Category: Analysis

How to boil your egg perfectly every time

How to boil your egg perfectly every time – according to simulation

April 14th 2022

Search ‘how to boil an egg’ on Google, and you get over three billion results, some telling you to put the egg in cold water after boiling to preserve the runny yolk. Intrigued, we decided to investigate the science behind this advice.

Rather than heading straight to our lab for experimentation, we used computer simulation to calculate and model the movement of heat and temperature through the egg and surrounding fluid. Simulation lets us predict data at times that would be impractical or expensive in actual experiments.

Modeling the heat flow in a boiling egg could be a surprisingly tricky problem. An egg consists of a solid shell holding the white and yolk, initially in a liquid state but solidifying as the cooking continues. Being natural products, the exact properties and sizes of eggs vary.

To simplify the problem, we found technical publications that describe the average dimensions and thermal properties of the shell, white, and yolk for a typical egg. We decided to define these properties at a temperature of 60°C, which is around the point the yolk starts to solidify. Using computer-aided-design software, we created the geometry of the egg, and defined a body of fluid to surround it. This fluid body represents the boiling water in a saucepan during the first cooking stage. Afterward, the fluid body can be used to mimic cool-down in air or a bowl of 10°C cold water. We decided that the eggs would start the process from room temperature in all cases.

We ran the simulation using powerful software, Ansys Fluent. The software was initially developed for understanding problems such as the flow of air over planes or heat in a chemical plant, but it can be applied to domestic problems such as the humble boiled egg. To allow the simulation to run quickly on an ordinary computer, we took advantage of the fact an egg shape is a body-of-revolution and looks the same however it’s rotated around its axis. This lets us model it as an axisymmetric body that the computer considers two-dimensional. This reduces the number of calculations and gives us the answer quicker and more cheaply than simulating the real-life, three-dimensional shape.

As an example of the simulation results, Figure 1 shows the temperature distribution on a slice along the egg’s axis after cooking in boiling water for six minutes. The material towards the outside has heated up close to the temperature of the water. However, the central region corresponding to the yolk is still around 50°C, corresponding to a runny egg.

Figure 1: Temperature distribution on a slice across the egg after six minutes of immersion in boiling water.

Figure 2 shows a side-by-side comparison of subsequently cooling the egg in air or 10°C water for five minutes (five minutes being our estimate of the time it takes to finish eating our first dippy egg and move on to the second). When cooled in air, the central region of the egg continues to increase to 70°C, removing the prospect of a runny egg, even though the outer region and shell have decreased in temperature. In contrast, after cooling in water, the central region stays unchanged at 50°C while the shell has decreased close to 10°C. Leaving your perfect dippy egg in air risks ruining the runny yolk – but cooling it in water may save it.

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Figure 2: Temperature distribution on a slice through the egg following cooking
and five minutes of cooling in (a) air and (b) water.

As well as modeling the overall temperature in the egg, we extracted the data for two specific points – at the center and the edge of the egg – and plotted them on a graph (Figure 3) to see how they differed. The data showed that the yolk’s temperature lags that at the shell. This is because the thermal diffusivity of the white and yolk are relatively low. Thermal diffusivity is a measure of how quickly heat can move through a material. So, it takes a while for the yolk to heat up, but once it does, it keeps cooking, absorbing heat from the rest of the egg material. It’s slow to respond to changes in the surrounding water (or air). The temperature just inside the shell responds much more quickly to changes, though, since the path the heat needs to travel from the surrounding fluid is considerably shorter, and the thermal diffusivity of the shell markedly higher.

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Figure 3: Temperature profiles with time at the center point of the yolk (circles) and adjacent to the shell (crosses)

With the aid of some considered simplifications, we think this simulation analysis has proven the cookery expert right: cooling eggs down in cold water really does preserve the runny yolk. However, whenever you analyze a problem for the first time, it’s important to compare results against an experimental benchmark, so you can confirm the realism of the assumptions and simplifications in a computer simulation. We took three eggs and boiled each for six minutes in a lab beaker. One was opened straight away, and the other two after cooling in cold water or in air for five minutes. As predicted by our computer simulation, the yolks ranged from runny to fully cooked. And the best thing about this experiment? Everyone got an egg cooked precisely to their liking at the end.

 

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Reducing the carbon footprint and plastic waste of LFTs: Evidence-based opportunities

April 5th 2022
Dan Haworth

Dan Haworth 

Head of Diagnostics

Billions of lateral flow tests have been used worldwide during the COVID-19 pandemic – over two billion have been provided in the UK alone. Debate has raged on social media about why the tests need to use so much single-use plastic and how they could be made more ‘sustainable’. The test strip caseworks is a particular source of dismay – why so much plastic to house such a tiny test strip?

With the UK government ending the free distribution of lateral flow tests for the general public – citing a transition from emergency response to longer-term management of the pandemic – now is the ideal time to look more closely at the sustainability of these lateral flow tests, and to seek the data to demystify some of the emotional assumptions being made.

Familiarity with lateral flow testing has certainly increased, as has confidence in their clinical performance. It’s expected that lateral flow devices will be more present in our daily lives post-pandemic – not just for COVID-19 and pregnancy testing but to diagnose diseases such as seasonal influenza and sexually transmitted infections – all from the comfort of the home.

We’ve carried out a high-level assessment to quantify the approximate environmental impact of lateral flow tests and identify evidence-based suggestions for improving their environmental sustainability.

Why do COVID-19 lateral flow tests contain lots of single-use plastic in the first place?

The emergence of COVID-19 was a global emergency, and vast quantities of lateral flow tests were needed urgently. Once developers could produce the right immunoassay chemistry to detect the virus (SARS-CoV-2), it required implementation in a low-cost, low-risk device, that has a mature supply chain – with proven, readily available materials that wouldn’t compromise analytical or clinical performance.

This meant using existing plastic casework designs to retain and protect the nitrocellulose test strip. Plastic is robust, low cost, lightweight, easy to transport, and easily printed for QR codes and LOT numbers. Critically, it’s a consistent material proven for the highest volume manufacturing and won’t interfere with the immunoassay chemistry.

From a performance, cost, and manufacturing perspective, redesigning the product with new materials would have been high risk. Material changes may also have needed significant R&D costs, new capital equipment as well as additional cost and effort needed to demonstrate equivalence and achieve regulatory approval – risking the ability to provide sufficient numbers of high-quality tests, at speed during the pandemic.

