FP-00008

Section 1 - Basic information about you and your application:

Title of research project
Multi-Articulated Body Powered Prosthetic Hand

Grant Type
The Ronald Furlong Fund

Research area
Treatment

Duration
18

Start date
November 1, 2023

Have you previously received funding from ORUK?
No.

Profession
Entrepreneur

Your current job title/position
CEO

Are you an early-career researcher (ECR)? (definition of ECR)
no

Section 2 - Lay summary

Lay summary:

Robotic prosthetic hands have been the focus of upper-limb prosthetics development for 40 years and yet still today 40% of amputees choose to wear nothing at all. This is not just an issue of cost; even people using the most advanced robotic prosthetics abandon them at a high rate. In fact, the most popular and most functional prosthetic hand one can buy is still a simple mechanical hook. These open and closes by pulling a cable which is attached to a shoulder harness so that with shoulder, arm, and elbow movement, the user pulls the cable and creates a grip. It is a simple yet effective principle. Because the user is attached to the gripper, they can feel and precisely control the pressure that they are applying. With meaningful functionality, as well as being extremely robust and cost-effective, they are highly recommended by clinicians. However, many people will never use them simply because of the aesthetics and associated negative feelings of wearing a hook.

While robotic hands have inspired a new confidence in amputees, this comes at the cost of function due to poor control as well as the uncomfortable weight and fragility. In hooks, their raw function is often outweighed by their primitive appearance damaging the user’s confidence. This is why so many choose to wear no prosthetic at all. Users simply do not want these major compromises. Crucially, this is at the cost of their own health: by not using prosthetics, people will over-use their remaining limb leading to the rapid development of arthritis, tendonitis and a series of muscle imbalance issues. We need prosthetics without these major compromises for amputees.

At Metacarpal, we have created an entirely new category of prosthetic hand that has the major and desirable features delivered by robotic hands but can be operated using the cable-operation that users already know and love. We have upgraded the cable operation , transforming the functionality, and in a product that people can be proud to wear.

Omitting electronic components doesn’t just improve the function, but also increases robustness while making significant reductions in both cost and weight. This device will be accessible to those with lower incomes, and also for smaller individuals that cannot handle the weight of current prosthetics. This additional function will make an enormous quality of life improvement for more disabled people than ever.

Current robotic hands require a series of motors to have a grip with individual finger motion, however Metacarpal’s proprietary technology: PolyAdapt enables this same ability, yet controlled and powered through body-motion. This is paired with simple grip and wrist position switching to create a hand that meets all of the user functional needs, alongside confidence-boosting appearance, and affordability.

Section 3 - Purpose of research

Purpose of research:

Our research aims to utilise mechanical engineering innovations such as PolyAdapt that enable prosthetics with simple control to have advanced functionality. As such, our research is centrally product based:

• Developing PolyAdapt
• A multi-flex wrist that enables body-powered operation
• Developing the most robust bionic hand available (defined by end outcome through surveys: days out of action per year)
• Device that can be repaired at the clinic for the vast majority of issues
• Weight under 350g
• Meets the size requirement for a small hand (rough frame: 162mm x 122mm)

These are incredibly challenging requirements, currently unmet in the market due to the focus on robotic hands which inherently cannot meet all of these. We have developed PolyAdapt and Multi-flex (TRL5), however developing a product that achieves the required functionality while meeting the other criteria will be very difficult and will result in a world-first.

Our central deliverable will be a hand which will be the most functional hand available. Clearly, function is different for different people, so different devices suit different lifestyles. We have however created a “time trial” of various household tasks that is used to measure the device’s progress.

To measure against other devices, we will be entering the Cybathlon. This is a competitive event that pits P&O products and their chosen pilot, against one another in a series of everyday tasks like slicing bread and opening cans. Our aim is to win this. This is a really effective functional goal to set, as well as being fantastic commercially to show that our device is better than anything else out there.

Commercially, our aim is to replace the split hook as the “default” prosthetic hand given to new amputees.

