Clinical Trial Participation - Diversity

Medical products are safer and more effective for everyone when clinical research includes diverse populations.

Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products — drugs, biologics, and devices, submitted to the agency for marketing approval:

1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.

It is important to test drugs and medical products in the people they are meant to help. The FDA works to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.

The Office of Minority Health is leading groups made up of many FDA centers to develop actions to reduce health disparities.

  • FDASIA Section 907 required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation. Congress directed the Agency to issue the action plan one year following the Sec. 907 reports publication.
  • More information on CERSI (Centers of Excellence in Regulatory Science and Innovation)
  • Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
  • Questions and Answers about section 907
  • Drug Trials Snapshots: Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported new drugs' FDA approval. The Snapshots' information also highlights any differences in the benefits and side effects among sex, race, and age groups. Drug Trials Snapshots as part of an overall FDA effort to make demographic data more available and transparent.

More Information on Diversity in Clinical Trials

  • Men During Their Reproductive Years
    It gives men who were previously excluded because of potential reproductive harm access to clinical trials to treat life-threatening diseases.
  • Women
    See how the FDA and the Office of Women’s Health are working for diversity in clinical trials.
  • Minority Health Resources
    See how the FDA Office of Minority Health keeps you informed about; safe medication use, diabetes, food safety, product approvals, HIV/AIDS, and clinical trials.
  • Racial/Ethnic Groups
    Reviews the participation of racial or ethnic groups in clinical trials (data from 1995 to 1999).
  • NIH Office of Equity, Diversity, and Inclusion
    Sexual and Gender Minority
  • Older Adults
    Information on why older adults should participate in clinical trials.
  • Children
    A Consumer Update article from January 2010 on children and clinical trials.

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FDA Pre-Submission (Q-Sub) and Medical Device Companies

There is always uncertainty baked into any government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(k).

The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics, and drug submissions. It’s a great service to take advantage of, only we’ve found that it tends to get underutilized.

What is the Pre-submission?

The Pre-Submission allows you to request formal feedback on your medical device before you make a move to submit your 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following:

  • Pre-Submission (what we’re focusing on here)
  • An informal meeting
  • An agreement meeting
  • Other (such as submission issues or study risk determinations)

The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help keep your company on track for getting your device to market as soon as possible — it helps to be aware of possible issues ahead of time and deal with them before final submission.

The guidance for Pre-Submission is clearly laid out in the FDA document Requests for Feedback on Medical Device Submissions. If you happen to have a combination product (such as a stent that administers a drug or an inhaler), there may be other, similar processes you need to go through. The document to check out, in that case, is Guidance for Industry.

In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from the FDA to be provided in a formal written response, meeting, or teleconference. The feedback is documented in meeting minutes.

It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that keep you up at night and making your overall submission process easier.

The FDA continues to expand its Pre-Submission program to include several different medical device submissions that a manufacturer may choose to bring a device to market. The comprehensive list of submission types is known collectively as Q-Submissions(Q-Subs), which include:

E, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.

  • Investigational device exemptions (IDE)
  • Premarket approvals (PMA)
  • Premarket notifications (510(k))
  • Dual
  • HDE — Humanitarian Device Exemption
  • De novo requests
  • Clinical Laboratory Improvement Amendments (CLIA)
  • Certain Investigational New Drug Applications (IND) and Biologic License Applications (BLAs)
Benefits of the Pre-submissions

Should I really use a Pre-Submission? This is a key question that companies often ask, so it’s important to understand the relative pros and cons. Here are some of the pros:

  • You develop a “human” relationship with the FDA. They are, after all, humans themselves and want to know who you are.
  • You can remove some of the risk elements from your submission. You get asked about things you don’t know and confirm things that you think you do know.
  • You can get “free advice” to help drive your development and regulatory strategy.
  • Sometimes the FDA will request a review of Pre-Submission materials, giving you a “bonus round” ahead of your 510(k) submission. This is a great opportunity to gain valuable feedback.

One thing to note is that you’re not getting a final acceptance at this stage; the FDA will never give you this until the actual submission. However, it’s well worth getting the early heads-up.

Cons of the Pre-submission

There’s always a money and time aspect. You’re looking at $5,000 to $25,000 to have a consultant help you with a Pre-Submission. If all timelines are met, the typical process takes 60–75 days.

A con that is frequently raised is, “What if they tell us no and say we have to do X, Y, and Z instead of what we’re already doing?”

Our answer to this will always be the same: Isn’t it better to know about this now rather than go ahead with your 510(k) submission and find out then? The FDA will pick out that same issue regardless, so it’s a much better use of your time to find out about it during a Pre-Submission.

Perhaps these cons are a big part of the reason that the Pre-Submission is underutilized, but I would strongly suggest that you don’t let them put you off using it. The FDA actively encourages medical device manufacturers to use the Pre-Submission because doing so helps the final submission's overall quality.

Conclusions

A Pre-Submission program is a valuable tool that tends to be underutilized. Perhaps companies are put off by the idea that the process will take too much time and money, or they’re worried that the FDA will tell them they need to do something they hadn’t already planned on doing. In Kaiyan Medical, we make sure our devices are FDA cleared and we constantly communicate with the FDA. Like many other medical device companies, you may find it’s well worth the time and money.

Design Thinking is not Only for Products but Also for Sales

Over the past few years, design thinking has quickly gained momentum in the business world. Some of the world’s leading brands have embraced design thinking as a means of optimizing product innovation. At its core, design thinking is a methodology for creative problem-solving. In stark contrast to analytical thinking, which involves breaking down ideas, design thinking involves building up ideas.