Our results: The sustainability of lateral flow tests

But how serious an environmental impact do these tests have? To find out, we broke down a test into its constituent components and weighed them to calculate the approximate environmental impact, using standard emissions factors to calculate the carbon footprint of a single test.

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We focused on carbon footprint (the carbon dioxide and other greenhouse gases emitted during manufacture, transport, and disposal of the tests) and plastic waste (waste that would persist indefinitely if released into the environment) – the two issues that have attracted the most attention around lateral flow tests. A more comprehensive study should consider a broader range of environmental impacts, for example, the use of scarce resources and emission of other pollutants to avoid unintended consequences of any product changes.

Our results reveal:

  • The components needed to conduct the test account for around half of the carbon footprint and around two-thirds of the plastic waste. Packaging makes up most of the rest – as is often the case, a surprisingly high proportion of the total environmental impact
  • The test strip caseworks, which attracts the most comment online, is responsible for around 30% of the carbon footprint and 40% of the plastic waste. While it’s the most significant single contributor to the environmental impacts we evaluated, the large number of other small parts is also significant. Focusing on the caseworks therefore might not be the best strategy for improving the sustainability of the tests overall.
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Lateral flow tests a minor piece of UK healthcare’s environmental impact

To put these numbers into context, we can compare the environmental impact of the two billion COVID-19 lateral flow tests distributed in the UK with the UK healthcare system’s overall environmental impact. We estimate the UK’s lateral flow tests have a carbon footprint equivalent to around 0.5% of the total NHS carbon footprint. This isn’t a trivial amount, but it’s also not the largest single contributor to the impact of the UK health system.

It’s also worth considering the positive environmental impact of a user-administered test on the health system. Conducting a test at home can eliminate the need for an individual to visit a test site, GP’s surgery, or hospital (assuming the clinical performance of the lateral flow test is adequate). Based on estimates from the Sustainable Healthcare Coalition, one lateral flow test has around 5% of the carbon footprint of a single GP appointment and produces a similarly low percentage of non-degradable (plastic) waste.

And that’s before we consider travel. We estimate one lateral flow test has the same carbon footprint as driving 350 metres in an average UK car. So, if you’re driving yourself to a test site or GP surgery some distance away, at-home lateral flow tests compare even more favorably.

If a lateral flow test prevents an individual from transmitting COVID-19 to a vulnerable person, there’s a public health benefit – as well as an environmental benefit – to keeping people out of the hospital. We can all see the discarded waste from home tests, but the less visible impact from energy- and material-intensive medical interventions is often significantly higher.

These approximate figures demonstrate why building an evidence base is vital during product development targeting sustainability objectives – because the results can be unexpected and non-intuitive.

Quick ways to optimize today’s lateral flow tests

Just because waste from lateral flow tests might not be the most urgent sustainability issue for UK healthcare, that doesn’t mean we can’t and shouldn’t do something about it.

We used the ‘avoid/shift/improve’ model to find potential quick wins for lateral flow tests. These reduce the carbon footprint of each test by nearly a third and the plastic waste by almost a quarter – without impacting the fundamentals of how the test works.

They include:

  • Eliminate waste bags. There’s a case for quickly isolating contaminated waste (even given COVID-19 also spreads from infected individuals through the air), but the bags account for around 5% of the carbon footprint of the test. It’s not clear how widely used they are in a domestic setting – there may be a risk-based justification for not including them in the test kit.
  • Package all the test strips in a single foil pouch. Using a single re-sealable pouch to protect the tests from ambient humidity (rather than individually packing each test in a pouch with desiccant) is common in packs of lateral flow tests designed for use by healthcare professionals. However, once opened, the stability lifetime of the remaining tests is affected.
  • Reduce the size of paper instructions. These are important for the effectiveness of the tests and are a regulatory requirement, but account for 5% of the carbon footprint of a test – could they be reduced in size?
  • Eliminate the cardboard sleeve. This packaging isn’t essential to the safe and effective functioning of the test, and it seems likely that the functions it does provide could be achieved with less material.
  • Prefill the extraction tubes with buffer solution. This is already done in some test kits, although manufacturers need to be conscious of moisture loss and the effect on shelf life. However, the separate plastic vial used in the test kit we studied accounts for around 5% of the carbon footprint and plastic waste.
  • Increase the size of the pack from seven to ten tests. This would mean less package waste per individual test. Including ten tests in one pack instead of seven reduces the carbon footprint by around 5% (depending on how many other optimizations are done at the same time). Perhaps a pack of seven tests was originally designed to cover a week of daily testing – but is that how tests are being used in practice?
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Redesign of the test strip caseworks

Looking to the longer-term gets us into product redesign – creating a new generation of the product with sustainability in mind. Doing this can take significant investment since, for medical devices, it’s likely to require new regulatory approval, which is a lengthy and costly process.

A popular idea circulating for lateral flow tests is to minimize the plastic test strip caseworks (without compromising the essential functions of providing a stable platform, and protecting the nitrocellulose test strip). It might be possible to halve the caseworks mass and reduce the overall carbon footprint and plastic waste by 15-20%. This would require significant investment in R&D, production tooling, and regulatory approval hoops to jump through – but could be worthwhile if future demand for tests stays high.

Longer-term options

If we consider that the world may require billions more lateral flow tests over the coming decade, a more comprehensive redesign becomes commercially viable. This could involve stripping the design back to the fundamental requirements for a lateral flow test – flowing a sample through the test strip in a way that is controlled and free from contamination. Current designs take advantage of established components to collect, buffer, and dose the sample – but, at this production volume, it may be worthwhile designing a system from the ground up that is optimized for cost, usability, performance, and sustainability.

Sustainability as a brand differentiator

It’s clear there’s scope to optimize lateral flow tests to reduce their environmental impact – and a systematic analysis reveals options beyond those that might jump out to someone when they use the tests. But it’s essential to put the impact of lateral flow tests in the context of the wider healthcare system, to focus resources where they can have the most environmental impact – and to recognize that, sometimes, the plastic waste people can see helps to avoid more serious, but less visible consequences.

On the other hand, while visible plastic waste from lateral flow tests may not be the most pressing environmental issue facing the healthcare industry, it highlights the growing influence consumer opinion is likely to have as diagnosis and treatment shift from hospitals to homes. And as lateral flow tests become (in the UK, at least) a product people buy with their own money, choosing from a range of options, there may be a competitive advantage for businesses that take note and optimize their products for sustainability.

