Category: Analysis

Pilot manufacture for drug delivery devices||

Prepare the way: Pilot manufacture for drug delivery devices

January 18th 2022 5 min read
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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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 4 min read

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 3 min read

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
Our brains in space|||||

Our brains in space: The next giant leap

November 18th 2021 8 min read
Dr Karla Sanchez

Dr Karla Sanchez 

Head of CNS Technology

Fifty-two years after the first lunar landing, NASA’s program Artemis prepares to land on the moon.It’s a major step towards future space explorations and Mars missions – one that’ll see women in deep space for the first time.

The technology being developed includes the next generation of rockets, space suits, lunar landers, and gateways for travel into deep space. However, we’re yet to solve one of the most fundamental aspects of long-duration space travel: how to keep our brains alive.

The human brain is a remarkable feat of physiological engineering. It has sensing systems, self-regulating mechanisms, valves, dampening features, adaptable form, and even a set of complex networks that developers of the most advanced AI can only dream of. Yet, we still know surprisingly little about the interactions and boundaries of these systems and how they respond to space travel.

In this article, I explore how mathematical modeling is improving our understanding of the brain, successfully predicting the existence of anatomical features no one’s identified before – with learnings for Mars missions and the diagnosis and treatment of conditions such as Alzheimer’s disease.

What happens to our brains in space?

The human body is adapted to operate with Earth’s gravity. In space, microgravity (reduced gravity) causes fluids in the body to shift. This is most noticeable in the brain, where microgravity increases fluid volume, putting pressure on the nervous tissue.

Having a rigid cranium is good news for many reasons, but holding excess fluid isn’t one of them. Luckily, the increased intracranial pressure isn’t high enough to be immediately fatal. Still, it can introduce chronic knock-on effects with long-term implications.

Immediate brain-related effects experienced by astronauts due to increased intracranial pressure and fluid movement in the inner ear include headaches, dizziness, nausea, temporary blurred vision, and disturbed perception and spatial awareness. During space flight, the brain’s vestibular (orientation) system adapts to the new environment, reducing some of the effects. But others persist or appear in different forms, such as sleep disturbances.

After returning to Earth, astronauts who’ve taken long-duration flights have had one or more of these effects:

  • visual impairment – ophthalmic changes due to excess pressure in the optic nerve
  • brain ‘swelling’ – changes in ventricles (fluid-filled cavities) and grey and white matter (brain tissue composed of nerve fibers and nerve cells)
  • pituitary gland shrinkage – downsizing of the hormone-secreting gland that helps regulate body functions, including blood pressure and kidney function.

There’s a correlation between longer-duration space flight and increased severity of post-flight effects. These effects can be present long after the mission ends, and some can cause irreversible damage, for example, visual impairment.

Why does this happen?

The brain is protected for changes in gravity by a surrounding fluid called cerebrospinal fluid (CSF), a non-permeable layer called dura mater where CSF is contained, and one-way valves called arachnoid villi on the dura mater where CSF exits.

CSF is responsible for compensating changes in pressure, such as those created by the arteries or changes in posture. It’s also involved in cellular waste removal from the brain during sleep, ‘cushioning’ the brain to prevent trauma, and maintaining the best possible environment for the brain, for example, optimizing ion concentration levels to prevent cell death.

Dura mater is the ‘sac’ that contains the CSF. It plays a pivotal role in ensuring CSF exits the cranial and spinal spaces in a controlled way through the arachnoid villi.

 

web_mathematical-modelling-our-brains-in-space-diagram-1

As gravity lessens, important events take place which exert pressure in the brain:

  • CSF in the cranium is no longer free to flow towards the spinal spaces. It concentrates mainly in the cranial space, increasing intracranial pressure.
  • The spinal dura mater, usually relaxed and undisturbed, becomes compressed by other fluids and nearby organs as they shift upwards.
  • Upward movement of the brain and spinal cord stem obstructs one of the main CSF exit routes, the superior sagittal sinus (SSS, composed of arachnoid villi). This prevents relief from increasing CSF pressure in the brain.

Gravity influences low-pressure systems most, so blood flow in the veins is affected, causing ‘pooling’ where blood accumulates because of poor circulation. This matters because cerebral veins lack valves, relying on CSF to ‘push’ venous blood forwards. There’s also movement of organs in the upper body and extracellular fluid, putting extra pressure on the spinal cavity and the veins in the head and neck. Other effects play a role in what’s known as ‘fluid shift’. These include osmotic pressure changes (fluid motion between areas of different solute concentration levels), variation in heart rate and respiration, and changes to lymphatic dynamics (the movement of a fluid, known as lymph, from tissues and organs).

How do we model the brain?

Scientific efforts focus on three approaches:

  • microgravity testing – space mission and Zero-G flights with, for example, lower-body negative-pressure gravity suits, which aim to ‘pull’ fluid away from the upper body
  • on-Earth simulated testing – bed-tilt tests to measure physiological changes during bed rest
  • mathematical modeling.

Given the promise of mathematical modeling in predicting difficult-to-measure behaviors, such as epidemiological events like the ongoing COVID-19 pandemic, it’s worth exploring further.

Modeling the brain and spinal cord in microgravity

As part of my research, I’m investigating the relationship between pressure fluctuations in the brain and spinal cord and their impact under different gravitational conditions.

Using mathematical modeling, I outline the relationship of a single arterial root vessel and its blood flow with the next generation of vessels. This root vessel branches into two vessels, and each of those to another two, and so on. Each generation carries information of the preceding vessel from which the rest of the parameters can be derived. The arterial branching continues until reaching the capillaries (tiny vessels where cellular nutrients and waste are exchanged), before converging again to complete the venous tree.

