Care tech: exploring the latest trends in dementia care

September 21st 2023

Dr Karla Sanchez

Head of CNS Technology

We are witnessing important advances in the treatment of the most common cause of dementia, Alzheimer’s disease, most noticeably by the emergence of disease-modifying therapeutics. And this trend is only set to continue, with new innovations and technologies promising to help slow the progression of this devastating disease.

However, patients who do not yet have access to these treatments or are in a more advanced stage of the disease will continue to require significant care support. The caregiving sector is already under significant pressure due to the increasing demand for long-term care within aging populations [1]. As the disease progresses, family members, including elderly spouses, are often the main caregiver – but they may be left poorly equipped to do this without the right support.

With the cost of dementia care running to £32,250 per person per annum [2] technology innovators are finding new ways to make resources go further and give dementia patients independence for longer – providing reassurance to the caregiver and peace of mind to family members.

The challenge lies in making these solutions accessible to caregivers and usable for patients. In this article, we take a deep dive into the technologies available to support dementia care and explore emerging trends that are transforming the landscape by using the right technology at the right time.

Alzheimer’s disease is a progressive and irreversible neurodegenerative condition that primarily affects the cognitive functions of the brain, particularly memory, thinking and behavior. It is the most common cause of dementia, a broader term for a set of symptoms that impact a person’s ability to live independently.

In the UK, it is estimated that more than 900,000 people live with dementia, and this is projected to double by 2040 [3]. Of the people diagnosed, up to a third live alone [4]. With the aging population outpacing the rate of training and recruiting caregivers, the already significant caregiver shortage is set to increase [5].

Meanwhile, family members are taking on caregiver responsibilities, often with unsustainable and distressing consequences. This is in part because every patient journey is different and the rate of their disease progression can vary widely. Some patients may require discreet support at the early stages of the disease, while others may require constant care. Knowing when and how to intervene to provide the care support needed is crucial.

The care sector is increasingly looking to technology to maximize the impact of the professional and informal caregiver workforce. There is an increasing recognition that caregivers require ongoing support to make their role more manageable, especially following the pandemic.

Assistive technologies rarely exist in isolation. In fact, it is often the combination of these technologies that yields the best results. Here are some of the technologies available to support independent living and managing disease progression.

Personal alarms and safety tracking

Alarms and tracking technologies allow people to call for help if they need it – wherever they are – as well as providing peace of mind for caregivers and family members when they are not there. They are simple to use and can help patients stay independent for longer.

Location. GPS trackers such as Mindme, Ubeequee, and Angelsense consist of battery powered or rechargeable wearables that connect to a 24/7 monitoring support center to alert family members and emergency services if a vulnerable adult is outside designated safe zones. Direct-to-consumer devices, such as Medpage, work similarly, but the information links directly to family members and may not have predefined safety zones or raise an alarm. Connectivity is based on broadband and subject to subscription charges.

Alarms and calls. Technologies such as Tunstall’s MyAmie, Oysta, and Saga’s SOS allow patients to raise an alarm for relatives, caregivers or emergency services with the use of a single button. These technologies often come in the form of a pendant worn around the house and are connected to a hub via a radio signal. The patient can also use the hub to raise an alarm. The pendant must be within reach of the hub for it to work. Other technologies, however, work similarly to the GPS tracker and can rely on broadband for wider network reach. These technologies often also incorporate fall detection and GPS.

Fall detection. Wearables such as Buddi, Telecare, and Careline are designed specifically for dementia care. These use inertia measurement units, gyroscopes, and pressure sensors to detect falls and automatically send messages to caregivers, family members, and first-aid responders. These devices are often accompanied by an alarm button for the user and GPS tracking. Many of these technologies can also be connected to a 24/7 monitoring support team.

Reminders and medication adherence. There are a variety of technologies in this category which allow caregivers to set reminders for patients to take medication, drink water, eat, or remember appointments or social events. Memory aid kits available include the MemRabel care alarm clock with a large screen, connected to a Pivotell Vibratime rechargeable wrist watch that vibrates for reminders. These can be in photo, video or audio format.

The challenge many of these technologies face is that they depend on a caregiver to ensure the patient remembers to engage with and wear the device, charge it when necessary, and crucially, press the button if in distress. In the case of some technologies, they must also be within reach of a hub.

These technologies are good for the early stages of the disease, but as cognitive decline continues, patients will rely more on caregivers to support them, thus limiting their advantages.

In other words, the longevity of these technologies can become incompatible with the patient’s journey, and this is one of the key hurdles to consider when designing and adopting technology in dementia care.

Remote monitoring

This is a fast-growing area for dementia care. Remote monitoring technologies share information on the patient’s daily living patterns with caregivers and family members. The purpose is to provide peace of mind to family members and enable caregivers to make informed care decisions in the short and long term.

Common functions include:

Movement monitoring. Generally delivered by several passive infrared (PIR) sensors installed around the house, and pressure mats in beds and sofas, connected to a hub.
House occupancy. Sensors on external doors to monitor whether an individual has left the house.
Appliance usage. Monitored by connected sensors placed between the mains inlet and the device plug.
Fall detection. Cameras or mmWave radar sensors to detect when an individual has had a fall, without the need for a wearable.

Many of these functions can be delivered by single systems, e.g. Taking Care Home Alert, with the more sophisticated fall detection systems generally targeted at professional care provider users, e.g. Hikvision and Vayyar Care.

It is also common for families to create their own solutions, especially when they feel no existing single solution works for them. This includes the use of consumer tech, such as smartphones, video doorbells, smart home speakers, and cameras around the house. Video doorbells, for example, can be valuable in preventing scams, while smart home speakers can set reminders, automate house functions, or call a relative. However, the use of cameras around the house does pose privacy concerns which need to be considered.

Although the overall objective is to monitor daily independent living, the information often requires interpretation by the caregiver. This can often be facilitated through a dashboard, although the information can be disjointed, and assessment of patterns may not be clear-cut.

