Acrylamide is a chemical that can form in certain foods during high-temperature processing. Scientific evidence has linked acrylamide exposure to increased long-term health risks, including a higher likelihood of cancer and potential effects on the nervous system. As awareness and regulatory scrutiny grow, the client needed a practical, evidence-based way to reduce acrylamide formation without compromising product quality, safety, or commercial viability.

The challenge was threefold:

• Understand market expectations and regulatory pressures around acrylamide reduction
• Define a clear path to commercialisation for an acrylamide-reduction solution
• Validate the technical effectiveness of the approach under real-world conditions

Approach

Cambridge Medtech Solutions delivered the project in three integrated phases:

1. Market Research

• Assessed global regulatory guidelines, industry benchmarks, and emerging best practices related to acrylamide reduction
• Interviewed key stakeholders across manufacturing, quality, and regulatory functions
• Evaluated customer willingness to adopt new technologies aimed at improving food safety and public health outcomes

2. Go-to-Market Strategy Development

• Defined the value proposition around health protection, regulatory compliance, and brand trust
• Identified priority market segments and early adopters
• Developed a phased commercialisation roadmap aligned with manufacturing and regulatory timelines

3. Pilot Trials

• Designed and executed pilot trials to test acrylamide-reduction performance in representative production conditions
• Collected and analysed data to quantify reductions while monitoring taste, texture, and process efficiency
• Refined technical and operational requirements to support scale-up

Outcome

• Demonstrated measurable acrylamide reduction in pilot trials, supporting the solution’s role in improving consumer health outcomes
• Delivered a robust, data-driven go-to-market strategy that aligned health benefits with commercial and regulatory needs
• Enabled the client to move forward confidently toward scale-up and market launch, positioning the solution as a proactive response to public health concerns and evolving regulations

By addressing acrylamide reduction through both technical validation and strategic planning, the project helped bridge the gap between health science, technology development, and real-world adoption.

The post Acrylamide Reduction appeared first on Cambridge Medtech Solutions.

Challenge

Cryopreservation is a foundational technology for IVF, advanced therapy medicinal products (ATMPs), and biobanking. However, a persistent and industry-wide challenge is uncontrolled ice crystal formation and growth during freeze–thaw cycles. Both intracellular and extracellular ice cause mechanical damage to cells and tissues, leading to reduced viability, inconsistent outcomes, and limited post-thaw performance.

These limitations negatively impact IVF pregnancy and live birth rates, create variability and risk in cell therapy development, and constrain the reliability of biobanked samples. For technology developers, this technical uncertainty also represents a significant commercial and regulatory risk, complicating investment decisions and go-to-market planning.

Approach

Cambridge Medtech Solutions was engaged to inform and de-risk technology development by conducting in-depth market research and preparing a robust go-to-market strategy for improved cryopreservation solutions.

Key activities included:

• Primary market research with over 30 experienced cryopreservation stakeholders across clinical, scientific, commercial, regulatory, and equipment supply domains
• Assessment of current cryopreservation workflows, pain points, and unmet needs across IVF, ATMP manufacturing, and biobanking
• Evaluation of market size, segmentation, adoption drivers, and barriers to entry
• Analysis of regulatory considerations and purchasing decision dynamics across target markets
• Development of a clear go-to-market strategy, including value proposition, target customer profiles, positioning, and commercialization pathways

This cross-functional insight ensured alignment between technical innovation, clinical relevance, and commercial viability.

Outcome

The project delivered a clear, evidence-based foundation to guide both technology development and market entry. Outcomes included:

• Reduced technical and commercial risk through validated market and stakeholder insights
• Clear prioritisation of use cases and customer segments with the highest unmet need and adoption potential
• A differentiated value proposition aligned to clinical outcomes, operational efficiency, and regulatory expectations
• A structured go-to-market strategy to support successful commercialisation

The work ultimately supports improved IVF pregnancy and live birth outcomes, more reliable cell therapy and biobanking processes, faster progression and approval of ATMPs, and improved long-term patient health outcomes.

