Validation
Validation
Validation
Assumption Testing & Stakeholder Validation
Assumption Testing & Stakeholder Validation
To de-risk our market entry and strengthen investor confidence, we identified the most critical assumptions and designed targeted validation experiments with government bodies, clinics, NGOs, and end-users. While we have validated many key assumptions throughout, the following experiments aim to further confirm additional critical factors.
To de-risk our market entry and strengthen investor confidence, we identified the most critical assumptions and designed targeted validation experiments with government bodies, clinics, NGOs, and end-users. This data-driven approach ensures real-world demand, early adoption commitments, and policy alignment, providing clear, evidence-backed insights into Akrolimb’s scalability and impact potential.
Business Assumptions
Business Assumptions
1
Clinics/charities will want to adopt our business model.
1
Clinics/charities will want to adopt our business model.
1
Clinics/charities will want to adopt our business model.
2
Amputees will want to use our prosthetic.
2
Amputees will want to use our prosthetic.
2
Amputees will want to use our prosthetic.
3
We can protect our generative software IP.
3
We can protect our generative software IP.
3
We can protect our generative software IP.
Clinics/charities will want to
adopt our business model.
Key Insights
Clinics and charities are open to adopting a new solution but face significant workflow constraints:
Current prosthetic workflows are outdated, requiring molds to be manually made and sent to manufacturers, increasing lead time.
Charities manufacture prosthetics on-site, but this requires multiple iterations to ensure a proper fit, making the process inefficient.
Most clinics employ engineers and technicians who specialise in electronics and hardware, suggesting technical staff can adapt to digital solutions.
Current scanning software is a major bottleneck, as it does not allow amendments, making it unsuitable for real-time adjustments for patients.
Method of testing:
To test this assumption we conducted in-depth field research with 6 clinics and 2 charity branches within India.
We mapped out and photographed their process, and asked them to rate each step in terms of how much time and effort it takes. We then worked with them to look at which areas Akrolimb may or may not help, as below.
Outcome: clinics are open to adopting a new process
Validation: Partial, requires refinement
Amputees will want to use our prosthetic
Method of testing:
We conducted 0.5-1 hour interviews with 20 amputees to gather qualitative feedback on our first prototype, Shunya. To minimise bias, we:
Ensured participants had a range of limb loss levels and experiences with prosthetics.
Gave time for users to feel and look at the prototype and concept in their own time
Showed the prosthetic concept and materials without making performance claims.
Positive Validation on Concept & Design
"The idea of getting a prosthetic this quickly is exciting. Most options take months, so this could really help people like me get back to living, not just managing."
"It feels very lightweight. Many prosthetics I’ve tried are bulky and uncomfortable, especially in hot weather due to sweat build-up."
"The customisation aspect is most interesting to me. My current socket slips off easily, and I usually need to add socks for padding."
Contructive criticism
"You need to think about the wrist component as well. It’s often overlooked, but wrist rotation is essential for picking up objects properly."
"Having all fingers bend seems too complex and likely to break often. Focus on key features—like a simple open-and-close motion for the index finger and thumb. Think about the most common daily tasks and prioritize accordingly."
Validation: Achieved
We can protect our generative software IP
Method of testing:
Akrolimb’s legal strategy, developed in consultation with IP and corporate lawyers, balances cost-effective risk mitigation and strong IP protection. We use strategic disclosure to prevent competitors from filing similar patents while securing key innovations through patents, copyrights, and trade secrets. Our approach ensures compliance with Indian, US, UK, and EU regulations, covering medical certifications, data protection (GDPR, HIPAA), and fair partnership agreements with Endolite and Jaipur Foot. This framework safeguards our technology, minimises legal risks, and strengthens our global market position.
Sanantinee Kasemmongkol
Corporate & IP Lawyer
Our novel method for creating comfortable and Durable sockets.
Durability of Socket Sleeve material
After speaking to 100+ amputees, we identified durability and comfort as key challenges in 3D-printed sockets. Here, we present how we validated the ability of our socket creation method to provide these qualities.
Validation Method: We developed a Python script to automate socket design and optimize thickness. After durability and user testing with amputees at Jaipur Foot Ahmedabad in December 2024, we refined the script to produce sockets rated for a 2-year lifespan under extreme use.
Our Python script for creating socket sleeves
We use a 5mm TPU Material Layer for out sockets after consulting experts & users.
Comfort of Socket lining Material
Method of validation: We conducted a study with Amputees in India with two socket liner materials (silicone and polyurethane) and user feedback favoured silicone for comfort.