While design thinking has firmly implanted itself across product development teams, it has not secured a stronghold across sales teams — yet. Characterized by routinized activities, traditional sales methodologies tend to be at odds with the iterative methodology underpinning design thinking.

Times are changing. The sales cycle is becoming increasingly complex, and customers are demanding a more personalized experience. If you’re a sales rep, you know you need to up your game and become more innovative. Sales teams are recognizing the value of incorporating a design thinking approach into their daily activities. Salesforce’s sales team, for example, has embraced design thinking in its sales discovery process and has realized a 100% increase in revenue growth as a result. It’s time sales teams more broadly recognize the value of design thinking.

1. Empathize

Empathy is at the core of design thinking. Empathy involves both a cognitive dimension — an ability to look at a situation from another person’s perspective — and an affective dimension — an ability to relate to a person and develop an emotional bond with them.

The importance of empathy in sales cannot be overstated. Empathy is a key predictor of sales success. A groundbreaking study published in The Journal of Marketing Theory and Practice found a strong positive relationship between empathy and a buyer’s level of trust and his/her level of satisfaction. In our current sales landscape where a mere 3% of buyers trust reps — the only professions with less credibility include car sales, politics, and lobbying — seller trust is in short supply and high demand.

Empathy is especially valuable in the sales process because it encourages information sharing. Research has found that, according to buyers, the number one way for salespeople to create a positive sales experience is to listen to their needs. When we’re armed with so much information and data and a slew of AI and machine learning solutions, it’s easy to assume we know everything about the buyer. It’s important to first step inside your customers' shoes and listen to what really matters to them and what is top-of-mind.

2. Define

The defining stage's objective is to craft a problem statement or, in design thinking speak, a point of view. So often, salespeople define the problem before developing an empathetic understanding of a buyer’s needs. The result is solution selling. Solution selling has long past its expiration date. At least 50% of sales reps’ prospects are not good fits for their offering. Only by defining the buyer’s problem can salespeople determine whether there is a lucrative fit.

The define stage involves asking a lot of questions. Perhaps contrary to popular belief, this focus on questioning does not impair sales conversation but enhances it. According to one analysis of 519,000 discovery calls, there’s a clear relationship between the number of questions a sales rep asks a buyer and his/her likelihood of success.

3. Ideate

The ideate stage unlocks the true potential of design thinking, especially in the context of sales. This is when the focus shifts from problem identification to solution generation. And it’s all about quantity — about generating a wide range of possible solutions, not necessarily the final solution. It involves thinking beyond the obvious and necessarily entails significant creativity. How can I craft an offering that is uniquely suited to my buyer?

While often pushed under the carpet in sales, creativity is essential to sales and a key predictor of success. Research from the Aston Business School, a highly-regarded business school in Europe, revealed that sales professionals who were more creative generated higher sales than their less creative counterparts. Another study by Adobe found that companies that foster creativity are 3.5 times more likely to outperform their peers in revenue growth.

When crafting solutions to customers’ problems, sales reps must dig deep for their creative juices. How can you craft a sales pitch that strikes a strong emotional chord with the customer? Which decision-makers, in and beyond the C-Suite, should you involve? If the customer sells a free or inexpensive product or service, take it for a test run. Read through customer community forums and reviews. Don’t let up in terms of stepping inside the shoes of your customer. Only by embracing these types of activities can ideation be optimized.

4. Prototype

The fourth stage of the design thinking process is prototyping — developing more fleshed-out and scaled solutions. Prototyping shouldn’t be done in a black box — otherwise, you are sure to lose momentum. Prototyping is an opportunity to have a more directed conversation with your customer after the discovery calls. The most effective sales reps will involve champions and other affiliates from the customer’s organization in the prototyping process and vet ideas. Involving tangential stakeholders in the solution process goes a long way in making them feel valued and invested in the final solution.

5. Test

The final stage of the design thinking process is to test the final offering. This necessarily involves unveiling the fully fleshed-out pitch to all key stakeholders. During the test phase, salespeople need to be strategic and see themselves on the same team as the customer. They should use collaborative words and phrases — words like “we” and “together.” The “you versus us” mentality is dangerous.

Forrester predicts that one million US B2B sales reps will be out of a job by 2020. Salespeople can no longer afford to rely on so-called tried and true approaches. Nearly six in ten salespeople say that they don't change it when figuring out what works for them. In a world where each customer yearns personalized selling wants, this mindset is problematic. Design thinking — which is especially well suited for solving ambiguously defined problems — is key to establishing a genuine connection with customers and engaging them throughout the sales process. It’s key to sales success.

What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies aim to improve disorders' prediction by identifying and understanding how genes and illnesses may be related. Research in this area may explore how a person’s genes make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological Studies seek to identify the patterns, causes, and control of disorders in groups of people.

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some are “impatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.

Phases of Clinical Trials: When Clinical Research is Used to Evaluate Medications and Devices
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

  • Phase I trials
    Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
  • Phase II trials
    The experimental drug or treatment is given to a larger group of people to see if it is effective and further evaluate its safety.
  • Phase III trials
    The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information to allow the experimental drug or treatment to be used safely.
  • Phase IV trials
    Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information, including the treatment or drug’s risks, benefits, and best use.

Examples of Other Kinds of Clinical Research
Many people believe that all clinical research involves testing new medications or devices. This is not true, however. Some studies do not involve testing medications, and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to the results of people with the illness being studied. Some examples of other kinds of research include the following:

  • A long-term study that involves psychological tests or brain scans
  • A genetic study that involves blood tests but no changes in medication
  • A family history study involves talking to family members to learn about people’s medical needs and history.

Advantages of Medical Device Manufacturing in China Post Covid-19

China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. The medical device manufacturing sector specifically recorded an astounding 46.4% growth.

