Avoiding app store rejection – the importance of using a medical app development specialist

There are many risks associated with using an app development agency that doesn’t specialise in developing medical apps but the most common one is app store rejection. Read on.

Over the past few years the gApps team have heard stories of a number of eHealth entrepreneurs and healthcare companies that have embarked on an app development project with a generalist digital agency only to find out that at the end of the development process they’ve have been unable to get their newly developed medical app published onto the app store.

This is because more often than not the main reason why their app has been rejected is because it does not conform to the regulatory guidelines that have been set for publishing medical apps. If you’re developing an app that is going to be classed as a medical device, then Apple will need to see evidence that you’ve compiled the appropriate paperwork required for launching an app of that nature onto the market. This will often include a genuine copy of the CE Mark certificate that only gets issued to the manufacturer of the device once all the required paperwork has been submitted to the appropriate competent authority within your country, like the MHRA in the UK.

Apple released their expanded section focused on safety requirements for health and medical apps back in 2016, so we get a little surprised when we get requests for help from companies who have had their app rejected due to regulatory issues.

Under the “Physical Harm” section, the guidelines provide several examples of user risk issues that may lead to rejection of an app.

  • For instance, medical apps intended for diagnosis or treatment or that run the risk of generating inaccurate health data “may” undergo more vigorous review by Apple; apps that have received regulatory clearance should provide links to appropriate documentation, as well
  • If your medical app has received regulatory clearance, please submit a link to that documentation with your app.
  • Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, pharmacy or other approved entity, or receive approval by the FDA or one of its international counterparts. Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.

If you’re looking to develop a medical device app then it’s vital that you do the required regulatory research and due-diligence on the app development companies that are being considered for your project. Ask them to show you apps that they have developed which carry the CE Mark (all apps that are classed as medical devices need to have a page within the app itself where the CE Mark is displayed).

You’ll need to consider the classification of your device as the guidelines differ for the various regulatory classes as well as the software safety class, while making sure your organisation can meet all of those guidelines. Also don’t forget that as of May 2021 your app all will need to conform to the Medical Device Regulation MDR.

At the end of the day the guidelines are there to protect patients and healthcare professionals that will be using your app and if you or your chosen app developer doesn’t have the required expertise to not only code these types of apps but to also produce the appropriate compliance paperwork for submission, then you will end up facing the same scenario above, which could prove very costly.

If your app meets the definition of a medical device then you could also face a significant fine for a regulatory violation, from the competent authority responsible for the registration of medical devices. Developing mobile applications that function as medical devices is complex. Choosing the right partner is more than just about assessing their technical capability. Medical device app developers also need to understand the regulatory and data security requirements, so make sure you do the right research before choosing your app development partner.

Useful resources

We have created a number of useful resources which will help you to better understand what additional aspects of app development you’ll need to consider if you’re developing an app that will be classed as a medical device:

Tips for designing a medical app – is connectivity on your list?

One of of the gApps team came across an interesting discussion on LinkedIn titled: “One tip for designing a medical device.”
Members of one of the medical device groups were being asked to share their views on what advice they would give someone when it came to designing a medical device?

The post as you can imagine got a great deal of response (the group currently has over 320,000 members). I read through the responses with interest and although all the responses were well considered. Some of the advice shared was:

“I would recommend co-development of the product with the customer. This provides clear understanding by both parties of what the design requirements are, what testing is required, expected costs, lead times, design for manufacturability issues, and mostly, you have the most important thing, at least one customer.”
“In my past we were successful by starting a voice of customer assessment and convert that into a list of customer requirements. Then have R&D translate that into functional spec of what they could provide and on top of that what other features or capabilities that customers are not aware of. Then a negotiation occurs where there are mismatches and confirmed with customers. In parallel how will it be verified and validated, sample availability, collaborations needed? Then and only then do we start development.
“Ask the customer exactly what they need and why, what are the features they could not do without? Would this new product get then to move away from what they already use, and why, why not? ensure they get just that… and quickly. Then ensure their experience is backed up with service.”

