Project2_Research_Summary
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Project 2 What is the process of taking medical devices from development to implementation?
Marshall Rasmussen
Research Summary
Overarching Questions:
How are medical devices developed?
How are medical devices certified and tested?
How are medical devices implemented in hospitals?
What are potential inefficiencies in this system?
What are potential solutions to some of these inefficiencies?
Description
:
This project aims to address the interconnected departments and facilities associated
with the development of medical devices. Medical devices will proceed through
development, certification, and eventual implementation after advertising and bidding
performed by the developmental company. Each of these functions provides an
interconnected nature and builds on the results of the previous group. Furthermore,
with the interconnected nature, there are difficulties that arise and inefficiencies that
decrease the customer satisfaction on multiple ends. There are dissatisfactions from the
medical facilities, from the patients, and from the developers due to wasted time,
transportation, over-production, etc.
Source 1.1 (Video)
Summary:
This video takes the development and certification process of medical devices and
explains in a general format the individualized process. Medical devices are developed in
a parallel system that works with development and certification to ensure the future
certification after development has been finalized. To ensure proper requirements are
met, a traceability matrix is utilized to outline process and requirements to be met at
each phase. Using the traceability matrix helps to limit inefficient use of materials and
designs during the development process. Then following the design and development
process, the device is submitted to the certification agencies to check compliance with
class standards.
Learning
:
This video clearly outlined the different departments of development and certification
process. There are departments assigned to the design, material selection, preliminary
development, requirement testing, finalization, certification, and relations and sales.
Each of these departments allows for the flexibility necessary in the industry but offers
inefficiency in transportation and potential overprocessing due to expectations being set
by a different entity. Furthermore, the mind map displayed by Medical Devices HQ,
shows the flow of information and products within the development phase. I placed this
similarly to a spaghetti map for the flow of information and products. One of the only
spots that detailed an efficient system came with the verification protocols. This process
clearly passes the product from test to test and outputs the data efficiently. Although
customizable, this process displayed many potential inefficiencies in relation to the
interactions between different departments and the certification process.
Citation
:
https://www.youtube.com/watch?v=ZqW4PS9-NIA
Source 1.2 (Video)
Summary:
Tom Contrucci, Director of Supply Chain Management and Procurement of Michigan
Hospitals outlines the selection process that goes into purchasing and implementation of
medical devices in hospitals. There are select differences between public and private
entities that influence these purchasing decisions mainly that of investor interest and
governmental funding discrepancies. In both organizations there is a long timeline to
take devices from bidding to actual implementation. First companies must bid the
devices to clinicians and doctors who will ultimately bid the product to the approval
committee of the facilities. While this bid process occurs, the development company is
securing certification and conducting test research of the training with the device and
usability in physical locations. The approval committee uses the information gained from
these tests, focusing on benefits granted to the customer or patient. Their focus is to
ensure patient experience and through ratings and metrices in the clinical trials the
committee will determine the usefulness of the product. If the product is approved and
certified, the development team will work directly with manufacturers to ensure a
constant supply and resupply to the facility. Recent changes have inspired closer
communication between facilities and manufacturers enabling a more seamless
transition from developers to clinical practice.
Learning:
This lecture clarified the certification and purchasing process and further explained
some of the inter-relationships displayed in the previous outline. The purpose of medical
facilities falls in helping the consumers and designing systems that benefit them. As
such, there appears to be a slight disconnect between the development companies who
need this information and the hospitals who have access to this information. Mr.
Contrucci slightly addressed this concern in the development or relationships between
the medical facilities and the developers. With these growing relationships there will be
less over-production costs and the development to implementation time will also
decrease increasing satisfaction for the consumers. As the approval committee relies
heavily on patient satisfaction, the information received from the clinical trials becomes
critical to their approval and understanding of a product. Furthermore, with the costs of
false positives being higher than false negatives, the importance of sure results
outweighs the negatives of time delays in the process. These costs have inspired better
relations with specific developers and manufacturers that when working together are
able to develop and test these products more efficiently. This video outlined the process
map of implementation part of medical devices and the costs associated with approval.
Citation
:
https://www.youtube.com/watch?v=vPEU7Yy94qg
Source 1.3 (Chat GPT)
Question
: How are medical devices developed, certified, and selected by hospitals?
