Using Design Science, Develop

Q1. Using design science, develop a concept paper (1,500 – 2,000 words, excluding references) that leverages Kelly’s 12 technological forces, ideas and concepts from this session, and emerging technologies to propose an innovation that addresses a problem of organizational or societal interest. Your report should be organized around the five phases (Empathize, Define, Ideate, Prototype, and Test). Naturally, more of the report will focus on the first three. The last section (section 6) would conclude the report by providing a discussion about how one or more ‘emerging’ technology is leveraged with one (or more) of Kelly’s 12 forces to address (empathize) with the target user/user group. Introduction:

Design science mindset is a structured method for implementation. Design thinking is effective in terms of bringing value to the organization. It is not only about being ‘creative’ but it is also like applying the design thinking principle to the problem or increasing the business value. According to Design pundits, design thinking is just a way of solving problem in a more scientific and disciplined way (Dam & Siang). Design thinking follows below approach.

Empathize:

Clinical trial and patient recruitments: Clinical trial is a complex recruitment process, because it is difficult to find people for the specific clinical studies/trials. It is difficult to find a group of people in certain geo area and to complete their enrollment in a specific period. Patient recruitment is one of the biggest challenges that pharma and medical device company must overcome. Poor recruitment and retention results in delayed trial, increased financial losses and potentially skewed statistical data (Lou, 2015). This also results in medical treatment’s not getting FDA approval because of low patient enrollment. In general at least 60-80 percent of pharma or the medical companies don’t recruit patience on time which ultimately results in millions of dollars of losses every year (Lou, 2015).

Some patients cannot afford the ever rising cost of the treatments, these patients who cannot afford expensive treatment can participate for free using the App which we will design. Terminally ill patients who don’t have any treatments available will be able to participate in the trial which would in turn results in improved medical conditions.

Trials are important from regulatory standpoint but patients are not enrolling. Out of the biggest challenges facing the clinical trial professions, patient access and recruitments constitutes about 12% Pharmaceutical companies and Clinical Research organizations often fail to meet their deadlines due to lack of patience availability for their desired study, thus leading to project failure in the phases of clinical trials (Burrows, 2017). On an average it takes about 2.5 billion dollars to gain FDA approval and majority of the cost is incurred in the recruitment of the patients to conduct these trials and drug development (Andrew, 2018).

Define

Presently there are a lot of ways by which patients can be recruited but it lacks awareness among patients and reaching the patients for the right study is important. This is a huge threat. Companies are trying various channels to advertise the ongoing, future clinical trials in order to obtain patients but, is this reaching the right audience at the right time is a question? The tools these companies are using to enroll patients have drastically changed along with the tools patients are using to find the information about clinical trials (Lou, 2015). We are going to focus to build new innovative app that will help to bridge the gap, fasten in the recruitment process, help patients communicate with Doctor and clinical research organization from all levels. We will be a trusted third party to connect Doctor, patience and pharma/CRO to improve medical research for better tomorrow.

Idea of the app is not to conduct multiple number of trials but help in achieving required patients for the trials and accuracy with the current patient levels. Sometimes patients do not want to participate in the trials or the patients are not aware at the right time of their medical condition to be able to participate. The app will help to simplify the requirements to participate in the research with the communication and consent of the patients. Additionally, we will create a platform which will help the Doctor provide an incentive to communicate with their patient and bring awareness in them to participate in the clinical trials. All the communication and patient consent will be under the regular and government compliance as per the law. Currently patient data in already generated at the Doctor side and already available but not used to its full potential for the right benefit. The app will help to channel and connect patient, Doctor and Clinical Research Organizations (CRO`s). Additionally, also encourage more Doctors//Physicians to participate in the studies.

Ideate:

The new app will have all the data about all the patience and conditions in certain geographic areas to the. All physicians will have access to the patience data and all pharma and medical companies will have access to those physicians who can help them enroll (currently pharma companies don’t have access to patient data. Patient consent to reveal their data to the parma company needs to be pre-obtained.) The idea of the portal is to connect and bridge the existing gap. For any new patient referred, the Doctor will get a referral from the Pharmaceutical or a clinical research organization. Also, for CRO to communicate and post their requirements on the portal, they will have to subscribe to the portal to get access to the patients (only with their consent) and list of Doctor. Patient will not have to pay any fees but the subscriber will need to pay the fees.

The pharma companies will post all of their Clinical trial on their app (Both existing and future trials). Patients will get access to the app to get all the notifications to keep themself informed. The app will also increase physician awareness and cultivate collaborations between pharma company and patients. Doctor can also communicate with the patients and explain them the role and methods to participate. To make tech friendly, human representatives who know how to use the app can also be hired to work in hospitals who can help patient enroll faster. Moreover, the app will also make it mandatory for the Doctor and Pharmaceutical companies to communicate clearly regarding the importance of the trials. Overall the participation of the studies will need to focus on the important benefits of the studies to the current and future patients.

The App for Clinical trials is going to be an innovation for patients and for the physicians.