After the blood vessels are described, I add the CSF spaces in the cranium and spine. These spaces allow CSF to interact with the blood vessels, which I can study for behavior under different physiological and gravitational conditions

web_mathematical-modelling-our-brains-in-space-diagram-2-1

The model accounts for several key features of cerebral circulation, including autoregulation (the ability of blood vessels to expand and contract to metabolic demands and pressure changes), CSF exit routes (arachnoid villi), and gravitational components. As I add gravity to the model, I can test different postures, for example, lying flat on the back (supine).

By mathematical modeling, I successfully predicted the existence of anatomical features that had never before been identified – arachnoid villi in the spinal dura mater. These additional exit routes appear to be a crucial element to relieve CSF pressure under different gravitational conditions. The model showed that the cranial and spinal exit routes work together to keep CSF pressure fluctuations stable, ensuring undisturbed cerebral blood flow.

web_mathematical-modelling-our-brains-in-space-diagram-3

On Earth, standing allows CSF to shift downwards, lowering pressure inside the cranium, which causes the cranial exit route to close. The spinal exit route can work as the main exit route, but it also has to deal with increased pressure outside the spinal cavity, such as the interstitial fluid (fluid between cells) of surrounding organs. If the external pressure is greater, the spinal exit route closes, and the pressure inside the cranium increases until the cranial exit route opens again. A supine position allows exit through either the cranial or spinal routes.

In microgravity, the upward shift of fluid causes CSF pressure in the cranium to increase, whether standing or supine. This can be modeled using a bed-tilt test where the body is positioned at a negative angle. The spinal exit route closure intensifies CSF intracranial pressure because of increased pressure from other fluids and organs on the spinal cavity. The combined effect forces the cranial exit route to open to stabilize pressure fluctuations. However, recent research suggests the upward movement of the nervous tissue (brain and spinal cord) may block the main cranial exit route (the SSS). Blocking the SSS in the model leads to sustained intracranial pressure, resulting in irreversible consequences, which we see in space missions.

I also found that cerebral autoregulation plays a key role in overcoming gravitational changes in space and on Earth. Where autoregulation is absent or abnormal, constant blood isn’t delivered adequately to the brain, compromising oxygen to the brain. This can cause a range of conditions, including hypoxic events, where lack of oxygen leads to impaired or permanent nervous tissue damage.

All of this means that the brain, on its own, isn’t sufficiently adaptable to prevent tissue damage in microgravity environments. Sustained high intracranial pressure needs a path of least resistance to relieve the brain tissue of excess fluid. Extending space missions without fully understanding this behavior poses a significant risk.

The next stage of my modeling involves testing acute postural changes in combination with chronic physiological conditions, such as aging, to further analyze the effects I observed.

Why does this matter – and what can we do about it?

Beyond space exploration, understanding fluid movements in the brain and spinal cord is critically important to better diagnose and treat conditions such as Alzheimer’s disease, hydrocephalus (a life-changing and often fatal condition due to excess of CSF volume), spinal syringomyelia (a fluid-filled cyst disorder in the spine), stroke, and Multiple Sclerosis. Until we understand how these mechanisms can cause permanent damage, it’s vital to keep analyzing abnormal CSF-cerebrovascular behaviors under any gravitational conditions.

On whether we can go to Mars, it’s possible, but landing on Mars (roughly seven months of space travel each way) would increase the risk of developing long-term health conditions, and as the mission extends, so does the likelihood and seriousness of those risks.

However, by pursuing an understanding of those risks, we’ll understand our physiology better. What adaptations could be expected of the human brain under any gravitational condition? What can we learn from other mammals overcoming significant gravitational challenges, such as bats and giraffes? Can an understanding of human brain adaptations help us treat neurological or neurodegenerative conditions?

As we aim for ever more challenging space missions, mathematical modeling can help us characterize the boundaries of human physiology – and take the next giant leap in understanding our brains.

References
  • Kramer, L.A., Hasan, K.M., Stenger, M.B., Sargsyan, A., Laurie, S.S., Otto, C., Ploutz-Snyder, R.J., Marshall-Goebel, K., Riascos, R.F. and Macias, B.R., 2020. Intracranial effects of microgravity: a prospective longitudinal MRI study. Radiology, 295(3), pp.640-648.
  • Li, K., Guo, X., Jin, Z., Ouyang, X., Zeng, Y., Feng, J., Wang, Y., Yao, L. and Ma, L., 2015. Effect of simulated microgravity on human brain gray matter and white matter–evidence from MRI. PloS one, 10(8), p.e0135835.
  • Petersen, L.G., Lawley, J.S., Lilja‐Cyron, A., Petersen, J.C., Howden, E.J., Sarma, S., Cornwell 3rd, W.K., Zhang, R., Whitworth, L.A., Williams, M.A. and Juhler, M., 2019. Lower body negative pressure to safely reduce intracranial pressure. The Journal of physiology, 597(1), pp.237-248.
  • Roberts, D.R., Albrecht, M.H., Collins, H.R., Asemani, D., Chatterjee, A.R., Spampinato, M.V., Zhu, X., Chimowitz, M.I. and Antonucci, M.U., 2017. Effects of spaceflight on astronaut brain structure as indicated on MRI. New England Journal of Medicine, 377(18), pp.1746-1753.
  • Roberts, D.R., Asemani, D., Nietert, P.J., Eckert, M.A., Inglesby, D.C., Bloomberg, J.J., George, M.S. and Brown, T.R., 2019. Prolonged microgravity affects human brain structure and function. American Journal of Neuroradiology, 40(11), pp.1878-1885.
  • Sanchez-Cazares, K E 2018, ‘Mathematical Model of the Cerebral Circulation and Distribution of Cerebrospinal Fluid’, PhD thesis, Imperial College, London.
Noga Sella & Dan Mayhew discuss why people with dyslexia can make great innovators

Dyslexia Week: “We make great innovators”

October 6th 2021 5 min read

Dan Mayhew 

Noga Sella 

Dyslexia Week takes place from October 4 to 10 this year and is centered on the theme of invisibility.