References
  • Prime Minister sets out plan for living with COVID [Internet]. GOV.UK. 2022 [cited 1 April 2022]. Available from: https://www.gov.uk/government/news/prime-minister-sets-out-plan-for-living-with-covid
  • The Sustainable Healthcare Coalition. Care Pathways Calculator. [Internet]. Sustainable Healthcare Coalition. 2022 [cited 1 April 2022]. Available from: https://shcoalition.org/

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Mastering fluid flow to enhance user experience|

Mastering fluid flow to enhance user experience

March 22nd 2022

Ice cream and blood are two things you probably don’t want to think about simultaneously. But both are full of organic proteins and fats and behave differently from a fluid like water when they’re pumped through tubes. Innovators sometimes think about these similarities when creating, for example, a novel ice cream dispenser or device that filters out platelets from donor blood .

How a substance flows is a vitally important consideration for many products, from foods to skincare to medical devices to household paints. Development teams need to keep in mind a wide range of flow behaviors (for example, flow through nozzles, non-Newtonian flow, and foaming) to hit the sweet spot: a positive user experience that makes a product stand out in a crowded market. This means thinking about the science of how liquids and gases behave (fluid dynamics), as well as how the product responds to user interaction.

Look at how the squeezable plastic ketchup bottle differs from the glass bottles that were standard before 1983. The new design completely changed the user experience – no more digging down into the bottle with a knife to get the ketchup flowing again. Things became even easier for ketchup lovers with the debut of the upside-down squeezable bottle – no more awkwardly storing ‘regular’ bottles upside down in the fridge.

Or think about how the experience of washing your hands changed after the arrival of the liquid soap dispenser. Instead of having to share the same bar of soap with others, people can now wash “without the soapy mess”, as Robert R Taylor, who introduced SoftSoap liquid soap, put it, and can take only as much soap as they need.

While the flow of some liquids is analogous to water, whose behavior is well understood, other substances behave in much more complicated ways, requiring in-depth analysis work to understand when designing new products. For example, the air bubbles in ice cream make it behave as a liquid foam. Ice cream’s flow will change depending on how you’re dispensing it: Push it at high pressure through a narrow channel or nozzle, and the air bubbles will be compressed, allowing more ice cream to flow through the nozzle at once. When the ice cream is returned to normal pressure, the air bubbles re-expand, and the ice cream returns to its original size. Because of this complex and variable behavior, designing a product to dispense ice cream relies on hands-on experiments… which can mean going through gallons of ice cream before you can create a design that works as intended. Only by conducting these experiments to understand ice cream’s behavior can you build the mathematical model required to effectively develop a high-performance machine.

While it’s a shame to use gallons of ice cream in the quest for a better product, it’s not an environmental disaster. But shipping water-based products around the world does contribute to fossil fuel consumption and climate change. Removing water from laundry detergent helps cut shipping emissions by reducing bulk and making shipping more efficient. But it also dramatically changes how detergent flows and gets used by consumers. For example, measuring out 10 ml more detergent than recommended likely wouldn’t have an impact if you’re using a product that’s mostly water. But being off by 10 ml when detergent is concentrated could make a big difference for your laundry. So, it’s vital to ensure that dispensing is accurate, which requires an understanding of flow.

There are so many flow behaviors that can affect a product’s design. For example, should a container for insecticide include a mechanism to avoid skin contact and spillage? How could a medical device for freezing tumors be redesigned to eliminate vapor locks without the use of heavy and bulky high-pressure gas cylinders? Is there a way to dispense foaming hand soap in a decorative pattern for a premium experience?

Getting the design right for a flowing substance can differentiate between a product that fails and one that creates an experience that shifts category norms and delivers breakthrough consumer delight.

References

FemTech : #2 Experience-led design

The three pillars of FemTech success: #2 Experience-led design

March 10th 2022
Cambridge Design Partnership

Cambridge Design Partnership 

In the first of a series of articles covering the three pillars of our FemTech philosophy, we discussed inclusivity. Here, we move on to experience-led design, before ending with the smart use of technology.

Product innovation is shifting focus – from making things to designing seamless experiences. An experience-led design process leads to simple, intuitive, and enjoyable solutions, increasing customer satisfaction and retention.

How a user feels when using a product or service is becoming as important (if not more so) than the solution itself. More than ever, themes such as brand ethical position, purpose, and sustainability credentials are influencing where consumers place their cash and their loyalties. To address this, FemTech innovators must do three things:

  • Understand external influences
  • Focus on the end-to-end user experience
  • Leverage multi-disciplinary perspectives

Understand external influences

Understanding what drives change in the consumer and healthcare space is vital. The challenge for FemTech innovators is to understand how these factors will affect user expectations and behavior.

Take environmental factors: ‘flushability’ has long been a selling point for hygiene products, such as wipes and sanitaryware. However, some manufacturers have drawn historical criticism for stretching the technical definition of flushable to what may be sent on its way with the press of a lever. ‘Solubility’ is a more meaningful definition in the context of the environment and related consumer aspirations. These criteria are determined by industry standards such as Water Industry Specification (WIS) 4-02-06, ‘Fine to Flush’, and other standards with similar objectives across different international legislative jurisdictions.

Sanitary disposal bag firm Fab Little Bags is banking on consumer sentiment changing amid increasing awareness of water pollution. By providing a way to dispose of a tampon in a way that aligns with changing environmental beliefs – binning is better than flushing – it removes eco-guilt and improves the end-user experience.

Regulation is another factor that could affect user experience. If users know that a product, such as a fertility monitor, has been medically approved, they may feel more confident when entrusting it with a potentially life-changing task.

Focus on the end-to-end user experience

User experience isn’t limited to using a product or service but encompasses the whole consumer journey, including product research, purchase, delivery, unboxing, and after-life.

Consumers have ‘Moments of Truth’ during this journey – key points when they form an impression of a brand – and emotional and social drivers can have equal, if not overriding influence, over functional ones. The Zero Moment of Truth occurs during pre-purchase research. The intimate wellbeing e-commerce platform, Bloomi, which screens every product against a checklist of banned ingredients to ensure they meet its clean standards, recognizes the importance of this stage. The attention to the customer experience is continued with the promise of delivery in discreet packaging. Bloomi has designed a customer experience free of anxiety about harmful ingredients and privacy by considering elements of the user journey beyond use.