High-Quality Human Resources

Despite living in the age of automation, labor remains one of the higher costs of manufacturing. Manufacturing companies in the west have to deal with worker’s unions, paying high wages, and inflexible staffing that cannot readily scale and resize as fluctuating production output needs may require. On the other hand, achieving this flexibility level is easier for Chinese manufacturers due to China’s readily available, efficient workforce. This used to be the primary reason for companies to outsource their manufacturing activities in China.

Manufacturing in China can significantly bring down overall production costs, and a large part of those savings is due to Chinese labor efficiency. Chinese facilities have been optimizing manufacturing costs for decades and have largely achieved very efficient workforce operations. Depending on the labor intensity of product manufacturing activities, a Chinese facility can offer an excellent number of parts produced per work hour spent.

Low Raw Materials Cost

Another most important manufacturing cost is raw materials cost, for which China also provides a cost-effective option, for two main reasons. Firstly, the same labor efficiency condition exists throughout the entire raw materials production value chain. So Chinese manufacturing companies can themselves access cost-efficient raw materials than most companies based in other countries. Secondly, the transfer of materials is cheap since it only happens from close sources and within China. This results in avoiding long shipping routes, additional customs tariffs, and long delivery waiting times. When manufacturers in all industries are trying to cut expenses and maximize profits to remain competitive, access to affordable raw materials can help bring down manufacturing costs to a considerable extent.

Most Chinese manufacturing facilities will typically have low cost local (or close) material suppliers. This way, they gain a significant cost advantage that further contributes to their cost-effectiveness.

Strategic Location

Companies worldwide are nowadays targeting the growing Asian markets, so much so that the phrase “expand to Asia” has become somewhat of a cliché business term. China is the largest of those markets, with its consumer market surpassing $6 trillion in value. Moreover, it also benefits from its proximity to several large and growing markets, such as India and South Korea. In terms of regulatory compliance, medical devices of Chinese manufacturing have no issues in being accepted in both the country’s domestic and other Asian markets. So outsourcing medical device production to China gives manufacturers access to its rapidly growing domestic market, as well as immediate access to its developing neighboring markets.

Evolving Supply Chain Network

In times of market, instability is when a supply chain is a huge determining factor for a manufacturer’s chance for survival. Chinese materials suppliers have been rapidly evolving, following the country's growing trend of becoming an international manufacturing hub. This has made it easier for medical device contract manufacturers to identify and establish a trustworthy network of reliable local suppliers.
This gives the more top tier Chinese manufacturers such as Kaiyan, the opportunity to create resilience in the face of the coronavirus outbreak. Additionally, a robust supply chain allows for a manufacturer’s flexibility to offer simple, efficient, and flexible options for increasing or scaling production as market needs change. What’s also important is that this supply chain evolution has also increased quality standards, which is a decisive factor in medical device manufacturing.

Access to Cutting-edge Technology

Realizing the potential of its market in the era of globalization, China has spent the last decades developing its technology. Heavy investments in research and development, importing talent and technology, and the emergence of specialized tech hubs have helped China gain an innovation edge over other emerging countries. The mentality of rapid research and development is of notable importance and surpasses the speed of many tech hubs in the west. Part of the reason this happens is that such a large portion of the world’s product manufacturing has been outsourced to China. And the low costs achieved by Chinese companies are not the result of just cheap labor, but also, to an extent, involve practical applications of innovative technologies.

Flexible Scale of Manufacturing

Another benefit of manufacturing in China is the ability to scale up or down as needs change. Top tier Chinese factories such as Kaiyan’s facilities are manufacturing products for many companies at the same facility, so they have the means to produce large quantities and adapt according to the market’s and customer’s needs. And being able to scale up easily is an obvious advantage. A critical characteristic of every trade is offering product availability. As you market your medical device to new markets, customers, importers, and distributors, you will be required to increase quantities and ensure timely delivery. Manufacturing your medical device in a Chinese facility that can support scaling up production becomes an obvious advantage.

Clinical Trials for Medical Devices: FDA and the IDE Process

What is a Medical Device?

Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.

Medical Device Classes
  • Class I — General Controls — Most exempt from premarket submission.
  • Class II — Special Controls — Premarket Notification [510(k)].
  • Class III — Premarket Approval — Require Premarket Application [PMA].
510(k) Premarket Notification
  • Substantial equivalence.
  • 10–15% require clinical data.
  • Performance testing.
  • Usually confirmatory.
  • Type of study dictated by
  • The ability of bench and animal testing to answer questions.
  • Amount of difference between subject device and predicate.
PMA Premarket Approval Application
  • Establish reasonable assurance of safety and effectiveness.
  • Bench-Animal-Human.
  • Clinical Studies.
  • Feasibility and pivotal.
Stages of Review for PMA Device
  1. Pre-Sub: Discuss the device design, bench/animal testing, and the clinical trial
  2. IDE: Request approval for a clinical trial.
  3. PMA: Request market approval.
  4. PMA-S: Request approval for device change or upgrade.

What is an Investigational Device Exemption (IDE)?

The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.

Device trials are unique.

  • Trials tend to be smaller than drug trials.
  • Some novel, many “me-too.”
  • Many difficult to blind, randomize, and control.
  • Many depend on physician technique.
  • Device modifications occur during the trial.
  • Endpoints are highly diverse.
  • Typically, a single pivotal trial follows the feasibility stage(s).
  • Designed to support a “reasonable assurance of safety and effectiveness” for the marketing application.

