Team:Stockholm/Applied Design

Applied Design

From the beginning of our project, we knew that we wanted to create a product that had the potential to help people and solve a real need in the world. Because of that, in order to develop our product, we made sure we always had the final customer (the patient in need for a way to improve their life) in the center, taking into account their needs, concerns and opinions. This concept is widely explored in our entrepreneurship part of the wiki.

To make sure we were solving a real need (a new medication for the treatment diseases that involve production of thick mucus) of a real person (patients with a respiratory disease with high mucus production), we have conducted research on the disease state fundamentals, the existing solutions, the stakeholders and the landscape of market for a treatment to respiratory diseases related to high mucus production. But most importantly, we have found the need behind our product, by listening to the opinions of different stakeholders.

With all this information, we were able to successfully develop our product design. After studying all of the background information we had and the intellectual property landscape and the regulations our project would be subjected to, we have been able to elaborate a clear description of what our product brings to the market. We have also been able to assess what makes it more beneficial than other products, but have also considered which problems our product cause, and what could be its risk-benefit ratio.

Existing solutions

There are no solutions today that target the specific area of breaking down the mucus directly. The most common medications for cystic fibrosis, COPD and asthma are inhalation devices like bronchodilators, mucus thinners, and steroids.

In the case of inhaled devices, different problems arises from their use as therapeutic agents.

  • These problems include:
  • Uncertainty about drug dose at the target site, drug delivery depends on inhalation technique and device performance
  • Severely affected lung areas may not be reached
  • Local side effects (e.g., cough, airway narrowing, hoarseness)
  • Time-consuming drug administration
  • Need for education and training
  • Limited information on drug interactions in the lung
  • These medications need to be taken together with airway clearance techniques and in severe cases, a lung transplant may be needed. Additionally, thick mucus also contributes to bad bacteria in the lungs were often antibiotics are necessary.

You can read more information about the specific existing solutions for each disease in the existing solutions part of our Entrepreneurship wiki.

A real need

The market for cystic fibrosis is growing due to increasing prevalence with a size of $ 3.56 billion. For COPD and asthma, the market is as well expanding, with asthma having the largest market size of $ 20.7 billion and COPD, one of $ 11.3 billion.

To know more about the market landscape for respiratory diseases with excessive mucus production please visit the Market analysis part of our Entrepreneurship wiki.

The problems with the existing solutions were even further highlighted while conducting patient surveys in our search for a need

Up to 50 % have changed their treatments more than 5 times, which showed that the current medications don’t work sufficiently enough for longer time use. Only 20 % of the survey patients are very satisfied with their current treatments, which also highlights the need for a change in the way these diseases are targeted. The majority that answered the survey does not think that their current treatment is good enough against the mucus.

To learn more about the structure and results of our surveys please visit the Need part of our Entrepreneurship wiki.

Our solution

The solution iGEM Stockholm has developed for the need “a treatment for diseases with excessive mucus production” is a smart genetically modified bacteria that secretes mucus degrading enzymes. The solution we have developed combines a nebulizer for the administration of the genetically modified bacteria, the genetically modified bacteria and the enzyme that will degrade the mucus in the lungs.

To know more about our solution please visit the product design part of our Entrepreneurship wiki.

As previously discussed, there are different disadvantages over the use of the current solutions. These include drugs that target only subpopulations of the disease, time-consuming drug administration, time-consuming breathing techniques exercises for the elimination of mucus, need for education and training or a need for very specialized trainers in the area, that are costly.

On the other hand, the current solutions have different positive aspects as well. For example, their mode of action has been well researched and is well known, the doctors and other healthcare personnel is well trained to prescribe it and there is a big amount of information covering the use of combinations of these treatments in patients.

Our solution proposes a revolutionary change to the treatment of these diseases. The main advantages over the current solutions we can foresee are:

  • An increase in the quality of life of the patient, that would need less hours to move the mucus out of the lungs, allowing them to have a more active role in society.
  • A decrease in the economic burden these diseases put on the society. With the use of the product, the patients would be able to increase their productivity and have full-time jobs. The patients would not need to visit as many times the doctor’s office and their education in breathing techniques would be shorter and more effective, liberating pressures on the professionals working in the field.
  • No need for new training for physicians, nurses and physical therapists. Since the product uses the same technology as the widely spread nebulizers, support and opinion of the healthcare personnel is expected to be positive.

Additionally, the survey we executed with different patients showed that about 40% of the cohort is open to their medication being a GMO, and the rest stated maybe. This opens the door for the development of other therapeutic products using a GMO.

Nevertheless, the developed product brings different related concerns as well. For example, there is no practice that can certainly predict if the product will be well adopted by patients and healthcare personnel, as the know-how is a very important variable in this industry. The product raises new questions with regards to measuring safety and effectiveness by regulatory authorities and about how the reimbursement codes should be assigned by different countries, having different reimbursement systems. Even if the product is able to successfully break down mucus, it may need from the use in combination with bronchodilators and from training in effective elimination from the lungs. The product may also raise different ethical concerns in the population.

In the end, the product does not provide a cure for any of the diseases, or potentially increases the number of years a patient will live with the diseases, but makes the disease more bearable and increases the quality of the disease (this is all to be tested in clinical trials).