Whether you’re a dermatologist, physical therapist, fitness enthusiast or just someone considering integrating light therapy into their practice, you’ve likely heard about the multitude of benefits that these non-invasive yet powerful devices offer. As light therapy continues to gain popularity, more professionals are looking for light therapy devices to level up.
Naturally, you can purchase professional devices from light therapy companies, but you can also develop a light therapy device that can be customized to fit your individual client’s needs. This is where we, Kaiyan Medical, come in to help guide you through the process of producing your very own private label light therapy products at our state-of-the-art manufacturing facility.
If you’re interested in creating your own light therapy products, it’s crucial you understand the development process.
We want our clients to comprehend the creative and manufacturing process of developing private label light therapy devices. As this is your idea we’re bringing to life, you need to be included every step of the way. Here’s our step-by-step process:
Step 1: Feasibility Study
It’s easy to lose money by investing in a product without understanding user needs. If you don’t know your target audience, you’ll struggle to create a viable product. During the feasibility step, we determine the practicality of your project and examine its strengths and weaknesses. This helps to ensure the idea you want to bring to life is viable and effective in achieving its goal.
Step 2: Industrial Design
With our advanced conceptual design team, we determine how we can best engage with your target audience. While we focus on design, we also make sure your device fits under the required safety and health regulations. Our in-house design process creates visually appealing, high-quality, and functional concepts for manufacturing and product planning.
Step 3: Electrical Engineering
Our in-house team has vast experience in lasers, sourcing, prototyping, and LEDs to incorporate these components and masterfully develop your product. Our electrical engineers, who are in charge of this step, take your idea and bring it to life while ensuring high-quality performance.
Step 4: Rapid Prototyping
Rapid prototyping is essential for our projects and allows the client to see and feel their idea in the palm of their hands. In addition, it also helps clients test products with their users and receive constructive feedback. Our rapid prototyping is completed in-house as we have the capacity to create a range of samples varying from simple to complex, multi-piece models.
Step 5: Mass Production
After your idea is turned into a tangible product and has been tested, we then plan production with in-house, pre-pilot quantities. By doing so, we’re able to identify production areas that need to be fine-tuned while ensuring high-quality and performance standards. Once these steps are completed, your product will be ready for shipment. Through our vast experience and stellar team, we can ensure a smooth manufacturing process and will guide you each step along the way, from start to finish.
We’ve been creating MDA-certified and FDA-approved light therapy devices for years. That said, we’ve successfully worked with various brands in different industries, taking their ideas and bringing them to life. Here are some of the brands and products we’ve developed.
DemarkQ
DenmarkQ offers skin care devices that use red and blue light LED to target acne and scarring. The LED light uses the body's natural healing process to improve its overall wellbeing.
Aduro Mask
Established in 2006, Aduro Skincare specializes in LED beauty-related products under a medical license. The product is internationally renowned and clinically proven as an effective, non-invasive therapeutic skin care treatment.
Perfect Countour
Perfect Contour is our line of permanent make-up machines. Our permanent make-up machines were designed for clinical use; however, we feel permanent make-up is more of an art form than a medical procedure through our experience.
Golden Eagles
Teeth whitening has been around for ages, and we've mastered the art of developing effective teeth whitening devices. We currently have over 20 different OEM models for professional whitening and devices for at-home whitening.
Akstra
Akstra's brand focuses on hair regrowth and hair rejuvenation and offers products ranging from home-use to professional-use models. Since Asktra's first line of hair lasers was made for clinical environments, we opted for a sleek and clean design.
Lumiceuticals
Lumiceuticals is a brand focusing on using LED technology for pain relief. We combined LED technology with neoprene material for practical treatment pads. The pads are secured by Velcro straps, making them easy-to-use for customers.
If you’re considering developing private label light therapy devices, at Kaiyan Medical, we create MDA-certified and FDA-approved light therapy devices, ensuring you medical-grade, high-quality devices for your business. We are eager to work with like-minded partners in developing truly effective, safe, and valuable products that tap into the power of light therapy.