Types of IDEs

Feasibility Study
  • May provide support for a future pivotal study or may be used to answer basic research questions.
  • Not intended to be the primary support for a marketing application.
  • Endpoints and sample size are generally not statistically driven.
  • Often required by the FDA before the pivotal study to assess basic safety and potential for effectiveness.
  • Generally ~10–40 patients but may be larger.
  • The FDA review is primarily focused on safety and whether the data's potential benefit or value justifies the risk.
Pivotal Study
  • Designed to demonstrate a “reasonable assurance of safety and effectiveness. ness.”
  • Generally intended as the primary clinical support for a marketing application.
  • Endpoints and sample size are statistically driven.
  • Designed to assess both safety and effectiveness.
  • FDA review is much more complex.

Basic Submission Elements

Background of medical issue, the study goals, and why this study will further the science.

A Detailed Description of the Device Understudy
  • Previous studies (preclinical and clinical).
  • Summary of available data.
  • Why is a clinical study needed at this stage?
  • What evidence supports this study/device's safety and the study data's potential to be meaningful?
  • Are there outstanding safety questions that should be addressed with preclinical data?
Risk analysis

Should include:

  • What are the potential risks to the patient?
  • Does the study mitigate the risks where possible?
  • Are the risks outweighed by the potential for benefit and/or value of the study?
  • Patient monitoring and follow-up plan.
  • Inclusion and exclusion criteria.
  • Informed consent document.
  • Sample size and the number of investigational centers, with justification.

Submission Elements, Pivotal IDEs

Primary and Secondary Endpoints

Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria

Basic Trial Design
  • Controlled? If not, why not?
  •   Randomized? If not, why not?
  •   Blinded? If not, why not?
Trial Conduct and Study Monitoring
  • Sponsor blinding
  • Data handling and adjudication process
  • Independent committees
  • Case report forms
  • Is the right information being gathered to support the study endpoints, and are investigators adequately prompted to report adverse events?

Primary Endpoint Design

Should evaluate the safety and effectiveness of the device in the population expected to be indicated.

  • Generally divided into 1 or more “safety” endpoints and 1 or more “effectiveness” endpoints.
  • A study will be considered successful if both the safety and effectiveness endpoints are met.
  • The clinical protocol should clearly and prospectively detail: — Methods for obtaining endpoint data — Definitions for what will be counted as a primary event in the analysis — Situations in which patient data will be excluded — How missing data will be handled — How the impact of covariates will be assessed.

Sample Size & Follow-Up

Driven by either:

  • Primary safety endpoint
  • Primary effectiveness endpoint

The minimum number of patients and/or minimum duration of follow-up may be required depending on:

  • Understanding of the device's safety and effectiveness  
  • concerns regarding the durability of device safety or effectiveness.

Secondary Endpoints

Generally used to evaluate additional meaningful claims.

  • Generally only considered if primary endpoints are successful.
  • It should be used to provide further insight into the device's effects and mechanisms of action.
  • Definitions and analysis methods should be clearly detailed prospectively.
  • Not considered “statistically significant” unless a pre-specified alpha allocation plan is in the protocol, even if the p-value is < 0.05.

FDA’s IDE Review Decisions

  1. Approval — Approves the trial for a specified number of patients and investigational centers.
  2. Approval with Conditions — Allows sponsor to begin the trial if the sponsor agrees to address the conditions (deficiencies) from the conditional approval letter within 45 days.
  3. Disapproval — The trial may not start until the sponsor addresses the letter's deficiencies, submits this information to the FDA, and receives approval.

Conclusions

One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.

Clinical Trial Participation - Diversity

Medical products are safer and more effective for everyone when clinical research includes diverse populations.

Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products — drugs, biologics, and devices, submitted to the agency for marketing approval:

1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.

It is important to test drugs and medical products in the people they are meant to help. The FDA works to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.

The Office of Minority Health is leading groups made up of many FDA centers to develop actions to reduce health disparities.

  • FDASIA Section 907 required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation. Congress directed the Agency to issue the action plan one year following the Sec. 907 reports publication.
  • More information on CERSI (Centers of Excellence in Regulatory Science and Innovation)
  • Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
  • Questions and Answers about section 907
  • Drug Trials Snapshots: Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported new drugs' FDA approval. The Snapshots' information also highlights any differences in the benefits and side effects among sex, race, and age groups. Drug Trials Snapshots as part of an overall FDA effort to make demographic data more available and transparent.

More Information on Diversity in Clinical Trials

  • Men During Their Reproductive Years
    It gives men who were previously excluded because of potential reproductive harm access to clinical trials to treat life-threatening diseases.
  • Women
    See how the FDA and the Office of Women’s Health are working for diversity in clinical trials.
  • Minority Health Resources
    See how the FDA Office of Minority Health keeps you informed about; safe medication use, diabetes, food safety, product approvals, HIV/AIDS, and clinical trials.
  • Racial/Ethnic Groups
    Reviews the participation of racial or ethnic groups in clinical trials (data from 1995 to 1999).
  • NIH Office of Equity, Diversity, and Inclusion
    Sexual and Gender Minority
  • Older Adults
    Information on why older adults should participate in clinical trials.
  • Children
    A Consumer Update article from January 2010 on children and clinical trials.

Light Therapy & the Five Steps of the Creative Process

The creative process has traditionally been broken down into the following five stages: preparation, incubation, insight, evaluation, and elaboration. These terms themselves likely won’t do much for your creative spirit, but below, we’ve broken each down to help you understand and relate to them more easily.

Preparation

Preparation sounds a bit like you’re studying for an excruciating exam you’ve got to take in the morning, but this feel-good phase is where your best ideas are born.