Innovator Matt Ash from Supersense Technologies, however, believes we can do more to obtain valuable insights and monitor disease progression efficiently and noninvasively.

“There is a real need for technologies that support caregivers in their role and provide them with the confidence to take a break, knowing their loved one is safe. Though there are some credible assistive technologies out there, the unique needs of families living with dementia are not well served. Projects like the Longitude Prize on Dementia are investing in radical thinking to generate solutions with families living with dementia.”

Talking about some of the latest advancements being tested, Ash continues:

“Everyone’s journey with dementia is different. Right now, we are working on leveraging recent consumer developments in sensor technology, machine learning, and user experience to create personalized assistive systems that can evolve with the needs of an individual with dementia and their caregivers. It’s an incredible opportunity to provide the community with supporting technologies that serve their needs.”

If we want to empower those with dementia to live independently, maximize the impact of caregivers, and provide peace of mind to family members, we must enable the right type of intervention at the right time. Someone with early Alzheimer’s disease may feel overwhelmed or suspicious of new technology, while a person in later stages may be too vulnerable to learn how to use it.

The future of dementia care will center around collecting the right data and extracting the right insights from it to enable better care choices. By allowing technology to provide information on the progression rate of the disease for a particular patient, we can start building a profile of care by recognizing changes in patterns to a baseline. Emerging technologies such as remote monitoring platforms can support this and guide the longevity of other technological interventions to ensure that they align with the individual patient’s journey. At the heart of these technologies, privacy must be a top priority, which may include the use of AI and other methods to allow for patterns to be recognized quickly and with minimal need of human intervention.

We are entering a new era of therapeutics for Alzheimer’s disease, but there is still much to do, particularly in care. Although the use of technology can ultimately support patients, caregivers and family members, it is often incompatible with the individual’s stage of the disease, or inaccessible to caregivers. But as new technologies emerge, data and AI can unlock new insights to support a personalized care plan that scopes each patient to their individual needs – allowing caregivers and families to provide the best care at the right time.

References

E. adult social care insight. The size and structure of the adult social care sector and workforce in England. Technical report, Skills for Care, Workforce Intelligence, 2023.
Alzheimer’s Society, How much does dementia care cost? https://www.alzheimers.org.uk/blog/how-much-does-dementia-care-cost
L. B.-A. A. R. Raphael Wittenberg, Bo Hu. Projections of older people with dementia and costs of dementia care in the United Kingdom, 2019–2040. Technical report, Care Policy and Evaluation Centre, London School of Economics and Political Science, 2019.
B. W. Claudia Miranda-Castillo and M. Orrell. People with dementia living alone: what are their needs and what kind of support are they receiving? International Psychogeriatrics, 2010.
E. adult social care insight. The size and structure of the adult social care sector and workforce in England. Technical report, Skills for Care, Workforce Intelligence, 2023.

Connect with CDP

For more on how to accelerate patient-centred innovation in dementia care technology and device design, contact Cambridge Design Partnership.

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The importance of education and innovation in WOC nursing – Reflections on WOCNext 2023

September 1st 2023

Erik Andersen

Insights Research Associate

For 10 years, I’ve been a critical care nurse in the ER and ICU. My colleague, Nicki Sutton, Head of Insights and Strategy and I recently attended the WOCNext 2023 conference in Las Vegas, Nevada – the first I’d been to.

Perhaps a wound, ostomy, and continence (WOC) conference would seem an odd choice for a critical care nurse, devoid of ventilators and vasopressin, and in that light, I guess it is. However, while I am still a practicing ICU nurse, I also work for Cambridge Design Partnership, an end-to-end innovation partner with expertise in product development from idea to production.

So, getting to learn more about the nuanced world of WOC certainly helps inform the clinical perspective I can bring to our clients as we work to help them develop new and novel products to heal patients in a variety of ways.

Our Insights Research Associate, Erik Andersen, at WOCNext2023

As a non-WOC nurse, I must say: I am hugely impressed by the skill and the art that is WOC nursing. Especially, the art of being able to perform astute assessments on skin tones that vary so greatly and being able to ‘read’ the stoma and peristomal skin to overcome the convexity challenges, much like a golfer ‘reads the green’ to sink the putt.

I’ve always respected the knowledge that my WOCN colleagues bring to the table, but frankly, it’s easier to apportion patient care responsibilities in a hospital setting. Even though I try to help with wound care and appliance changes when I can, I don’t always get to appreciate the total value-add they bring to their patients. At WOCNext, it was a different story: the sheer breadth and depth of knowledge that the presenters and attendees possessed was astounding.

Aside from the fact that I still have a lot to learn about wound care, stoma management, and incontinence interventions, there were a number of interesting themes that we were able to pick up on throughout the presentations and discussions:

We’re losing the WOC numbers game

While it’s true of nursing across the board, many folks highlighted the systemic lack of qualified or certified WOC nurses nationally which makes satisfying the needs of their patient populations exceedingly difficult. This scarcity seems to be much more evident in home care settings where resources are already sparse, and now making both access to patient-appropriate products and WOC nurses a huge struggle.

We need to extend education to non-WOC nurses

The second thing that struck me was how much WOC-related knowledge simply doesn’t make it to the bedside nurses, with many people pointing to a lack of education and awareness about wound care best practices and appropriate products held by non-WOC nurses. It seems as though there is an incredible degree of knowledge about these topics that don’t quite reach the broader nursing population, myself very much included.

There’s an opportunity for innovation

As a healthcare innovator, this shows me there is potential opportunity for manufacturers developing healthcare products, specifically those in the wound care and ostomy space, to understand the stark knowledge gap between WOC and non-WOC nurses, and design systems and products that can help upskill non-WOC nurses to offer better coverage of WOC management.

By no means am I suggesting a WOC nurse could be replaced, but rather to the contrary: they’re at a numeric disadvantage and already working hard to cover the patients that need them.

