The light therapy industry, though unique, is no different than other industries when it comes to organization and product management. If a product is going to be manufactured and released to the public, it needs to undergo the manufacturing process from point A to point B.
This is where product management plays a vital role in the success of a product. While you may be thinking that product management only focuses on developing a product, there's much more to it than that.
We’re going to be talking about why product management matters in light therapy development and what it brings to the table.
Creates meaningful relationships
Product management goes beyond the physical product. Product managers work with various departments within the company, from the sales team to suppliers. They're the connecting piece of the puzzle that creates strong and meaningful relationships with key people. By having a sturdy foundation, the development of the product can run smoothly.
They know the product very well
A company is only as good as their product, and if they don’t know their product like the back of their hand, well, then they’re not a good company. It’s as simple as that.
With light therapy development, you must be familiar with every inch of your product. These are devices that medical professionals and individuals will be using on their bodies for many wellness purposes.
That said, product managers take the time to maintain a product and ensure it’s adhering to company guidelines and policy.
Being masters of their domain also helps connect various departments when there are questions or internal issues that need resolution. Product management goes beyond simply knowing the product is; it's about understanding every aspect of it.
They connect with the sales team
Creating a product is one thing, but it also needs to align with your customer's needs. And this is where the sales team plays a crucial role. Since they have direct communication with customers, they know the customer's needs.
Product management connects with the sales team to understand if the customers' needs are being met and the steps needed to take to do so. While the company may love its product, the customers have the final say at the end of the day. So the link between the design team and sales team is crucial in creating a well-rounded product.
Make thoughtful yet necessary shifts as you go
Yes, all companies have a roadmap of a general plan for how to manufacture and launch a product. However, things can change depending on customer needs, etc. Product management is crucial as it can help light therapy companies make quick changes to their devices or marketing plans, if needed.
For example, our clients said they wanted a non-handheld version of a face mask for light therapy. So, the Kaiyan design team was able to take their needs and create the Aduro 7+1 facial mask with an adjustable strap.
Listen and learn from customer stories
Listening to individual customer stories can provide helpful information on how the type of light therapy devices that are used out in the world. Product management includes listening to customer stories and understanding how to solve real-world problems, if there happens to be one. These stories can also inspire upcoming devices and help take the products to the next level.
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!
As humans, we are made of energy and fueled by light. While nutrition and exercise play a role in our well-being and health, light plays a crucial role in us functioning optimally. New and groundbreaking research is unearthing a new understanding of how our cells function and the evidence points to the power of light.
Through technological advancements in science, it’s discovered that our bodies operate similar to a battery. Wavelengths of light give us power, while our overall health determines our ability to receive and maintain the energy from light. And this is where light therapy comes into the equation.
Science has proven that our bodies interact with specific wavelengths that benefit our bodies in various ways.
Red light therapy devices, such as light therapy masks, shine red and near-infrared light onto the skin, stimulating the production of adenosine triphosphate (ATP) within the mitochondria. By stimulating ATP, damaged cells heal, and new cells are produced faster than normal. But we’ll talk more about that in-depth a little later.
Red light therapy comprises both red light and infrared wavelengths, penetrating through the skin’s layers, right into the cells. Red light wavelengths boost collagen and elastin and improve cell communication. It penetrates superficially and helps aid various skin conditions.
Near-infrared wavelengths stimulate healing, increase mitochondrial function, and improve blood flow and tissue oxygenation. Near-infrared wavelengths penetrate deeply into the body.
At the core of your body’s healing capabilities are the mitochondria. The mitochondria play a vital role in your internal organs and tissue, including the liver, skin, heart, and muscles. It’s in charge of the body’s energy supply via ATP (adenosine triphosphate).
With both working together, they provide energy to our body and maintain the cell cycle and growth. This is why you’ll often hear the mitochondria referred to as the “powerhouse of the cell.”
Here's how the mitochondria is affected by red light:
Interestingly, our body weight is made of 70% water, with 99% of our bodies' molecules also made of water, making it a powerful component in red light therapy treatment.
Research by Prof Gerald Pollock of the University of Washington proved that water adjacent to a cell is structured water, also known as EZ water. This specific water forms a separation of charge, functioning in the body as positive and negative poles - similar to a battery.
While we’ve been talking about red light therapy, what does it actually mean? Typically, “red light therapy” refers to natural light treatments which deliver red and near-infrared wavelengths as natural sunlight using LEDs or cold lasers.
