Monthly Archives: April 2016

How to Build an Ark for your Medical Device

Who’d be a medical device project manager?

It takes a particular outlook to want to delve into managing the competing needs and demands of the sometimes disparate disciplines that make up a development project team.

The Medical Device Project Management track

The Medical Device Project Management track (click to view the whole map)

People consistently say they struggle to get to grips with the nuts and bolts of project delivery. These trials suggest there is a fracture between the theory of project management and the reality of working in a project. A fracture that probably isn’t confined to medical devices or combination products.

The field of project management is considered by many to be a maturing discipline. There are several professional organisations around the world that have developed detailed methodologies to manage projects along with certification programmes for their use. The number of books written on the subject would fill many, many book shelves, mainly focussing on the technical aspects. There are conferences, webinars, journals, industry interest groups and numerous training courses available for the interested person.

There is often a focus, some might say over-reliance, on sticking to the letter of methodologies. Certainly these have their place, as a framework around which to build an approach to delivering a particular project. But, and this is a big but, they aren’t the be all and end all of delivering a successful project.

It is all too easy to lose sight of what the project is there to achieve, getting sucked down into the details of navigating the project processes, playing the system. Much energy is devoted to checking up on what has (or hasn’t) been done, beating people up for missing often arbitrary dates. Is it surprising that people are motivated to meet KPI targets, leaving little space for getting on with the people they’re working with, and even (dare I say it) having fun?

There is another way!

A way that ensures you take care to really set out what your project is How To Build An Arkthere to achieve and then helps you navigate the stations across this route map. It helps you navigate them together.

The detail is captured in a book I co-authored a five years ago, called “How to Build an Ark”.

Numerous project managers, engineers, designers, risk managers, Human Factors specialists and quality managers have copies of this book and tell me how useful it is, that they dip into it daily, weekly or to triage particular problems.

“I unapologetically ripped off your process on Wednesday and have had some very positive feedback from the team.”

“I found delivering the methodology really interesting and learnt loads. Whilst I could of done some things very differently the results were very positive and I now seem to have myself a re-energised team! So thank you.”

“…I found Martin and Matthew’s approach in their book brilliant. They draw on a lot of familiar territory from various sources and join up the dots. A really useful read.”

“Almost by accident, I came across “How to build an Ark”. It’s a great little book. It contains about 120 pages, but is brimming over with very useful information.”

Perhaps you’re curious about seeing for yourself what they found so helpful. Maybe you’re already planning on reading the book and then applying it?

Head on over right now to Amazon for your paper or Kindle copy, because you’ll be glad you did.

9 questions to find out if your app is a medical device

It seems like every month another raft of “wellness” apps and “not-medical” apps are released into the wild. There’s clearly a lot of energy being expended to create apps that help people manage their lives, wellness and medical conditions. However, many developers that we speak with are really not sure how to tell if their wizzy new project needs to be worrying about complying with medical device regulations.

Navigating medical app development

FTC mobile app tool

Click to visit the tool

Help is at hand, if you’re developing an app that collects, manages or creates user data, diagnoses or treats diseases, for the US market. The US Federal Trade Commission (FTC) has launched an online tool to help you understand which (if any) of these laws and regulations you will need to comply with:

  • Health Insurance Portability and Accountability Act (HIPAA), enforced by the US Department of Health & Human Services
    Click here to show more
    The Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information and require certain entities to provide notifications of health information breaches.
  • Food, Drug & Cosmetic Act, enforced by the FDA
    Click here to show more
    The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps. The FDA focuses its regulatory oversight on a small subset of health apps that pose a higher risk if they don’t work as intended.
  • Federal Trade Commission Act, enforced by the FTC
    Click here to show more
    The FTC enforces the FTC Act, which prohibits deceptive or unfair acts or practices in or affecting commerce, including those relating to privacy and data security, and those involving false or misleading claims about apps’ safety or performance.
  • Health Breach Notification Rule, enforced by the FTC
    Click here to show more
    The FTC’s Health Breach Notification Rule requires certain businesses to provide notifications following breaches of personal health record information.

Finding out if your app is a Medical app

The tool holds your hand through answering 9 questions, resulting in guidance about which (if any) of these laws apply to your product.

1. Do you create, receive, maintain, or transmit identifiable health information?

2. Are you a health care provider or health plan?

3. Do consumers need a prescription to access your app?

4. Are you developing this app on behalf of a HIPAA covered entity (such as a hospital, doctor’s office, health insurer, or health plan’s wellness program)?

5. Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?

6. Does your app pose “minimal risk” to a user?

Click here to show more about 'minimal risk'

According to the FDA, “minimal risk” apps are those that are only intended for one or more of the following:

  • helping users self-manage their disease or condition without providing specific treatment suggestions;
  • providing users with simple tools to organize and track their health information;
  • providing easy access to information related to health conditions or treatments;
  • helping users document, show or communicate potential medical conditions to health care providers;
  • automating simple tasks for health care providers;
  • enabling users or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems; and
  • transferring, storing, converting format or displaying medical device data, as defined by the FDA’s Medical Device Data Systems regulations.

7. Is your app a “mobile medical app?”

Click here to show more about medical apps
A “mobile medical app” is one that is intended for any of the following:

  • use as an accessory to a regulated medical device (for example, an app that alters the function or settings of an infusion pump)
  • transforming a mobile platform into a regulated medical device (for example, an app that uses an attachment to the mobile platform to measure blood glucose levels)
  • performing sophisticated analysis or interpreting data from another medical device (for example, an app that uses consumer-specific parameters and creates a dosage plan for radiation therapy)

8. Are you a non-profit organization?

9. Do you offer health records directly to consumers (or do you interact with or offer services to someone who does)?

Developers unfamiliar with the requirements surrounding medical devices, such as the Quality System Regulation, FDA registration and approval process may find the tool useful in understanding whether the “thing” they’re creating qualifies as a medical device.


Evaluate your medical app development project

Talk with us about your medical app, because an independent view of your development project checks you’re on the right track.

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.