Dyslexia’s common, with one in ten people believed to have it – but because dyslexia itself isn’t visible, it’s not immediately obvious who does.

To raise awareness and bust the many myths about this learning difference, the British Dyslexia Association has asked people to share their experiences.

Senior Lab Technician Dan Mayhew and Consultant Physicist Noga Sella discuss the challenges of working from home with dyslexia, and why people with dyslexia can make great innovators.

How does dyslexia impact you?

Dan: I mainly have issues around written communication, so report writing can take longer, and my written work needs additional reviews. The lack of face-to-face interactions in the work-from-home age means written language has become more critical, making exchanges harder.

Noga: I lost my ways of communicating when we all started having to work from home because of the pandemic. Being able to speak to someone in person, and see their non-verbal communication, like facial expressions and gestures, are so helpful to me. Suddenly, everyone switched to using emails and messaging. Video calls are better than written messages, but then you’re up against unwritten protocols. For example, are you allowed to just call someone out of the blue, or do you have to set it up beforehand? It’s been hard finding a way to work with people all over again. I think the more you use video calling like you’re going over to someone’s desk, the better.

What encouraged you to study science?

Noga: When I was nine years old, I fell in love with space after visiting The Royal Observatory in Edinburgh. Yes, dyslexia makes learning harder, but reading and writing aren’t the only ways to learn. Immersive activities are a great way to get children with dyslexia into science, or any topic.

Dan: Both of my parents are involved in STEM subjects, but my main inspiration was visiting the Science Museum in London as a child and finding out Lego then was made from oil. The practical aspects of chemistry and a more ‘applied’ course at university really encouraged me to follow my science passion.

What do you enjoy about working in innovation?

Noga: I enjoy working in science within industry, as opposed to academia. In academia, there’s pressure to write fast and well. Industry lets me do my innovation without having to fight against my dyslexia as much. For example, I can put my graphs in PowerPoint and explain them verbally.

Dan: I love the ability to chuck out traditional ideas and come out with new products and services that can improve the daily lives of billions of people worldwide.

Why does innovation need (more) people with dyslexia?

Dan: People with dyslexia tend to be highly creative, think outside the box, have good pattern recognition, be picture thinkers, and see the bigger picture. All these traits are great for innovation.

Noga: Innovation needs diversity of all kinds. Diverse teams let you see things in different ways and catch things you might miss if everyone were to see things in the same way.

How can employers support people with dyslexia in the workplace?

Noga: Don’t take tools like spell check or searchability for granted. Twenty years ago, I wouldn’t have been able to search for something using a search term that had a spelling mistake in, so I couldn’t have been where I am now. Organizations can help by making sure people have access to the most up-to-date tools.

Dan: Things always start with education and awareness. We need to develop environments that adjust to the needs and skills of individuals.

Can you recommend any tips or tools you find helpful?

Dan: The writing assistant Grammarly is a bit of software that I find incredibly powerful. Also, being open and honest about your disability can be a real asset. I’ve found that being genuine to a potential employer about your disability builds trust.

Noga: My piece of advice would be that asking is better than presuming. Don’t be shy to talk to me about my dyslexia. It took me a while to feel comfortable discussing it, but now I’m happy to, especially if it helps a child with dyslexia realize that if one path doesn’t look possible, there are always others.

About dyslexia

The British Dyslexia Association defines dyslexia as a neurological and learning difference that impacts how people process information. It primarily affects reading and writing but can also have an influence on someone’s ability to absorb information and their organizational skills.

Dyslexia and science: Busting the myths

Dyslexia occurs across the range of intellectual abilities and many dyslexics show strength in reasoning and visual creativity. Biophysicist Jacques Dubochet, who picked up the Nobel Prize in Chemistry in 2017, speaks openly about how dyslexia impacted his early education, as does molecular biologist Carol Greider, who won the Nobel Prize in Medicine in 2009. In an interview for The Yale Centre for Dyslexia & Creativity, she said, “Perhaps my ability to pull more information out of context and put together difficult ideas may have been affected by what I learned to do from dyslexia.”

What can everyone do to help?

As Dan and Noga say, change starts with awareness. The British Dyslexia Association’s website is a good source of information and offers advice on how to make life easier for employees and colleagues with dyslexia. Tips include:

  • Record meetings (rather than emailing a summary).
  • Give additional time to digest information, for example by sending materials in advance of a meeting.
  • Use different formats to convey information, such as diagrams and flowcharts.
  • Provide hard-copy resources on colored paper (find out which color helps the person read best).
  • Give verbal as well as written instructions.
References
The lockdown beauty trends here to stay

The lockdown beauty trends here to stay

August 24th 2021 4 min read

Jessica Platt 

Lockdowns, video calls and face coverings dramatically changed our relationship with beauty. Meanwhile, COVID-19 restrictions shook up how we bought cosmetics and skincare.

Jessica Platt, Associate Insights Researcher, examines how beauty habits changed and which are set to last.

How lockdown changed beauty

Months of virtual meetings, dinner parties and quizzes made us ask whether our existing cosmetics could keep us looking camera-ready all day.

