregivers may use SMDs for activities like calculating doses, medication reminders, tracking symptoms and diagnosis recommendations for individual patients. Like other types of medical devices, SMDs are regulated by boards of health globally.

Software Medical Devices (SMDs)

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A variety of Mobile Applications distributed via online distribution platforms and Software Medical Devices open up a vast range of interactions between the pharma industry and various users of medicinal products. This unleashes great opportunities for instant communication and thus better customer’s engagement. Such interactions where there is opportunity for a patient, consumer or healthcare professionals to communicate safety information, such as adverse events, to a pharmaceutical company directly or through a third party vendor are called CEPs. CEPs are a subject for strict FDA, EMA and other authorities regulations and they need to be monitored.

Strategic framework for app investment determination

**Investment Consideration**

Technical support
- How many updates/versions do you expect to have?
- Does the information within that app change rapidly?
Staffing 
- How time intensive will the development and ongoing management of the app be?
Promotion and PR 
- How big is the target customer group? How difficult is it to reach them?
- What is involved in the promotional driver mix?
- What resources are needed to build and maintain traffic to the download page?
Platform Decision:
- What is the cost of launching on Android/iOS platforms, or both?
Appropriate Functionality:
- Have you included only those functions you know to be beneficial to our customers?

**The risk of an app**

Adverse Events/CEP 
- Does the app design allow for two-way communication and the reporting of adverse events?
- How do you monitor other forums where users can review your app?
Review Committees 
- What concerns does app functionality pose to internet review committees? (i.e., treatment calculators)
- What is the appropriate language for promoting your app?
- What are the CEP implications based on app functionality?
Medical Devices regulation
- Given app functionality, is it likely that your app will be subjected to FDA scrutiny?
Pharma mistrust
- Should you use a branded or unbranded approach? What impact does that have on downloads? 
Malfunction
- Are these significant health risks associated with your app malfunction?
Reviewers
- How can we mitigate any negative review/feedback?

**Other considerations**

- Competitors: is there a marketplace need based on competitor activity?
- Build or buy: Is there a company that already has an audience we want? 
- App as a Channel: Can you use the app for targeted ads? 
- Data: Who owns the data and what are the implications for your company? 
- Pricing: How do pricing scenarios impact ROI and usage?
- Test Control: Can you set up a test/control group to measure performance? 
- End-User license agreement: Should language be for underage users and/or parents? Should language reflect information sharing? (e.g., with consortiums)
- Measurement (Mobile App Analytics)


Customer Engagement Programs (CEPs)

Developers can create content that blend real world situations and virtual reality within applications. This is Augmented Reality. It allows users to interact with the content and distinguish between reality. One of the ways of doing this is using Google glasses for example.

doctor with VR googles in Animativ Health's article about software as medical devices

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Virtual & Augmented Reality

Most people have social media accounts whereby we can have profiles, see friends and suggested content everyday. There is now a new trend of healthcare focus in social networking. 

Animativ Health article about digital medicine and social media

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Digital Medicine & Social Media

Other component

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**Developers can create content that blend real world situations and virtual reality within applications. This is **Augmented Reality**. It allows users to interact with the content and distinguish between reality. One of the ways of doing this is using Google glasses for example.**

**Virtual reality**, however, is the creation of a world where users find it difficult to distinguish between real life and a virtual world. Users should not be able to differentiate between the two. VR is usually accessed by wearing goggles or helmets similar to Oculus Rift.

AR and VR both immerse the user in the technology but in different ways. AR users remain in the real world while interacting with virtual objects but VR users are isolated from it  and are fully absorbed into a fabricated world.



With the use of a 360-degree camera it is possible to create a 3D video for medical educational purposes. Fully immersive environments can be achieved whereby the user believes that they are in the examination room so as to prepare them for what to expect at the time of their visit. 

The equipment that may be used to accomplish the 3D effect can be 12 GoPro cameras, a V.360, a Ricoh Theta or a Giroptic 360. 

The aforementioned cameras may also be used for live interactive transmission during medical exhibitions scientific congresses. A 360-degree cameraman equipped with the correct VR equipment can be remotely guided by viewers at great distances from the event.

Google Glass can be used in live educational events allowing large numbers of people to be able to see and hear exactly what is presented.
3D immersive technology can improve education in virtual anatomy or physiology.

**Virtual reality therapy** (VRT), also known as **virtual reality immersion therapy** (VRIT) and **simulation for therapy** (SFT) is a method of psychotherapy that uses virtual reality technology to treat patients with anxiety disorders, phobias and addictions (e.g.smoking) proving to be very effective.