Section 4 - Background to investigation

Background to investigation:

• Metacarpal was born out of extensive research into the prosthetics space and liaising with over 70 key industry and clinical experts; and users. Given the pivotal role prosthetics play in the rehabilitation process for amputees, we wanted to understand the reasons for such high rejection rates of current devices (44%) [1]. Despite major innovations in robotic hands, “clinical reality still shows high rejection rates of cost-intensive prosthetic devices” [1].The most major design concern was consistent across academic research and our own findings: comfort [1][2]. It does not matter what the device does, if it is not comfortable, it will not be worn. This is centrally controlled by the socket fit and the weight of the device.While robotic hands have been the focus of prosthetics development, these devices rely on a series of motors and heavy batteries creating major problems for users. We spoke with one user who complained she could not wear the device on consecutive days as a result. From interviewing clinicians, we quickly found that the other major concerns were around repair: 78% of clinicians feel the devices break too often and 89% said they then take too long to be replaced.In stark comparison, body-powered hooks have not really changed from the original patent from 1912 yet remain the most popular [3]. This was confirmed by Sarah Day, Strathclyde University’s leading upper limb prosthetics Teaching fellow who noted the resurgence in the popularity of body-powered hooks amongst UK users.Body-powered hooks are naturally light and very robust due to their simplicity. Additionally, functionally they can be considered more effective than robotic hands. While robotic hands may have more functions, the precise and intuitive control of body-powered hooks gives them generally greater utility. This has been showcased at the Cybathlon (a competitive event for prosthetic components), where a body-powered device has won on each occasion [4].The clinicians we consulted with found the hooks primitive design to put off many potential users and some amputees we spoke with had stopped being interested in prosthetics when they were recommended a hook. Whilst there are hand adaptations, these generally use a glove over the top creating huge inefficiencies, requiring a minimum of 42N just to close a grip [5]. This is a major problem that means they are now characterised by their stiff operation. Additionally, the extra fingers do not provide any functional benefit, only cosmetic which means that the middle, ring, and pinky finger all just get in the way. For these reasons, clinicians will very rarely recommend body-powered hands over hooks and as a result they have limited popularity.Based on our research at Metacarpal we recognised that the problem with body-powered hands were due to poor engineering. Because there had been such tunnel-vision on robotic technology, innovations in body-power have been static. Our focus became to update and upgrade body-power prosthetics, starting with a flagship product, the body-powered hand.Our design would give people the major features that they really want from the robotic hands such as a variety of grips, wrist positions, and in a form factor users can be proud to wear. By using body-powered operation we would retain the inherent advantages around weight, robustness and control.Measuring function is very difficult since good function means different things to different people. With robotic hands, many people are frustrated with the delay and the speed of these devices. In comparison, during trials with our hand, within an hour users have been able to pick up and a ball and catch it.With hook devices, whilst they pinch objects effectively, this is only a single grip. For an activity like cooking, with many different shapes of objects, one will require a variety of grips. This is where Metacarpal PolyAdapt Technology is used. The fingers will grasp around the shape of any object giving a grip no matter if a spoon or a pasta packet.Americo Marinelli, who first trialled the hand stated: “I have tried just about every prosthetic device, I don’t use them but I’d use this”.Lillyanna, another trialist, a Polish native speaker, opted to show her enthusiasm via a big hug at the end, such was her satisfaction, even compared with her £20,000 robotic hand she had been using, and was in need of a repair.

Section 5 - Plan of investigation

Plan of investigation:

With the IP at an advanced stage now, we feel comfortable moving forwards with patent filing applications. This includes a patent on the central hand technology and also the multi-flex wrist giving significant protection of how the hand functions and how the hand interacts with current prosthetic technology in the wrist.

For clinical adoption, clinicians will want to see evidence of:

• Functional benefits
• The robustness and ease of repair of the device
• The device must integrate with current prosthetic technology
• The device must be clinically verified and tested (although clinical trials are not a stipulation for a class 1 self-certified device)

To mitigate the risk, Metacarpal’s development plan ensures that these aspects are considered. Patents enable us to begin sending Metacarpal prototypes off for testing with clinical partners that have already agreed to test (HandSpring, Arm Dynamics, MCOP, among others). These trials will be scaled up into clinical trials as development continues. Clinical input will help refine the design in the final 9 months of its development, alongside Metacarpal’s own testing including:

• Trials with local users who will wear the device over the course of weeks
• Robustness testing using workshop apparatus
• Design for manufacture and assembly

Although the refinement presents technical challenges, our talented team and consulting with Ted Varley who has already led the design of two of the most advanced prosthetic hands available, enables us to avoid pitfalls that he has already made through his experience of prosthetic and design, ensuring that the product which is released in April 2024 will be well-tested and ready for everyday use.

The manufacture of components will be outsourced to local companies. The reason for this is to have close control of the process so we can travel to see any problems occurring and refine the design as we go. Assembly will be handled by the design team while sales pick up. This will give the designers knowledge of the difficulties in assembling their designs so that they may be tweaked to improve this.