So how can we democratize WOC care so that the lack of available specialists doesn’t have such a negative impact on the patients requiring their care? For instance, maybe there’s room to lean on a technology aid to remove some of the subjectivity that an artful WOC nurse can account for, but that the less specialized nurses among us, like me, can leverage to do a better job with assessments or appliance management.

That’s the kind of work we can support at CDP, where we have been innovating in the healthcare industry for over 25 years. We have experts across the product development pathway: from patient and clinician research, to design and engineering, to usability testing and validation, all blanketed under our ISO 9001 and 13485 certifications for medical device development and manufacture.

We aim to improve lives through innovation much like our clinical colleagues, aim to improve lives through healthcare delivery. One such example is the work we’ve done with ostomy product innovation start-up, Ostique. Over four months, we supplied the technical rigor to help them develop a concept for a unique ostomy appliance and build prototypes of the device for user feedback. Today, having successfully brought their product to market, Ostique’s revolutionary pouch covers are available in a range of colors and skin tones to meet patients’ needs.

The need for improved healthcare and delivery is there – we could see it everywhere at WOCNext 2023 – and we’re here to help you address it. To discuss how we can help your organization take your product to market, chat to the team today.

Neurodegenerative conditions: turning a corner to better treatment?

June 21st 2023

Dr Karla Sanchez

Head of CNS Technology

Pace is accelerating for tackling neurodegenerative diseases. Can we unlock better treatment? Can we reach a cure?

Ageing populations face neurodegenerative conditions, such as Alzheimer’s Disease, Parkinson’s Disease, Motor Neurone Disease, Multiple Sclerosis, and others. These impact an estimated 60 million people worldwide, equivalent to the current UK population.

Whilst each condition has different mechanisms of neurodegeneration, they all have something in common: prognosis is bleak, treatment is limited, and there is no cure.

However, after decades of research, there has been a series of breakthroughs. Here, we focus on two areas of progress: how treatments have moved on and hope for the future.

The rise of RNA-based therapeutics

The effective development of RNA-based vaccines during the COVID-19 outbreak catapulted RNA-based therapeutics into the spotlight. Whilst theoretical knowledge of RNA therapy has existed for over 30 years, the bulk of associated FDA approval for treatments involving the nervous system has occurred in the last decade⁽¹⁾.

A major advantage of RNA-based therapy over conventional small molecule and protein-based approaches is its high specificity and precision, resulting in a more targeted approach to treating disease with specific gene mutations or overexpression.

However, to devise effective RNA-based therapeutics, the genetic hallmarks of the neurodegenerative disease of interest must be known.

Motor Neurone Disease (MND) is one such condition where specific mutations in the SOD1 gene have been identified and in this case, in two per cent of diagnosed cases.

A recent breakthrough in phase three clinical trials targeted this gene using the drug Tofersen. Tofersen, developed by Biogen, directly interferes with the faulty overproduction of SOD1. After six months, patients had a reduction in SOD1 levels, and after 12 months the same patients reported better mobility and lung function^(2,3). Although patients with SOD1 mutations only represent two per cent of those living with MND, these trials provide ‘proof of concept’ that similar gene therapy-based approaches may help other forms of the disease.

Another pioneering strategy, developed by Atalanta Therapeutics and Genentech, focuses on a technology called branched siRNA (small interference RNA). This is a type of molecule that helps regulate gene expression by binding to a complementary messenger RNA, which in turn can encode the gene of interest.

Branched siRNA uses novel RNA interference nucleotide technology to suppress the activity of genes that function abnormally, such as mutations. This slows the progression of the disease or stops it altogether.

It is hoped this approach can be applied across multiple neurodegenerative diseases, including Parkinson’s Disease, Huntington’s Disease and Alzheimer’s Disease.

Although testing is still in the pre-clinical stage, the branched siRNA platform aims to enable RNA interference to be deployed as a therapeutic approach throughout the brain and spinal cord. This overcomes the long-standing challenge of achieving adequate distribution within the central nervous system (CNS) to ensure the therapeutic agent reaches the nervous tissue^(4,5).

Progress in non-RNA therapeutics

Non-RNA therapeutics for neurodegenerative conditions also continue to progress. Examples include the monoclonal antibody Donanemab, developed by Eli Lilly. Phase three clinical trials showed it to slow clinical decline by 35% in patients with Alzheimer’s Disease, compared to a placebo⁽⁶⁾.

Effective delivery remains a major challenge

One of the main challenges in developing RNA therapeutics, and therapeutics for the brain in general, remains the efficiency of its delivery to the target tissue.

To treat neurodegenerative conditions, the therapeutic agent aims to reach the CNS. The presence of the blood-brain barrier (BBB), a cell-formed wall separating the bloodstream and the CNS, makes it difficult to deliver drugs. The BBB’s almost impermeable characteristics allow very few molecules to cross and make systemic drug delivery less efficacious.

There are two common approaches to overcome this: re-engineering the therapeutic agent to make it compatible with BBB permeability or bypassing the BBB altogether.

Re-engineering the therapeutic agent

This typically involves chemical modification of the drug (e.g., from water-soluble to lipid-soluble molecules) to enable passive diffusion through the BBB. Another approach is to design drug carriers that mimic the structure of endogenous molecules (e.g., monosaccharides, hormones) to activate carrier-mediated transport or nanocarriers^(7,8). Both approaches add complexity to manufacturing.

Another cross-BBB approach is Focused Ultrasound (FUS), where high-intensity sound waves temporarily disrupt the BBB to enable drug-loaded microbubbles to enter the CNS⁹.

Bypassing the blood-brain barrier

Bypassing the BBB can save time and effort in formulation by using a range of therapeutic agents not constricted by size or BBB compatibility. Of its three most common types of delivery: intraparenchymal, intranasal, and cerebrospinal fluid (CSF) delivery; the latter is often the favored approach, due to lower clinical complexity¹⁰.

Evaluating CSF delivery routes

CSF delivery most commonly include intrathecal (IT) or intraventricular (ICV) routes.

IT involves an injection either on the lumbar or a cisterna magna region to deliver the drug and let CSF pulsatile flow support the distribution of the therapeutic agent in the brain and spinal cord.