Think of it as if you’re taking an exciting journey into the creative space that appeals most to you. In today’s modern world, that might look like exploring a specific hashtag like — #lighttherapy, #redlight, #redlighttherapuy, etc. It could also look like deep-diving into autobiographies of artists who inspire you, perusing artist websites and their virtual galleries, watching documentary films on the topic, listening to music, reading through poetry, or as I do, just watching my surroundings.

In some cases, how you “prepare” may not be directly related to your specific medium. Can be from the coffee you are taking to the peer you are speaking to. Wherever this stage takes you, commit to it wholly and truly relish in it. Take notes. Observe what (and how) these other entities have created, lay down ideas as they come to you, colors that inspire you, sounds that move you, and words that catch you by surprise.

Incubation

Now is the time to let all that information and inspiration you just breathed in soak into your very core. In this stage, it may not even feel like you’re really doing anything since it’s your subconscious that’s actually doing all the work. In that sense, you can liken this step of the creative process to allowing a piece of steak to marinate overnight in a juicy bath of flavors. The meat is just sitting there to the naked eye, but a delicious transformation occurs, in reality occurs.

Insights

We alluded to a lightbulb flickering on in the previous stage, sending a person into a full-fledged creative frenzy they couldn’t possibly suppress. This moment is traditionally referred to as the “insight” stage of the creative process, or what some have playfully dubbed the “Eureka” moment.

This is the step we’re arguably most all familiar with, and the one we wrongfully assume is a stepping one. Perhaps this incorrect assumption causes many to conclude that you must be an inherently gifted creative person ever to experience such a moment. As you now know, the reality is that it might have taken days, weeks, months, or even years for such inspiration to hit. This is true even of the greatest artists our world has seen.

Another false assumption is that this Eureka moment is always loud and gut-punching powerful. While it does sometimes hit as an unmistakable spark of inspiration-born direction, it is important to note that sometimes the insight moment is more of a quiet, contemplative whisper. It also might not happen quite as cinematically as we’d like to think. Many even say that such inspiration strikes or develops when they least expect it — while making dinner, having a conversation with a friend, or in the middle of folding a giant load of laundry. The argument is that doing something that doesn’t require much brainpower gives your subconscious some time to churn.

Evaluation

The creative process would be remiss without acknowledging that not every creative idea is a great (or even good) idea worth pursuing. This is the phase where you really dig deep — as tricky and painful as it might be to your ego — and ask yourself if this is an idea that’s ultimately worth working on.

Instead of framing it as a potential way to squash your hopes and dreams, consider it an opportunity to put your idea to the ultimate test. Does it hold up against a flood of critical thinking, honest questions, and in some cases, the scrutiny of your peers?

Elaboration

Once your project idea has passed the scrutiny test, it’s finally time to “elaborate.” It’s officially time to put pen to paper, ink to canvas, and clay to the wheel in easier-to-understand terminology. This is the phase where you’re actively creating something and bringing your idea to life.

For many, this final step of the creative process can take just as long as all the other four put together (or even longer). It typically involves many hours of brainstorming the best approach and experimenting to figure out what works and what doesn’t. You might nail it on the first try (and some really do!), but what’s more likely to happen is that you create something, dislike it, and either rewind a bit or start completely from scratch. You might do this over and over again until it’s perfect in your eyes. Real sweat, real tears, and real joy are bred during this step of the creative process. Embrace it.


Understanding the Basics of Design Thinking

In his book The Sciences of the Artificial, Herbert Simon started what we now refer to as design thinking. Since then, numerous other works have been published detailing design thinking concepts and how it relates to all manner of different business models. One of the most famous icons to design thinking in the modern era is probably Apple, Inc. Let’s ask ourselves:

· Did you feel you needed an iPod before Apple created?

· Did you feel you needed an iPhone before Apple created it?

Apple’s genius during the early 2000s was not in creating new products that no one had ever heard of. There were dozens of cell phone manufacturers making quality cell phones before the iPhone landed. There were dozens of MP3 players on the market before the original iPod.

But, once Apple entered the arena, none of that mattered. Why? Because Apple understood the unarticulated needs (and in fact, you could even argue that Apple’s real genius was creating a need for a product by releasing that product!) of its customers. How were they able to do this?

How can we solve a problem for our customer in such a way that they don’t even know the problem exists until we show the solution?
The Five Phases of Design Thinking

Design thinking is a process of five distinct phases of execution. Those phases are:

· Empathize

· Define

· Ideate

· Prototype

· Test

Looking at that list, it seems to be a mix of skills from various disciplines. “Prototype” and “test” seem to be drawn from engineering and product development, whereas “empathize” and “ideate” come from a more psychological, social methodology.

Phase 1 — Empathize

Empathizing immediately sets design thinking apart from most of the other business models out there. True, most business models strive to understand their ideal client’s needs and wants, but few do it from a relational perspective. This is what Simon Sinek talks about in his book Start With Why: That people don’t buy what you do, they buy why you do it. For Apple, that meant understanding the desire of their customers to be a part of something. They weren’t buying things because it was the best. They were buying it because of the reasons behind WHY Apple made it. When the corporate world was turning its back on customer relations and focused more on profits than on value, Apple communicated a different mission and mindset, which allowed their sales to skyrocket.

Phase 2 — Define (The Problem)

Another crucial part of design thinking. The problem. The majority of creators will fail at this part because they think about problems as nouns. Problems are verbs. If you see a little girl trying to get cookies from the shelf, people will start listing the problems as:

· She needs a cookie

· She needs an adult

· She needs a ladder

· Maybe she needs milk with those cookies

While the truth is, she needs to reach. Reaching is the problem, not the cookies. If you solve the reaching problem, you solve anything she will want to reach in the future. Once we understand others' unarticulated needs through authentically empathizing, it’s time to define the problem.