Leverage multi-disciplinary perspectives

User experience isn’t the remit of front-end innovation alone. Harnessing a multi-disciplinary team allows for a wealth of experience, perceptions, and viewpoints to be incorporated into the end-to-end design process. For example, our designers and engineers accompanied our research team to hear first-hand the frustrations women have when undertaking a breast cancer biopsy. This ensured that we could design an accurate medical tool and an empathetic user experience.

Certain environments, such as innovation sprint programs and start-up incubators, foster multi-disciplinary design. FemTech Labs, the first FemTech accelerator in Europe, is one example. It brings together experts, investors, and business coaches to kickstart FemTech businesses. The FemTech Lab accelerator program is short and intense, supplying opportunities for participants to grow quickly and sustainably by drawing on the expertise of its comprehensive interdisciplinary network.

As we’ve seen from the above examples, many FemTech companies are already prioritizing experience-led design as part of their development process. One of the mentioned case studies, Fab Little Bags, doesn’t ostensibly have any tech in it, which brings us to our upcoming article: the smart use of technology.

References

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Product design: Is plastic ever the best choice?

Product design: Is plastic ever the best choice?

February 16th 2022

Mark Buckingham 

Amy King

Amy King 

Head of Insight & Strategy

Plastics’ reputation has gone from miraculous to maligned in the last half-century. Suppliers have even resorted to disguising their use with brand names and faux-natural finishes. However, if good product design means selecting the right tool for the job, there are many applications where these unfashionable materials may still be the best choice in products with design lifetimes of many years.

Below we look at the case for considering plastics in the design of durable products, and why they don’t need to spell disaster for the environment when used responsibly.

The rise and fall of plastics

Short for ‘thermoplastic’, the term ‘plastics’ describes materials that will soften and melt under heat, meaning they can be molded into intricate shapes at moderate cost.

The first synthetic plastic was patented in 1907, and by the mid-20th century, plastics were enjoying a heyday. As manufacturing techniques and costs improved, products, such as plastic bags and cling film wrap, became prolific. By the end of the century, the realization that these packaging materials could take thousands of years to break down (and may cause environmental harm when they do so), resulted in an anti-plastic movement.

The challenge for today’s innovators is that the case for durable-use plastics got swept up in the backlash against single-use items. There have also been many examples of low-cost reusable plastic items which are often thrown away after being used for only a brief time. This has made it harder to convince manufacturers, product designers, and consumers that sometimes plastics may be the most suitable option for products designed to be used for ten years or longer.

When plastic may be the only choice

There are many factors to consider when choosing the most appropriate material for an application: properties, price, ease of processing, and sustainability. These have different weightings depending on the intended application.

For example, in ‘life-or-death’ products, a material’s properties will often outweigh its eco-score. For example, would you choose a biodegradable yet less effective version of the following: a bulletproof vest, hospital machinery part, or heart valve? In less critical applications, choosing between different materials may be more finely balanced, and selecting a material that permits a long design-life remains a key factor.

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A versatile material

Plastics’ original (and ongoing) attraction is that they can be blended with additives, such as colored pigments, stabilizers, antioxidants, flame retardants, and reinforcing fillers, to take on an incredible range of properties. The flip side of these additives is that they make recycling harder, so they should only be included when they provide an important benefit. The range of properties includes:

  • Durability – plastics’ perceived environmental weakness can also be its strength: if a plastic product works well and is designed to last many years, it’s a better solution than an alternative with a shorter lifetime. Buried PVC plastic pipes outlast iron or concrete pipes, with a service life of over 100 years.
  • Resistance to bacteria – more relevant than ever is the ability of specially-designed additives to make some plastics repel or inhibit the growth of microorganisms. As well as reducing the transmission of disease, the product’s lifetime may also be extended.
  • Heat and electrical resistance – most electrical products need housing to keep dust, water, and fingers away from live current. It must be electrically insulating, protect components, and provide an opportunity for branding and ergonomics. For many applications, plastic housing is more suitable than metal.
  • Density – the low comparative weight of some plastics can lead to them becoming the most sustainable option. For example, replacing metal parts with plastics in cars makes a vehicle lighter. A 10% drop in weight leads to a 6-8% improvement in fuel economy. That’s a lot of fuel (or electricity) over its lifetime.
  • Ease of manufacture – the processing temperatures of plastics are much lower than for glass or metal, and less energy is needed to heat the material for manufacture. Substituting plastics with alternatives would increase lifecycle energy consumption by over 50%.
  • Availability – the materials which form plastics can be any one of a wide range of synthetic or naturally derived polymers. As issues around sourcing and disposal become increasingly important, this is leading to the increasing selection of bioplastics in some applications.

‘Designing in’ the responsible use of plastics

A comprehensive design process should look at the whole lifecycle of any material, including sourcing and afterlife. Here are three ways to ensure plastic is used responsibly:

Look for sustainable sources. In the medium to long term, all plastics will need to come from a renewable resource. In many cases, a part- or wholly recycled material may be suitable. Lego, for example, has started designing its bricks from recycled plastic bottles. Designing with plastics, such as nylon and polyethylene, for which plant-based sources are already available, enables these to increasingly compete with fossil-fuel sources.

Design for ease of repair and longevity. In our article, Making it last, we looked at how materials and design can work together to ensure a long useful product lifetime. The ‘Right to Repair’ will become increasingly important for durable products. Where wear is anticipated, the product should be designed so individual parts can easily be repaired or replaced. We examined these issues in the context of electronic products in another article, Ten ways to reduce e-waste in product development. Many of the same principles may be applied to reduce plastic waste.

Take responsibility for the afterlife of plastics. We can design plastic products with as long a lifetime as possible. Still, we also need to consider their eventual disposal and the likely changes in regulations during the product lifetime. The diversity of plastics means it’s hard to recycle them all. Manufacturers will need to take increasing responsibility for the fate of products at the end of their useful life. They will also be required to work locally with legislators to design waste streams so plastic products are specifically designed for ease of recycling and users are incentivized to recycle or reuse them whenever possible.

The right material for the job

Evaluating materials is a key element of product design. Putting a product’s intended application at the center of this choice leads not only to a better end-user experience but can be the more sustainable option too.

References
Over-the-counter HRT: Why design matters?

