AIMinded

Risk 1 - Commercial

External Distribution Channel when Scaling-up outside Romania

Probability: Medium

Impact: High

From a sales perspective, we have a partnership with Supermedical, who will be our sales team in Romania but we acknowledge that when scaling up and moving abroad, we will have to find new commercial strategies.

Our plan for international expansion is to participate in the biggest conferences in the radiotherapy field. Also, we want to leverage Supermedical’s network, as they have a partnership with Siemens. As such, we will access a broad range of potential new clients.

Risk 2 - Commercial

Adoption and skeptical doctors

Probability: Low

Impact: Medium

The adoption of this solution might be low due to skeptical doctors regarding artificial intelligence. We will be present at all radiotherapy events to present the results from our AI, where we can show doctors that AI is a natural solution for the future of contouring. Also, we propose to have multiple live demos, in radiotherapy clinics where we want to ask for their most challenging case to run through our application, which is the best test to demonstrate what we can do.

Risk 3 - Technological

AI results are poor

Probability: Low

Impact: High

We are permanently increasing our database with patients from partner hospitals that are contoured by the doctors as part of our medical team and verified for their quality. With a large database, the result from our AI algorithms will increase constantly, right now achieving results that surpass 90% in accuracy (full stop). As you can imagine, using a continuously expanding database will only increase the efficiency of AIM-Contouring.

Risk 4 - Regulatory

Not achieving the CE Mark and accreditation from Health Minister

Probability: Low

Impact: High

CE Mark is mandatory accreditation from the European Union to certify the system for future commercialization and clinical usage.

We already started the process of achieving the accreditation, which is a laborious one, including multiple technical files regarding the product and maintenance procedures, clinical trials, and an audit from the authority that gives the accreditation. We have commenced the process. Furthermore, we have a consultant specializing in CE Mark from the UK, who helped another medical startup in Romania to receive this accreditation. Also, we have a partnership and agreement with a clinic in Romania to do the clinical test in collaboration with them, helping us with both patients from their hospital and scientific expertise. Once obtained, the accreditation from Health Minister is a formality.

Risk 5 - Financial

The next round of funding is not obtained

Probability: Low

Impact: Medium

We know where we are headed. And we want to help as many people as soon as possible. This is why we will raise another round of funding after one year, to help catalyze the process. During the next 12 months, we will both succeed in obtaining the CE Mark and securing our first monthly recurring revenue. And this is the main reason we are very optimistic about the AIMinded future. 

Risk 6 - Development

Not finding AI talents to work on AIMinded product

Probability: Medium

Impact: Low

Our current team has strong AI capabilities, being a multidisciplinary team with all the resources in-house. Acquiring new AI talents, to accelerate the development and make algorithm trials much faster, could be a problem but we mitigate it by having a hands-on approach regarding AI in the team (The co-founding team is AI specialists ).

Risk 7 - Commercial

Competition when it comes to big players like Varian, Elekta

Probability: Medium

Impact: Medium

There are big players with solutions for contouring that already have other products regarding radiotherapy in the market, which could represent a blocker for sales due to the lack of time in the market for AIMinded.

Our product is winning by the high quality of the contours. The major differentiator is that we supply the contouring of tumors as well, not just organs at risk, and that is something that big players don't offer. Clinics that want the contouring of the tumor will acquire the contouring of organs at risk together because it comes with financial advantages and having only one software distributor for contouring action is less complicated. Also, compared with companies of this level, our solution is more accessible financially speaking which leads to advantages in both the annual budget and services offered in exchange. And the most important thing: These financial benefits can be passed towards patients, thus helping equality and democratizing access to top-quality medical services

1. What does AIMinded do?

AIMinded is a system based on Artificial Intelligence that automates the image analysis process in radiotherapy, generating contours of the patient's organs at risk (around the tumour). Through this automated process, radiology doctors gain time for more complex interventions and for interacting more with the patient.

2. Do we use third party API providers?

We don’t use third party APIs. The algorithms that we are running are made in-house and we have full control over them.

3. What is the system's accuracy?

Currently, the system’s accuracy is between 90-92%. We have to consider the variation of the contours, as two doctors will have a slightly different contouring for the same patient.

4. How big is the problem?

There are 5 000 cancer patients who need radiotherapy every day and 25% of them don’t have acces to the radiotherapy treatment they need.

