Quality Systems for Increased & Responsible Humanitarian Medical Device Production
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We empower creators of low-resource "appropriate" medical devices with Quality Systems for responsible & effective development, production, and distribution!
About You
About You
First Name
Keith
Last Name
Pennington
Twitter URL
Facebook URL
About Your Organization
Organization Name
EQUIPT Global Health
Organization Website
Organization Country
United States, IN, Warsaw, Kosciusko County
Country where this project is creating social impact
Is your organization a
For‐profit
How long has your organization been operating?
Less than a year
Has the organization received awards or honors? Please tell us about them
n/a
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Innovation
Select the stage that best applies to your solution
Growth (your pilot is up and running, and starting to expand)
How long have you been in operation?
Operating for less than a year
The Need: What problem are you trying to solve?
There is a lack of 'appropriate' medical devices in the developing world in general, this is well documented. The causes for this are a lack of:
1) Proven appropriate humanitarian medical device designs
2) Production and distribution of proven designs
The lack of a “Culture of Quality” in the field is a major contributing factor to both of these causes. Government regulations may not be in place to require quality systems to guarantee patient safety, so these systems may not exist.
Quality systems and principles are necessary for responsible device development: minimizing risk to patients, and even recognizing success!
Local manufacturers are often lacking modern quality systems, so devices are made elsewhere and need to be (expensively) shipped, prohibitively increasing costs.
The Solution: What is your solution? Be specific!
We will work with promising humanitarian medical device projects, implementing appropriate Quality Systems from early on, as well as training to make the quality system self-sustaining within the company.
These Quality Systems will establish a framework to address the following areas: Management Responsibility, Design Controls, Risk Management, Document Controls, Postmarket Surveillance, Statistics, CAPA, and Production and Process Controls. Special attention will be paid to Training, Design Inputs, Design Risks, Postmarket Surveillance, as well as Supply Chain Management and Preservation of Product as these have unique challenges for humanitarian devices.
We will also guide responsible design transfer, as most of the manufacturing will likely be accomplished outside the organization itself. This is particularly important - the manufacturer may need similar structure themselves if they are new to manufacturing medical devices. This will enable production and build local capacity.
The Model: Walk us through a specific example of how your solution makes a difference; include your primary activities
First, we do an assessment of the medical device group's current systems in terms of their progress and specific situation. Sometimes they even have a (usually unregulated) device on the market... so we can adjust to audit the most important parts of the system for responsible operations.
We then compare their systems with GHTF guidelines (basically the backbone of all international regulations for responsible medical device development) and applicable standards and regulations, looking for the presence of all key areas crucial to the correct methods of development, production, and distribution.
We may find, for example, a system with no supplier controls, no meaningful method of postmarket surveillance, or no adequate process for incoming inspection. (These problems, if severe enough and under FDA jurisdiction, could get company executives put in prison - but these controls are often seen, amazingly, as *optional* in the developing world!)
We then work closely with the company to create the appropriate procedures, policies, manuals, specific work instructions, and/or forms necessary to align with the GHTF and relevant standards & regulations, and to do their best to guarantee patient safety and device effectiveness.
Following implementation, we will work with and train members of the organization so that the Quality System is self-sustaining.
We then similarly work with the primary organization's local suppliers (or manufacturing "hand-off" partners), who may be new to medical device development.
The Marketplace: Who are your peers and competitors? Identify others also working to address the needs you are and what differentiates you from them. What challenges could these players pose to your success or growth?
Our primary competitors as I see it are:
1. People operating outside their expertise (sometimes busy engineers or designers, sometimes lawyers trying merely to work around regulations!),
and
2. Professional medical device quality consultants who do not work primarily with appropriate devices in low-resource settings - there are only a few instances of this that I am aware of.
We have no direct competitors who focus on Quality Systems in the low-resource appropriate medical device field (that I know of).
This is a big part of why I say there is a lack of a "Culture of Quality" in general, and a big part of the inspiration for EQUIPT to exist!
This Entry is about (Issues)
Social Impact
Founding Story: We want to hear about your "Aha!" moment. Share the story of where and when the founder(s) saw this solution's potential to change the world.
We noticed at a conference that most “appropriate” medical devices are ideas and prototypes, often presented as “design exercises” – and are only rarely produced and distributed. That is going to shift, and everybody sees it. There is no such thing as a successful design that is not used, and many groups are gearing up toward production.
Since these devices are often created by design firms or students who have little to no experience designing medical devices, they can be unaware of Quality Systems required to responsibly produce ANY medical device. Production without a Quality System is dangerous, counterproductive, and often illegal. Furthermore, many target areas for distribution do not have regulations for medical devices, creating a dangerous combination.
We saw that this was an enormous weakness in what is otherwise a great effort. Many issues with these devices can be remedied and improved using Quality principles.
We know quality well, the rest is implementation.