During the clinical trials and certification process, we will be utilising Edwin Lindsay, principal consultant of Compliance Solutions, a medical regulation consultant that has been working closely with Metacarpal’s strategy so far. He will help to ensure that Metacarpal’s product meets all of the necessary criteria for the CE, UKCA and FDA approval. It should be noted, that as a Class 1, self-certified device, there is no necessity for clinical trials to begin sales, however, particularly in foreign regions, this is preferred and why we will be working with foreign clinic groups to test the product extensively through the remainder of its development.

The major product launch will be done at OTWorld, by far the world’s largest prosthetics conference in held every 2 years in Leipzig. This will give Metacarpal the major opportunity to show the value of our work on a worldwide stage.

The next major marketing milestone is the Cybathlon in October. This will pit our hand against competitor products, devices costing over £50,000. We are confident that our technology will ultimately win this competition, giving us the clear backing to claim to be the world’s most functional prosthetic hand. Further, we will work with Strathclyde University prosthetics department to get more academic research on the hand.

Long term, we believe that the US will be our largest market due to their favourability for body-powered prosthetics. However, logistically, as we are building up sales and scaling our manufacture and assembly, we will push this through European nations through carefully selected distributor partners. This will begin with the UK as a test bed, then looking to go to Germany and France. This is benefitted by our Commercial Lead Matthew having a fantastic experience in these markets and fluently speaking both languages.

Quickly we will expand to the US where we expect our early sales growth to increase rapidly. We will initially focus on the East Coast (and mid-west) due to logistics and having very good connections already with the best upper limb prosthetic clinic groups in the region, and a distributor with very clear interest. We have begun talking with KOL prosthetist Karl Lindborg to have him as part of the team to ensure that we meet all of the clinician’s needs in the States.

Our US sales strategy is to first sell under a miscellaneous reimbursement code, as there is not a code for a multi-articulated body-powered hand (this distinction is made in robotic hands).

There are meetings twice each year where we can begin making our case starting with this month where a KOL US prosthetist is raising the issue. From here we can find the specific data they would need to support our application. We expect that having the code granted in time for launch is unlikely but by January 2025, to have made the case very clear.

Selling under a miscellaneous code lets us decide the value, although standard insurance packages are less likely to reimburse, Worker’s Compensation and Veterans will have no trouble in reimbursement. Since early market fit analysis has shown these groups to be ideal for the Metacarpal hand given its robust design. This enables us to drive up the value of body-powered devices, so that when we are awarded a code, we will get a fair reimbursement.

As we are awarded this code, we expect to close a Series A round. This will take the sales pathway that we have been optimising over the last 18 months, the new code, then hire a salesforce that enables us to scale up very quickly thereon.

Going forwards from here we want to have products that integrate more and more with the prosthetic fittings themselves which is why we will bring clinicians into the design and sales team. Our first product fits with current prosthetic technology so there is very little change for the clinician, de-risking the fitting process for them. Going forwards, our products will integrate more and upgrade clinical aspects of the prosthetics process.

Section 6 - Research environment and resources

Research environment and resources:

Metacarpal has an office workshop space. With the £1 million raise which ORUK’s potential £100,000 would be a part of, we will look to move to a larger facility able to support spaces for office work, R&D, and Assembly. Currently, we are investigating the Robotarium at Heriot-Watt University for this potential.

The seed investment raise will be utilised to hire the launch team including:

• Bring Matthew, our current part-time Commercial Lead into a CCO role
• Hire 2 more Design Engineers to finalise the product
• A part-time Finance Director who’s role will grow year on year.
• A Clinical Lead to help sell the product and train the growing sales force. They will have input in the design
• US Sales Lead to build our US sales and strategy

Funds will also be used to:

• Build the technical file for medical compliance as a Class 1 Self-Certified product is all major regions.
• Market the product across target regions, visiting clinics with distributors and attending conferences and trade shows around the target regions
• Develop the product pipeline for future releases
• Internationalise IP
• Purchase equipment needed for the assembly process

This will give Metacarpal the ability to have a product ready for the launch date of OTWorld, with the funds necessary to get sales started and industry talking about our technology. From the beginning of sales, we will have a total of around 12 months of runway, with our objective to make the first £1 million in revenue. Leading into our Series A, we will have a product refined, a clear product pipeline moving forwards, optimised sales pathway and internationalised IP. Using this information, a Series A will enable Metacarpal to quickly scale thereon, driving incredible value into the business.

Section 7: Research impact

Who will benefit from this research?

