I have an assignment and the details are below.

This final media clip assessment will test your understanding of how regulatory frameworks are important to the design, development and adoption of new technology.  You will use a media clip (10 minutes) to communicate how a product operates and articulate the regulatory frameworks that are required to design such a product.

Overview 
For your written pieces of coursework, you created a specification and a design of a 
diagnostic system incorporating a biosensor (CW1), and developed a commercialisation plan
(CW2). In your practical sessions you explored the types of experiments that would be 
required in the development of a technical file for an innovative measurement technology. 
For this coursework you will produce a 10-minute video clip designed for a potential funder. 
The video clip will be a pitch in which you will explain why your device is needed, how your 
device operates and what data you will be collecting as evidence required for the 
submission to the regulators.
The scenario is that your start-up company has designed a novel diagnostic system (CW1) to
address one of the challenges outlined below. You have already undertaken the proof-ofprinciple project (project plan presented in CW1) and you have developed a 
commercialisation plan to develop the technology (CW2). The practicals gave you and 
insight into the types of data required to develop a technical file for submission to a 
regulator. The practical session was focused on the development of a lateral flow type of 
technology. Apply the same approaches that you used during the practicals to your device 
identified in CW1.
This piece of coursework will build on both the written assignments and the practical 
sessions.
A. This opportunity is to develop a system to be used in the home for detecting an 
exacerbation of COPD using the saliva from a patient. In the literature, two
biomarkers have been found to be raised in the four days preceding an exacerbation. 
The table below shows the biomarkers and their levels.
Biomarker Reference range
C-Reactive Protein (CRP) 10 – 40 ng/ml
Procalcitonin (PCT) 0.1 – 0.5 ng/ml
B. This opportunity is to develop a rapid method for detecting Dengue fever in a fingerprick blood sample. This should be suitable to be used as part of a new public health 
tracking system in tropical regions of the world and will detect viral protein shed 
from infected cells. A positive result will be defined as being a level of viral protein 
greater than 0.2 ng/ml. The product must differentiate Dengue virus from Influenza 
virus and Coronaviruses.

Report Format 
Using your skills and the information you learnt in the session on how to make a video clip, 
prepare a 10-minute video clip that addresses the following in the content. Make sure that 
you apportion appropriate amounts of time to the address these points.
1. The need for the technology - What health need is being addressed?
This draws information from CW1 and show the societal need for your technology
and the anticipated impact
2. How does your device work?
Explain clearly how your device works and what is novel. Use diagrams and 
animations. Explain what classification of the invitro-diagnostic device and what 
other standards will need to be included.
3. What experimental data will you collect for regulatory approval?
This answer is in response to the imaginary scenario. What tests would you have 
done if it was for real? Draw on the experience of the practicals but in the context of 
your device. Think about all aspects of the assay you have designed and how each 
can be validated and recorded in a technical file. How long will this take?
Each point above will count for 20% of the marks and a further 40% will be given for 
presentation style and visual impact with a focus on clarity and innovation in the 
presentation.

Marking Scheme is below:

Technology need (20%)	Comments													Element Mark %	Weighted Mark
A clear explanation of the need for the technology bringing in the healthcare and societal needs.	Some detail given but you could have been more clear about the healthcare and societal needs,													100.0	20
How does your device work (20%)														Element Mark %	Weighted Mark
Clear explanation of how the device works and pointing out the features that are important in determining the in-vitro diagnostic regulatory classification.  Mention of appropriate standards should be included.	A brief out line given and classification and some standards given.  More detail of the mechanism of action could be given in this section.  You do give more detail later in the presentation.  Why do you need two antibodies?													100.0	20
Evidence for regulatory approval (20%)														Element Mark %	Weighted Mark
Clear understanding of the evidence that is required for regulatory approval and what evidence is required from the various trials.  How and where will the trials take place? How long will this take? 	More detail about the evidence collected from analytical and clinical trails should be given  How long will it take to get regulatory approval.  You give some information about the company and management of the company later in the presentation.													100.0	20
Presentation style (20%)														Element Mark %	
A clear, vibrant and engaging presentation that will encourage an investor to fund your development.  Presentation should be audible, well paced and structured and not longer than 10 minutes.	Clear presentation but you probably did not need such a long introduction but go more quickly into the need.  The presentation was more a lecture than a pitch for investment and more attention should be given to you logical flow.  For example, showing how the device works is covered in two places in the presentation but should have been brought together in one place.  References are not needed in a pitch. You were only 7 minutes so you have another 3 minute to go into detail - particularly need and what evidence is collected from different trials.													100.0	20
Visual impact (20%)														Element Mark %	
The video clip should hold the attention of the viewer through the use of clear imagery and innovative animation.	A nice presentation with the "talking head" giving viewer engagement .   It did look like your were reading a script so try to show a greater eye contact and vitality.  There is room for including some innovative presentation methodologies.													100.0	20