VR in Medicine

Animativ Health's article about virtual and augmented reality in medicine

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AR can assist patients to understand how a prescribed drug affects them without having to rely on information in the enclosed leaflet.
Laboratory technicians are able to monitor experiments using AR equipment.
AR can allow untrained workers to carry out tasks without prior experience or knowledge.
During surgery, it is important that precision is maintained. Thanks to AR, surgery remains precise yet more efficient. 


AR in Medicine

Animativ Health's video about virtual & augmented reality

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**Most people have social media accounts whereby we can have profiles, see friends and suggested content everyday. There is now a new trend of healthcare focus in social networking. There are a number of specifically dedicated services for physicians and patients. These include: Doctors.net.uk, Medcenter, Dooox, Esanum, Egora, Doktorsitesi, iVrach, Doximity or Sermo and SmartPatients or PatientsLikeMe.**

The above mentioned are online communities where patients and caregivers learn from each other about treatments, clinical trials, the latest science, and how it all fits into the context of their experience. Due to social media listening, a large amount of information can be gained about a particular company, individual, product or brand.

Apple has Apple Health, Google has Google Fit and Samsung has S Health. Now, Facebook is also reportedly jumping into the health bandwagon and developing its own healthcare platform. The social networking site has plans of building a platform for developing health-related apps and establishing online communities where **users who share common health problems can interact and provide support for one another**. Facebook bought Oculus VR as their mission is to make it possible to experience anything, anywhere through the power of virtual reality. Social networking as we know today will soon evolve using platforms, which will enable even more useful, entertaining and personal experiences.

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world's most popular social media platforms

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As we are social there is no doubt it is necessary nowadays to have our own dedicated Website, YouTube Channel or Facebook page available. However, it is not enough to create them. We must fulfill them with some interesting, fresh and engaging content and let our customer find them easily. This is why "search" is one of the most powerful elements of Network Resources. Additionally, it is also great to get some feedback by measurement implemented, to check if content provided fulfills our customers' needs and expectations.

If you would like to know more about how search engine optimization works, or if you need professionally-made medical content, please [contact us at Animativ Health](mailto:hello@animativhealth.com).


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Delivering medical-digital solutions for the healthcare industry 

Animativ Health is an international digital healthcare agency and production house delivering tailor-made digital solutions from concept and design to polished production.
Our products are designed with the latest in-line design thinking. We use the most advanced and safest technologies to produce web and mobile apps which apply artificial intelligence and virtual or augmented reality.

Ideas are transformed into products with the utmost focus on the patient, the regulations and technical accuracy. 

Our services will assist your development by offering you continuous consultation, content creation, marketing and salesforce support.


- Diverse formats of medical, pharmaceutical and scientific content
- Framing tailored for HCPs, technicians, students or patients
- Development and communication of a non-promotional content that strategically complements promotional activities and addresses customers’ needs
- Use of content and digital channels focused on the customer experience of healthcare professionals - ensuring HCPs have a greater understanding of your product

See Case Study

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Digital-Medical Strategy & Content

- Software as a Medical Device (SaMD), 
- Social Media (medical-to-medical information exchange), 
- Patient Support Programs (PSP),  
- Continuing Medical Education (CME) 
- We enable digital communication which makes it easier for customers to reach out to your Medical Affairs colleagues in a way and at a time that is convenient for them.


See case study

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 Value Added Programs & Enablers

- Scientifically accurate videos, graphics, 2D & 3D animations, banners 
- Impressive multimedia to boost promotion of your products 
- Modern and effective means of education for HCPs, students and patients 
- Memorable interfaces for unique user experience 

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Medical Multimedia

- Full scope of website & web/mobile app delivery: design, prototype, development, tests, release 
- Custom, accessible digital products to serve as educational or support programmes for patients or medical professionals  
- Development & support in registering SaMD (Software as a Medical Device)
- Meticulously devised promotional materials to attract wider publicity 

Animativ Health's healthcare websites and apps

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Healthcare Websites & Apps

- Ongoing maintenance of digital products until proper and safe decommissioning 
- Continuous security patches and fixes 
- Upgrades related to new versions of operating systems or stakeholders’ requests 
- L1, L2 and L3 Support Lines in given SLA levels 

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Websites & App Maintenance 

- Compliance with the current state of science, laws & regulatory requirements  
- Guaranteed support in the premarket approval application process 
- Expert knowledge on the applicable American and European regulations  
- Counselling on approval-related formalities 

Medical Approval Process for Digital projects

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Medical Approval Support

We aim at employing the best practices in our workflow, development and communication with our clients.

Our process

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Our projects are completed in-house guaranteeing effective protection of sensitive data, confidential information or intellectual property. 

During the last 15 years we have gained recognition and trust from numerous medical and academic institutions, pharmaceutical companies, as well as creative agencies. 