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Dotplot is an at-home breast health monitoring tool that offers guided self-checks on a monthly basis. It is designed to facilitate the early detection of breast cancer by enabling and encouraging women to stick to a regular breast-self check routine. Dotplot won the UK James Dyson Award 2022.

While they had a strong product concept, they faced critical challenges:

• Uncertainty in development priorities: With a complex blend of hardware, software, and clinical requirements, the team needed a clear, actionable product development strategy.
• Investor readiness: Generating early proof-of-concept data was essential to secure funding and build stakeholder confidence.
• Regulatory complexity: As a novel medical device, Dotplot has to balance speed to market with regulatory compliance and technical rigor.
• Hardware development sequencing: The path from MVP to a fully market-ready device needed careful structuring to minimize risk and development cost.

Approach

Cambridge Medtech Solutions led a collaborative workshop to refine Dotplot’s value proposition, target users, and product mission, and to identify key technical uncertainties and clinical assumptions. We also mapped out key milestones across funding, prototyping, MVP, and launch phases

This session established a unified product vision and clear roadmap, aligned with commercial, technical, and regulatory goals.

We also prepared a phased product development strategy from MVP to launch, with checkpoints for risk management, design reviews, and human factors testing.

Outcome

Our structured and analytical approach to medical device development and industrialisation de-risked Dotplot’s development, aligning the team on a pragmatic yet ambitious path to market, and making them investor-ready with a compelling story backed by credible data.

We continue to support Dotplot with their bold and exciting vision.

“The workshop brought real clarity to the vision we have for Dotplot. It helped us align our core priorities and gave us an actionable roadmap for Dotplot’s next steps.” 

Shefali Bohra – Dotplot co-founder and CEO

“The session helped us refine our value proposition and clarify what to focus on in the near and long term to achieve the vision we are working towards.

Debra Babalola – Dotplot co-founder and COO

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Our client supplies critical infrastructure monitoring equipment used in clinical environments, and they want to introduce a lifetime warranty for one of their flagship products. Offering such a guarantee for mission-critical equipment would not only differentiate their product in a competitive market but also reflect confidence in its long-term performance.

However, to justify this level of commitment, the client needed robust, data-driven insights into product reliability across its expected lifespan. While MEOST (Multiple Environment, Over-Stress Testing) had previously been used in early development stages to identify and mitigate failure modes (Stages 1–5), the current challenge was to design a structured test plan using MEOST Stages 6 and 7 to estimate product life at 0, 6, and 12 months using field-returned units.

The key objective was to simulate the combined effects of real-world stressors on these used samples, quantify degradation patterns, and develop predictive models that could validate claims of lifetime performance.

Approach

Our reliability engineers applied the disciplined, MEOST-based methodology, with a focus on Stages 6 and 7 (Life Testing and Warranty Estimation) building on the comprehensive failure mode insights already uncovered in prior development stages.

1.  Data-Driven Sample Selection

We began by defining criteria for selecting representative field-returned units at the 0, 6, and 12-month marks. Devices were chosen from varying geographic locations and use profiles to account for environmental and operational variability. Each unit underwent an initial diagnostic to document wear levels and baseline performance metrics.

2.  MEOST Stage 6 – Accelerated Life Testing Under Combined Stress

Using a test matrix grounded in known stressors (e.g. thermal cycling, vibration, electrical load, humidity, and contamination), we subjected each sample to accelerated life testing with multiple simultaneous overstress conditions. Crucially, these stress levels were increased just beyond expected field conditions – as prescribed by MEOST – but below the threshold of destruction, ensuring meaningful life prediction without catastrophic failure.

The goals of this stage were to:

• Capture performance degradation curves across timepoints
• Identify new failure mechanisms emerging from combined stress environments
• Establish failure thresholds in relation to real-world use

3.  MEOST Stage 7 – Statistical Modelling and Life Estimation

Following testing, we applied statistical reliability modelling to extrapolate failure rates and performance decay curves across a theoretical full lifespan. Tools included Weibull and log-normal analyses, adjusted for MEOST-specific acceleration factors. This provided failure probability estimates across time intervals and stress combinations.