My CW1 is below:

Introduction
Simple, innovative diagnostic and monitoring tools are needed to diagnose COPD, predict acute exacerbations, and track disease progression. Exacerbations remain despite maintenance therapies, which diminish physical activity, quality of life, and increase death risk in severe patients, making exacerbation prediction crucial. Biosensor technology must be leveraged creatively to develop a home COPD exacerbation detection system using patients’ saliva.
Healthcare need and impact
COPD is a severe public health issue due to its rising social impact (Yoshimatsu et al., 2019) and its status as the 3rd greatest cause of mortality (Lozano et al., 2012) and morbidity worldwide (Dong et al., 2020). It is an inflammatory reaction to environmental stress and tobacco smoking, 44 million people have been diagnosed and 160 million are unconfirmed cases (Fletcher et al., 2011).
COPD has considerable economic effects in many developed and developing nations (Foo et al., 2016). Due to poor diagnosis and follow-up, developing nations have more occurrences of this disease (Vogelmeier et al., 2017; Hyrkäs-Palmu, 2018). COPD is one of the costliest health conditions in terms of direct (healthcare and medical) and indirect (home and work productivity) expenses, largely due to acute exacerbation hospitalisations as the gold standard equipment cannot anticipate them. The UK has over 6 million COPD sufferers, significantly impacting health care and society. COPD causes 24 million lost working days and 23,000 deaths annually, resulting in about £4 billion in lost productivity.
Although COPD is stable, abrupt exacerbations aggravate the patient's condition. Recent proteomics study suggests saliva protein biomarkers can improve diagnosis and exacerbation forecasts. There is a lack of plain, simple, accurate diagnostic procedures for diagnosing exacerbation of COPD utilising a patient's saliva. The project will involve developing a product incorporating a biosensor for a system for detecting COPD exacerbations which will go a long way in improving physical wellbeing as well as identifying and handling acute exacerbations in patient care, may improve medical associated lifestyle according to (Zwerink et al., 2014; Bischoff et al., 2012). National Institute for Health and Care Excellence (NICE, 2010) advises self-monitoring to be used in patient care.
Innovation 
Traditional COPD diagnosis methods are expensive, time-consuming, and lack sensitivity and selectivity, necessitating the development of new techniques. Biosensors offer unparalleled potential for cost-effective diagnosis of COPD (Huang et al., 2019). Currently, there is a need to create efficient, accurate and readily available health monitoring systems for assessing the health condition of patients with COPD. A portable, low-cost, easy-to-use, and fast analysis tool for COPD patients to self-manage and detect acute exacerbations is proposed.
The design objective is to create a portable electrochemical biosensor that can accurately and quickly detect exacerbation of COPD by analysing a patient's saliva. This biosensor will provide real-time data, extremely sensitive, selective, and reproducible, making it an effective diagnostic tool. Typically, the technology can handle small quantities of samples, which are usually not difficult for most patients to provide. This is important because it is now commonly recognised that frequently assessing symptoms is necessary for classifying and predicting COPD (Vestbo et al., 2013). The diagnostic approach relies on a biosensor that utilises a combination of many biomarkers to enhance the accuracy of diagnosing and predicting the outcome of COPD. The advanced biosensor will have the ability to rapidly analyse patient saliva and accurately assess the patient's condition.  
Many COPD exacerbation-detecting technologies exist. Spirometry, the primary and secondary care standard, has low accuracy, limited outcome prediction, and requires specialised operators for evaluation. Device quality, leaks, and patient condition may distort results (Dong et al.,2020). Yee et al. 2017 developed a colourimetric immunoassay to detect MMP-8 and MMP-9 in periodontal disease saliva. The sample was dropped on the biosensing zone for luminous biomarker concentration evaluation after antibodies were injected in a controlled flow. Using a microscope to measure made it inappropriate for home care. Fluorescence-based LoC biosensors measure salivary IL-8 and MMP-9 (Nie et al., 2014). The measurements required a 20 µL sample volume and yielded results in 70 minutes. Its small sample size makes it comfortable for patients to use every day, but its lengthy and difficult technique limits homecare use.
Technical approach 