Phase 3 — Ideate

Ideation, the process of coming up with potential solutions to your customers’ unarticulated needs, can only occur after those needs have been identified through empathy and the problem defined. Do we solve the problem through a product, or a relationship, or a service? Is it through expanding our business model to include other forms of retail or consumer service? As an operations manager, the unarticulated needs that I wasn’t meeting for my fellow workers were found in the way I was focused on problems, not on them personally. I felt like, and if nothing was going wrong, there was nothing for me to do. What was going on underneath the surface, and what I was failing to do, was to spend time with them, to learn their processes to the point that I could spot potential problems before they actually became problems. Again, this human-centered approach must consider, above all else, the user's experience, whether customer, employee, or client.

Phase 4 — Prototype

Prototyping doesn’t necessarily have to involve models or scaled-down products. Prototyping also applies to non-physical solutions as well, in terms of how we construct frameworks to solve problems. Obviously, there are times when physical prototyping is important, but the overarching goal of prototyping is to apply solutions in a controlled environment to allow for testing, the fifth phase.

Phase 5 — Test

The final and simplest phase of design thinking. Since design thinking doesn’t flow like time in a strictly linear fashion between stages, there are times when prototyping leads back to ideation and when defining the problem actually requires more time spent empathizing to reassess the customer’s needs. Because of this frequently recursive nature, by the time we arrive at the design thinking process's final phase, sometimes testing merely confirms the last step in our solution. Other times, it can restart the entire process from the beginning. The importance of moving fluidly throughout all five phases.

Conclusion

Creativity is about doing, not thinking. Design thinking as well is about playing and acting. Those actions will swing between a process-oriented approach and a human-oriented approach depending on the project. At the end of it all, whether we are talking about coworkers or customers, the one thing they all have in common is that they are people looking for solutions to their problems. Solving the problem without addressing the people will only lead to frustration and failure. Providing a solutions-based approach to problems rather than a problems-based approach to problems will guarantee a greater chance of lasting implementation and effectiveness of whatever problem we’re solving.

Sources:

· https://www.ideou.com/pages/design-thinking

· https://www.creativityatwork.com/design-thinking-strategy-for-innovation/

· https://dschool.stanford.edu/resources-collections/a-virtual-crash-course-in-design-thinking

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

· https://hbr.org/2008/06/design-thinking

The Bright Hope for Allergic Rhinitis

As the name suggests, Allergic rhinitis (also known as hay fever) is an inflammatory disorder of the nasal mucosa, which occurs when the immune system overreacts to allergens in the air. This might sound small, but it affects 20% of the adult population and up to 40% of children.

Allergic rhinitis is biologically associated and equated with decreased learning, performance, productivity at work and school, and reduced life quality. It affects the quality of life, including fatigue, irritability, memory deficits, and depression. It is reflecting the social-economic costs and the negative impact on the quality of life.

Light Therapy for Rhinitis

If we talk about the current therapeutic options like allergen avoidance, medication, and immunotherapy, they are quite far from ideal. Light therapy has been treating immune-mediated dermatological conditions, e.g., psoriasis and atopic dermatitis.

Light Therapy has been There!

It is one of the oldest treatments that has been practiced in ancient times. Red light therapy has profound immunosuppressive effects on the human body.

As per ARIA guidelines, Red light therapy has been recommended for patients with allergic rhinitis who do not respond to standard medical treatment.

Now, the questions arise what the benefits of red light therapy are? Why should you opt for it?

Well, there are many benefits to using red light therapy:

  • Better and increased blood circulation in the nasal tissues
  • Enhanced local blood oxygen saturation
  • Reduced nasal obstruction (congestion) caused by nasal swelling
  • Improved nasal anti-virus ability
  • Repaired local blood capillaries
  • Strengthened detoxification ability of the nasal mucosa
The Mechanism

Light therapy treatment delivers light to pathological areas to promote tissue regeneration, reduce inflammation, and relieve pain. This treatment improves the nasal obstruction caused by Allergic rhinitis. The sessions involve illuminating the nasal cavity through specific wavelength log light ((660nm — 810nm) to the nose for a certain amount of time.

Most light therapy devices include one or two small LED light-emitting probes, which quickly stimulate the nasal cavity's blood capillaries.

Light therapy mechanisms reduce the number and function of dendritic cells and induce immunomodulatory cytokines like IL-10. Cytokines are a large group of proteins, peptides secreted by specific cells of our immune system. The Red Light therapy generates little heat, modulating mucosal blood supply and histamine release (organic nitrogenous compound involved in local immune responses). This heat alters mucosal blood supply.

The therapy shows improvement in the symptoms of nasal congestion and a decrease in nasal resistance. Studies showed that Phototherapy resulted in a significant improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Red light therapy resulted in a remarkable improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Adopt light therapy and give your life a better quality. Improve the shape of your life; let the negativity and obstructions be at bay!

References:

What You Need to Know About Red Light Therapy and Homeostasis

Our bodies are in constant need of replenishing our cells with oxygen, nutrients, and ATP energy to stay on top of our day to day activities. Also, the optimal function of our cells boils down to maintaining the balance that our body needs. This is also known as homeostasis.

Homeostasis Defined

The scientific definition of homeostasis is in a state of equilibrium, wherein the body’s chemical and physical processes are stable. The balance of the body is dependent on a plethora of factors, such as body temperature, calorie intake, level of blood sugar, the balance of fluid, and pH levels.

These factors are constantly changing and require regulation. They also adapt to changing environments like temperature, light, and activities. Reaching homeostasis requires balance for the body to reach its optimal state. This is present in humans' biology and animals' biology because it determines physical and mental performance, even stress response.