But while online with FaceTime, Teams and Zoom, in the physical world we stepped back, observing the social distancing rules, and hiding behind face coverings. It’s no surprise that these two extreme worlds ignited new consumer behavior:

We became beauty DIY experts

Hair and nail salons closed, yet hair and nails stubbornly continued to grow. While some of us embraced hair bands and visible roots, others took matters into their own hands.

Amazon reportedly achieved a 172% year-on-year increase in sales of hair coloring products for the four weeks ending April 11, 2020. Nail care sales increased by 218% in the same period.

Post-lockdown wait times for a cut and color suggest most consumers are eager to get back to the salon. However, some will continue to practice their newly honed (and money-saving) skills at home, presenting an opportunity for brands to expand into this category.

We tried independent brands

As online marketing replaced shelf presence, small indie brands found a (more) level playing field to compete for customer attention. It was no longer essential to have a large in-store presence to catch a browser’s eye. Instead, smaller companies could focus on sharing their message through social media and influencer marketing.

US-based medicated skincare brand Topicals is one such brand. Its Gen Z-focused packaging, website and social media presence drove momentum in a year when many small companies floundered. In August 2020, it announced a $2.6 million investment from investors, including Netflix CMO Bozoma Saint John.

We embraced self-care

In a time of uncertainty, people turned to self-care. This further expanded the definition of beauty as a category of products that nourish and support rather than mask perceived imperfections.

Despite specializing in products that deal with flaky and dry skin, Topicals firmly positions itself in the self-care (rather than medicinal) camp, with the strapline ‘Funner flare-ups’.

Pause Well-Aging, a US brand targeting menopausal skincare, is another example. Its website states, “Pause is more than just skincare. It’s a movement affirming that beauty gets better with age.” Instead of promoting the anti-aging properties traditionally touted on skincare packaging, it provides women with what they need to age well.

Also, a new need for hand cream arose as people sought to soothe dry hands caused by antibacterial sanitizers.

We braved online cosmetics shopping

Before the pandemic, in-store shopping accounted for around 85% of make-up purchases. Beauty shoppers, who never purchased products without a trial and in-person advice (including me), were forced to dabble in online shopping. We began the painstaking process of working out which foundation shade, lipstick color or eyeshadow palette would suit us without the help of a tester. Though beauty brands have been exploring augmented reality (AR) and artificial intelligence (AI) for some time, lockdown accelerated its adoption. The technologies enabled customers to try on products from the comfort and safety of home.

Augmented Reality

L’Oréal saw usage of its virtual make-up tools rise fivefold during 2020’s lockdowns. Its ‘Virtual Try On’ tool uses AR to enable its website visitors to try on its products, either live using a phone camera or by uploading a photo. A feature that might once have appeared gimmicky, this option has become an essential offer for customers to experiment with new looks.

Premium brands, including Bobbi Brown and Chanel, have similar web-based AR technology that provides insights into how make-up might look when worn.

These brands demonstrated that this feature appeals to a far wider audience than Gen Z and Millennials already familiar with Snapchat filters.

Artificial Intelligence

US beauty brand IL Makiage, which launched in the UK in May 2020, solves the color match problem with a 90-second quiz. It asks consumers to look at images of people with different skin shades and identify which one most closely matches their skin tone. Images are repeated and refined until the customer is deciding between subtle differences in skin tone. It also collects additional information, such as skin type (oily, dry, combination) and vein color.

Results are analyzed using machine learning technology from NeoWize Inc, the Israeli AI company that IL Makiage acquired in 2019. Potential customers are presented with the foundation that’s best suited for them, along with the accompanying concealer.

Following the quiz, all the products displayed on the home screen are shown in the color most suited to your skin tone, making it easy to fill up your shopping cart in a few clicks.

Innovating for success – what’s next for beauty brands?

The past 18 months have taught us that the world can change in a moment. They’ve also taught us the power of innovation and agility. The most nimble brands can gain first-mover advantage. We’ve seen online presence, e-commerce and smart tools reaching consumers in a different way to traditional retail experiences, which is the new normal for many. Having seen what can be achieved in exceptional circumstances, beauty brands should feel confident about embracing future change. For an industry specializing in makeovers, this shouldn’t pose a problem.

References
FemTech||

Realizing the potential of FemTech – your questions answered

August 10th 2021 4 min read

Jessica Platt 

Martha Hodgson 

In our webinar, Realizing the potential of FemTech, CDP’s Martha Hodgson and Jessica Platt gave their take on the principles of FemTech, and how forerunners are implementing them to succeed.

Here, Martha, Senior Insight & Strategy Consultant, and Jessica, Associate Insights Researcher, share more ideas, answering questions sparked by their presentation.

How important are digital security and data privacy in FemTech innovation?

Jessica: Digital security and data privacy are hugely important – so many FemTech products are linked to the internet and share information. They should be part of any design process from the start. Mishandling them can be costly. For example, a leading sex toy maker ran into trouble when their remote-controlled Bluetooth vibrator was found to be vulnerable to hackers who could take control of the product. They also shared data about the temperature of the vibrator with their parent company. As a result, they were ordered to make huge pay-outs to customers.

The Internet of Things poses challenges for internet products – how do you recommend we deal with them?

Jessica: Regulation and privacy are exciting areas because brands can become pioneers in these spaces. There’s a vast knowledge gap around women’s health, and the data FemTech collects should be used for research, but it must be done carefully. Transparency is key. Users should be empowered and told how their data will be used, stored, and shared – and not in pages of terms and conditions that most users accept without reading.