The project aims to develop a diagnostic system involving a novel biosensor design to be used in the home for detecting exacerbation of COPD using biomarkers C-reactive protein (CRP) and Procalcitonin (PCT) from the saliva of a patient. The project begins by identifying the need for simple, reliable, accurate, accurate and readily available COPD patients’ health monitoring tools, especially during home exacerbations. After determining the goal, biosensors are developed to detect and characterise biological targets using biochemical reactions or biomarkers like CRP and PCT. CRP and PCT, saliva levels in COPD patients were evaluated as another possible testing sample to blood. According to Patel et al. (2014). C-reactive protein (CRP) and Procalcitonin (PCT) levels provide clinically useful information on disease status. Using many biomarkers to reliably predict COPD exacerbation will create a sensitive biosensor. A handheld gadget that measures COPD patients' saliva for diagnosis will be created by integrating this sensor.
The main objectives:
Assess the diagnostic solutions that are most suitable for the goal of diagnosing COPD excerbations.
Review essential technologies to develop a diagnostic system for COPD,
including salivary biomarkers related to COPD exacerbation. 
Determine the panel of salivary protein biomarkers that signifies the onset and exacerbation of COPD. 
Establish the fundamental basis for the creation of biosensors and the corresponding methodology.
Develop an electrochemical biosensor to detect C-reactive protein (CRP) and Procalcitonin (PCT) as COPD biomarkers in saliva.
Clinical testing and performance evaluations
A biosensor designed for protein detection consists of three fundamental components: a bioreceptor, which is a biological recognition element that specifically reacts to one or more target analytes; a transducer, which generates a quantifiable signal when bio-recognition events occur; and a signal processor, which gathers, enhances, and presents the signal. Electrochemical transducers are biosensors' main biosensing components (Barhoumi et al., 2018).
Exploitation 
There is a high probability that sales of self-care products for respiratory illnesses will increase in the UK. As the world becomes more connected, individuals with various health conditions are taking charge of their conditions with expert guidance and peer support in the community and online. The yearly economic burden of COPD on the NHS is approximated at 
£1.9 billion respectively. The UK has over 6 million COPD sufferers, significantly impacting health care and society. COPD results in a total of 24 million working days being lost each year, resulting in about £4 billion in lost productivity. The human cost of COPD is significant, about 50% of COPD patients are unaware of their diagnosis, with 23,000 deaths annually, or one every 20 minutes. A significant amount of COPD costs is spent on managing patients in acute exacerbations as inpatients. The primary market for the product is COPD patients in the UK, Europe, and North America due to higher healthcare spending and well-developed healthcare infrastructure. 
The product market is expected to expand globally as COPD levels rise due to global air pollution and lifestyle changes. The Asia-Pacific region: China, India, and Japan, market is expected to develop rapidly due to rising air pollution, these regions are predicted to experience the greatest growth in respiratory ailments. Pre-market capitalization is a helpful tool for obtaining insights, data, and projections that are essential for developing corporate strategies, capitalising on market possibilities, evaluating risks, establishing goals, identifying trends, and comprehending target customers. 
Assessing recent technologies, target market regulations, market investment, pipeline products, political and economic factors that could impact market growth, using tools such as opportunity map analysis, market attractiveness index, PORTER's five forces analysis, drivers and restraints impact analysis, and PESTLE Analysis, will aid in determining the appropriate price for the target market.
PRODUCT DIAGRAM


                                                                                                                                        Result 



    Analyte


                                                             Biological sensing platform  



















RISK REGISTER
Description of risk	Impact	Risk level	Risk response
Technical risk	Cost Overrun
Extend project timeline	High	Maintain a rigorous prototyping and testing schedule
Management
(Key Personnel Availability)	Extend project timeline	High	Plan important task backups, 
Maintain open communication among team members about potential conflicts.

