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AdamFrame: A Low-cost, High-performance, Software guided Quadrilateral Octopod External Fixator

Periodic Reporting for period 1 - AdamFrame (AdamFrame: A Low-cost, High-performance, Software guided Quadrilateral Octopod External Fixator)

Reporting period: 2018-02-01 to 2018-07-31

AdamFrame feasibility study primary research results offer to common external fixation problems below:

- The long & hard treatment process is a barrier for external fixation treatment results as rarely to be prefered by surgeons.
- Orthopedic surgeons do not use external fixators to infants having congenital deformities because common fixators are not suitable for infants. Early fixation offers a shorter treatment period and healthier psychology for children.
- External fixators are fixed to the long bones by rigid screws and soft pins. These pins let the rigid fixators to dynamize and accelerate the treatment. However these pins comes with the pin site infection which is the most common problem of patients during their long term external fixation treatment.

Carrying out interviews and marketing studies with orthopedic surgeons describing:
- The novelty and ease of use coming with AdamFrame like short period treatment and very few visit or hospitalization need.
- AdamFrame lets surgeons to be able to use external fixation treatment to infants successfully.
- Using pins to dynamize the external fixator is not a must anymore with AdamFrame. One of the innovative features for the product is adjustable dynamization that lets surgeons free from extra pins. Less pin usage results less pin site infection for patients during their long term external fixation treatment.

The feasibility study of this project, was focused on the problems below:

- Determining the most effective target markets.
- Market barriers (Local regulations, product and brand awareness, etc)
- Target market competition.
- Development of pediatric external fixation market.

Studying analyzes on strategies of legal authorities and their future plans for external fixation market including:
- Target market decision from Asia-Pacific Countries (Malezia, Phillipines, Indonesia, etc.), Middle East Countries (Iran, Saudi Arabia, etc), South America Countries (Brazil, Argentina) These countries were selected due to their high population, external fixator treatment rate, WHO healthcare index and medical device statistics.
- Distributor search who can cover regulations needs. (Licence to Operate a Medical Device Establishment, Registration of Medical Devices, Free Sale Certificate, etc.)
- Competition analysis data obtained from the purchased market reports.

The most important societal benefit of AdamFrame is making the External Fixator technology accessible to everyone, even to patients with low disposable income. Moreover; as stated in Regulation EU No 282/2014, clause 3; According to the definition of the World Health Organisation (WHO) “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” AdamFrame can also be considered as a well-being tool for orthopedic patients; which not only corrects orthopedic deformities but also improves mental motivation of the patient by decreasing follow-up visits & biases and increasing patient comfort during the treatment.

Patients with limb deformities are end users of AdamFrame. Limb deformities can be congenital (they are born with it), developmental, or acquired as the result of fracture, infection, arthritis or tumor. Patients might be of various ages ranging from 12 to beyond 70s. One of the importance for society is AdamFrame’s is the solution developed for pediatric patients. This is an unaddressed segment in the marke and AdamFrame is the only solution. Developing the pediatric external fixation market is a viable economic opportunity beside the regular adult patients market.

Imed Surgical aims to make with AdamFrame, external fixation technique to be the most preferred bone fracture and bone deformity treatment method. Minimizing the risk of fixator caused infections is one of the AdamFrame’s objectives for increasing patients life quality and success rate of the treatment.

The past field trials verifies that AdamFrame is a powerful candidate to solve the both economic and social problems with its cost-effective design and surgeon friendly use.

The main objective of this project is to prepare a proper feasibility study and an in-depth business plan, which will map the route to a successful introduction and diffusion of AdamFrame into global market and maximize its economic and societal impact.
In the beginning of the project, we started a detailed primary research including interviews with and AdamFrame introduction to orthopedic surgeons. Research also included interview with medical device vendors/distributors and public buyers. Primary research took place during the first two months, February and March of 2018.

Our sales manager visited surgeons to follow and observe their treatments to analyze their decision making on preferences & choices. These visits took place between March and May of 2018.

In May, we set up a global market research team of three export specialists and started to analyse markets. From May to the end of July, this team worked on target market analysis and figured out market barriers, market regulations and legal authorities for each potential target markets. Management decided target markets as 22 countries to be focused on different time periods and varying priorities with the help of this team and global market report in July. 9 different market entry / distribution strategies were developed for these countries.

A detailed global market analysis report was purchased from a reputable global research company in July. This report includes a deep analysis of the external fixator market for 2013 - 2017 and an opportunity analysis for 2018 - 2028. The report defines the regional market trends, annual market size and shares with forecasts for each market.

Report analyzes the markets below:
- North America
- Western Europe
- Eastern Europe
- Latin America
- Asia Pacific (Excluding China & Japan)
- China
- Japan
- Middle East and Africa

The research methodology of the market report is:
- Primary Research
Major drivers and restraints in External Fixator Market, Opportunities for External Fixator Market, Key winning strategies followed by Digital External Fixator Equipment manufacturers, Market segmentation based on product type, Application and end user Regional value split, Present and future market value potential, Anticipated growth projections, Market concentrations, Major manufacturers
- Secondary Research
Global External Fixator Market scenario, Global External Fixator Market structure, Global External Fixator Market trends and opportunities, Global Digital X-External Fixator Equipment overview by product type, Application and end user, Industry growth projections, Market share analysis by region

Another action is business coaching supplied by EASME. At the beginning of the project, a coach pool was shared with Imed by our(local) national contact point of EASME. After selecting a coach, we had video calls and both sides agreed to share information and advices. At the first two months, we shared a limited information and signed a mutual disclosure agreement. In the last month we had detailed video calls according the coaching plan we agreed mutually. At the end of the project, our business coach was preparing to visit our office for a final full day coaching session.
According to the new and dynamically changed conditions, there should be always research and development in the sector. Imed Surgical Company is constructed on innovative research and development, so our R&D activities continue based on the AdamFrame's disruptive innovation concept.

With the wind of the EU Champions League Honour, our companies' motivation and production is increased. Also, this effect shows itself in the public relations and recognition/reputation of the company. Therefore global charities have contacted with Imed to use AdamFrame for war injuries and poor patients.

This progress showed itself in the local market. The clinical tries and the number of patients that have been benefiting from AdamFrame are significantly increased.

As a major step forward, Imed Surgical has signed a contract with a local distributor and AdamFrame was used in surgical operations at June.

Also, Imed has contracted with Turkish Public Buyer Authority (DMO) for locating AdamFrame to their online catalog. Public and private hospitals can purchase the product from local public buyer authority’s online catalog in 2 months.