Data from each timepoint enabled:

• Trend analysis of degradation over time
• Correlation of observed failures with prior MEOST-identified modes
• Confidence interval estimates for “no failure” operation scenarios

4.  Alignment with Lifetime Warranty Strategy

Results were mapped against warranty risk tolerance levels, allowing the client to define a quantitative reliability benchmark that could credibly underpin a future lifetime warranty offering. Additionally, outputs fed directly into their product quality surveillance system to inform post-market monitoring.

Outcome

The test plan, developed and executed through the MEOST framework, provided a validated, evidence-based understanding of product life and failure behaviour under real-world and accelerated conditions. Tangible outcomes included:

• Life prediction curves for each tested timepoint, supporting robust forecasting of long-term product performance,
• Zero unexpected failure modes beyond those already identified in earlier MEOST stages; affirming product maturity,
• Quantifiable reliability thresholds, giving the client the confidence to proceed toward a phased launch of their lifetime warranty offering,
• Enhanced field reliability strategy, with test plan architecture now integrated into ongoing quality assurance programs.

This case demonstrates how structured overstress methodologies – when applied rigorously at later stages of the product lifecycle – can provide the confidence needed to make bold, market-defining warranty commitments.

The post Lifetime Warranty Testing appeared first on Cambridge Medtech Solutions.

For in the shadows of uncertainty dwell the errors of man; bias, inconsistency, and haste. Without Gage Repeatability and Reproducibility (GR&R), your numbers are but illusions, your data mere whispers in the dark. You may think your process capable, your control charts steady, yet if your gage falters, all crumbles to dust.

So, heed my counsel. Test your gages as you would test your courage. Let each operator, each part, and each measure be known and trusted. Only then shall your data bear truth. For if your gage be unworthy …

…you shall not pass.”

– Gandalf in conversation with Boromir

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That path is treacherous, lined with endless inspection time, skyrocketing machining costs, and machinists’ curses whispered into the wind.

Tight tolerances are not free. They demand precision tooling, slower feeds, more scrap, and meticulous quality control. Each extra decimal place is another coin tossed into the furnace of manufacturing cost.

Only specify tight tolerances where function demands it. Leave the rest with generous fits. Consider function, material choice, manufacturing process, part geometry. Determine what actually matters.

For in manufacturing, wisdom lies not in precision alone, but in knowing where precision is needed.”

– Lord Boromir, Captain of the White Tower, High Warden of the White Tower, Steward-prince of Gondor

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In today’s fast-paced clinical environments, early detection of subtle changes in a patient’s condition can mean the difference between recovery and crisis.

That’s where the Rothman Index and the NHS Early Warning Scores help.

They are both powerful, real-time patient acuity score derived from routine EMR data – vitals, lab results, and nursing assessments. It’s visual, easy to interpret, and continuously updates as new data comes in.

Why it matters:
Identifies at-risk patients earlier
Supports timely interventions
Reduces readmissions
  Reduces unplanned ICU transfers
Enhances discharge planning
Improves patient outcomes

Hospitals using these metrics are seeing measurable improvements in care quality and operational efficiency.

It’s not just data – it’s insight. And insight saves lives.

Source: DOI:10.1186/s13037-024-00391-2

The post Predicting Patient Deterioration appeared first on Cambridge Medtech Solutions.

Working to support the industrialisation and scale-up of a generic equivalent to a well-established Diskus inhaler. The objective was to design, develop, and industrialise a bioequivalent device suitable for Abbreviated New Drug Application (ANDA) submission to the FDA.

Approach 

Given the complexity of dry powder inhaler mechanisms, this project demanded not only precision engineering and regulatory rigour but also comprehensive risk control and robust planning methodologies.

We worked closely with the client to provide inhaler industrialisation engineering support, to develop a device that met bioequivalence and functional equivalence requirements to the reference Diskus inhaler, in order to bring the device closer to market.

Outcome 

The project provided our client with new insights into the design, function, and manufacturability of their device, critical for the progressing the design into commercial tooling.

To progress development and industrialisation, our client required specialist engineering support, and Cambridge Medtech Solution were asked to join the team.