Commercial	Delay launch marketing	Moderate	Conduct a market analysis
Differentiate the biosensor with distinctive features, and form collaborative partnerships.
Management (Regulatory Compliance Delays)	Delay launch
Extend project timeline	High	Regularly communicate with regulators 
Provide project  compliance resources

Environmental 
(Supply 
Chain Disruptions)	Cost overrun.
Delay launch
Extend project timeline	High	Diversify sources, maintain buffer stockpiles, and track global supply chain trends.
Environmental 
(Environmental Impact)	Delay launch	Moderate	Follow environmental regulations and prioritise sustainable practices.



My CW2 is below:
Introduction 
In vitro diagnostic (IVD) tools are devices utilised outside the human body to analyse human samples (such as body fluids, tissue samples and cells) to detect diseases or assess organ function (Wang et al., 2023). The objective of the project is to create a diagnostic system that uses an innovative biosensor design. The device will be used in a home setting to detect the excerbation of Chronic Obstructive Pulmonary Disease (COPD) by analysing the biomarkers C-reactive protein (CRP) and Procalcitonin (PCT) present in a patient's saliva. 
Regulatory requirements
IVD, also known as the "doctor's eyes", are essential for modern laboratory medicine (Müller et al., 2022). IVD includes laboratory-based and point-of-care testing (Apacmed, 2022). The device is a Portable electrochemical biosensor with high sensitivity, precision, and consistency enabling it to generate real-time data, making it an efficient diagnostic tool.
The Medical Devices Directive (93/42/EEC) classifies the product as an in-vitro diagnostic medical device (IVD) based on risk. Classification regulation requires class three IVDs to test for biomarkers, antigens, or antibodies. The device is a class three IVD in terms of use and risk. It is a self-testing device which makes it a high risk IVD. To gauge the severity of COPD exacerbation, the device is engineered to detect biomarkers. 
There are fundamental characteristics that serve as guides for identifying IVDs. Self-testing IVD devices are designed for laypeople to collect data independently following manufacturer instructions (IMDRF, 2021). The public's safety must be considered before medical equipment, which are powerful, are distributed. Regulatory bodies must control the distribution of such device. Regulatory permission for the IVD's dissemination to the public is contingent upon the following ISO standards being reviewed.
ISO 14971: Medical device companies worldwide must follow ISO risk management standards, which focus on the international community.
ISO 10993: This standard underpins medical device biocompatibility testing, including IVDs. When evaluating IVD biomarkers, ISO 10993 criteria must be followed to protect patients from hazards.
The following countries are where I will be seeking approval for the IVD. 
The United States of America 
The United Kingdom 
China 
Japan
The FDA and MHRA oversee US and UK medical devices. The FDA oversees commercial laboratory medical test system safety and efficacy. The FDA prioritises patient-safety-risky devices to maximise resource use (Mansfield et al., 2005). The MHRA oversees medicines, devices, and blood products in the UK to safeguard public health and advance science. 
They have aligned requirements and regulatory procedures, resulting in a similar approval process for medical devices in both countries. However, depending on the risk of the device, the quantity and quality of clinical data required to obtain market approval differs in each country (Fink and Akra, 2023). US-approved medical devices merely require basic post-market surveillance, UK (EU) producers must regularly collect clinical data and submit particular reports to right agencies (Fink and Akra, 2023).
Collecting evidence:
Obtaining regulatory clearance for the technology requires proof that it is effective, produces reliable outcomes, and poses no risk to patients' lives. Further, there is need to show that patients can operate the gadget properly even when not being supervised by a doctor. 
Laboratory trials are planned and approved before being carried out. The results of these trials are used in clinical care. Analyte-specific reagents (ASRs) from the laboratory or a different manufacturer are used in laboratory studies (Mansfield et al., 2005). No medical device can be developed without first completing the necessary laboratory and clinical testing.  The process involved in a laboratory trial include the following,
Selecting Appropriate test: This process aims to get the best approach to the test for maximum effectiveness of the product.
Obtaining the specimen: For a laboratory test to be effective, the specimen must include the right biomarkers to ensure the result is reliable, accurate, and gives the desired result.
Experimental/testing Phase: This phase entails the carrying out of laboratory procedures on the chosen specimen. 
Interpreting of results: In this step, the experiment results are carefully examined to determine if they meet the requirements and if the process is ready for the Clinical Trial.
Post analytical phase.
When laboratory experiments show promise, the Medical and Healthcare Products Regulatory Agency (MHRA) reviews and approves them. Once the MHRA approves all safety measures, clinical trials can begin.
The clinical trial will be divided into three phases:
Phase 1 trial: Data on patients' response to the device is the main focus of this phase. Its sample size is modest. In this phase, the device's use and patients' responses will be monitored.
This phase primarily aims to gather data on patients' response to the device. It is characterised by a relatively small sample size. During this phase, the device's application will be observed, and observe patients' responses to it.
Phase 2 trial: This requires a larger sample than phase 1 trial. This phase determines the optimal device application method and assesses any potential side effects.
Phase 3 trial: This step involves mitigating any adverse effects of using the technology. 
The necessary physical resources include patient samples, manufacturing materials, and technicians throughout the invention process. Evidence will be collected on the COPD device's diagnosis accuracy and functionality. Clinical trials involve volunteers who help us understand health and medicine, unlike laboratory investigations.