Summary
:
This is a complicated process that is highly regulated. Development takes a clinical need
and researches, designs, and prototypes a solution that will eventually be passed to
regulation testing. The certification ensures compliance with standards set by different
organizations (FDA, EMA, etc.) to protect the safety and efficacy of the proposed device.
A hospital team of physicians, administration, and supply chain specialists, evaluate the
device for compatibility with current systems, and cost to improvement for their
patients. If approved the device will be implemented with training and maintained
expectations put in place to ensure continued compliance with expectations.
Question
: Does certification and development occur simultaneously?
Summary
:
The certification will follow a complete product has been produced. Regulatory practices
and tests are commonly implemented in the process to ensure the product passes the
certification, but certification can not occur in different segments. These certifications
are necessary to sell and produce a product marketed to healthcare providers.
Question
: How are medical devices selected by hospitals?
Summary
:
Hospitals prioritize selection based on clinical needs like population, disease prevalence,
and ulterior treatment options. Then the safety and efficacy displayed through clinical
trials, and post-market surveillance. Following this cost and compatibility are determined
with current systems to view the if the new product could be implemented. In
conjunction with compatibility are training costs associated with the device higher or
lower than expected because this will determine consistency in use and safety for the
patients. Furthermore, the manufacturer must maintain a high reputation and
relationship with the facilities to ensure continued acceptance of their devices because
previous issues or failed promises will impact the facilities ultimate decision.
Question
: How are these selected medical devices re-supplied?
Summary
:
During acceptance of a device, the expectations are set in the contract and are required
to be fulfilled by the manufacturer. The hospital will provide departments of inventory
management or ordering crews who ensure the accurate accounting of product. This
allows facilities to continue operating at optimal levels. Then delivery and replenishment
of materials comes from the manufacturer on order from the facilities or at scheduled
intervals. To ensure compliance on both ends, documentation is required to be managed
and reviewed at consistent intervals.
Question
: Do all medical devices need to be certified?
Summary
:
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In most countries medical devices are required to pass through regulatory agencies.
Within each of these agencies classification systems help to determine the degree of
tests and safety need to each device. There are commonly three classes which the risk
associated increasing with each class. Each of these will require additional development
and certification time due to the risk factor associated with the product. The biggest
difference is at class III pre-market verification is required before developers can even
approach facilities about their product and being clinical testing.
Question
: What does a traceability matrix do in developmental process?
Summary
:
A traceability matrix is a development process tool that outlines all requirements, design
elements, and test cases required for the entire cycle. The name comes from the process
of tracing the product through the entire development process and help provide a
timeline for the entire process. Normally before a traceability matrix can be used the
main idea and regulations associated with the device must be established.
Learning
:
The innerworkings of the process and clarity regarding some specific tools for the
development process came from this conversation. In the developmental phase one of
the most critical steps comes in forming a specific purpose and finding the regulations
assigned with that specific purpose. Without outline the benefits to the consumer and
necessary plan to accomplish that goal, a company cannot hope to succeed and
maintain efficiency in the development process. Furthermore, there are many costs
associated with implementing a device that are commonly not thought of like training
and compatibility with current systems. Each of these defines either a simple injection
solution or a complete process rework. If the benefits associated with product outweigh
the injection or rework costs, then the hospital is likely to request and supply the new
device. Furthermore, these costs and regulations must be accounted for during
development to craft a usable traceability matrix and achieve clear expectations for their
product.
Citation
: Chat GPT
Level 2 Sources
Source 2.1 (Doctoral Theses) “Systems Theoretic Hazard Analysis (STPA) applied to the risk
review of complex systems”
Summary
:
An inefficiency in the process and development system comes from quantifying the
safety and risk of different medical devices. The current systems fail to utilize the
interactions between human, software, and systems leading to inaccurate data and time
inefficiencies. These inefficiencies increase costs and fail to allocate resources correctly.
As these safety checks are required for most products in the medical field,
improvements in this system would help decrease costs and increase the quality of
customer satisfaction with the medical industry. Mr. Blandline outlines a new process
STPA (System-Theoretic Process Analysis) which utilizes the connections between
departments to better understand and identify risks points in a products certification
process. He outlines different disconnects in the system that cause inefficiencies while
assessing the risks within the facilities of hospitals. His system implements better
connection between software and human analysis which allow more accurate readings
to be made.