Homeostasis in Cellular Energy

The mitochondria break down food and oxygen to produce ATP energy for the body during the cellular respiration process. Healthy light intake is important in cellular energy to stimulate the mitochondria and efficiently produce ATP energy without inflammation and oxidative stress that may disrupt the cellular respiration process. Red and NIR light therapy enhances cellular and mitochondrial function to ensure that the cellular respiration process works efficiently.

Homeostasis in Body Temperature

Our bodies respond to changes in external temperature through sweating and shivering. These internal temperature processes regulate the body to maintain a temperature balance. The normal body temperature is about 98.6 degrees Fahrenheit. When the body is at a normal temperature, it’s easier to perform well. It can also indicate homeostasis and balance in the body, which we naturally try to achieve. On the other hand, experiencing a fever or being exposed to the cold can make it hard to function well for a long time.

Homeostasis and Calcium Levels

The body’s calcium is usually found in the bones and teeth, but the calcium in the blood requires constant maintenance at about 10 mg/dL. Calcium is essential for blood circulation, coagulation, and bone mineralization. When calcium is low, you may suffer from an irregular heartbeat and other health risks. Meanwhile, when calcium is high, the body may feel exhausted and sluggish because of the nervous system's inactivity. Skeletal, endocrine, and digestive systems in the bodywork hand in hand to maintain basic calcium homeostasis and balance.

Imbalance in the Body

The natural and continuous goal of the body in homeostasis, but many factors are at play. When we use our digestive, respiratory systems, and all the other organs, we need the necessary energy to process nutrients from food, oxygen, and light. The bodily systems are interdependent with one another and need each other to maintain balance.

When one system is lacking, the body naturally compensates by getting from another system to maintain balance. An example is a homeostasis in calcium levels in the bloodstream, which relies on food intake. If the diet lacks calcium, the body gets calcium from the bones, which technically regulates the calcium needed in the bloodstream, but eventually, it will make the bones weak and brittle.

The resourcefulness of the body to shift functions is a great deal. Still, in the long run, it may lead to serious health problems, possibly building up deficiencies and difficulties over time. It is imperative to be aware of the body’s balance and how diet, exercise, and light exposure are interconnected.

Healthy Light’s Effects on Biological Balance and Good Health

Light empowers the cells and enhances the cellular respiration process, creating ATP energy more efficiently. Aside from being essential for our life on earth, having enough light intake is an indication of biological balance. In fact, not getting your regular dose of sunlight may result in inflammation, sluggishness, off circadian rhythms, and poor sleeping habits. Most of the time, people don’t get enough light from their environment since they stay indoors and are surrounded by artificial light.

Being indoors is not how bodies are designed. We are programmed to thrive when our cells intake a good amount of healthy light. Not enough sunlight exposure can make the body imbalanced and lead to decreased energy production and Vitamin D.

Red Light Therapy and Homeostasis

You must be intentional in spending time outdoors to ensure that your body gets the amount of healthy light it requires. However, given the circumstances and limitations that we have, most people really do not get enough natural light, which red light therapy can solve.

Red light therapy is a non-invasive treatment that delivers red and NIR light wavelengths to the skin and cells and helps the mitochondria in cells produce enough ATP energy. Red light therapy helps keep the body and cells balanced, giving enough energy and power to the body even if there’s not enough light in the environment.

Final Thoughts

Our bodies function better when we reach biological balance or homeostasis. A balanced cellular environment indicates good health, and getting healthy light is an important variable to biological balance, on top of exercise, diet, and sleep. Red light therapy helps promote homeostasis and improve overall health by supporting a more efficient cellular environment. Red and NIR light wavelengths stimulate the mitochondria, producing more ATP energy that empowers the body.

If you want to read more about red light therapy and its benefits, you may go to our red light therapy blog. On the other hand, if you want to see our red light therapy devices breakdown, please don’t hesitate to browse through our catalog.

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The Effect of Green & Red Light Therapy on Hearing

Low-level laser therapy

Low-level laser therapy (LLLT) has been practiced for over 20 years in Europe and has been introduced in the United States as a treatment for pain and postsurgical tissue repair. It has been proposed that laser energy in the red and near-infrared light spectrum may aid in the repair of tissue damage. A proposed mechanism for this therapeutic effect is the stimulation of mitochondria in the cells to produce more energy through the production of adenosine triphosphate.

Studies in humans have investigated the effects of LLLT on both hearing loss and tinnitus, with equivocal results. Some studies have found an improvement in hearing thresholds and tinnitus symptoms.

The Subjects

A total of 35 adult subjects were enrolled in the study. Two subjects withdrew from the study due to loss of interest and/or scheduling difficulty. The data from three additional subjects were not included in the analysis. One subject yielded unreliable audiometric and speech understanding data, speech scores could not be obtained from one subject with a profound hearing loss, and calibration problems compromised data from the third subject. Data from the remaining 30 subjects were included in the analyses. The experimental protocol was approved by the Institutional Review Board of The University of Iowa, and written informed consent was obtained from all participants.

The Device

An Erchonia EHL laser was used to provide the laser stimulation. The device was a portable unit that consisted of a hand-held probe and a main body. The probe contained two laser diodes. One diode produced light in the green part of the visible light spectrum (532 nm wavelength), and the other diode produced light in the red part of the visible light spectrum (635 nm wavelength). Both diodes produced energy levels of 7.5 mW (class IIIb). The laser beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. A second Erchonia EHL device served as the placebo. It was identical to the treatment device, except that the laser diodes were replaced with nonfunctioning standard light-emitting diodes.

The Groups

The study used three groups: treatment, placebo, and control. Subjects were pseudorandomly assigned to one of the three groups.