The number of radiation oncologists is very limited. One radiation oncologist is responsible for multiple tasks such as taking care of patients, contouring, and the whole irradiation process. This reduces the interaction between doctor and patient to a few minutes, affecting the patient’s state throughout the irradiation process. A patient needs psychological and emotional support during the entire treatment process.

5. What is the vision of AIMinded?

A world that brings life force to cancer patients.

•Every doctor is helped by an AI. 

•Medicine is more human.

•Patients are treated faster and with a lower cost.

6. What is the mission of AIMinded?

Building Artificial Intelligence tools that restore the oncological healthcare system into a patient-centric culture.

•Doctors have more time for complex cases.

•Accelerated cancer treatments, achieving a more efficient workflow that supports more patients.

•A strong connection between the doctor and the patient.

7. What is radiotherapy?

Radiotherapy is one of the most effective cancer treatments. In this process, the doctor uses radiation to hit the tumour volume and thus eliminate its cells. Radiotherapy is a treatment based on a treatment plan and multiple irradiation sessions for a specific patient. 

The radiation dosage is delivered in a few minutes and it doesn’t imply any pain for the patient. The patient must receive this treatment as fast as possible because every day can accentuate the cancer stage.

8. What is contouring?

Contouring is a mandatory step in the course of creating the treatment plan and it consists in delimitating the tumour volume and the organs-at-risk volumes, thus creating a 3D map in the body, where every organ is located.

This is crucial because contours are sent to the linear accelerator, where the patient is irradiated. It is essential that we know exactly what volume to irradiate (the tumor) and what volumes to protect from radiation (the organs at risk).

9. What is the CE Mark? Why is this useful?

The CE Mark is the European accreditation for products that are commercialized on the European market, and it is divided into multiple domains. The CE Mark that AIMinded addresses is for medical devices. In order for the product to be certified and commercialized, we need the CE Mark.

This is a laborious process that requires high standard procedures and technical files, which take approximately 1 year to be accomplished. 

Once obtained, this proves our product meets high-quality standards and that it can safely be used in the clinical flow.

10. What GDPR measures are needed?

The privacy of the patient's personal data is the main GDPR measure to be respected. This means that the patients that are stored in our database should be kept anonymous (e.g. name, unique ID number - CNP in Romania -). For this process, we have developed a software that effectuates the anonymization process.

We also collaborate with a consultancy firm, in order to be GDPR compliant.

11. What are organs at risk? Why do we need them to be contoured?

Organs at risk are healthy organs in the tumor’s proximity that have a high risk of irradiation during treatment. 

In this process, the tumour gets irradiated, but the healthy organs around it (e.g. lungs, heart, brain etc.) will also be irradiated in a limited quantity. 

It is crucial for us to contour organs at risk with high-precision because this way we can calculate the exact irradiation dosage that we can use during the radiotherapy process.

12.What would be your potential roadblocks in achieving your full potential?

The CE Mark is our number one priority, since we depend on it to start commercialising our product. We believe this is our number one potential roadblock. To mitigate this risk, we have brought in our team a British consultant, specialised in CE Mark approval, with experience in helping startups achieve this mark.

13.As Romania is a relatively small market, what would you require to internationalise successfully?

Romania is our sandbox. Once the entirety of our product is market validated, we will focus on internationalising. For this to happen successfully, we plan to start partnering with medical equipment distributors. By doing so, we will gain a solid foothold in as many radiotherapy clinics as possible.

14.What is needed to improve the quality of your product?

Our product is centered around AI, hence we need to train our algorithm with as many images and models as possible. The doctors that we have recruited help us by validating and offering feedback, thus constantly improving our product aligned with the radiotherapy industry.

15.Where does AIMinded bring added value within the radiotherapy course of treatment?

As of right now, our MVP is already installed in one clinic. It contours the Organs at Risk. The product is on track to achieve the CE Mark, with the formalities already begun. For the tumour part, the MVP is in the development stage.

16.What are AIMinded’s advantages compared to its key competitors?

On a national level, our main advantage is the quality of our product, which comes from a very well trained AI-based algorithm. The key success factor here is the access to increased volume of real-life data, such as images and scans. This organic advantage gives a strong foothold in the local market, thus accelerating the adoption rate among clinics.

From an international competitors angle, there is a history of some well established players attempting and failing in penetrating the CEE market. Their main drawbacks were a too expensive price structure, unadjusted for the local market, and a lack of flexibility (operational, technological)