ICV is more invasive. It involves two surgical interventions, one to place a catheter connecting the cerebral ventricles to the injection port at the top of the skull and one to remove the catheter.

To date, ICV has two approved drugs (Rituxan for CNS Lymphoma, and Brineura for Neuronal Ceroid Lipofuscinoses type two). IT lumbar injection has one (Spiranza for Spinal Muscular Atrophy) and plenty more in clinical and pre-clinical stages across a spectrum of neurodegenerative and neurological diseases⁽¹¹⁾. Irrespective of the approach, the trend is clear: less invasive, lower dosage, and targeted delivery is the way to go.

In the race to show safety and efficacy with either invasive or non-invasive approaches, all solutions will have to be patient-centered.

A new dawn for the treatment of neurodegenerative diseases

The complexities of neurodegeneration have long frustrated scientists and clinicians alike, despite decades dedicated to studying its diseases, aetiologies, and treatments. However, we are making more rapid and more significant progress.

We have some way to go, but we mustn’t overlook the magnitude of these milestones. New therapeutics and delivery techniques are paving the way to more effective and efficient treatment.

By increasing our understanding of genetic hallmarks of the diseases, and using tools such as AI in drug discovery, we can unlock faster pathways to RNA-based treatments. Similarly, by finding innovative ways of demonstrating the safety and efficacy of delivery methods, such as modeling, we can edge closer to less invasive procedures and lower dosages to minimize potential side effects.

We need more research, more awareness, earlier diagnosis, and a better understanding of risk factors to enable prevention and earlier intervention.

But we are now getting closer to better treatment and one day finding a cure.

References

http://nectar.northampton.ac.uk/16015/1/Anthony_Karen_RNAB_2022_RNA_based_therapeutics_for_neurological_diseases.pdf
https://www.sheffield.ac.uk/neuroscience-institute/news/promising-mnd-drug-helps-slow-disease-progression-and-benefits-patients-physically
https://www.nejm.org/doi/full/10.1056/NEJMoa2204705
https://www.gene.com/stories/pioneering-novel-therapeutics-in-neuroscience
https://www.nature.com/articles/s41587-019-0205-0
https://clinicaltrials.gov/ct2/show/NCT04437511?term=TRAILBLAZER-ALZ&cond=Alzheimer+Disease&draw=2&rank=3
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905930/
https://ijponline.biomedcentral.com/articles/10.1186/s13052-018-0563-0#:~:text=Modification%20of%20the%20drug%20to,capable%20of%20crossing%20the%20BBB.
https://clinicaltrials.gov/ct2/show/NCT03321487
https://www.frontiersin.org/articles/10.3389/fnagi.2019.00373/full
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9305158/

Connect with CDP

For more on how to advance RNA therapeutics and targeted CNS drug delivery for neurodegenerative diseases, contact Cambridge Design Partnership.

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Could oligonucleotide manufacturing advances redefine therapy?

June 20th 2023

Alejandra Sanchez

Carla Greig

Oligonucleotides have the potential to address some of the most devastating diseases that remain stubbornly resistant to treatment. These include neurodegenerative, vascular, respiratory, and oncological illnesses. As exciting as this branch of science is, the oligo industry is still in its commercial infancy. Large-scale oligonucleotide manufacturing is not straightforward, and various challenges need addressing.

To understand these, Alejandra and Carla, two Consultant biomedical engineers at Cambridge Design Partnership (CDP), were invited to take part in the Innovation in Oligonucleotide Manufacturing Symposium hosted by CPI at their new facilities in Glasgow. After an intensive day of discussion between key stakeholders from industry, academia, government, and the regulatory sector, we present the main takeaways. For this to make sense, let’s start from the beginning.

How do oligonucleotides work?

Oligonucleotides are short DNA or RNA molecules, typically around 20 nucleotides (basic building blocks of nucleic acids) in length. They can modulate gene expression, the process by which information included in a gene informs the assembly of a protein molecule. They do this by binding to pre-mRNA and mRNA, the carriers of genetic information before the mature mRNA is translated into proteins. Because mRNAs carry code for all cellular proteins, oligonucleotides could be effective for targets and diseases not treatable by current drugs¹.

What is their importance as therapeutic agents?

Oligonucleotide therapeutics prevent or modulate the expression of almost any gene as part of highly targeted treatment. They aim to target the genetic basis of the disease rather than the symptoms. Compared to conventional therapies, oligonucleotides have a higher specificity with reduced side effects. They can target specific molecules that are currently difficult to target, such as RNA. Several oligonucleotide therapeutics are already on the market, with Novartis Pharmaceutical’s Vitravene, for treating cytomegalovirus retinitis in immunocompromised patients, being the first to be approved by the FDA in 1998.

The list of diseases that oligonucleotides can target is ever-growing, with the market valued at USD 5.19 billion in 2020 and expected to rise to USD 26.09 billion by 2030².

How are oligonucleotides manufactured?

Oligonucleotides are synthesized chemically, where nucleotides are added stepwise, resulting in a growing chain. Each nucleotide is subjected to a series of chemical reactions to create a stable component allowing the chain to grow.

The two different types of oligonucleotide manufacturing are solid-phase and liquid-phase synthesis. Solid-phase oligonucleotide synthesis is carried out on a solid insoluble object, such as polystyrene beads, placed in columns that enable all reagents and solvents to pass through freely.

In liquid-phase synthesis, the oligonucleotides are grown on soluble polymeric support within a homogeneous media; the polymer-bound product is commonly recovered from the reaction mixture by precipitation, thus allowing the rapid elimination of excess reagent and soluble by-products.

Solid phase allows high throughput synthesis and purification, with liquid phase taking longer to synthesize the oligonucleotides. However, liquid-phase has the advantage of being performed on a larger scale and typically being less expensive than solid-phase synthesis. Once the desired oligonucleotide has been synthesized, the material can be passed to the next processing steps, including purification, concentration and, commonly, lyophilization.