Over-the-counter HRT: Why design matters

February 9th 2022

Jessica Platt 

Ben Strutt 

The recent move by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to enable women to pick up hormone replacement therapy (HRT) treatment from a pharmacy without a prescription should be applauded. If rubber-stamped, thousands of women over the age of 50 who suffer from vaginal dryness will no longer need a trip to their doctor for treatment. However, a successful move from prescription (Rx) to over-the-counter (OTC) drug isn’t just a case of administrative reclassification; design also plays an essential part in mitigating risks.

What has design got to do with the success of over-the-counter HRT?

On February 2 2022, the MHRA opened consultation on a proposal to make the prescription-only estradiol vaginal tablet, Gina10, available as a pharmacy medicine. To qualify, a drug must fulfill the following:

  • It must be unlikely to be a direct or indirect danger to human health when used without the supervision of a doctor, even if used correctly.
  • It must not contain substances or preparations of substances where the activity of the product or its side effects require further investigation.
  • It must not normally be prescribed by a doctor for injection (parenteral administration).
  • It must generally be used correctly (i.e. not frequently or to a wide extent used incorrectly).

This last item isn’t a factor of the medicine’s efficacy but mainly of how it is used. The task of helping meet this criterion falls to design. In the absence of a prescribing doctor, factors such as packaging usability, information, instructions, and labeling must step in to support the pharmacist and empower the consumer to make safe and informed choices.

The move to self-health

The commercial opportunity enabled by such redesign is growing – the global Rx to OTC switch market was valued at US$ 33 billion in 2020 and is predicted to expand by over 5% each year between 2021 and 2031.

This will require an industry mindset shift from relying on doctors to pharmacists or consumers themselves. As demonstrated by the widespread adoption of home lateral flow tests during the COVID-19 pandemic, design can be an enabler. Suddenly, the public was expected to carry out and report on a process that previously (most likely) would have been the domain of a medical professional.

We became de facto lab technicians overnight, swabbing younger patients and recording results at the kitchen table. Design was central to the scheme’s success, from letterbox-sized kits to step-by-step graphical instruction books. Lateral Flow Technology made in-home results that would once have been the domain of well-equipped labs, available in minutes.

Their user-friendliness was improved in design iterations, with the introduction of nose-only swab kits and all-in-one buffer solution tubes. Of course, if the tests had been rolled out without the time and cost pressures of a global pandemic, the intuitiveness and usability of the product-pack experience could have been improved. For example, the ever-confusing ‘C’, which clearly means ‘Control’ to scientists, raises the risk of erroneous reporting if interpreted as ‘COVID-19’ by others.

The good news for most pharma companies considering an Rx to OTC switch is that there is time to optimize this experience, thanks (or no thanks) to an often-lengthy reclassification process.

The evolution of the over-the-counter experience

The evolution of the OTC user experience can be demonstrated by another landmark for women’s health: the reclassification of the morning-after pill. When the pill became available in UK pharmacies in 2001, women had to endure a face-to-face interview with a pharmacist in a private side room (which only made the whole process more indiscreet and potentially a barrier to freedom of health choices.) Today, people can order online from multiple consumer-friendly websites for next-day delivery.

Telehealth website ForHims, founded in 2017, achieves the same for men seeking treatment for highly emotive personal problems such as hair loss and erectile dysfunction. An easy-to-navigate website encourages users to fill out a five-minute questionnaire sent to a clinician to approve the requested treatment. Available drugs include Sildenafil and Viagra Connect, which became OTC treatments in the UK in 2018.

A joint effort

The ability to zip into a pharmacy and pick up HRT will be life-changing for many women. There are many candidate drug opportunities with the potential to ‘switch’ in the future, which can only be a good thing for consumers. The design industry will play a critical role working in pharma and regulatory partnerships to ensure this evolving landscape and the packaging and surrounding experience are optimized to best inform and empower those it seeks to benefit.

A landmark for women’s health innovation

There were two victories in the MHRA’s announcement that it’s seeking to reclassify Gina10, an HRT treatment for vaginal dryness, as a non-prescription drug.

The first is that the medical industry is waking up to accessibility needs in healthcare, particularly for women. This group has significantly less free time than men to organize and attend a doctor’s appointment. OTC treatment will make a difference to the 80% of menopausal women who contend with the impact of vaginal dryness on their quality of life.

The second is the medical industry’s increasing willingness to develop a product that addresses the sexual wellness of menopausal women, a traditionally taboo subject. Moreover, the media are willing to talk about this advance for women constructively without the titillating headlines we might have seen in the past.

Both these points mark substantial progress in advancing equality in women’s healthcare.

References

  1. Proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies [Internet]. GOV.UK. 2022 [cited 8 February 2022]. Available from: https://www.gov.uk/government/consultations/consultation-on-proposal-to-make-gina-10-microgram-vaginal-tablets-estradiol-available-from-pharmacies
  2. Rx-to-OTC Switches Market [Internet]. Futuremarketinsights.com. 2021 [cited 8 February 2022]. Available from: https://www.futuremarketinsights.com/reports/rx-to-otc-switches-market
  3. Men enjoy five hours more leisure time per week than women – Office for National Statistics [Internet]. Ons.gov.uk. 2018 [cited 8 February 2022]. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/articles/menenjoyfivehoursmoreleisuretimeperweekthanwomen/2018-01-09
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The three pillars of FemTech success: #1 Inclusivity

January 28th 2022
Cambridge Design Partnership

Cambridge Design Partnership 

Welcome to the first in a series of articles outlining the three pillars of our FemTech philosophy: inclusion, experience-led design, and the smart integration of technology. Here, we start with inclusion, a crucial topic for success in innovation.

While there are initiatives to ensure gender diversity in the boardroom, there’s rarely the same in product development. This need for equilibrium has historically often been overlooked in market research and product testing, resulting in design that misses a proportion of end-users. For example, it wasn’t until 2011 that female crash test dummies were introduced in the US.

There are three steps to achieving inclusivity in end-to-end innovation:

  • Understand the problem
  • Understand the context
  • Understand the ecosystem

Understand the problem

We use an Insights for Innovation approach underpinned by the ‘jobs to be done’ perspective. This focuses on understanding a task or ‘job’ independently of any existing solutions used to achieve it. This means we start with the problem rather than the solution. For example, our starting question is: ‘What needs might a couple have when trying for a baby?’ (the jobs), rather than ‘How can we design a biometrics tracker to gauge fertility?’ (a solution).