Your presentation highlighted that people have functional, social, and emotional needs – which are most important for FemTech to meet?

Martha: When you’re thinking about the importance of a need, consider the context. Also, you should know how well existing products are meeting that need. A highly important need might already be being met with a high level of satisfaction. Some exciting innovations have come from focusing on highly important needs that are being met with low levels of satisfaction – or needs of low importance that are being met with (overly) high levels of satisfaction. For example, budget airlines disrupted the travel industry by understanding that in-flight meals are of low importance to their customers on short-haul flights, so they strip them out to offer a low-price service. In FemTech, experienceis as important as the tangible product, or even more so. Therefore, think about current levels of satisfaction and explore needs being over- and under-served by existing solutions.

How can FemTech leverage existing technology?

Martha: A lot of amazing innovations are the result of transferable learnings. The answer isn’t always new technology. Sometimes, it comes from looking at a problem differently and seeing that you could reapply an existing solution to deliver a different value in a different context. So, take a step back from the technology. Understand that it’s a point-in-time solution to a problem. Then, take a solution-agnostic approach to the job you’re trying to do.

How can we deliver excitement when repurposing existing technology?

Martha: Experience is shaped by all five of our senses, so think about the sensorial experience when translating consumer needs into solutions. Also, be aware of pre-existing mental models – shaped by culture, environment, influencers and so on – and how far consumers are willing to stretch these. Take sanitary products. There are loads of new, exciting materials that are thinner, more flexible, and more absorbent than those used today. However, mental models around security and comfort might mean users won’t willingly go down these routes, even though they might provide a better solution. Excitement doesn’t just come from technology enablers but understanding the outcome as a series of sensory attributes and translating these into experiences.

There are many tech innovations around infertility, and it seems other areas are being ignored. Is this true? If so, why?

Jessica: FemTech Focus define FemTech as “Technology, services, and products that improve women, females, and girls’ health and wellness. This includes addressing challenges that solely, disproportionately, or differently affect them.” This is my starting point when thinking about FemTech, and it tells you how inclusive FemTech is – it’s not limited to fertility and menstruation, though a lot of attention has been focussed on these. There are opportunities around conditions that affect women differently. For example, heart attacks have different symptoms in women. This means women’s heart attacks are sometimes missed or treated later, resulting in worse outcomes. FemTech solutions that address heart health might help mitigate these adverse outcomes.

Why does only a small percentage of investment in digital health go to FemTech?

Jessica: FemTech is relatively new – there have only been a handful of billion-dollar exits. So, there’s still a long way to go to educate investors that FemTech is lucrative, and products and services designed to meet women’s needs aren’t niche. However, we’re on the cusp of a transformation in the way FemTech is funded.

Martha: Changing investors’ perceptions of FemTech needs us to think about how we communicate the opportunity. Industries must be able to see long-term commercial profit. The needs that FemTech addresses are stable and shared by 51% of the population – this helps explain the long-term gains that could be made through FemTech investment.

Is FemTech only about healthcare and sexual health?

Martha: Absolutely not. Take the sports industry. Women’s sport has been on a growth trajectory, and there are many examples of women-focused services and products thriving based on the ergonomics, size, and shape of women’s bodies. Women’s football-boot maker IDA Sports’ tagline is spot on: “You are not an afterthought”. Traditional category borders are blurring, which is opening exciting innovation opportunities, like FemTech. Seeing FemTech as an innovation philosophy lets you focus on the needs you can meet – rather than the sector label.

To continue the conversation, get in touch: womenshealth@cambridge-design.com

REFERENCES
Key to success in FemTech

The key to FemTech success? Forget about the tech

July 9th 2021 5 min read

Jessica Platt 

Martha Hodgson 

Ben Strutt 

Nicki Sutton 

From contraception to catheters, at CDP we’ve successfully pioneered women’s health innovation for over a decade.

Now that increasing numbers of our clients are entering the $19bn¹ FemTech market, we’re in a strong position to share some powerful lessons from our established approach to inclusive design.

Refocus your lens

Fertility entrepreneur, Ida Tin, coined the term ‘FemTech’ in 2016 in a frustrated bid to explain her work to male investors. The resulting discussion revealed the breath-taking extent to which the marketplace is short-changing women.

Despite decades of progress in gender equality, product development (until very recently) has operated through a male lens. It wasn’t, for example, until 1993 that the US National Institute of Health made it obligatory to include women in government-funded health research. This lack of data has resulted in a significant knowledge gap in women’s health, meaning that female patients have missed out on critical advances in medical technology.

And it wasn’t just men’s bodies that were the default; it was also the male viewpoint. Take the launch of Apple Health in 2014. The much-anticipated app promised to monitor “all of your metrics that you’re most interested in”. Yet it omitted a menstrual cycle tracking function². This is arguably something of great interest to 50% of its users. It wasn’t until a year and a lot of media pressure later that developers added it in.

Fight assumption with insight

The Apple Health oversight could have been avoided by one simple step – asking women what they thought.

At CDP, we believe the key to design inclusivity lies in a strong front-end innovation (FEI) capability. FEI is the identification and activation of opportunities, and the translation of insights into product and service solutions. This is the function that feeds insight into strategy, design, and specification. Importantly, it can guide decisions made later in the product development cycle.

To put a woman’s needs at the center of a brief, teams must take research beyond quantitative surveys. A mere tick box won’t capture the emotional and social circumstances in which a product is used.

For example, could the tone and volume of the beep that a basal fertility thermometer emits first thing in the morning (when it must be used) be so grating that it results in lower levels of compliance?