From this study we also noted that liner thickness should be highly dependent on the weight of the user. Using this insight we fine-tuned code to creates a custom liner mesh around the stump for our generated sockets.
The Liner Material
Generating Liner material layer using our code.
Outcome: Established Comfort and Durability standard
3D scanning is accurate enough for clinics to achieve a proper fit for patients
Method of testing:
To ensure our scanning software is suitable for clinics, we conducted a literature review and then we ran demos with 5 prosthetists showing a real amputee limb scan to understand what is needed to integrate our scanning software within the current system
(1) Cullen S, Mackay R, Mohagheghi A, Du X. The Use of Smartphone Photogrammetry to Digitise Transtibial Sockets: Optimisation of Method and Quantitative Evaluation of Suitability. Sensors (Basel). 2021 Dec 16;21(24):8405. doi: 10.3390/s21248405. PMID: 34960503; PMCID: PMC8703273.
(2) Hernandez, Amaia1,; Lemaire, Edward2. A smartphone photogrammetry method for digitizing prosthetic socket interiors. Prosthetics and Orthotics International 41(2):p 210-214, April 2017. | DOI: 10.1177/0309364616664150
Overview of feedback:
All professionals agreed that the scanning software itself is able to produce high quality scans and this has already been backed up with research
They also said it is a lot quicker than the method being used currently and so 'has great potential'
However we found that the reason for scanning technology missing from current solutions is largely due to the lack of modifications which can be made to the mesh.
This means that even if the scan is accurate, sockets will not be comfortable due sensitive areas not being accounted for
Next steps:
Our next steps are to implement all the changes we found from our testing within our scanning software and carry out another round of demos to iteratively develop a scanning application which matches the needs of our users
Validation: Partial, requires refinement
3D Printed materials meet the
mechanical requirements of
a prosthetic.
Method of testing:
TPU Socket: We conducted flexural, fatigue, and thermal tests after changing various 3d printing slicer parameters, ensuring that the flexible socket achieves the mechanical properties of traditional silicone sockets. 16 infill patterns and 6 infill densities were tested to find the ideal permutation of parameters that ensure flexibility and comfort whilst maintaining structure and support.
A testing rig was created using a 3-axis mini robotic actuator, and used to apply varying forces at various angles and frequencies.
The following table shows the results of our tests, which have mechanical properties in line with non-3D-printed traditional prosthetic materials.
Validation from professor at Tsinghua University Advanced Materials Lab:
‘Based on your test data, I can see that your 3D printed materials do meet the mechanical properties of silicone’
‘However, you should look into how the layer-by-layer deposition method of 3D printing affects these properties, through physical testing not just simulation’
Validation: Partial, requires refinement
We can train technicians to manufacture Akrolimb using our 3D scanning, printing, and fitting process to our standard.
Method of testing:
We conducted a controlled training experiment with a diverse group of 20 participants to simulate real-world adoption. The test group included:
Engineers with extensive hardware experience
People with basic engineering skills (e.g., technicians, mechanics, makers)
People with no prior experience in 3D printing or prosthetics
Verification: Incomplete, needs improvement
Positive Insights:
Users with engineering backgrounds sent print requests with minimal issues.
Basic maintenance tasks were easy to learn for all participants, including those with no prior experience.
The app was clear and raised no concerns
Challenges Identified:
Participants with no prior experience struggled with capturing accurate limb dimensions, indicating a need for real-time scan validation or automated corrections.
Printer troubleshooting (e.g., misaligned prints, bed levelling) was a challenge for users unfamiliar with 3D printing, highlighting the need for clearer repair documentation or remote support options.
Technical Assumptions
1
TPU sockets are usable for prosthetics .
2
The 3D scan is accurate and detailed enough for clinics to adjust and achieve a proper fit for patients.
3
3D printing is valid to produce a robust enough prosthetic.
4
We can train technicians to manufacture Akrolimb using our 3D scanning, printing, and fitting process to our standard.
1
TPU sockets are usable for prosthetics .
2
The 3D scan is accurate and detailed enough for clinics to adjust and achieve a proper fit for patients.
3
3D printing is valid to produce a robust enough prosthetic.
4
We can train technicians to manufacture Akrolimb using our 3D scanning, printing, and fitting process to our standard.
1
TPU sockets are usable for prosthetics .
2
The 3D scan is accurate and detailed enough for clinics to adjust and achieve a proper fit for patients.
3
3D printing is valid to produce a robust enough prosthetic.
4
We can train technicians to manufacture Akrolimb using our 3D scanning, printing, and fitting process to our standard.