What are the main challenges in the process?

Oligonucleotide manufacturing is a complex process with many limitations, especially in scalability. The major problems researchers face are currently due to high expenses regarding the raw materials for oligonucleotide synthesis, a lack of funding for oligonucleotide therapies, and a shortage of skilled resources in the oligonucleotide synthesis field. These problems create substantial bottlenecks in the research required for therapeutic oligonucleotides and, ultimately, the clinical use of these therapies.

Key takeaways on the manufacturing of oligonucleotides

Moving towards liquid-phase oligonucleotide synthesis. Solid-phase oligonucleotide synthesis is a great tool for rapidly making lots of oligos in the lab. However, it has drawbacks when manufacturing hundreds of kg or even multi-ton quantities per year, which might be the case for emergent nucleotide products targeting more common diseases³.
The major problems include:
- As the oligo grows, the space for the fresh nucleotides to diffuse and react gets tight, leading to incomplete couplings. This results in an altered sequence of monomers and incorrect genetic information in the final product, which must be removed by extensive and expensive processes.
- It is hard to scale up the solid beds (insoluble particles to which the oligonucleotide is bound during synthesis).
- The synthesis and purification steps generate large amounts of organic and aqueous waste.

Liquid-phase synthesis stands as a promising approach to increase the yield of the overall process while allowing the production of large amounts of oligonucleotides in, potentially, a more sustainable manner⁴.

New alternatives to current purification methods are under investigation. Promising approaches to simplifying the purification steps show good results in the investigational phase5. Examples are membrane-sieving technology and biocatalytic processes used for phase separation. In the biocatalytic process, oligonucleotides are synthesized in a single operation, with fewer impurities and by-product production, and in aqueous media. All these are promising features that target the current limitations of existing synthesis methods3.

New approaches come with new challenges: The development of novel and alternative technologies offers opportunities to address some of the limitations of solid-phase synthesis while also creating new challenges. For instance, using nanofiltration membranes to support the synthesis of oligonucleotides in liquid phase can present issues such as membrane stability and fouling. Another concern regarding the enzymatic approach is the availability of raw material with the right purity.
If we consider the bigger picture, another novel approach in the pharmaceutical industry is the adoption of digital manufacturing technologies. However, this up-and-coming tool may come with its own challenges due to lack of pharmaceutical manufacturing expertise and the high cost of initial funds.

Raw materials suppliers are already working towards reducing the gap. Strategies to reduce the prices of chemicals and deliver sustainable solutions are already underway. For instance, Honeywell US, a major supplier of the raw material required for oligonucleotide production, recycles solvents and assigns dedicated chemical drums to individual businesses to avoid cross-contamination.

Big wins for early pioneers

At CDP, we see every challenge as an opportunity, and we are pleased to know that governments and large industries have already recognized these problems. Major efforts to accelerate research in the UK have been launched, not only as funding from governmental innovation agencies but also from pharmaceutical companies. In addition, the 18 oligonucleotide therapies already approved by the US Food and Drug Administration (FDA) for clinical use are leading the way⁶.

There is a need for rapid adoption of next-generation processes that reduce risk, cut costs and save time while enabling on-demand therapies for every patient. However, regulatory-wise, standards in this industry are yet to be established. The risk around safety and efficacy remains a significant concern: How do we ensure we have the right sequence in each molecule? How do these molecules behave for a specific treatment? And what is the risk for the patient? These are just a few questions that still need to be addressed.

The event at CPI highlighted the importance of bringing experts together to shape the path and accelerate innovation. Understanding the challenges in the oligonucleotide space and planning around them will allow us to drive successful manufacturing at scale. The moment to build the future is now!

References

Kole R, Krainer AR, Altman S. Nat Rev Drug Discov. 2012 Jan 20;11(2):125-40. doi: 10.1038/nrd3625.
Allied Market Research, Oligonucleotide Synthesis Market report, Code A08356, July 2021
Sarah Lovelock, “Biocatalytic approaches to therapeutic oligonucleotide manufacture” in “Enzyme Engineering XXVI”, Andy Bommarius, Georgia Institute of Technology, USA; Vesna Mitchell, Codexis, USA; Doug Fuerst, GSK, USA Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/enzyme_xxvi/37. Abstract: https://dc.engconfintl.org/cgi/viewcontent.cgi?filename=0&article=1034&context=enzyme_xxvi&type=additional
J. Org. Chem. 2021, 86, 1, 49–61 Publication Date: November 30, 2020 https://doi.org/10.1021/acs.joc.0c02291
Dousis A, Ravichandran K, Hobert EM, Moore MJ, Rabideau AE. Nat Biotechnol. 2023 Apr;41(4):560-568. doi: 10.1038/s41587-022-01525-6.
Martin Egli, Muthiah Manoharan, Nucleic Acids Research, Volume 51, Issue 6, 11 April 2023, Pages 2529–2573.

Key trends in respiratory drug delivery

January 25th 2023

Mark Allen

Senior Consultant Biomedical Engineer

It was great to be back in person for the Drug Delivery to the Lungs conference in Edinburgh recently. Here, we share insights on three major themes from the event and a trend we think will reshape the future of respiratory drug delivery in the next 10-20 years.

Sustainable pMDIs

The shift in pMDIs from using HFC propellants towards less polluting gases has gained momentum with California imposing a ban on the sale and distribution of R227ea from the end of 2030 and R134a from the end of 2032, including medical use. This provides an end-of-the-line for the sale of all current pMDI products in California.

The transition needs formulators, device designers, scientists, and other disciplines to collaborate to solve the challenges presented by the different physical properties of the new gases. The assessment of all types of inhalers from a sustainability perspective has advanced, too, with life cycle analysis (LCA) and carbon credits schemes being discussed – our sustainability team provides reviews and recommendations for a range of medical devices to help our clients improve their devices and provide evidence to back up their green credentials.

Usability for adherence

Time and again, studies show that it’s challenging to measure asthma and COPD patients’ adherence to their medication. Medication adherence appears much lower than for other diseases – estimates range from 22-78% adherence, compared to 70% for diabetes.