We recommend in-depth qualitative interviews to understand people as part of a contextual system, rather than groups of personas. Categorizing a user as a “32-year-old soccer mom from California” fails to capture the nuances of when, where, and how a product is used. As an aside, it also turns out that women take a dim view of being pigeonholed, as a former boss of UK retail chain Marks & Spencer discovered when (to female shoppers’ outrage) he described its typical customer as “Mrs M&S”³.

Where possible, we engage in immersive, ethnographic methodologies – seeing people in their cultural setting, often at home – to uncover user needs. This extends to international travel to understand the cultural contexts that inform decision making in different markets.

Futureproof for regulation

As a young sector, it’s no surprise that there are grey areas when it comes to the regulation of FemTech.

This is slowly changing as FemTech creeps into the realm of (regulated) medical devices. In 2018, Natural Cycles was the first digital birth control app to receive clearance from the FDA; fertility pioneer Clue was the second in March 2021.

Somewhat shockingly, regulation for sex toys doesn’t extend beyond the electrical compliance required for a Bluetooth speaker, escaping more stringent scrutiny through a “novelty use” labelling loophole.

Again, this is set to change, with the ISO making progress towards new standards⁴. Until this is finalized, the regulation of medical devices provides a good clue as to what action is needed to futureproof FemTech.

On a recent sex toy project, CDP ensured that all materials were biocompatible, although no regulations required it. Not only was this the right thing in terms of reducing risk for the user, but also protected our client against potential changes in regulation.

Forget about the tech

It may sound counterintuitive, but at CDP we feel the best way to succeed in FemTech is to forget the tech…at first, anyway. This is where we often see both big corporates and startups trip up.

We recommend a “solution agnostic” approach to design – that’s to say starting with a user need and looking for the best way to fulfil it. This might involve tech; it might not. Even then, the “tech” might not necessarily be digital, which is often what comes to mind when we think of FemTech. Instead, it might focus on the device itself, the manufacturing process, choice of material, or service. Whatever the solution, this method establishes early on if there is a market and business case for a product.

The alternative is “tech for tech’s sake”: just because it’s possible to measure the veracity of the female orgasm doesn’t mean that women want this data, as a startup that claimed to “spot women’s orgasms” found out when it was widely lampooned in the media⁵.

On this, it’s worth noting that we don’t see FemTech as limited to the fields of sex or fertility. The same contextual and experiential empathy that goes into designing for these areas must also be applied to other issues that disproportionally impact women. For example, we recently worked on a minimally invasive breast cancer biopsy device. Our goal was not only to design an accurate medical tool but to consider the experiential needs of the female patient – something that is often ignored.

Consider user acceptance

You’ve established a user need and a great tech-driven solution, but will female consumers feel comfortable using it?

It’s important to consider whether women are culturally ready to adopt a tech-led solution, particularly if it involves intimate wearables or sensitive data.

For example, current technology is capable of analyzing menstrual flow, but are women willing to accept intimate electronics? Let’s remember that in some parts of the world, tampon usage is still taboo.

Baking the female experience into the design process will answer these questions early on.

Ditch the defaults

We’ve discussed reframing design to include females; however, the same principles apply to other areas of inclusivity, such as race, sexuality, disability, gender identity, and economics.

In FemTech, this means considering, for example, the male experience – a heterosexual couple trying for a baby may want the capability for the male to log into a fertility app as part of the shared experience.

Likewise, it means considering the affordability of a design for various socio-economic groups. An expensive pelvic floor trainer may be financially out of reach for many women, so is it possible to reduce costs with smarter manufacturing or a new business model?

Good design considers all perspectives. It’s time to ditch the defaults.

To continue the conversation, get in touch: womenshealth@cambridge-design.com

1 – The Global Femtech Market was valued at $19bn in 2019 and is expected to reach $60bn Billion by 2027, according to Emergen Research.
https://www.emergenresearch.com/industry-report/femtech-market
2 – https://techcrunch.com/2015/06/09/apple-stops-ignoring-womens-health-with-ios-9-healthkit-update-now-featuring-period-tracking/
3 – https://www.cityam.com/mrs-ms-steve-rowes-first-blunder/
4 – https://www.iso.org/standard/59752.html
5 – https://www.bbc.co.uk/news/technology-53024123

DC to DC converter design

DC to DC converter design – Don’t blow your fuse (and other lessons)

June 30th 2021 6 min read

Finlay Knops-Mckim 

Consultant Electronics Engineer

With a vast range of off-the-shelf and feature-rich control ICs available, the selection and design of DC to DC converters is a superficially simple process.

But even with these highly integrated parts and design resources there are still many common pitfalls that can lead to Electromagnetic Compatibility (EMC) or thermal nightmares, blowing budgets, timescales, and the occasional fuse in the process.

I’ll share a few of the most common “gotchas” that electronics engineers will contend with early in their careers. We’ll dodge the complex calculations here, but there are excellent resources such as “The Art of Electronics” that can provide a deeper mathematical explanation of the issues at hand.

Medical device or arc furnace? Context is key

You wouldn’t use a trailer truck to commute to work, nor would you use the family car to ship potatoes to a supermarket. Both are vehicles but, clearly, they operate in different contexts so have different strengths and weaknesses.

The same logic applies to switch-mode converters and controllers. A quick glance at the cover page of any switcher datasheet will often reveal potential use cases. This is not just marketing: if a switcher is intended for industrial machinery or large server farms, it is quite likely that its EMC performance faces different limits to those marketed at consumer or healthcare devices. For example, while higher noise limits in industrial settings liberate chip designers to focus more on power efficiency by maximizing switching speed and slew rate, this can also increase emissions.