While you may think red light therapy includes all colors of light, it doesn’t. The term doesn’t include blue or white light, and it isn’t equivalent to full-spectrum light. Red light therapy doesn’t rely on heat, differentiating it from other light-based treatments such as infrared saunas and heat therapy.
Red light therapy is also known as RLT, photobiomodulation (PBM), phototherapy, LED therapy, LED light therapy, infrared therapy, low-level laser therapy, or low-level light therapy (LLLT).
As stated before, red light therapy works to heal the entire body and functions on multiple levels.
Red light therapy affects the body in multiple ways, including bodily systems:
Fascia
Fascia is the thin casing of connective tissue that surrounds virtually every organ, muscle, nerve fiber, blood vessel, and bone in place. While it performs as an internal structure for your body, the fascia also contains nerves, making it almost as sensitive as skin.
The fascia may look like a layer of tissue; however, it’s made up of interwoven layers of collagen and elastin fibers. The fascia is overlooked, yet over recent years, it has been the key to understanding how changes in one area of our body affect others. Red light therapy works to improve communication within the fascia network.
Gut-Brain Axis
The gut-brain axis connects the emotional and cognitive centers of the brain with peripheral intestinal functions. Recent research discovered the importance of gut microbiota concerning these interactions.
Red light therapy can positively influence mood and neuropsychological issues by the following:
Immune System
Red and near-infrared light penetrate through the skin into the cells, which results in low-dose metabolic stress that strengthens the cells’ anti-inflammatory and natural defense systems. In turn, the body becomes resilient to infections.
Safe and low exposure to red light therapy improves the body’s response to external viruses and bacteria. Red light therapy can influence the immune response in the following ways:
Circulatory System
Red light therapy is scientifically proven to increase the micro-circulation of blood and support the circulatory system as a whole by stimulating the development of new capillaries which carry oxygen throughout the body.
Proper oxygen supply and flow are essential for the proliferation of cells, protein synthesis, tissue restoration, inflammatory response, and angiogenesis. In addition, circulation is also responsible for waste elimination, specifically degenerated cells.
Nervous System
The nervous system includes the brain, spinal cord, neurons, and neural support cells, which is your body’s command center. It controls your movements, automatic responses, and other body systems such as digestion and breathing.
Red light therapy affects the nervous system in the following ways:
For all forms of nerve damage, red light therapy offers non-pharmaceutical treatment options.
Stem Cells
Red light therapy shows impressive results regarding stem cell growth, maximizing the potential of stem cell implantation for various medical needs. Therefore, red light therapy may show positive results after surgery to stimulate stem cells which repair tissues and organs.
In studies, red light therapy has proven to stimulate mesenchymal stem cells in bone marrow, enhancing their ability to reach the brain. This research shows the possibilities of using red light therapy to heal degenerative conditions, including Alzheimer’s, Parkinson’s disease, and dementia.
It’s clear red light therapy provides multilevel treatment to the body, becoming a popular natural and holistic option for both professionals and consumers, but where did it come from?
Light therapy technology isn’t new; it’s been around for decades as NASA experimented with red light therapy during the 1980s and 1990s. Over the past 10-20 years, red light therapy reached a breakthrough in LED lighting technology, allowing the production of safe and affordable clinical and at-home devices.
In 2016, Kaiyan Medical became the first leading manufacturer of red light therapy of affordable FDA-approved and MDASAP-approved light therapy devices.
We mentioned red light therapy being a holistic treatment option, but what does that mean. Holistic medicine is a full-body approach to healthcare. By focusing on the body, mind, and soul, the body receives the full support and care it needs to function optimally.
Principles of Holistic Medicine
Holistic medicine is based on the following principles:
The purpose of treatment is to identify the underlying cause of the disease, rather than treating only the symptoms.
While there are endless benefits the body receives from red light therapy, here are the six main benefits.
Photobiomodulation, in other words, red light therapy, has proven effective against carpal tunnel syndrome, mucositis, neck pain, menstrual cramps, temporomandibular joint pain, and neuropathic pain from amputation. It also significantly reduces the pain of hypersensitivity while improving sensorimotor function.
These improvements come after anti-inflammatory cells populate the injured area, providing long-lasting pain relief. In addition, it’s also been shown to provide effective relief by affecting the following:
Red light therapy has proven to be highly effective in rapidly treating wounds from burns, scars, bedsores, ulcers, surgery incisions, and diabetic neuropathy.