Low adherence needs to be addressed by making devices easier to use and tailoring them to the patient’s needs. Reducing user steps is key to make using the device easier, but patient feedback and tailoring to specific needs are necessary, too – something connected inhalers could help solve through digital reminders appropriate to the patient’s needs. Independently verifying that increased adherence is due to connected or smart inhalers is difficult to prove – something the industry is investigating.

Modelling of drug delivery

Several talks at this year’s event covered modelling, with in-silico methods advancing in capability and popularity over the last 10 years. Topics covered included constructing a full airway model to assess drug deposition under different breathing profiles and using maths with physiological signals to detect disease and drug-induced changes. Posters demonstrated an even wider range of possible models, including our own.

Our modelling and simulation teams produce models for clients that highlight potential robustness issues with mechanical components and digital sensing techniques at early stages to determine suitable technologies for medical devices.

Learning from the past, looking to the future

Federico Lavorini, Professor and Consultant in Respiratory Medicine at the Department of Clinical and Experimental Medicine, Careggi University Hospital, Florence, Italy, gave an excellent summary of drug delivery over the last 100 years, including innovations where design has reduced user error.

Further talks considered what pharma could learn from other markets, especially as we move from ‘sick care’ to ‘health care’ – where technology identifies and treats conditions before they become symptomatic. Our Drug Delivery and Insight & Strategy teams work closely together to understand upcoming trends and draw on insights into consumer expectations from the consumer and digital markets for our clients.

Biologic treatments are coming to respiratory drug delivery and are likely to use Soft Mist Inhalers (SMIs) and Dry Powder Inhalers (DPIs) for delivery, with current trends looking to lean heavily on DPIs. This is likely to lead to the development of new, higher-performance DPIs to provide the best efficiency delivering these high-cost treatments to the patient. We have dramatically increased the performance of DPI engines for our clients through our science-based approach to increase fine particle fraction for their devices.

How we can help

Our team are experienced in all stages of the development of drug delivery devices for a wide range of scenarios and applications in the medical industry, with a dedicated team working in these areas. Here at CDP, we have these specialists all under one roof to partner with you to bring your device to market and can also draw on the learnings of our colleagues in consumer markets to guide on relevant future consumer expectations.

Cambridge Design Partnership and CPI launch the UK’s In Vitro Diagnostics Roadmap

January 11th 2023

Cambridge Design Partnership and technology innovation catalyst CPI today launch A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry, a major new report for industry leaders, government, and the UK’s health tech companies.

The UK in vitro diagnostics (IVD) industry has the potential to help boost UK economic growth and make the UK a global leader in the industry while improving health in the UK and for people worldwide. A new strategy, applied over the next 10 years, can see the industry transformed. The Roadmap, researched and written by Cambridge Design Partnership, in partnership with CPI, the Association of British HealthTech Industries (ABHI), and funded by Innovate UK, defines the key technologies and strategies that can place the UK at the forefront of this industry.

In vitro diagnostics – analysing biological samples outside of the body to determine health status – shows huge promise, from earlier cancer detection to the prevention and management of infectious and chronic diseases. The UK is already a global leader for science and technology. Many of the technologies at the heart of this thriving industry were pioneered in the UK, from lateral flow tests to the genetic sequencing technology used in around 80% of the world’s genetic sequencing systems. But the UK is not at the top table of the growing IVD industry, with recent estimates suggesting it accounts for just 3% of a £90bn industry. While the UK excels at research, it is held back by the commercialisation process. As a result, many UK inventions are commercialised by overseas companies – start-ups and scale-ups are acquired by global leaders, and we are yet to see the emergence of major UK IVD companies or state-of-the-art R&D centres from the global industry.

A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry sets out a programme of change to help meet the clinical needs of the future and support the UK IVD industry, government, and Innovate UK to make informed investment and capability development decisions. This Roadmap is a resource for:

Companies planning their strategies over the medium to long term, particularly leaders in medical technology, the pharma industry, and the investment community that supports them
Policy makers and broader government stakeholders shaping future UK government strategy and funding decisions
All those interested in and charged with the success of UK PLC.

Pari Datta, Principal Consultant in Strategy at Cambridge Design Partnership and the Roadmap’s lead author, says, “It’s hugely encouraging that the UK continues to lead the science behind all the major opportunities for the IVD industry – just as it did before for lateral flow testing and DNA sequencing. But we’ve yet to create global IVD industry leaders of our own or attract investment in UK R&D from global IVD leaders. Our strong position in research means we can change that. We can become one of the global IVD leaders of the future, boosting national economic growth and taking a global leadership role while improving patients’ lives worldwide.”

The Roadmap is part of the Health Technology Regulatory and Innovation Programme, an Innovate UK-sponsored initiative led by CPI in partnership with ABHI. This programme delivers a package of support to UK health tech companies to help them meet the regulatory requirements for developing, commercialising, and deploying their medical technology in the UK and globally.

A second report – Challenges and Opportunities for the UK HealthTech Industry – was also published today. For this report, CPI and ABHI worked with over 350 small-to-medium-sized enterprises (SMEs), Innovate UK and health tech stakeholders to identify the key challenges faced by the UK health tech SME community.

Dr Arun Harish, Strategy Director at CPI, said: “As a Catapult centre leading on HealthTech in the UK that works with many health SMEs in the sector, we understand how hard they find the navigation of the regulatory approvals process and the route to commercialisation. These two first-of-their-kind reports will help industry, policymakers, government, funding agencies and the wider HealthTech ecosystem immensely with shaping future interventions to grow the HealthTech industry in the UK. They also highlight the need for further intervention to support UK HealthTech businesses in developing and scaling-up innovative technologies, which will ultimately benefit UK populations.”