“Most of the time customers, don’t really know very clearly what their needs are, especially physicians. But patients, caregivers probably understand better way what can help them and what they are willing to pay for it. Latin America still needs help in rural medicine: handle chronic disease, early diagnosis especially in oncology. I agree about co-development.

As you can expect with any conversation around new product development there is this recurring theme of start with the end-user. And this is all sound advice and as a marketer this notion that the customers’ needs drive the NPD process is etched into my brain. But it also got me thinking that when it comes to medical devices we should also be considering how we can take advantage of new technological advances taking place and look for opportunities to future-proof any device that we are looking to design. This will help to increase the product’s shelf-life as well as improve the product’s chances of generating a healthy return on investment. But as we know technology is moving faster than ever so this becomes and an even greater challenge for medical device manufacturers.

One area that can sometimes get missed during the initial concept and business analysis phases is “connectivity” – so assessing the capacity for the interconnection of platforms, systems, and applications. We would most certainly be bringing connectivity to the table early on in the process and exploring how mobile technologies could help to improve the user experience and also the cost effectiveness of developing such a device.

Here are some examples of companies that have benefited from developing medical device apps and apps that connect with existing hardware devices:

Improving end-user experience

  1. Control interfaces: OvuSense streamlines the user experience taking advantage of high res screens with more real estate to graphically monitor temperatures and get fertility predictions compared the original black and white LCD screen on the original hardware product http://www.ovusense.com/uk/
  2. Portability and access: Rosemont Pharma changed a very large ring bound folder which references their entire product range and has consolidated all the information into an online database which is updated to an app every time the app is opened and fits in the pocket. The app also included a dosage calculator (CE Marked) to make it easy for HCPs to calculate the dosage requirements based on key factors: https://www.rosemontpharma.com/prg/
  3. On Demand: Dr Now / Push Doctor, these types of on demand apps are the future of medical services. Real time access to medical professionals when required with minimum disruption to your own schedule. http://www.drnow.com/ http://www.pushdoctor.co.uk/
  4. Data sharing and analysis: Diabetes apps like enable patients to accurately monitor their blood sugar levels and at the same time automatically share this data with healthcare professionals who can monitor their patients remotely and intervene if necessary. http://www.mystarsanofi.com/web/products/glucometers/ibgstar

Cost of development

  1. Less investment in hardware: Fertility Focus have moved away from the physical production of a hardware reader to an app that utilises the hardware within a device. This massively reduces the investment in manufacturing and enable a constant evolution of the product features http://www.ovusense.com/uk/
  2. Concept testing / rapid prototyping: The Instant Weight For Height calculator was prototyped and tested by healthcare professionals to make sure it was easy to use and complex calculations would be simple to interpret before going to the coding stage. This allowed for a much quicker development cycle having ironed out any design issues before hand
  3. Updating firmware: Fitbit is a good example of where the product software or firmware is constantly evolving to incorporate customer feedback and improve user experience. Distribution is over the air via an app update which in turn updates the firmware on the wrist band. http://www.fitbit.com
  4. Distribution: The distribution and update of apps has become a seamless process with both Apple and Android devices performing automatic updates for the apps running on their devices. This massively improves reliability of the apps, the devices and is a simple push to an app store that then distributes the apps to millions of devices. http://www.apple.com http://www.android.com

Can Text Messaging Improve Patient Engagement Outcomes?

Text messagesMedication non adherence is a significant problem, it always has been and it will continue to be so with an estimated cost to the NHS of £600m* a year! So what can be done to improve patient outcomes? Changing patient behaviour is key to this and there have been a number of clinically led studies conducted that demonstrate that apps can help to improve compliance.  But, when looking at patient engagement, perhaps there is another solution where a person-centric approach is more likely to improve the odds of success. A successful engagement programme needs healthcare providers to be able to reach their patients in familiar and effective ways and by doing this, patients are encouraged to take an active role in their treatment which will in turn lead to better healthcare outcomes.

