Very interesting and relevant lecture by Ian Hewitt entitled “Design for Medical and Well Being”

Ian discussed one of the most important considerations when designing medical products which is standards and classifications which are determined by Implant, intrusive and data recording.

There are 3 classes:

Class 1

• Low risk .. e.g. walking stick, wheel chair

Class 2

• Stringent Regulations
• Record data, Limited diagnosis
• E.g. Syringe, gloves, pregnancy Kit- self diagnostic

Class 3

• Highest category
• High Risk- complex devices
• Pace Maker, Ocular tweezers, Insulin Pen, Cannula.

Considerations:

• British Standards
• If it has a battery – needs to be able to be accessed later for recycling

Cleaning

• Surface finish
• Limitations
• How easy

Maintenance

• Is it externally serviced
• Parts
• Screws- easily accessible
• Parts based- disposable

Reuse

• Sterilised
• Collected
• Stored
• Re- distributed

Consider

• NHS may not likely adopt your project just due to the system , pricing range, competitors …  “disruptive innovation”
• Labels
• Colours

Data recording

• Legality with holding data
• Has to be stored in a certain way

Diagnosis

• Safety
• Delivery of Information

Sharps

• Disposal
• Storage
• Contamination
• Replaceable

Materials

• Paint
• Material type (Allergies)
• Finishes

End User

• Age groups
• Different user perspectives

Consider constructing DARL and CRL logs as method for development

An incredibly relevant and useful lecture and I have discussed to have a meeting with Ian in the upcoming weeks to gain his thoughts and views on the project.

Had a Spontaneous brief discussion with Neil Smith regarding the project.

As Neil and I had not had a follow up discussion for a while – I realised it was rather complex to briefly explain the status of the project.

After discussing one of the directions Neil bought up some key thoughts that I noted:

“Some people need constant monitoring and adjustable provision others not”

“Could you consider some permission to dial up/ down the pump”

“It comes down to a decision factor regarding viability between one and the other for who you are caring for”

“I used to know people at the university who were 24/7 reliant and it was really important they had appropriate management”

Our meeting was very brief and we plan to follow up later in the week.

Dr Rachel Clarke quoted a famous Dr William Osler “Just listen to your patient, he is telling you the diagnosis”.

“Stories are important. As a doctor my job is to listen to my patients stories and shape them for the better.

Palliative care doctor (focuses on providing relief from the symptoms, pain, physical stress, and mental stress of a terminal diagnosis. Dr Rachel Clarke specifically specialises in patients at the end of their life)

A very powerful story and example came from The Royal Marsden one of the foremost cancer treatment hospitals where one of the ‘Play specialists’ was trying to make radio therapy less stressful to children. Children face radio therapy for tumours alone inside a radiotherapy machine which is loud and distressing. This can be a challenging and frightening experience for a child or anyone to go through by themselves.

To cope with the challenge the play specialist developed something very simple yet quite ingenious called ‘magic string’ .

The magic string was a ball of twine which could be held at one end by the child/patient and the other end of the thread under the door  and by the parent. The play specialist invented a literal story. Narrative thread that enabled the child to tell them selves that even though they were behind a hard lead door and going through the experience themselves they were still being cared for by their mother and father outside the room. A lovely Idea”

Reflection

In terms of Diabetes patients and devices, specifically referring to those first being introduced to the condition, it is particularly important for them to understand the value of connection and support from those close to them as well as others also suffering. For development I must move forward taking into consideration the device monitoring/ provision functionality but also the data recording its meaning and the connection with family members or doctors.

Had a positive discussion reviewing the project with David O’Leary today .

I updated David on the position, routes of the project. I discussed my analysis of companies and universities performing research into non-intrusive laser based scanning systems, Arduino base models and refractive laser light systems as the route for moving forward with for monitoring. We also had a brief discussion about ‘hypos’ and the consideration for the management device to act as a wearable for night use. I discussed how I had been working on connecting with various people with PHD’s specialising in electronic and biomedical systems in the department of Electrical Engineering at various other universities.

David provided his thoughts on the appropriate way to approach the questions to ask regarding the project. David also opened up the opportunity for design discussion and feedback with a few of his contacts in different areas of the industry. This is a great opportunity and I look forward to following up with these contacts.

Key questions and consideration points arose:

• How far away do you believe till something like this could be possible?
• What volumetric size could the technology be reduced to? Arduino and other mockups are very large but demonstrative… could this eventually be something as small as a headphone or button?
• Could it be kinetically self-powering and last for ages without a charge?

Basic foam models to visualise raw concept routes to evaluate and assess interaction values.

From my concept ideation and taking into account diabetics needs I had three main routes.