This solution-agnostic approach involves defining a ‘job’ in terms of the user’s functional, emotional, and social needs, for example:

  • The functional need to ‘know when I’m ovulating’
  • The emotional need to ‘feel like conception is a natural process’

An excellent example of a solution that has fulfilled these needs is Inne. This fertility monitoring system uses saliva to detect ovulation. Saliva analysis can help women increase the chance of falling pregnant (functional need) by identifying the fertile window each month. It offers clear feedback to reduce anxiety around the results (emotional need) and comes in a discreet format, allowing women to keep their fertility journey private, if they wish to.

Understand the context

FemTech teams must take research beyond quantitative surveys to truly have a clear idea of a woman’s needs. This requires in-depth qualitative interviews to understand women as part of a contextual system. This recognizes that women don’t buy a product because of who they are; no two women are the same; the same person can have different needs in different contexts.

We believe the team behind the breastmilk expresser Elvie Pump took this approach by considering the context of when it would be used, for example, while running after a child or in the workplace. This revealed needs far beyond extracting milk.

Historically, breast pumps have been cumbersome and noisy, with long tubes that significantly restrict movement. On the other hand, Elvie Pump’s design is hands-free, silent, cordless, and easy to clean. By addressing context, the design became a market leader in the US and UK.

Understand the ecosystem

Understanding the ‘job to be done’ as part of an ecosystem helps multi-disciplinary teams consider the experience of other key stakeholders.

Take the example of contraception; a heterosexual couple might have the same emotional need to ‘feel like contraception is natural’. However, to one, it could mean hormone-free cream; to the other, it might mean no physical intervention at all (for example, relying on a fertility monitor). Addressing the need from different perspectives ensures the solution is meaningful, intuitive, and enjoyable for everyone it impacts.

The Maven Clinic is a telehealth platform that offers fertility, pregnancy, postpartum, and family care services. It caters to what would largely be considered female needs. However, 30% of its members are men. Founder Kate Ryder is careful not to exclude them when she talks about the platform. Rather than referring to Maven Clinic as FemTech, she defines her mission in terms of “people” to ensure that all members feel included.

As these examples show, inclusivity is an essential ingredient of FemTech success. The following articles in our series will cover why experience-led design and the smart integration of technology are equally important.

References
  • Criado Perez C. The deadly truth about a world built for men – from stab vests to car crashes [Internet]. The Guardian. 2019 [cited 10 January 2022]. Available from: https://www.theguardian.com/lifeandstyle/2019/feb/23/truth-world-built-for-men-car-crashes
  • Science [Internet]. Inne.io. 2022 [cited 10 January 2022]. Available from: https://www.inne.io/en/science
  • Elvie Pump: from idea to execution [Internet]. Elvie. 2019 [cited 10 January 2022]. Available from: https://www.elvie.com/en-gb/blog/elvie-pump-from-idea-to-execution
  • Srivastava A. British femtech Elvie lands £58M funding for its smart breast pumps and more – UKTN | UK Tech News | [Internet]. UKTN | UK Tech News |. 2021 [cited 10 January 2022]. Available from: https://www.uktech.news/news/british-femtech-elvie-funding-20210727
  • Maven – The next generation of care for women and families [Internet]. Mavenclinic.com. 2022 [cited 10 January 2022]. Available from: https://www.mavenclinic.com/
  • Pallarito K. ‘Femtech’ Is Busting Taboos Around Women’s Health and Wellness—But What Is It Exactly? [Internet]. Health.com. 2020 [cited 10 January 2022]. Available from: https://www.health.com/mind-body/femtech-womens-health

Connect with CDP

For more on how to design inclusive, experience-led FemTech products that meet the real needs of women, contact Cambridge Design Partnership.

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Prepare the way: Pilot manufacture for drug delivery devices

January 18th 2022
Jon Powell

Jon Powell 

Head of Manufacturing

Bringing a drug delivery device to a clinical trial is a complex endeavor. You need to keep a handle on multiple moving parts, for example, the active pharmaceutical ingredient (API) development, the regulatory pathway, establishing the supply chain, and labeling. Developing a novel drug delivery device takes things to another level.

Many manufacturers shy away from the challenge, relying instead on proven technologies, so patients and clinicians don’t benefit from the most advanced user-centered design, and pharma companies can’t leverage the competitive advantage new technology delivers.

Here, I share some of the obstacles encountered conducting pilot builds in-house to help our clients bring devices to market – and give four pointers for ideal pilot manufacturing for clinical trials.

Develop your manufacturing process and architecture in tandem

3D CAD makes it all too easy to lose touch with reality and forget that the model on the screen is only an idealized representation. Zoom in 4,000%, and everything lines up beautifully. There’s no gravity, and parts have infinite stiffness, no tolerance, and perfect alignment. But, when you get natural variation in the manufacturing process, results can be disastrous. Components may not even fit together.

Once a design is frozen, making changes is expensive. After it’s passed to a high-volume manufacturer, costs become exponentially higher. Understanding manufacturing processes – and how changes can impact a project’s timeline – is critical for successful delivery. You need to prepare for the supply-chain ‘whiplash effect’: a tiny change at the top of the chain can mean seismic shifts at the end of it. That knock-on is the reason your product development strategy should incorporate pilot manufacture. Pilot manufacture keeps this effect in check by minimizing the volumes involved.

It’s vital to consider the whole supply chain, not just the component manufacturer, but the process equipment partners, filling, packaging, sterilization, and logistics. Each step has requirements to be understood and communicated to relevant parties. By developing manufacturing and assembly processes in tandem with device design, we can be flexible to insights arriving from either direction.

Pick the right partners for success

One of my first jobs was for a major automotive company. In their heyday, they ran the foundries that made the ball bearings for their vehicles. Today, they wouldn’t dream of it. No company does everything anymore. Few organizations would claim to be experts in all areas of drug delivery. Even those that manufacture and fill their own devices rely on external partners to produce the plastic resin and packaging materials and often outsource activities such as sterilization.

Partnering with experts to contribute specific knowledge is a time-efficient way to overcome obstacles in the development pathway. It also unlocks access to cutting-edge equipment and facilities that are expensive to maintain. While developing a breath-actuated inhaler, we engaged an external test house to conduct bio-compatibility evaluations on the device. We may have the skills in-house to perform this testing but maintaining accreditation for an activity that isn’t core to our business doesn’t make financial sense.