Selected Roadmap highlights

The Roadmap begins by defining a shared vision, acting as a focal point for stakeholders involved in the project and those going on to implement and follow the Roadmap. The vision statement is: “The UK will be the industry nucleus for world-leading businesses, with the resources, skills, and proven pathways for advancing pioneering technologies into successful data-enabled IVD solutions.”
Using oncology and infectious diseases as key disease states, input was collected from clinicians, publications, and patents to define nine key technology-enabled opportunities for the global IVD industry over the next 10 years. These are:
1. Digital PCR
2. Sequencing
3. Cell-free nucleic acids
4. Digital biomarkers
5. Proteomics
6. Combined biomarkers
7. Single cell analytics
8. Exosomes
9. Metabolomics
The report recommends that the UK develops specific technologies in materials, enzymes, artificial intelligence (AI)/data, optics, microfluidics, and sensors. To advance in these opportunities, the IVD industry also needs to build collaborations with companies that have expertise in these areas.
Seven major challenges are identified that must be resolved, including lack of UK infrastructure and ecosystem for design and development, acquiring patient samples, clinical studies, commercialisation, adoption, clinical reimbursement, and financing and investment.
In conclusion, the report recommends that the UK needs to adopt the following strategies to overcome these challenges and realise its vision for the UK’s IVD industry:
- Boost the IVD industry’s profile in the UK
- Create a focused government-led strategy for the UK IVD industry
- Support access to NHS resources during development and commercialisation
- Assist IVD companies through a well-defined and harmonised regulatory pathway
- Develop partnerships for high-risk IVD developments that have defined pathways to clinical use

Download the In Vitro Diagnostics Roadmap

For further information and media enquiries, please contact: media@cambridge-design.com or call 01223 264428.

WHITE PAPER

A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry

A major new report for industry leaders, government, and health tech companies

“The UK will be the industry nucleus for world-leading businesses, with the resources, skills and proven pathways for advancing pioneering technologies into successful data-enabled IVD solutions”

The Roadmap, researched and written by Cambridge Design Partnership, in partnership with CPI, the Association of British HealthTech Industries (ABHI), and funded by Innovate UK, defines the key technologies and strategies that can place the UK at the forefront of this industry.

Download the Roadmap

Realizing the potential of FemTech

July 14th 2021

Martha Hodgson

Jessica Platt

WEBINAR

With Jessica Platt and Martha Hodgson

14 JUL 2021

FemTech is a relatively new and often misunderstood term. Some associate it with products unique to reproductive health. However, it encompasses so much more such as chronic conditions and general healthcare and software, diagnostics, and technology to support women’s health. In addition, there are many other unaddressed women’s health areas that make this sector prime for growth. According to Frost & Sulivan, FemTech has a market potential of $50bn by 2025, while FemTech predictions around the size of the market illustrate the potential in FemTech innovation and the value of inclusive design as we consider the future of this sector.

Join Martha Hodgson and Jessica Platt and explore how the power of inclusive, experience-centered design and smart application of technology has accelerated the rise of FemTech.

During this webinar, you’ll learn about the sector’s growth and how an increasing focus on FemTech solutions will offer far-reaching opportunities to define new products, services, and technology experiences that improve women’s lives through meaningful consumer and healthcare innovation.

Watch the webinar

Connect with the speakers

Jessica Platt

FemTech Lead and Associate Insights Researcher

Martha Hodgson

Senior Insights & Strategy Consultant

Cambridge Design Partnership announces global partnership with CPI

May 20th 2021

Partnership aims to ensure that transformative diagnostic and healthcare technologies reach patients fast.

Cambridge Design Partnership and CPI today announce a global partnership with ambitious goals: To maximize the potential of next-generation diagnostic and healthcare technologies, to shape the leading edge of innovation into commercial readiness and ultimately, to ensure UK leadership in medical technologies that transform the healthcare experience.

UK-based CPI is an independent deep-tech innovation center and founding member of the High Value Manufacturing Catapult. CPI helps drive organizations through their innovation journey, uniting academia, businesses, and investors to accelerate bright ideas and research into the marketplace. It does this by connecting organizations to a bespoke team of experts, specialized innovation development facilities, funding support, and innovation tools.

Now in its 25th year and enjoying record growth, Cambridge Design Partnership delivers end-to-end product and technology development for clients in the healthcare, consumer, and industrial equipment sectors. CDP’s work starts at the point a business decides on the need for innovation within a market area and finishes with the launch of a breakthrough new product or service that is customer focused and commercially effective.

The partnership enriches the capability of both businesses. Cambridge Design Partnership gains access to CPI’s specialist expertise and capabilities in development and business scale-up. As a result, it can accelerate its most innovative client projects to market-seeding volumes. Projects at CPI benefit from its GMP and ISO13485 certified Quality Management System, ensuring compliance with relevant legislation and standards. CPI specializes in emergent disciplines such as flexible and hybrid electronics, photonics, biotechnology, advanced materials, and formulation providing game-changing innovation to markets with world-changing potential, such as diagnostics and therapeutic medicines.

CPI secures access to Cambridge Design Partnership’s world-leading expertise, built over hundreds of innovative client projects, and a deep, cutting-edge understanding of global market and technology movements in medical technology. This includes novel technologies such as molecular diagnostics, synthetic biology, and advanced therapies. Cambridge Design Partnership will provide expert guidance in strategy, planning, product development, manufacture and due diligence as CPI links the UK’s science and research base with supply and value chains. Together, they will drive future growth, and aim to establish the UK as a world leading player in diagnostic and healthcare technologies.

The success of the partnership will be measured in terms of commercial and patient impact. The two companies plan to shape early-stage innovation into investment ready business cases and market-ready products. This will streamline the development of effective products and technologies, providing value to patients within key clinical areas such as infectious disease and oncology. A particular goal is to maximize the impact of the UK’s scientific and technology research base, improving the path to commercialization and the clinic.

Commenting on the partnership, Cambridge Design Partnership’s Senior Innovation Consultant Pari Datta said, “The UK has a strong science and technology base, with a history of scientific firsts behind many great products now on the global stage. But we don’t always spot the opportunities or navigate the path to commercialization, particularly in the regulated medical space. With CPI, we’re working to grow the ecosystem which will discover, nurture, and scale these promising businesses, leading to great new products delivering real value to patients, professionals, and the UK economy.”