For this project, CMS provided additional expertise in mechanical and production engineering, medical device risk management, and device testing and verification.

Services to our client included:

• Preparation of the Device Functionality Profile (DFP) in accordance with ISO 20072 and other applicable standards, based on the requirements specification,
• Led Tolerance Management (allocation and analysis) activities, where critical dimensions, tolerances and process capability expectations were a key consideration when placing orders for multi-cavity tooling and assembly equipment,
• Identified functional critical-to-quality (CTQ) features for control.
• Contributed to Substitutability Planning
• Participated in Risk Management activities,
• Supported Tooling Strategy for development of multi-cavity tools with offshore toolmakers.
• Supported Device Manufacturing Strategy Planning, from PK Study to Commercial Scale,
• Supported Design Verification Planning, in accordance with Device Functionality Profile.

Client project leader commented “Industrialisation of a generic DPI brings its own particular engineering and regulatory challenges, and we benefited from Cambridge Medtech Solutions’ considerable experience and insight in inhaler development and industrialisation.”

This project illustrates how expert consultancy input – combining tolerance engineering, risk management, industrialisation engineering, and structured project execution – can significantly de-risk complex drug delivery device development. Our partnership enabled the client to accelerate their ANDA programme with confidence in both device performance and industrial viability.

The post Industrialisation Support for Generic DPI appeared first on Cambridge Medtech Solutions.

Approach
We worked with researchers at Newcastle University to develop a device architecture, concept design and prototype, working towards bringing organ persufflation to market.

Outcome
ScubaTx was launched in July 2020, and is initiating its first funding round in Q3/Q4 2020.

The viability of organs for transplant currently relies on a range of factors. Key limiting considerations include: the time the organ sits outside of the body before transplantation, and the availability of surgeons to retrieve, transport and implant the organ. Such logistics necessitate night-time work known to lead to mistakes while increasing financial costs to healthcare systems and personal tolls to healthcare professionals. In some cases, this may preclude the use of an otherwise healthy organ.

Storing precious recovered organs in ice boxes is still the norm. But this technique can only preserve an organ for a short period. For a long time, healthcare providers have sought an organ preservation technique that could increase the time available for an organ to reach a patient in need without compromising outcome.

Persufflation is a technique that perfuses an organ’s blood vessels with oxygenated gas. This ensures that oxygen reaches all parts of the organ, maintaining energy and increasing its chances of survival over a longer period.

Cambridge Medtech Solutions have worked with researchers from the Transplant Regenerative Medicine Laboratory at Newcastle University to develop a persufflation device that is designed for efficacy, portability, simplicity in use, and reimbursement.

The ScubaTx System comprises a small, portable, multi-organ system and a portfolio of organ-specific consumables. It will deliver the 3 key components of Persufflation:

• Cool – Organs are submerged in cold saline. This decreases kinetics of metabolic activities.
• Oxygenate – Humidified oxygen-rich gas is delivered through the organ’s vascular to reduce hypoxia.
• Control – Gas pressure and flow are controlled to deliver perfusion without tissue damage.

Cambridge Medtech Solutions was also instrumental in preparing the initial market assessment, to understand key market drivers, and developing a credible strategy and business plan.

Dr Bill Scott, Scientific Director of the Transplant Regenerative Medicine Laboratory at Newcastle University explains:

“The concept of what we’re doing is relatively simple, but it is very hard to do it in practice. Persufflation has historically relied on highly trained technicians to constantly monitor and adjust the system during transport. Working with Cambridge Medtech Solutions, we use state-of-the-art technology to create an automated, self-correcting and self-reporting device.”

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Why do we need Shisa Kanko?

Humans are fallible, we all make misteaks. Like that one, the majority of these mistakes are of little importance, but sometimes the consequences are significant. In industry and healthcare, human error impacts finances, efficiency, deadlines, reputations and lives. We are all equally capable of seeing what we want or expect to see at times, rather than what is actually there. Any method that is proven to minimise the potential for error is worthy of our attention.