Excessive switcher noise can lead to poor performance of analogue circuitry, and in severe cases can interfere with the function of nearby devices. So, while those efficiency figures might be tempting, using the switcher in a compact medical device could lead to months of work to achieve compliance in EMC test chambers.

Lesson: Use parts in the context for which they are designed. Parts targeted at industrial applications may lead to issues if used in consumer or medical devices.

The heat must go somewhere

So, you’ve found a very neat five-amp switcher with a 3x3mm footprint that is 90% efficient? Sounds perfect for your space-constrained, high-power design. Except you’ve just plugged it in, and it cuts out after ten seconds at load. This is less than ideal. The problem is that, even at 90% efficiency, the switching losses at 5A are enough to make a 3×3 chip quite toasty – so much so that the thermal cut-out is operating. You might have been fine if you had a large copper flood to take the heat away, but this is a space constrained design so of course you don’t.

Lesson: Always consider the thermal design of a high-power system. Even if a small switcher is electrically capable of high currents, it may require substantial heatsinking that wipes out any size or efficiency benefits.

Evaluation modules are there to help

Datasheets are an important resource for correctly integrating a switcher design into a larger electronic system, but they are also a company’s marketing collateral, and can mask certain “gotchas” in product performance.

They do not guarantee that your design or use-case will play nicely with the chosen parts. Evaluation modules (EVMs) provide a less theoretical way of confirming that a part is fit for purpose, and further provide a “best case” performance benchmark given exactly the right implementation.

Taking an EVM along when performing pre-compliance EMC tests is a quick way to confirm that the chosen part is not going to be an emissions nightmare in the final design, and similarly if the EVM overheats, your design probably will as well.

Lesson: Buy in an EVM for your chosen switcher part and perform a set of tests that represent the final use case. If you have problems at this stage, it’s fair to say you should pick a different part or modify your design to mitigate the issues.

Saturation current is not standardized

If your switcher’s primary inductor becomes saturated, the efficiency of the system will rapidly plummet, and it will likely lose regulation or overheat. Most switcher manufacturers helpfully include the necessary inductor current calculations to enable you to make the correct part choice; however, the inductor datasheets can themselves be misleading.

Saturation current is universally defined as the current at which inductance decreases by a certain percentage, but different manufacturers use different percentages. Wurth often take a 20% inductance drop to mean saturation, but other manufacturers may use a 50% or even 80% drop.

Careful consideration must be given to peak inductor current, not just expected output current. High efficiency switcher designs typically look to minimize switching time and thereby losses, but this inherently drives up peak inductor current (and also EMC emissions!)

Lesson: When specifying an inductor, check what inductance drop the saturation current parameter refers to. If 80%, then you need to design more current headroom into your system to maintain correct regulation. Pay attention to peak currents!

Switchers aren’t always best

Switchers are more efficient than linear regulators, so does that mean they should be used wherever possible? Not quite.

Look at the efficiency curves on the datasheet. See that bit where the efficiency curve falls off a cliff at low loads? If your mobile widget, for example, needs a 3V0 rail derived from a 3V7 LiPo, and spends most of its time in a micro-power sleep mode, your switcher will likely burn more power than an LDO in those periods when the load is not drawing much current. If you then add in inductor switching losses and quiescent current, you could end up throwing a lot more power away through trying to use an “efficient” switcher than by using an “inefficient” linear regulator.

Lesson: When designing power supplies for very low power devices, consider if a switcher is honestly the best option. Even low power optimized designs (such as Analog Devices Micropower ICs) may still yield worse results overall than a carefully specified LDO in a low power application, so a system level power budget analysis is a must.

Keep it (the high current path) simple

Switchers create circulating paths of rapidly switching high currents as part of normal operation. If you don’t carefully implement these paths, then the system is likely to radiate or couple excess noise to other parts of the system, causing yet more EMC issues.

If possible, design the converter on a single layer to avoid layer transitions by vias, and with short, low impedance paths between the diode, inductor, and capacitors on the output side, with similarly low impedance paths between the input capacitors and switch FET. The ground path between all these components should also be robust and low impedance. If using a four-layer board, placing a ground plane under the switcher can suppress coupling to other parts of the circuit, but make sure to follow layout guidelines for the particular part, as coupling between traces and ground can be relevant to operation and performance!

Lesson: Keep the entire switcher design compact, and keep the ground return path short and on the same layer if possible. Ground planes and careful splits can be useful for reducing coupling of the circulating currents into other parts of the system.

This is far from an exhaustive list of all possible design considerations for DC to DC converters, but hopefully it gives you some useful guidelines on what to look out for when embarking on a new power supply design, particularly for those at the start of their engineering career.

Here at CDP we employ a talented range of engineers across all disciplines who solve problems like these on a daily basis. If you are interested in joining our team, check out our vacancies in Cambridge, UK or Raleigh, N.C. USA.

If on the other hand you are experiencing these sorts of issues at your company, please do reach out to CDP to see how our business can help yours.

Ten ways to reduce E-waste in product development

Ten ways to reduce E-waste in product development

June 7th 2021 5 min read

We all have that drawer – the graveyard for discarded electronics. What’s in yours? A cracked phone, an obsolete activity tracker, maybe an original iPod? You hang onto them, because it seems wrong to throw them away.
You’re right. Globally, 53.6 million metric tons of electronic waste, or E-waste, were generated in 2019 but only around one-fifth of this was recycled. Roughly half this pile comes from personal devices, which can be hard to round up from consumers.

Any product that includes some form of circuitry or electrical components is classed as electronic equipment. Once this product has been discarded without the intent to reuse, it falls under the category of E-waste.