Differences between the laboratory and clinical trials
	CLINICAL TRIAL	LABORATORY TRIAL
Definition	Entails the examination of the safety and efficacy of medical therapies in human subjects.	Entails research inside a controlled laboratory environment to comprehend biological mechanisms.
Setting	Clinical settings, such as hospitals 	Laboratory environment
Subjects	Individuals who volunteer to take part in the trial	Make use of Cell cultures, animals, and tissues besides humans
Methods	Case series, Randomized controlled trials, observational studies	In vivo and in vitro experiments
Outcome	Improved medical interventions for human health	Understanding of biological processes
Example	Studying the safety and effectiveness of a new drug in humans	Investigating the mechanisms of a disease in a cell culture

Fund raising 
For innovative ideas to make an impact in healthcare, it must first be adopted and supported. Also, before a new medical product can be used on a patient, it must be proven safe and secure in providing solution to a medical problem. Innovators must proof the efficiency of their product before taking it to the market. 
The scope of this project can be funded by government grants, business partnerships, or venture capital. However, this initiative will be funded by government funds from relevant organisations that fund medical product research and development. The device's development, regulatory compliance, clinical trials, manufacture, marketing, distribution, regulatory clearance, and postproduction surveillance is estimated to be about 25–30 million dollars.
Some organisations, like the National Institute for Care and Research (NIHR), provide research grants and financing to inventive researchers who want to solve critical health issues. The FDA offers competitive grants to individuals and qualifying organisations for research and product development. 
NIHR Funding 
Advantages	Disadvantages 
Provides great Financial Support 	Highly competitive funding process
Provides Access to state-of-the-art facilities and infrastructure 	Strict rules and regulations guiding the funding process
Provides credibility for the product 	Lengthy approval procedure 
Opportunity to collaborate with other researchers 	High level of research constraint

FDA Funding 
Advantages 	Disadvantages 
Improved chances of regulatory approval success 	Possibility of limited funding sources 
Provides product with credibility boost 	Strict rules and regulations guiding the funding procedure 
Access to regulatory experts 	Grants is highly competitive 
High networking opportunity 	Long approval process 