Learning:
There are constantly methods that can be utilized to improve the overall efficiency of the
system. Commonly the issues associated with the medical process comes in the form of
time wasting and transportation costs between departments. These costs are wastes of
resources and can be better optimized as shown in the study above. In the study the
certification process for radiology technology falls under intensive requirements and
expectations that require constant monitoring and re-evaluations. These checks while
important are performed in a way where human information is passed from department
to department. These facilities already have software implementations of the
information and simply need to streamline the system and create more flow which will
empower the efficiency of certification desired by the patients. Furthermore, these
software and human solutions help to outline the risks associated with the different
devices which help guide the development companies when digesting their results from
these clinical and post-market trails.
Citation:
Antoine, Blandine. Systems Theoretic Hazard Analysis (STPA) applied to the risk review of
complex systems: an example from the medical device industry. Diss. Massachusetts Institute of
Technology, 2013.
Source 2.2 (Trade Journal) Trends in Biotechnology: The Regulation of Wearable Medical Devices
Summary
:
This provides specific information about the certification process in different agencies.
Furthermore, this process outlines the purposes and need of developers to prep devices
in a way that fulfills the different intended designs for the individuals. First, the product
must be classified, or its purpose must be categorized, and requirements associated with
that class must be met during design and development. Throughout the developmental
process regular checks and balances will take place to ensure compatibility with class
expectations and future certification after development. These devices are then taken to
certification facilities where they will undergo clinical trials to ensure compatibility with
regulations. If preliminary expectations are made, a pre-market assessment will be
granted to enable advertising and pre-sales of the product to different facilities.
Furthermore, this source outlines the pre and post classification processes that each
device must undergo to ensure compatibility and safety for the patients and consumers.
Learning:
These process specifics of certification became clearer using different visuals, examples,
and explanations. The development process is broken into three departments, design
and manufacturing, evidence collection, and conformity assessment. These departments
help to distribute the load of information and expectations across the available
resources and decrease the bottlenecks that one department could have. Each
department caries a specific part of the certification process to break up the wasted
waiting time associated with gathering evidence and assessing regulations. Another
process maps outlining the certification process provided critical timelines and
milestones for each device. The connection between certification and marketing are
critical to the success of a product. To begin the process of implementation and
advertising a company must receive preliminary results to provide practical proof of
devices uses and risks to begin crafting facility bids. These processes built on the
foundation of complexity of this process and how communication and departments are
required to the success of a medical device.
Citation:
Jiang, Nan, Julia E. Mück, and Ali K. Yetisen. "The regulation of wearable medical
devices." Trends in biotechnology 38.2 (2020): 129-133.
Source 2.3 (Ted-Talk) “How to get vaccines to the right place at the right time”
Summary
:
The development of vaccines follows the same processes outlined above but are more
generalized in their delivery to the world. With this generalization of the distribution,
many issues in transportation and quality have been exposed. Organizations, after the
vaccinations have been approved, will move to order, and receive the dosages to
vaccinate individuals. To ensure quality control the transportation companies have
implemented temperature verification devices and path assessment. Each of these
implementations help to improve the efficiency of the system and ultimately deliver
more product and improve the customer satisfaction.
Learning
:
The previous sources outlined the process and helped to display potential issues within
the interconnect processes, but this source takes a specific product and shows those
issues in action. Quality and safety are requirements within the healthcare industry and
those requirements lead to difficult in the transportation of goods especially in less
developed countries. While a product may be certified for use, the standards for
maintaining that certification often prove difficult to maintain. With longer
transportation time between facilities, goods, such as vaccines, can be exposed to high-
risk issues and lose their safety rating and must be tossed aside as waste. This article
clearly outlined issues in transportation, inventory, throughput time, defects, and
waiting time. The current systems fail to maintain certified standards causing defects
during transportation and decreasing the total amount of goods that can be transported
while maintaining quality and decreasing defects. These wasteful sections are different
in every facility, but nonetheless imply inefficiencies in the system overall.
Citation:
https://ideas.ted.com/how-to-get-vaccines-to-the-right-place-at-the-right-time/
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