Many years ago I lived in Japan and was aware of Shisa Kanko but I hadn’t appreciated its validity at the time. I recently happened across a post written by Malcolm Finlay, a Consultant Cardiologist working with the team building the Nightingale Hospital in London. Unintended human error in this setting could have disastrous consequences. Finlay foresees an increased likelihood of communication errors among tired/stressed individuals communicating through their PPE in a high pressure environment, treating COVID-19 patients. His suggestions to overcome this are three-fold:

• Individuals should introduce themselves at the start of every encounter
• Repeat back all critical data
• Use Shisa Kanko

What is Shisa Kanko and how does it reduce human error?

Shisa Kanko (指差喚呼) is the practice of pointing and calling, and it is used to increase occupational safety. Japan and China’s railway network implemented it to reduce human error, with impressive results. The 1994 Railway Technical Research Institute study revealed an 85% reduction in mistakes when carrying out simple tasks. Consequently, Shisa Kanko was rolled out across industry in Japan.

Shisa Kanko is a behaviour based approach using auditory, kinesthetic and visual stimuli to prevent tasks being carried out with a lack of attention. Instead of functioning on ‘auto-pilot’ to carry out routine tasks, the individual performs a coordinated response requiring him/her to point at the object of the action and call out its status. The process requires focus and attention and reduces the probability of user error.

Scientific research reveals an increase in blood flow to the frontal lobe of the brain when an individual uses Shisa Kanko; the frontal lobe is an area of the brain that controls attention. Shisa Kanko sharpens focus and attention while reinforcing learning and strengthening neural pathways. Incidence of error is drastically reduced, the potential is great.

Potential Applications of Shisa Kanko

Healthcare

The potential for human error across healthcare could be reduced significantly. Examples include: application of PPE, drug dispensing and administration, patient observations, equipment choice and use, selection of syringe/device, area of patient being attended to/operated on, and post surgical removal of swabs and instruments. The list is extensive.

The use of Shisa Kanko could be applied to procedures at every level. Individuals point to the task they are going to complete and say its current status out loud, e.g. (point to figure on screen) “Oxygen sats for patient Mr X, 78%”, (point to chart) “I am recording 78% on the patient’s chart”. Full attention is on the detail of the task.

Nightingale Hospitals

As London’s Nightingale Hospital opens, with others across the country following, systems that prevent error will be vital.

Communication will be restricted by additional PPE, workers will be unfamiliar with each other and the environment, routines will be altered and the situation will be challenging and stressful. Shisa Kanko could improve communication and minimise mistakes.

Never Events

In 2019, NHS England published 435 reported Never events, an increase from 423 the year before. Never events are, ‘serious, largely preventable patient safety incidents that should not occur if healthcare providers have implemented existing national guidance or safety recommendations’.

These events are highlighted and investigated as a learning tool, and their occurrence is indicative of the need for more robust safety measures. Universally practised Shisa Kanko could have a dramatic impact.

Pharmaceutical Industry

Within the pharmaceutical industry, research suggests that as much as 40% of deviations are due to human error, that translates to a lot of time and money wasted. Laboratory techniques can be repetitive and it is too easy to perform repetitive, seemingly mundane tasks without full attention. Unexpected or seemingly accurate data may result from undetected errors earlier in the procedure.

Patient Self-Administration

Non-adherence is a known problem with certain medications, and asthma self-medications are prime candidates, as I have previously discussed. Patients experience symptoms and require medical intervention which could have been avoided through better adherence.

Initial training for patients from healthcare professionals using Shisa Kanko would help patients ‘attend’ to the IFU (information for use) and memorise steps accurately. The result is correct, longer-lasting adherence of the medication and a reduction in symptoms.

The Future

Imagine future training within any industry that includes Shisa Kanko. Not just healthcare but also construction, manufacturing, transport, mining, automotive, energy, and travel. These industries among others could benefit from the application of Shisa Kanko, training individuals to improve attention to the task and reduce human error.

A BIG THANK YOU to the NHS and All Key Workers

Originally published as a LinkedIn Pulse article entitled Shisa Kanko could reduce mistakes and save lives (May 2020)

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