The problem is not just environmental; in some cases it’s pragmatic. Many minerals in the products we throw away are difficult to obtain. The long-term consequences are serious. For example, a shortage of lithium or cobalt, both critical materials in electric vehicle batteries, could slam the brakes on our migration to greener transport.

As with most environmental issues, the solution to E-waste lies with government, industry, and the consumer. This article focuses on how product developers can play their part in helping to reduce e-waste.

Ten ways to reduce E-waste

1. Think modular

If devices become more modular, it becomes easier for the consumer or an engineer to perform repairs. It also makes it easier to break up devices at the end of their lives, a growing incentive if more industries become responsible for waste disposal.

Small product changes can make a significant impact, for example identifying which components tend to break first. Is there a way to make the component easily removable and replaceable? And if not, could it be designed to be more resilient?

2. Anticipate legislation

E-waste is a growing area of concern for governments, leading to a marked increase in the regulatory restrictions on disposal. This is noticeable in the electric car industry, where the EU and China have made manufacturers responsible for collecting and disposing of car batteries.

Both regulation and taxation are likely to increase. There is an opportunity for product developers to anticipate these factors when designing new products.

3. Respect the Right to Repair

A generation ago, mending your own possessions was a standard solution. Commonplace electrical repairs involved a loose wire or blown fuse. Today, electronic goods are much harder to fix, not helped by moving from screws to adhesive in assembly. You can no longer replace the battery in your phone and must go to a specialized repair shop for a damaged screen – think back to that drawer of retired electronics.

Product reviews now include ratings for ease of repair. France has introduced a law requiring an index of repairability which has encouraged manufacturers to offer online fixing guides. Other EU countries are rolling this out, including a requirement for manufacturers to ensure that spares are available for up to a decade. Sweden is also reducing the VAT rate on repairs and spare parts.

The ‘Right to Repair’ is a growing consumer rights issue. Designers can reduce E-waste by making it easy to mend common faults.

4. Use recyclable materials

As materials and processing research have progressed, the range of options for easily recyclable electronics has increased. These vary from paper RFID tags and biodegradable PCB substrates to chemical methods for breaking down coatings which have traditionally complicated the recycling process. These are all options to keep in mind when starting a design.

5. Design for E-waste recycling early on

The E-waste recycling process has the potential to be very expensive, so designing with this in mind early on is vital. There is also the challenge of encouraging consumers to return their devices in the first place. It’s much more challenging to recycle post-consumer waste than materials still under the manufacturers’ control.

Material resources for electronic devices are becoming increasingly difficult to source and therefore more expensive. This highlights the benefits of setting up a ‘reverse supply chain’ in which waste products are returned to their suppliers for recycling, allowing manufacturers to extract reusable materials.

The electronics in many home appliances often only make up a tiny proportion of the product. If a more modular design is selected, it becomes far easier to separate the E-waste from the product for recycling.

6. Top the ratings

Concerns over “fast fashion” in the retail industry could easily translate into customers rejecting low-cost, short-lifetime electronic products.

A public rating system for electronics that includes ease of recycling and repair as two separate metrics would prompt brands to question their design choices. Are there other less toxic or less scarce materials that could be used instead? Are there different versions of the product with lower E-waste potential?

Eupedia, an online guide to the EU, recently combined four indices covering a range of sustainability factors to rank brands, including ratings for recycling and repair.

7. Question whether electronics are necessary

Recently, electronics with ever-increasing features have been incorporated into previously ‘dumb’ products. In many cases, this enables functionality that was previously unachievable. However, sometimes we can obtain the same advantages without electronics, leading to a lower-cost and more straightforward solution.

Designers should carefully consider the range of solutions available and weigh up the relative user benefits, costs, and environmental impacts to find the most appropriate one for their product. For a simple maximum temperature monitor, do electronics provide a unique additional benefit, or can a different type of innovation such as a chemically triggered color change give the same information to the user?

8. Partner with smart devices

The obvious way to reduce E-waste is to produce less in the first place, but is this realistic? One route is to design electronics-free devices made smart through combination with a phone app. This often allows for the same functionality with no extra electronic components. For example, in diagnostic healthcare, agriculture and food safety testing, a phone camera can read and analyze colored test strips.

9. Consider a more sustainable business model

Some companies, such as Rolls Royce jet engines, have pioneered a service business model, in which customers hire products and return them to the supplier after use. This allows the manufacturer to perform necessary repairs or replacements between hire periods. Under this model, the burden of recycling shifts back to the supplier, further encouraging them to design products with minimal E-waste.

10. Reduce material usage

Mobile phones have shrunk in size from a brick to a calculator. This has been made possible by the miniaturization of electronic components, printed circuits, and connectors. The amount of material contained within each device has reduced considerably, even though complexity has increased.

Moving from milling and other subtractive manufacturing technologies to molding and 3D printing has reduced waste. There are opportunities to mirror these changes in electronics. Instead of making a flat sheet of copper and then dissolving most of it to produce a printed circuit board, additive techniques such as printed electronics can lay down patterns of conductors and insulators only where they are needed.

Putting E-waste in context

Our customers want smaller, lighter, longer-lasting devices that are easy to recycle. We can take all these factors into account every time we create a new design.

Solutions to E-waste must be looked at in the unique context of a product’s market and usage.

If we follow rules such as the above, we will make the optimum use of our planet’s limited material resources, and lay the electronics graveyard drawer to rest.

Which improvements will you design into your next electronic product?  Want to discover more and connect with our sustainability experts?

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For more on how to reduce e-waste through smarter product design and development, contact Cambridge Design Partnership.

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