Know the limits

When developing a device, it’s essential to explore sources of potential variation. The same goes for the manufacturing process. You can use various tools to do this, but we frequently return to the humble ‘process failure modes and effects analysis’ (pFMEA). The pFMEA is a structured way to consider all the process steps – and how they could go awry. Developing a robust pFMEA ensures the team focuses on the highest risk areas and starts thinking about implementing mitigations.

A key checkbox for each manufacturing process step is if the results can be verified or validated. The US Food & Drug Administration Code of Federal Regulations Title 21 defines verification as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Many processes can be verified using in-process measurement systems. But several can’t, for example, the joining of two plastic parts by ultrasonic welding. You can’t determine the strength of this weld without destructive testing. The ultrasonic welding process needs to go through process validation to determine the limits within which the process should be operated.

When communicating with stakeholders, it’s crucial to know the volume limits and have a realistic plan for producing parts representative of the final production process. For example, how many parts can the mold tools make? There’s a trade-off between tool production speed, tool cost, and tool life. Low-cost soft aluminum tools might be ready in two weeks but only suitable for 2,000 shots, whereas a more expensive hardened steel version might take 16 weeks (without validation) but last for over 100,000 shots.

Validating injection mold tools can be a lengthy process. Exploring the process window needs planning and performing multiple molding and measurement runs and subsequent analysis. Companies only want to bear this cost once, so experienced development teams need to hold firm when encountering adverse test results. I know of an auto-injector that showed promise early on, albeit with an infrequent failure observed in testing during development, that was allowed to pass into design freeze. More thorough testing during design verification revealed results that triggered the regulatory application to be rejected. Cue months of tooling validation needing to be reassessed.

Combination products require the delivery devices to be filled or co-packaged with primary containers of the API. Clinical trials complicate this because they need devices filled with the API or safe and sterile placebo. The filling process can be complex, especially when the API is highly viscous or uses technologies such as microspheres to sustain the release of active components over time. You need to factor in time to explore the filling and develop the process settings. Thought needs to be given to the amount of API and placebo available and the lead times for new batches as this can limit the amount of filled and finished devices.

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Digital tooling to reduce time to market

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Not documented? You’re not done.

Understanding the controls needed to manage risk is essential for a manufacturer delivering high-quality, safe, and reliable products. ISO 14971 sets out a best practice framework for managing risk in the context of medical devices. We advise creating a quality control plan that summarizes the production risk mitigation controls identified through risk assessment in a clear, concise format. This control plan also blueprints the actions needed if a specific limit or check is breached.

Anyone who has experienced an audit by a notified body or regulatory agency will recognize their love of records. The mature management systems used by large manufacturers often aren’t available for the short-run low volumes involved at the scale-up stage. Building a bespoke database compliant with 21 CFR part 11 to handle records can be a lengthy activity, particularly when compared with the pace of setting up paper-based systems.

Managing paper records generated by the manufacturing process can be challenging, putting storage and recall burdens on a manufacturer. Companies scan these documents soon after completion to reduce this burden. But the destruction of originals is risky, and the recall and integrity of e-records must be checked before destruction.

Pilot manufacturing helps optimize the journey of a drug delivery device to clinical trial. It’s not without its own challenges, but synchronizing manufacturing process and device design development, partnering with experts, having a plan for producing components that’s representative of the final production process, and keeping a handle on records puts you in a position to maximize pilot manufacturing’s potential.

References

Connect with CDP

For more on how to navigate pilot manufacture and bring drug delivery devices to clinical trial with confidence, contact Cambridge Design Partnership.

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From medical devices to monitoring endangered species – 25 years of innovations improving lives

December 21st 2021

For 25 years, we’ve had one goal: to improve lives through innovation. To mark our first quarter-century, we asked some of our partners to talk about their personal standout projects. Their answers reveal how CDP innovation has built a better future for thousands – from facilitating treatment for breast cancer patients, to monitoring wildlife and detecting poachers in the most remote landscapes.

web_cameo_Visica Bringing breast cancer treatment into the physician’s office

Sanarus Technologies’ Visica 2 uses extremely cold temperatures to scarlessly destroy tumors. We completely redesigned this cryoablation system, enhancing performance and facilitating treatment in the physician’s office. Our advances reduced consumable cost by ten times and equipped our client with a strong IP position. Visica 2 was created to treat benign tumors – but it has since demonstrated impressive efficacy in clinical trials for malignant tumors, too.

“Our work on the Visica 2 breast cancer cryoablation system still excites me years later. We doubled performance and drove down costs, and clinical trials continue to prove the astounding efficacy of this no-scar, 30-minute procedure. Then there’s the human part: Sanarus Technologies’ chairman and CEO, BJ Hardman, shared her own Visica 2 treatment story, bringing to life the impact we’ve had on thousands of patients.” As stated by our Head of Medical Therapy.

 

web_cameo_Pulpex Groundbreaking sustainability project addressing plastic waste

Pulpex, a collaboration between Pilot Lite Group and Diageo PLC, is a patented, first-of-its-kind pulp packaging innovation. Renewable, recyclable, and biodegradable, Pulpex enables brands to completely rethink their packaging proposition. CDP set up an automated, short-run manufacturing line, helping to move this innovation from early concept to reality.

Chris Houghton, Head of FMCG: “Breakthrough innovation is what I’m most passionate about – pioneering new ground to improve lives. Tackling single-use plastic is a major challenge facing our generation, and our work with Pulpex promises to provide an alternative that’s better for the environment, encouraging consumers and society to live more sustainably.”

 

 

 

web_cameo_QpocPoint-of-care PCR COVID-19 testing instrument

In the early days of the COVID-19 pandemic, our team of mechanical, electronics and software engineers, as well as manufacturing and regulatory experts helped QuantuMDx develop their Q-POC point-of-care diagnostic instrument, which detects COVID-19 within around 30 minutes using PCR. Using our short-run manufacturing capability, we produced the first batch of instruments which were deployed to hospitals for COVID-19 testing studies.

Dan Haworth, Head of Diagnostics: “We worked at speed to develop QuantuMDx’s point-of-care molecular diagnostic device from an early prototype to a complete product for CE-IVD marking. We turned our meeting rooms into bustling labs, prototyped and tested over 100 design changes, and manufactured the first batch of 45 Q-POCs for QuantuMDx in little over 16 weeks. This was an extraordinary team effort and an emotional project from start to finish – one that our team is immensely proud of.”

web_cameo_zsl Satellite-enabled monitoring protecting endangered species

The Zoological Society of London’s Instant Detect 2.0 satellite-connected system monitors wildlife and detects poachers in the most remote and unconnected landscapes. The military-standard system is battery-powered and backpack-portable, so it can be deployed anywhere.