This is where I think text messaging could be the answer.

It’s a cost effective way of providing a more personalised experience with a greater reach than just smartphone users. Last year over 145 billion* text messages were sent and despite the rise of instant messaging platforms among younger users, text messages remain device agnostic and one of the easiest ways reach anyone with a mobile phone.

The Personal Touch

Your health is a private matter and the more personalised the experience, the more likely patients are to respond and take an active role in managing their own treatment. Medication reminders, exercise reminders, appointment booking, pre-op instructions, post op advise can all be communicated ‘one-on-one’ and doing this on a personal level, knowing that a real person is supporting them, can be a real motivator to empowering them to make the necessary changes.

A GSMA study in 2012 showed that 54% of consumers wanted to improve their healthcare using their mobiles in more personalised ways, taking more control in their treatment.

Patient Preferences

Reach

In order for any patient engagement programme to be successful the number of patients you are able to reach is very important. Patients comes from a variety of backgrounds and demographics with a range of communication preferences. Combined with the fact that it’s not always possible to be connected to the internet, text messaging offers the lowest common denominator and most reliable way of contacting patients. Text messaging also is the quickest way to reach the most people. The average text message is read within the first 90 seconds, whereas the average email is opened within the first 90 minutes*.

Security

Clearly security and compliance are also considerations for any healthcare system that communicates patient information. The text messages can be stored securely inline with HIPAA compliance but because security depends on the cooperation of all parties involved in the transmission process there are bound to be challenges. However if the tool is used correctly, with guidelines in place to support patients with their treatment plans and not for discussing medical issues, many of these security concerns are negated.

Conclusion

There is no doubt that apps and smartphones will make communication easier, reduce costs and improve efficiencies throughout the NHS. But let’s not just assume that apps are the answer before considering all the technologies available to us and the way in which patients use them. Familiarity, reach and simplicity can play a big role in the success of an initiative like this and, used in the correct way, could see tangible benefits in terms of outcomes and cost savings.

*http://europe.newsweek.com/health-apps-created-surgeons-put-patients-control-313531
*http://www.hsj.co.uk/resource-centre/best-practice/qipp-resources/how-improved-medication-adherence-can-prevent-costly-medicine-waste/5041067.article#.VVXLXJNVhBc
*http://www.theguardian.com/technology/2014/jan/13/number-text-messages-sent-britain-falls-first-time
*http://www.pewinternet.org/2012/11/30/the-best-and-worst-of-mobile-connectivity/
Image credit: Amancay Maahs (https://www.flickr.com/photos/amanky/3211478871/)

Internet and smartphone-based nursing can help diabetic patients

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Nursing via the internet and smartphones can be an effective way to help patients with uncontrolled diabetes to manage their care.

According to a new study conducted by McGill University, Canada for the Public Health Agency of Canada, tele-monitoring is also increasingly seen as a workable way of delivering care to patients with chronic conditions who live in remote places, or who require monitoring on a long-term basis.

During the pilot project, diabetic patients in four regions of Quebec submitted their blood sugar readings to a nurse every day using a secure website.

Patients also answered a series of questions online about their exercise, diet and food care.

Their nurses then monitored their responses, providing appropriate advice as and when required. If a patient’s readings were a cause for concern, then they appeared in red text and triggered an alarm.

Nurses also emailed their patients educational material to help them manage their conditions.

Antonia Arnaert, professor of nursing at McGill University, said: “Patients with chronic diseases like diabetes, or who have gone through surgery, often have lots of questions and the doctors and nurses don’t always have the time to answer them.

“With tele-nursing, whether using video-conferencing or text-messaging, patients say they feel they get lots of attention from their nurses, because they know that they have their full attention for an hour.”

“They said that tele-monitoring provided them with a sense of confidence in their ability to manage their diabetic condition themselves.”