1) A kit based system which still comprised of a pen for provision as well as standard testing device yet in a unified body bringing all elements together in a more compact and meaningful manner.

2)  A kit based system that held supporting elements for the provision device (either pen or pump) such components would be insulin cartridge and back up needles. This then worked with a non intrusive laser/ finger tester that could be either used separate or with the storage element.

3) A separate laser testing device that could also be bought for pre diabetes users.. This could alternatively be developed to be body mounted or worn as a wearable (watch/ necklace). Problem with this concept is it is still controlled by the user/ diabetic choice to test or check themselves.. also it does not effectively communicate with a provision device.

4) A wireless/ tubeless provision device with interchangeable elements similar to existing pumps yet worn and requiring insulin cartridges. This could also wirelessly communicate with a testing device (option 2/3) to act as an artificial pancreas.

“Glucose monitoring as you are aware is still not great, requires a kit, stabbing – inaccuracies in both the meters and the sampling and is pretty inconvenient.”

Following time of development and feedback from diabetics as well as professionals at ‘stc‘, discussion about the decision to remove the finger prick test was decided a while ago.  It is clear option 1 may be thinking in the past. Therefore attention has been directed toward communication of options 2-4 for diabetics and medical professionals feedback.

“Good thing about a continuous monitor is that it could alert for hypos and hypers giving people the chance to do something, many have hypos in their sleep for example which is very difficult to manage. Similarly exercise has a profound and quite long term (so 48 hrs ?) effect on blood glucose so enabling people to adjust medication would be a real asset.”

Feedback such as this could really encourage the direction of route 4 with 3 but as a wearable or management system. The consideration of sleeping and a way for monitoring but without the disturbance of the diabetic to wake up and test themselves is particularly interesting.

Sketch development to help progress into foam models. In the mean time I am developing stories of usage and set up for each concept.

The timeline above is a process analysis of the general pump set up process. This timeline explores the set up procedure for a wireless cartridge based pump as well as separate monitor device (like Freestyle Libre) wirelessly communicating and working together. Although not entirely a simplistic 2 stage process, a lot of the complex actions are removed from the current procedure considering the concern and risk during set up .  If insulin was pre packaged in cartridges such as the pens then that can reduce the set up procedure. Also less movement of insulin into different containers. Considering the technologies used and how the two devices communicate, this procedure could change with design development. Already this is a highly interesting and better managed set up rather than the existing procedure. Once the devices are mounted and operational the users management process while wearing the devices will be greatly reduced. The hope being that all management is performed automatically without the patient having to concern or interfere unless choosing to personally make adjustments.

Above portrays a break down of the basic stages to appropriately setting up a standard insulin pump. This does not consider the very minor but expected elements of the process including things like appropriately wash hands as well as body before starting. This is a very basic break down and other pumps have sleight variations on this process. I have analysed this process in contrast with the Omnipod (wireless Pumps). I have noticed key parts in the process that could be reduced or removed to aid the user. The key objective would be to make the set up as simplistic and with least stages as possible. The more stages as seen above the more risk and complexity for the user.

Apple CEO Tim Cook has been spotted by staff at the Palo Alto campus wearing a prototype blood glucose monitor.

Just over a month ago we reported that Apple was reportedly working on device that could help with the management of diabetes, but all we had to go on was reports of a secret team and a patent application.

Now it seems that the Apple CEO is being a fair amount more overt about the project. Sources confirmed to CNBC that: “Cook was wearing a prototype glucose-tracker on the Apple Watch”. The word ‘on’ is significant in that sentence.

Cook has previously been open about wearing a glucose monitoring device, but it hasn’t been clear whether this was an Apple device, or the device of another manufacturer.

In conversations with a group of students at Glasgow University, Cook very openly said: “I’ve been wearing a continuous glucose monitor for a few weeks, I just took it off before coming on this trip.”

– Tim Cook has been spotted wearing the top-secret Apple diabetes device.  Andrew London (May 19 2017) techradar

Image Source: The Hindu Business Line

Following my Interim discussion I have been thinking for a while the true progression of the project is dependent upon ‘how future does it go’. The one clear area that Diabetic’s are unhappy with and need improving is the finger prick! A lot of feedback and insights prove this. The finger prick and testing system along with provision devices is also incredibly bulky, requiring the user to test multiple times a day and carry many lancets and testing strips. I personally do not believe considering modern advances in technology that the intrusive finger prick system is going to stay the same for generations to come. Future concepts and testing systems are already in development and some are already functional and becoming patented. These include non permanent nano ink tattoo’s, contact lenses and laser scanners. Whether the testing system is still invasive but body mounted for a longer period of time (such as Free Style Libre) or an alternative technology is adopted, I have decided to develop the project down a route moving away from invasive finger pricking.