The current state of upper limb prosthetics is so deficient that 40% of people are rejecting them despite the clear and documented health benefits. At Metacarpal, our core focus is creating products with better user outcomes that meet user needs, enabling them to live independently, whilst out performing robotic prosthetics at a hugely reduced end-user cost and providing increased durability.

Our strategy is to meet the widest array of user needs across functional, social, and economical factors. This is enabled by our entirely unique design approach and patentable PolyAdapt Technology.

Independent living is significant both for the individual and society as a whole, enabling them to integrate and work.

For healthcare systems, for we can save considerable time and costs, reducing the number of appointments needed by providing a solution that is simple for a patient to adopt and will much fewer repairs and services across its lifetime.

How can your research be translated in real-life?

There is a clear direct impact that the funding will have into the lives of people very quickly. ORUK funding will make up part of our Seed fundraise, looking to raise £1 million pounds that will help to see Metacarpal commercialise the product. From the money arriving, we expect to have a product that will be impacting people’s lives through everyday use within 5 months.

How will your research be beneficial for ORUK and its purpose?

ORUK’s clear purpose to help research and commercial projects which combat poor musculoskeletal health is something that clearly aligns with Metacarpal’s mission.

Losing a limb causes a weight imbalance that leads to a series of musculoskeletal problems. Further, not using prosthetics will mean over-relying on the remaining limb which quickly develops into problems like arthritis and tendonitis.

Prosthetics restores a weight balance that is good for spinal health and ensures use of both limbs are used, extending the life of the intact limb. Clinicians will tell amputees this, yet such is the dissatisfaction with current prosthetics, that 4/10 choose to wear nothing at all, compromising their health, rather than compromise their comfort, function or psycho-social well-being.

Our mission is to meet the widest array of needs of any prosthetic device at any cost, encouraging more amputees to utilise prosthetics that give them more independence and increase their long-term musculoskeletal health.

Section 8: Outreach and engagement

Metacarpal have been engaging with amputees and people with limb differences, clinicians and academic prosthetics experts since the very beginning of the project in 2020, which formed the shape of what the company is today.

From our extensive engagement with industry players, we have had key introductions who are now an integral part of our team. This includes Ted Varley, who was CEO of Glaze and the lead designer behind the BeBionic Hand (bought by Ottobock) and the Covvi Nexus Hand. Ted is now contracted with Metacarpal providing his network, skills and experience as a design consultant.

More recently, Matthew Parkinson has come in as our Commercial Lead. Matthew has 10 years of experience selling upper limb prosthetics and has been making fantastic headway connecting with industry through prosthetic distributors and leaders of prosthetic clinic groups and clinicians. Here we have had incredible support:

“It is likely we would try to provide this prosthetic hand to every body-powered prosthetic user who is interested.” Tim Bump, Upper Limb Prosthetist – Handspring

“I have tried just about every prosthetic device, I don’t use them but I’d use this” Rico Marinelli, Upper-limb amputee& trialist
“I just couldn’t do that with mine” & “I am absolutely interested” Benjamin Dodds, Upper-limb amputee

“Patients will often reject these devices (body-powered) because they do not look or behave like a hand. Therefore, your project is novel and is targeting a major need.” Rahul Kaliki – Founder and CEO of Infinite Biomedical Technology (US distributor).

“We strongly believe there is a place in the market for a light weight, robust, cable operated hand. Glaze Prosthetic feel the metacarpal product would sit well with the Glaze range and therefore we would be interested in distributing it.” Ted Varley – CEO of Glaze Prosthetics (EU/US distributor).

We now have 4 letters of support from key target distributors (Uniprox, Glaze Prosthetics, Infinite Biomedical Technologies, EMO), all keen to run trials, and a further 3 letters from our preferred clinic groups (Arm Dynamics, Handspring, MCOP) – both integral to our commercial strategy.

Our plans are to keep engaging with industry and involving them with Metacarpal, from utilising KOLs to help with our regional market entry to bringing on prosthetic clinicians full time aiding our sales, training, and advising design as we develop more and more solutions in body-powered prosthetics.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£0

Salary
£0

Consumables
£0

Publications
£0

Conference attendance
£0

Other items
£100000

Total 'requested fund'
£100000



Other items
Investment



Other secured funds

Internal funding
£0

Partner (University)
£0

Partner (Commercial)
£0

Partner (Charity)
£0

Other sources
£0

Total 'other funds)
£0

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
Yes

Who owns and maintains this patent?

All foreground and background IP has been assigned from founders and employees to the company. The company owns 100% of the IP used for Metacarpal. Patents are currently in the process of being written and filed. Patent maintenance will be handled by Metacarpal.

Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?