Initial group assignment was random with occasional adjustment to ensure that the three groups were similar in terms of number of participants, female/male ratio, mean age of participants, and mean pure-tone audiometric thresholds. The treatment group received the laser treatment protocol using the functional laser device. The placebo group also received the laser treatment protocol, but using the nonfunctioning laser device. The control group made similarly timed visits to the laboratory but received no real or feigned “treatment.” The study used a repeated-measures design, with each subject taking a battery of pretests, followed by treatment followed by a battery of posttests.

Analysis

Data were obtained from both ears of each subject. Since no obvious differences were seen between left and right ears, data from both ears were combined in the following analyses. Strictly speaking, this likely violates the statistical assumption of independent sampling, since the test results from left and right ears of a single subject are likely to be highly correlated. None of the statistical tests used in the analyses are robust to the assumption of independent sampling, and the effect of including both ears is likely to be that of artificially increasing the sample size, making it more likely that a statistically significant result will be found. All statistical tests were conducted using a significance level of .

Conclusions

No statistically significant effect of LLLT on auditory function was found, as assessed by pure-tone audiometry, speech understanding, and TEOAEs in this test. Additionally, no individual subjects showed any clinically significant change. It remains possible that other methods of LLLT could have an effect on hearing. The type of device used was not the best one for this type of study. Further research elucidating the anatomic and physiologic bases for therapeutic effects of LLLT on hearing are needed before further clinical testing is warranted.

More References

Clinical Study | Open Access. Volume 2013 |Article ID 916370 | https://doi.org/10.1155/2013/916370

ClinicalTrials.gov (NCT01820416)

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What Electrical Engineers Do?

What electrical engineers do?

Electrical engineers design, develop, test, and manage the manufacturing of electrical equipment, from electric motors and navigation systems to power generation equipment and the electrical components of machines and personal devices.

Electrical engineering is an immensely broad field with job roles in a dizzying array of industries. From electric power generation and distribution to cars to smartphones, electrical engineers are integral parts of thousands of companies.

“Especially in today’s age, electrical engineering is integrated into almost everything we do because of the takeover of technology,” Angela Foss, associate dean of operations and innovation for Southern New Hampshire University’s “Nowadays, those applications are everywhere in every industry.”

According to the U.S. Bureau of Labor Statistics (BLS), electrical engineers typically:

  • Design new ways to use electrical power to develop or improve products
  • Develop manufacturing, construction, and installation standards
  • Direct the manufacturing, installation, and testing of electrical equipment
  • Manage the production of electrical projects to ensure work is completed well, on time, and within budget

While the basic electrical engineer job description is fairly standard across a wide range of electrical engineering jobs, where an electrical engineer works can vary significantly.

“There is a lot of variety in an electrical engineer’s job — from talking to a customer about the requirements of a project to designing the product, coordinating with manufacturing to get it made, ensuring quality assurance testing goes well and making sure the product is delivered to the customer on time,” said Monali Mujumdar, an electrical engineer for E Source.

From the article: https://www.snhu.edu/about-us/newsroom/2018/10/what-do-electrical-engineers-do

Best Practices for Leading Manufacturing Medical Device Teams During the COVID-19 Pandemic

COVID-19 has created challenges for nearly every market, and the medical device manufacturing industry is no exception. As the virus sweeps the globe, it’s becoming increasingly difficult for leaders to overcome the arising challenges and prepare for the future.

While I firmly believe the key to navigating this evolving landscape is putting quality at the forefront of all activities, a function made seamless through best of breed quality management tools, I was curious what other industry leaders had to say.

The following are some of their best tips for effectively leading and managing teams during the COVID-19 pandemic and preparing your organization for what’s to come.

Communication is the Key

Keep in touch. Let your people know where things stand with the business. At home or in the office practicing social distancing, each of your workers will be dealing with different issues, both private and professional. The distributed workforce requires even more channels to help people stay connected.

“Leadership needs to provide regular communication, be transparent about the impact of the pandemic on your company, and set expectations with your team, investors, partners, and customers. There is a great deal of uncertainty in the world, and clarity from management is one of the keys to a healthy organization.” — Paul Grand, CEO, MedTech Innovator

Be Sensitive to Personal Issues

Be sensitive to employees’ personal situations. Every member has their own worries and family needs during this crisis. Review goals and when needed realign expectations to match current circumstances.

Quick and Efficient Meetings

Balance the content. Focus on efficiency in meetings to ensure your team still has time to do their work and manage their personal situation. The recommended time for meetings should be 15 minutes with no more than 4 people per meeting

Manage your Expectations

Office time should be reduced. To avoid conflicts, make sure yo manage expectations. Be clear about your expectations and the expectation from your team during these challenging times. The last thing you want to do is have misunderstandings or conflicts with a good working team.

Be Mindful About the Mental Health

The key purpose of a leader is to continuously motivate and support the team. Talk about work-life structures, supporting flexible working arrangements, and vocalizing empathy towards your workmates. As a leader, you must empower them to deliver their best work while being absolutely empathetic towards challenges in their life.

Focus on the Future

Focus on the fact that COVID-19 is temporary. The natural instinct may be to slow down and withdraw resources. Instead, this is an excellent time to strategically plan and dedicate time, staff, and resources to ensuring that the post-pandemic time capitalizes on key changes.

Creative Research Methods

Just because you can’t conduct research the way you always have doesn’t mean you can’t conduct research at all. It is important to stay flexible with the research methods you use. Understanding the pros and cons of each method and their overall ability to contribute to your research goal is critical to conducting meaningful and useful research.

All companies are working to lead their teams through today’s challenges with confidence. By taking care of your team and keeping quality you will improve the teamwork collaboration, communication, and transparency.