Arun Harish, Director of Strategy at CPI added, “Increasingly, we’re witnessing collaborative approaches to innovation development. Collaboration is at the heart of CPI’s strategy as we continue to serve multiple established and emerging industries. We’re pleased to be partnering with CDP to develop and accelerate diagnostics and healthtech products, where the potential for innovation is immense.”

For further information and media inquiries, please contact: media@cambridge-design.com or call 01223 264428

Blockchain in real-world applications. It’s not just about cryptocurrency.

December 18th 2020

James Baker

Blockchain technology has been commonly used and popularised by Bitcoin. However, the original concept was simply to create a chain of data blocks that were robust of themselves, containing data within themselves to prove the integrity of the collected information. First seen in the 1990s, it is thought to be the earliest use of what became the blockchain concept to secure lists of information, using a combination of cryptographic algorithms and networks of data hashes. In this blog, James Baker from CDP explores other blockchain applications beyond Bitcoin.

How blockchain works

In a blockchain, each block contains an item of information – for example a certificate, an amount of money or a record of an event – and the identity of what or who this data relates to. The data in the block is encrypted. A hash is also calculated for each block, where a hash is a summary number of fixed length that can be reliably calculated from the block contents, but cannot be backwards calculated to determine those contents. The hash can be examined to determine if the contents have been changed, without knowing what the contents are. Each block also contains the hash from the previous block. This is what forms the blockchain, allowing it to be extended with new entries whilst maintaining its integrity. Each new block contains a hash of the previous iteration of the chain, providing a history of what came before. Often, it is called the ‘public ledger’ of records and provides a verifiable list of events within the chain of information. The sequence of hashes easily shows if any block within the chain is changed or tampered with.

In 2008, blockchain technology hit the limelight, driven by a virtual currency built as an application using the technology. It became known as Bitcoin, but there are now many different virtual currencies available. The architect behind this is known as Satoshi Nakamoto. It’s not clear if this is a real person, a pseudonym, or a collaborative group.

Blockchain is designed to be open, public and distributed, so is ideal to address the challenge of digital trust. The information and process is available and can be authenticated without reference to other sources. It is open to inspection by all, meaning that trust in blockchain is not trust in a single entity or organisation. This is the foundation that enables blockchain to add value in numerous applications, providing an economical and verifiable tool for identity, authentication, records, or duplication which would have been challenging to deploy with traditional approaches. The ultimate promise is to change how business is conducted, guaranteeing digital trust while cutting out many incumbents in the value chain.

At CDP, we see a wide variety of applications where we believe blockchain can help add value, for example:

Traceability throughout supply chains

This challenge exists in numerous markets. In food supply, connecting and verifying foodstuffs as they move between producers, suppliers, manufacturers, retailers, and consumers is the gold standard for traceability. We want to know where all the ingredients in our dinner come from, how they got here, and how old they are. The same challenge exists in all supply chains. Where did these components come from, and are they legitimate? Blockchain is providing traceability and transparency for everything from automotive spares to computer parts, from pharmaceuticals to diamonds. It’s a digital certificate for each item, with an unalterable record of events associated with each item.

Healthcare

Blockchain can support a wide range of healthcare applications, including management of clinical trial data, storage of insurance information and the handling of sensor data in remote monitoring applications. One particularly promising application is in medical records, where blockchain has the potential to allow patients to truly own and control access to their medical records, enabling instant updates and improving access to services as and when required. Modern delivery systems are increasingly becoming connected, so one day they could also update your medical record directly and in real time. When patients truly own and have immediate access to a detailed record of their health and related actions, they can take better control of their conditions and treatments. Blockchain is a building block for digital healthcare and can contribute to the goal of proactive wellness rather than reactive healthcare.

Contracts

Blockchain provides a great tool for authenticating contracts. Can we use it to get rid of lawyers? Maybe not. Once again, it is a digital certificate and a record of interactions between individuals or entities. So called Smart Contracts can be used to ensure that an agreement between parties will deliver what is agreed if the terms are met, as the contractual terms are written, or scripted, in software, which simply executes. We expect blockchain to be used in everything from employment contracts to rental agreements and beyond. One application we haven’t seen yet, for another type of contract, is blockchain marriage certificates. A scary thought: Digital weddings. Drunken Vegas weddings worldwide by app…

Trading

Blockchain can open up numerous trading markets, providing the means to eliminate some of the services traditionally offered by banking institutions. For example, blockchain can streamline ‘Know Your Customer’ verification and speed up trade settlements. But it’s not just about money – Blockchain can underpin the trading of any commodity. A poster child for this is renewable energy trading, seeking to take control away from the energy companies and allow direct trading between micro-producers, such as homeowners. We’ve described blockchain as a ‘public ledger’, and trading, which depends on robust recording of transaction agreements, is an ideal blockchain application.

Circular economy

There is considerable focus on the concepts of recycling, re-use, and the circular economy, as the world struggles to balance consumption with sustainability, and the need to reduce carbon emissions. Blockchain can provide a means to identify and authenticate products and parts through a digital identity and record of actions, and therefore can be a fundamental building block for circularity of use, both for direct re-use of products and for recycling of parts rather than just materials. Think here of reusable phone chargers and packaging. By proving a product’s origins in a transparent ledger we can begin to build the consumer trust that will be vital to behaviour change. With trust and provenance established, circular purchases and behaviours can be rewarded. Going further, blockchain can be used to ‘tokenise’ natural resources, such as trees, fish stocks or oil reserves, giving them a digital identity that can be properly valued and traded.

The time is now

It’s clear then that blockchain is moving out from under Bitcoin, becoming another tool in the innovation arsenal. If there is an aspect of your business that could benefit from traceability, authentication, logging of events, or public verification of information, then blockchain could be one of the technologies we deploy to ensure efficient operations in tomorrow’s global marketplace.