The app shall incorporate below features and usability :

1. Adding a patient-focused acceptance method

2. Provide details on the benefits of the study plan to support enrollment

3. The app will offer direct and quick monetary benefits for patients

4. The app will add social media integrations to bring awareness

5. Directly communication with their Doctor and evaluate their progress throughout the trial.

6. Simplifies the enrollment process by using the Mobile app

4) Prototype :

To check what will work? The idea of the prototype is to get all feedback from the users. Getting into cultural prototyping is a great way of communicating with the team to share details with heiracracy and people in the organization. Since future data is not available yet, we will generate the data of what we want by trying different models or variances. Hence in conceptual thinking we design our way forward (built prototype). Our product development will involve learning with incremental refinefinment. We will have to focus on identifying the different between the minimal viable product (MVP) vs. prototype and what roles it plays in problem solving for our needs. Once our hypothesis is ready, we can put that in test asap to get the initial validation. MVP is thus a smaller and reduced product to get a real time feedback.

We will incorporate bunch of options and features including subscription based payment models for accessing patient data (with their consent).

Model 1: Not charging a fee from the patient and generating the revenue from the ads to support the platform.

Model 2: If patients need, diagnosis information they will need to pay a minimum fees or this can be made free in the future iterations.

Model 3: Subscription fees to be paid by the Pharmaceutical Company to access Specialized Doctor and patients information.

Model 4: To expedite faster, Pharmaceutical Company will pay a premium fees to conduct clinical trial

Model 5: Referral tier structure for the Doctor who refer Patients to participate and explain them about the trial.

5) Test – to understand the problems in different ways. Test with customers.

Test App : An internal test plan will be developed.

Overall Adherence and Compliance to be followed: FDA approval and will need to followed in the development of this app. There will be a requirement of the data consent from the patient to participate in the trials and Doctor can only share patient data with the pharma and clinical trial organizations if patients agree. Since most of the patient data is already generated and residing at the each individual levels with the Doctor and providers, this app will help them connect with the patient`s consents. In addition the app will adhere to the licensing requirement and other regulatory trials as needed. Moreover, during the design of the trial, app will focus on the ethical and requirements from each of the collaborators participating in the clinical trials. App will simplify the importance of the study to the patients (Thoma, Farrokhyar, McKnight, & Bhandari, 2010). Conclusion:

Leveraging emerging technology with Kelly`s forces.

Accessing – One of our iteration model refers to building subscription for the Pharmaceutical companies to access current patient database who are willing to participate in the trial. The portal allows tier based subscription model and it will no longer be necessary for the pharmaceutical companies to buy the patients information, they can simply access data under the compliance. Ownership of data will no longer be necessary.

Sharing – From the patient benefit perspective, they will be will to share their feedback on the portal and participate in the studies for new discoveries. Their contribution and willingness to participation will encouraged with the help of the app. Additionally, Doctors will share the new research and advancement of the new discoveries from the clinical trials with their patients.

Filtering – The app will generate so much data, that it can help filter all the patient information based on the requirement of the medical research.

Design tenets used in our product:

With our design thinking we have applied the 8 design tenets in our product building. We have Identified our problem correctly but targeting the problem which is faced in the community, we are going to learn constantly from the app development and gain more insights to better understand future development, we are thinking systematically about our approach, we are working at all the scales including the regulatory and scientific community, we are connection people with technology and giving the power in the hands of the users, we are provoking and facilitating changes to, we are working in collaboration with different teams, and taking risk responsibly to build something new for the future.

To conclude, in our our design approach, we have to connect human with technology to solve our problems. One of the most important aspect of the design thinking is to understand the fact that the product development will need lot of teaching and collaboration with all the stakeholders. We have thoroughly publicized and continuously communicate our problems and seek help from collaborators throughout the scientific and the technological community. Our idea should focus on working together in a team. Since multiple domains are involved in this product it will be important how people are comfortable sharing ideas with the partners.

Reference:

Dam, R., & Siang, T. (n.d.). Retrieved from

https://www.interaction-design.org/literature/article/design-thinking-get-a-quick-overvie w-of-the-history

Dam, R., & Siang, T. (n.d.). 5 Stages in the Design Thinking Process. Retrieved from

https://www.interaction-design.org/literature/article/5-stages-in-the-design-thinking-proc ess

Burrows, A. (2017, May). REPORT: The 8 biggest challenges facing clinical trial professionals. Retrieved from https://knect365.com/clinical-trials-innovation/article/e414c9b9-8de9-4525-8fe6-fe6264d36df0/report-biggest-challenges-clinical-trials-pt-1

Lou, A. (2015, June) Five Tips for Clinical Trial Recruitment and Patient Retention. Retrieved from https://www.pharmavoice.com/article/clinical-trial-recruitment-0615/

Andrew, N. Here’s the Problem with Today’s Human Clinical Trials. (2018, March). Retrieved from http://fortune.com/2018/03/20/human-clinical-trials/

Dawn, B. Strategies for Successful Patient Recruitment. (2018, September). Retrieved from https://forteresearch.com/news/strategies-for-successful-patient-recruitment/ (Dawn, 2013)

Thoma, A., Farrokhyar, F., McKnight, L., & Bhandari, M. (2010, June). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2878987/