The breakdown of the commercialization process can be divided into three major parts which include the innovation phase, the clinical phase and the regulatory clearance phase. 
The estimated price for the innovation phase can be approximately 5 million dollars. The clinical phase estimate at approximately 9 to 10 million dollars. The regulatory clearance phases up to the post market surveillance will amount for the rest of the budget as well as the miscellaneous. The Innovation stage can take about 1- 2 years same as the regulatory and production stages. 
The commercialization time and associated cost for this device is divided into various steps:
Task ID	Commercialization process 	Start date 	Due date 	Budget (Dollars) 
1	Define Project Scope and Objectives:			
1.1	Project Charter	6/11/2023	13/11/23	250,000
1.1.1	Research	9/11/2023	25/11/23	300,000
1.2	Projections	15/11/23	20/11/23	50,000
1.3	Define project goals and success criteria	15/11/23	25/11/23	100,000
1.4	Stakeholders 	10/11/2023	23/11/23	100,000
1.5	Identify key features of the biosensor	20/11/23	23/11/23	400,000
1.6	Project Initiation	20/11/23	25/11/23	50,000
2	Project Planning			
2.1	Scope & Goal Setting	4/12/2023	8/12/2023	20,000
2.2	Budget	4/12/2023	22/12/23	20,000
2.3	Communication Plan	8/12/2023	13/12/23	30,000
2.4	Risk Management	12/12/2023	20/12/23	300,000
3	Research and Development			
3.1	Tracking existing biosensor	22/12/23	29/12/23	200,000
3.2	Developing sensor specifications	29/12/23	26/1/24	1,000,000
3.2.1	Electrode design and material selection	19/1/24	23/2/24	300,000
3.2.2	Initial testing of electrode prototypes	26/2/24	8/2/2024	4,000,000
3.3	Project Updates	4/2/2024	4/2/2024	30,000
4	Sensor Development (Milestone)			
4.1	Complete electrode design and material optimization.	5/2/2024	29/02/24	200,000
4.2	Assembling sensor components	1/3/2024	12/3/2024	4,000,000
4.3	Integration with electronic circuitry	15/03/24	30/03/24	100,000
4.4	Initial tests on integrated sensor	1/4/2024	8/4/2024	150,000
5	Algorithm Development (Milestone)			
5.1	Developing algorithms for signal processing	9/4/2024	4/5/2024	150,000
5.2	Integrating algorithms with sensor output	6/5/2024	24/6/2024	125,000
5.3	Conduct simulations	27/05/2024	4/6/2024	120,000
5.4	Initial testing of algorithm	9/6/2024	28/06/2024	120,000
6	Prototype Testing and Optimization (Go-no-go milestone)			
6.1	Initial Lab test of biosensor prototype	1/7/2024	2/8/2024	5,000,000
6.1.2	Obtaining the specimen	4/7/2024	10/7/2024	200,000
6.1.4	Experimental/testing Phase	15/7/2024	24/7/2024	5,000,000
6.1.5	Interpreting of results	25/7/2024	29/7/2024	200,000
6.1.6	Post analytical phase	30/7/2024	1/8/2024	1,000,000
6.2	Test the biosensor prototype under various conditions	5/8/2024	6/9/2024	4,000,000
6.2.1	Phase 1 trial	5/8/2024	9/8/2024	1,500,000
6.2.2	Phase 2 trial	12/8/2024	23/8/2024	2,000,000
6.2.3	Phase 3 trial	26/8/2024	6/9/2024	2,000,000
6.3	Collect data for optimization	9/9/2024	20/09/24	300,000
6.4	Iteratively refine sensor and algorithm based on test results	23/09/24	5/10/2025	2,000,000
7	Regulatory Compliance and Documentation			
7.1	Ensure compliance with relevant regulations	7/10/2024	1/11/2024	500,000
7.2	Prepare documentation for regulatory submissions	4/11/2024	22/11/24	300,000
7.3	Conduct pre-submission audits	25/11/24	29/11/24	300,000
7.4	submit regulatory documentations	2/12/2024	23/12/24	100,000
8	Production and Scale-Up			
8.1	Develop manufacturing processes	6/1/2025	7/2/2025	2,000,000
8.2	Scale up production	10/2/2025	17/02/25	4,000,000
8.3	Effort and Cost Tracking	17/02/25	28/02/25	1,000,000
8.4	Evaluation of project performance	3/3/2025	21/03/25	2,000,000




Explain to me as comprehensively detailed as possible, how to do this in the best way possible step by step.