Please describe the goal of your initiative; outline what you are trying to achieve
We aim to increase the impact of beneficial medical devices in low-resource settings by increasing the adoption of effective, modern, and appropriate quality systems and techniques within the organizations that make these devices.
We want to see:
1. More appropriate medical device projects get off the ground responsibly, quickly, and effectively!
2. "Appropriate" medical device development taken as seriously as "main-stream" medical devices:
- Designs of appropriate/low-resource medical devices done correctly, systematically factoring in risk at every stage.
- These devices responsibly handled with systematic safeguards to protect the end patient/user once produced.
3. A trend and awareness develop within the appropriate medical device community toward a culture of quality.
What has been the impact of your solution to date?
Examples:
We have developed responsible design controls and processes for an extremely low-cost blood transfusion device start-up, which is rapidly approaching clinical trial stage with our help.
We are closely working with group that has a low-cost, easily repairable manual centrifuge to develop an overall quality management system to prepare them to take their next step and get out of "proof-of-concept prototype stage" to become a responsible medical device company in their own right.
We are working on improving procedures related to product realization (especially sourcing, supplier controls, and inspection) for a manufacturer that produces thousands of appropriate medical devices per year, and is aiming to increase their impact by over tens of thousands of devices within 2012.
We currently have ongoing relationships with these groups and 6 others, and other potential partnerships are developing rapidly.
We remain quality resources to these organizations when needed.
What is your projected impact over the next five years?
We will broaden our base of partners to include large centers with multiple projects for larger impact, as well as significantly increase the number of individual project groups we work with.
Through these experiences through partners, we will develop new standard techniques and quality procedures that are especially effective in low-resource settings, and we will make these available for broad distribution to *all* groups engaged in low-resource appropriate medical device development (not only clients).
And, hopefully, we will help bring modern quality practices into the minds of the global health community!
Winning entries present a strong plan for how they will achieve and track growth. Identify your six-month milestone for growing your impact
Establish several solid partnerships & complete full system audits on each. Research low-resource quality issues.
Identify three major tasks you will have to complete to reach your six-month milestone
Task 1
Partner with 3-6 ongoing appropriate medical device projects (# depending on scope)
Task 2
Complete system audits on all partner projects, begin system strengthening
Task 3
Research / compile list of all Appropriate Medical Device Projects, & their success and failures
Now think bigger! Identify your 12-month impact milestone
Make partners successful!
Identify three major tasks you will have to complete to reach your 12-month milestone
Task 1
Successfully empower partners with excellent quality systems, ensuring patient safety!
Task 2
Advance projects to next stage (e.g., prototypes to clinical trials, trials to initial production, full distribution, etc)
Task 3
Publish a book describing, in simple terms, key Quality System aspects and how to implement them in medical device companies
Sustainability
Tell us about your partnerships
The relationships that we are currently fostering are: social entrepreneur groups with medical devices (both start-ups and established organizations), design groups, university tech-transfer departments, and start-up incubators where humanitarian medical device projects are growing.
We hope to partner with funding groups as well, to help identify the most serious projects with the most potential for success for future funding, as well as strengthen that group’s portfolio through quality improvements to the individual projects.
Are you currently targeting other specific populations, locations, or markets for your innovation? If so, where and why?
Humanitarian Medical Devices are created for every country, in every region. We hope to have broad influence and help to foster a culture of quality in the production and distribution systems of these devices.
What type of operating environment and internal organizational factors make your innovation successful?
Quality Systems are difficult to create in any medical device company, and they are especially difficult when the organization is producing and distributing in low-resource settings. Regrettably, though, in these especially-difficult situations, the systems are often made by non-quality-experts operating outside their expertise. This results in internal inefficiencies and wastes of time and effort by otherwise capable and productive professionals struggling to learn the foreign field of Quality.
We have a practical understanding of quality principles that apply globally, and I can say without reservation that every design group we have spoken with has been interested - usually, thrilled - that we are taking seriously what to them is troublesome and a chore - and that we enjoy it!
Please elaborate on any needs or offers you have mentioned above and/or suggest categories of support that aren't specified within the list
We need networking assistance most of all. We cannot exist without collaboration, and many medical device projects struggle and die during the phase when we could help.
 | 14 weeks agoKeith Pennington said: Pretty much, yes. We're not really saying that they should go out and get ISO 13485 certified (because that can cost 6000-15000 dollars ... about this Competition Entry. - read more > |
| 14 weeks agoKeith Pennington said: ".. Quality systems like ISO 13485 can typically only be embraced by major OEMs with deep pockets, and don't lend themselves to low ... about this Competition Entry. - read more > |
| 15 weeks agoKeith Pennington updated this Competition Entry. |
| 15 weeks agoKeith Pennington updated this Competition Entry. |
| 15 weeks agoKeith Pennington updated this Competition Entry. |
| 23 weeks agoKeith Pennington updated this Competition Entry. |
| 23 weeks agoKeith Pennington submitted this idea. |