We look forward to working with you!
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.
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.
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.
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.
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.
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.
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.
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.
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.
Background of medical issue, the study goals, and why this study will further the science.
Should include:
Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria
Should evaluate the safety and effectiveness of the device in the population expected to be indicated.
Driven by either:
The minimum number of patients and/or minimum duration of follow-up may be required depending on:
Generally used to evaluate additional meaningful claims.
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.
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.
More Information on Diversity in Clinical Trials
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.
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 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.
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
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.
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 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.
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.
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.
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:
Ontario is a known leader in conducting innovative clinical trials, and the clinical trials community in Ontario has proven this strength throughout the COVID-19 pandemic. One innovative trial underway in Ontario is Vielight Inc.’s COVIDlight trial, which tests whether the recovery of COVID-19 patients may be accelerated by the use of a specialized light therapy device. This trial was made possible in part by Clinical Trials Ontario’s Trial Site Network through a connection made between Vielight Inc. and Impact Clinical Trials. CTO spoke with representatives from Vielight and Impact Clinical Trials about their trial and their experience with the Trial Site Network.
Vielight Inc. has developed a compact and portable device named the “Vielight RX Plus,” based on the science of photobiomodulation (PBM). PBM uses certain light energy to modify cellular functions and can play a role in the management of COVID-19. This clinical trial assesses the efficacy of the Vielight RX Plus to reduce symptom duration and severity in patients suffering from COVID-19.
The Vielight RX Plus device delivers light therapy to the sternum and the nasal canal.
“This device brings a holistic approach to the treatment of COVID-19 patients,”
said Nazanin Hosseinkhah, Research Scientist and Physicist at Vielight Inc.
“The device stimulates the thymus gland, creates nitric oxide, increases natural killer cells, acts as an anti-inflammatory therapy, and increases cellular energy.”
This unique, at-home study has the potential to modulate immune cell and cytokine activity in COVID-19 patients with an easy to use the device.
“We are very hopeful that this trial will prove to help patients recover from COVID-19 at home, and result in less burden to the healthcare system,”
said Hosseinkhah.
This randomized controlled trial, being managed by Impact Clinical Trials, is actively recruiting 280 participants who are confirmed to have contracted COVID-19. The trial was authorized by Health Canada in early September and is recruiting participants in Ontario and the United States. Participants are allocated into a treatment or a control group, with 140 participants randomized to receive the Vielight RX Plus device and the other 140 participants receiving the current standard of care. The trial is conducted remotely with non-hospitalized participants.
Participants in the treatment group receive the device by courier within 24 hours of registering for the trial. They are asked to place the device on their chest and onto their nostril for 20 mins each day. They then track their symptoms within a daily survey over a 30-day period.
“This is a simple, at-home study for participants to be involved in,”
said Andrea Berk from Impact Clinical Trials.
“Participants in both the treatment and the control groups are completely supported throughout the trial, with a 24-hour number they can call if they have any questions.”
This trial was made possible in part by a connection made directly through CTO’s Trial Site Network. The Trial Site Network, part of CTO’s Industry Concierge program, comprises more than 230 sites. The Network allows CTO to provide warm introductions to Ontario’s hospitals, research institutions, private research networks, and CROs.
“We have been able to guide companies such as Vielight in getting their trials up and running in Ontario,”
said Andrew Haller.
“I was introduced to Andrew Haller from CTO a few months before the COVID-19 pandemic,”
said Berk.
“Pre-COVID I was working on half a dozen connections that had been made through the Trial Site Network. When COVID-19 hit, those projects were put on hold. I reached out to Andrew to let him know Impact Clinical Trials had the consulting capacity, and that is when he introduced us to Vielight.”
Haller knew that Vielight had been searching for someone to take on the management of their clinical trial. “When Andrew introduced us to Andrea Berk from Impact Clinical Trials, we immediately connected and knew they were the right fit,” said Hosseinkhah.