Head of Healthcare Insight & Strategy: “We created something with enormous conservation potential. Not only does it guard endangered species, but it can also monitor wildlife health, climate change, and the impact of ocean plastics.”

web_cameo_klarus Complete therapy management with adherence built-in

The Klarus drug delivery system improves the outcome of medical self-injection by eliminating the burden of everything a patient needs to think about, such as storing the medication at the correct temperature, dealing with sharps waste, and ordering repeat prescriptions.

Clare Beddoes, Head of Drug Delivery: “This shows how patient-centered design can change lives by considering every aspect of self-injection. Not only does it have the potential to improve medical outcomes, but it’s a more environmentally friendly solution, decreasing the waste normally linked with disposable autoinjectors.”

web_cameo_voke Taking a complex drug delivery device to market

Kind Consumer’s Voke is a smoking cessation product designed to imitate the experience of smoking regular combustible cigarettes while administering a pharmaceutical formulation. It’s a licensed medicine and a safer alternative to smoking.

Wade Tipton, Head of Manufacturing and Quality: “CDP quickly stepped into this project when the launch was at risk, overcoming complex engineering problems to gain regulation and take the device to volume production.”

Ben Illidge, Head of Tobacco Harm Reduction: “Our engineering expertise helped bring to market a product that went on to become the first nicotine inhaler to obtain a product license from the UK Medicines and Healthcare products Regulatory Agency (MHRA).”

web_cameo_biscuit Novel approach to energy management

Biscuit’s AI-powered smart building system monitors and controls building infrastructure to maximize comfort and minimize environmental impact. Its sensors report on essential parameters: energy consumption, temperature, humidity, air quality, pressure, VOCs, sound pressure, motion, and light levels.

We spend much of our lives in buildings, and they add up to nearly 40% of global CO2 emissions. Helping companies develop and deploy new products and technologies that help with the global need to decarbonize is always a ‘must-take-on’ challenge for us, and one where we can really help our clients succeed.

web_cameo_avon Smart packaging illuminating consumer behavior

Miniature sensing technology inside the dispenser of Avon’s ANEW Reversalist Infinite Effects Night Treatment Cream tested if users would rotate it every seven days to stop their skin from adjusting to the regime. The smart packaging trial revealed valuable insight about the intended product use experience when applied in a real-world context, and additional unexpected opportunities for innovation.

web_cameo_bloodhound Steering wheel to push the limits

Bloodhound’s goal was to break 1,000mph in a land speed attempt, inspiring a whole new generation of engineers along the way. Our role was to produce a titanium 3D-printed steering wheel to precisely fit the driver’s hands with custom controls for throttle, rocket boost, communications, and brakes.

Jez Clements, Business Development Leader: “In this project, everything got driven to its limits. It was a completely one-off experience: we got involved with schools, gave talks on 3D printing, and got to see the development of the car up close.”

Our clients trust us to identify, design, and build innovations that drive their success. Want to learn more? Explore our work.

A British NHS prescription paper bag isolated on a white background|

The chance to create the world’s first prescription electronic cigarette

November 26th 2021

David Lewis 

What should we make of the Medicines and Healthcare products Regulatory Agency (MHRA) updating its guidance for licensing e-cigarettes as medicinal products?

The updated ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’ (published on October 29, 2021) sets out with extra detail the steps needed to license e-cigarettes as medicinal products, meeting the quality, safety, and efficacy criteria demanded of other medicinal products.

Any medicinally licensed e-cigarette could potentially be prescribed to people who want to quit or cut down on smoking, meaning England would be the first country in the world to prescribe medicinally licensed e-cigarettes to help reduce smoking rates.

But hang on, it was already possible for e-cigarette manufacturers to submit their products for this regulatory approval process, so what’s going on?

Call to action

Dr June Raine, Chief Executive of the MHRA, said in a press release, “The MHRA will continue to support companies in the development of safe and effective e-cigarette products, to encourage the licensing of e-cigarette products as medicines in order to support patient-centred care and access.”

The MHRA’s announcement is a re-emphasis of its support of this product category’s role in smoking cessation and a call to action for the e-cigarette market. The update gives us cause to reflect that a commercially viable product hasn’t yet taken up this opportunity. Why?

The large companies in the tobacco space aren’t familiar with designing under the constraints of a medicinal product or going through regulatory approval for medicines. Smaller players are concerned about the funding required to go down the medicinal route.

There’s a perception that the medicinal pathway is complicated and costly. There’s no denying that the bar for regulatory approval as a medicinal product is set imposingly high as it seeks to ensure safety, quality, and efficacy for users.

A CE mark is required to sell a medicinal product in the European Union, indicating compliance with ISO 13485. This standard defines the quality management systems used to control the product’s design, manufacture, and post-market surveillance. Compared to consumer products, this places much greater emphasis on risk assessment and mitigation throughout the product lifecycle, along with robust documentation to demonstrate regulatory compliance.

If the MHRA’s announcement reflects its frustration at the lack of progress to meet the perceived demand for a prescription-based device, can manufacturers expect an easier route to a license as a result?

The requirements of ISO 13485 will still need to be met in full, but perhaps the MHRA will expedite engagement with the applicants, which could certainly help the process. The announcement is significant in reinforcing the prevailing UK public health policy that e-cigarettes can play a key role in smoking cessation, providing an ‘open door’ for a forward-thinking player to advance and elevate the product category.

Continuum of product stewardship

The reduced risk products market has been on a journey of increasing commitment to product stewardship, partly driven by increasing regulation, for example, Tobacco Products Directive (TPD) and Premarket Tobacco Product Application (PMTA), and the increasing sophistication of the major players.

CDP serves clients in consumer and regulated healthcare markets, so we’re familiar with the challenges of operating in these different regulatory frameworks. For those already invested in product stewardship, perhaps the leap to a medicinal product won’t be as challenging as they think.

While the MHRA’s announcement may not be ‘news’, it does perhaps signal a reappraisal of the opportunity to create the world’s first prescription e-cigarette.

To find out more, explore Reduced Risk Products.

References