A: We have worked with companies who are evolving the first principles and research into the technologies that go into wearable kidneys, mainly to do with membranes and some of the biochemistry that is involved. In university laboratories, and some small start-up companies, they have functional prototypes and are making good claims, but the technology is still a few years out. It is acknowledged that in the near term we need to try and push to meet the AAKH executive order. To do that, we need to really focus on making the types of technology that are currently available smaller, more functional and easier to use in the home. The wearable is certainly a part of our future but for now many wearable challenges need to be overcome, they need to be less be cumbersome and have more benefits for haemodialysis, peritoneal dialysis or other treatments, over plugging into a dialysis system overnight. For many reasons the overnight period is a really good time to give the patient treatment but most importantly, it affords the patient a more ‘normal’ daily life. Once variables are smaller and can be adhered to the skin or maybe even implanted subcutaneously, then something like the artificial pancreas will really change lives.

A: Yes, we focus on this display of peritoneal dialysis in this presentation, we talk about a technology that is in the home and how we can make it more widely adopted. Haemodialysis treatment is now starting to move towards the home, but it tends to be a more complicated system to set up and monitor. There is a burden of a health care professional visiting more frequently and a larger burden on the patient to run the system, but haemodialysis is one of the more exciting new areas of moving treatment from hospital to home.

A: To balance design constraints with cost, you need to understand the problem. What are your cost factors? Is it a high technology cost? Is it cost through complicated system architecture? The answer can often be found in thinking from the user perspective. Don’t add technology (and cost) for technologies sake. If there is no benefit or use experience gain for the user, it’s probably not worthwhile. If features are essential, go beyond simple DFM at latter stages with less room for manoeuvring and strive for significant step changes through good early system architecture options and simplification to really add value. We have a lot of experience and exposure with that here.

A: Taking in supplies and using them is relatively straightforward, and it is often the part that is lost in the workflow, but it really is an important part of moving from hospital to home. Many of the patients that we have in dialysis are young and able. They are technically competent, physically mobile, and can take the relatively heavy packages from the front doorstep into the bedroom or into the storage area, move them around and plug them in. Unfortunately, a lot of people with kidney disease are elderly and have comorbidities such as rheumatic arthritis and will therefore find it more difficult to move things around. Along with this, with COVID-19, it is hard for the delivery drivers to take these packages inside the house, particularly if we are worried about infection and keeping those who have weak immune systems away from the outside world. A big pain point is physically moving these things around. Another pain point is the storage, patients tend to stack up the boxes in the house and in their living space. Whilst it's not a problem, it is somewhat of a burden and hospitalizes the home. One solution is the reduction of the bulk of fluid by shipping smaller, lighter concentrates and mixing them locally with the patient’s own water supply. This localised dialysate generation is a simple improvement to the workflow, but one which requires a lot of technological innovation to deal with the variety of water suppliers.

A: We get asked this many times and in many different areas. Medical device development needs to follow user needs and should be relatively conservative in some of the things that it does. When we talk about innovation, we're thinking of new physical processes, new functionality etc. Innovation and cost reduction are the only ways that you can make a step change in the cost of a system. What we don't like to do is add cost through innovation, for example on a previous project looking at sensing and sensors, sensors that that monitor the fluid and contents of fluid going through a tube set are traditionally the size of your cell phone. They are relatively expensive and cumbersome, therefore through the understanding of first principles and design, we were able to reduce that to a component similar in size to a dollar and which could be disposed of after use. This sort of innovation both improves the functionality of the system and reduces the cost. Therefore, innovation and cost reduction are always linked.

A: Sagentia do this all the time, it's conceivable you use this output for road mapping with Minimum Viable Product (MVP) planning for two years, five years and ten years. The pain points that will be picked out, can be solved through either usability and human factors, or engineering and leveraging in technology to apply. Typically, the starting point for a two-year scenario is going to be more standard human factors or existing technology. Identifying new technology would be more applicable to five and ten-year roadmaps.

A: There are some conditions which are treated in the home that weren't a few years ago. Something simple like auto injectors, a treatment where previously the patient would have gone into the health care providers office as an outpatient for the injection. This would be a thick, gloopy, syrupy biologic drug, for in vitro fertilization and autoimmune treatments. It is due to good design and a reduced cost of components that the drugs can now be self-administered at home. At the other end of the spectrum we are interested in the advancements in treatment for cancer in oncology and chemotherapy. There is the example of a breast cancer drug which is very effective but can leave the patient nauseous, so they tend to treat this long and slow to give a very slow rate of the drug. This is normally treated in the hospital due to the length of treatment time and the need to monitor the patient’s temperature as if their temperature goes up and down it could be a sign that they are not responding well to the drug. But with the right supporting technology as with the overnight treatment in the home by dialysis, chemotherapy could be administered in the home which would be an incredible achievement.

A: The quick answer is a reduction in cognitive load communicated through intuitive interface design, vialed behind complex technology. There are good examples of deskilling in Point-of-Care (PoC) diagnostic systems by using more automation and good design. When considering a diagnostic system in a central processing lab, there are many complications from potential dosing errors in manual sample capture to the erroneous sequencing of chemistry steps on a typical assay. Just replicating that for a home setting would be a disaster, with untrained users and the CLIA Waiver directive has enabled significant de-skilling and better use experience on a PoC device. Systems employ clear indications of sample acquisition and direct transfer of samples in a single action like a simple prick of blood put onto an absorbent strip. Device automation de-couples the need for trained users preparing chemistry and the outputs are displayed in a clear and unambiguous yes/no format. The amount of back end verification and iteration must not be ignored. Error checking is a very important part of mor complex systems as if the system performs a step wrong, this should be displayed to avoid false results. A significant amount of time and engineering goes into developing seamless technology the user just doesn’t see.