NASA strongly supports this claim as this technology was used in treating wounds. Red and near-infrared light proves effective in all four phases of the wound-healing process:
These processes are regulated by various factors connected via nitric oxide (NO) signaling release, adjusted by light energy.
An issue the body encounters when trying to heal a wound is low oxygen flow, and red light increases the flow of oxygen, speeding up the natural healing process. By reducing inflammation and increasing oxygenation of the wounded area, blood vessels can form, rapidly repairing the area, lessening pain and scarring.
By reducing pain, red light therapy eliminates the reliant on pharmaceutical painkillers during the healing process.
The human body receives energy on the cellular level, maintaining communication between organs and ensuring disease resistance.
A strong immune system works to protect the body from harmful bacteria and viruses at all times. With red light therapy, the body receives a boost of support as it releases nitric oxide and melatonin, two components involved in DNA repair and antimicrobial.
This process is called hormesis. Red and near-infrared wavelengths penetrate through the skin into the cells, causing mild metabolic stress, which stimulates cells to activate their anti-inflammatory and antioxidant response.
With the support of red light therapy, the body is better prepared to fight infections. Numerous studies have proven red light therapy to have the following effects on the immune system:
Inflammation in the body can be acute and topical (short-term, resulting from sprains, infections, and accidents) or chronic and general (long-term, caused by ongoing conditions).
Acute inflammation is a healthy bodily response; however, chronic and general inflammation can negatively impact long-term health.
As of today, the current treatment for inflammation is NSAID or steroid drugs, both having a detrimental effect on the healing process and long-term health. Red light therapy stimulates the body to activate its natural healing mechanism, reducing the health risks of long-term drug use.
Red light therapy decreases the number of inflammatory cells, increases fibroblast proliferation (cells that synthesize collagen and other matrix macromolecules), stimulates angiogenesis (creation of new blood vessels), and activates the body’s anti-inflammatory, antioxidant response.
The following conditions are connected with chronic and acute inflammation, all proving promising results with red light therapy treatment:
Red light therapy is extremely popular in competitive sports and performance. It offers natural and non-pharmaceutical treatment, which applies to many areas of the body.
Aside from the overwhelming benefits on overall health, red light therapy encourages muscles growth and repair by stimulating the production of ATP, which aids in faster recovery and better performance.
Red light therapy used before training prepares and strengthens the body while aiding muscle recovery after training.
Here are the scientifically documented effects of red light therapy:
Seasonal affective disorder (SAD) is a form of depressions, impacting 5% of Americans, specifically during the winter when there’s less natural sunlight. SAD is also known as seasonal depression or winter blues.
Many people treat SAD symptoms via bright white light treatment, mimicking the sun’s light daily. However, researchers recommend natural light treatment, like red light therapy, to help with light deficiency. Over recent years, physicians recommend red light therapy alongside psychotherapy and medication.
While many people are using red light therapy devices for at-home treatment, red light therapy systems are found in many clinical and professional settings:
Skincare Professionals: Red light therapy is a popular skincare treatment among Hollywood celebrities, including Kourtney Kardashian, Julia Roberts, and Emma Stone. Leading skincare professionals like dermatologists and aestheticians use red light therapy to help promote collagen production, reduce wrinkles, and treat skin conditions.
Health Practitioners: Health practitioners from all specialties are incorporating red light therapy into their practice. Dentists use it to reduce inflammation, physicians for mental health conditions, and oncologists for cancer side effects.
Natural Health Experts: Leading voices in the health and wellness industry such as Dr. Sarah Ballantyne, Ben Greenfield, and Dave Asprey strongly support the use of red light therapy. Paleo and Keto health experts like Robb Wolf, Mark Sisson, Luke Story, and Dr. Anthony Gustin also support red light therapy.
Sports Medicine Pros: The National Sports Association of Sports Medicine (NASM) adopted red light therapy to treat sports injuries. Top trainers and doctors, including Dr. Troy Van Biezen and Dr. Ara Suppiah, use red light therapy to heal their athletes.
Elite Pro Athletes: Professional athletes worldwide, including NFL stars like Patrick Peterson, UFC champion Anthony Pettis, and gold medal gymnast Sanne Weavers use red light therapy to enhance performance and quicken recovery.
Fitness & Training: World-renown fitness trainers, including Lacey Stone and Jorge Cruise, use red light therapy to enhance athletic performance and muscle recovery.
Supportive Cancer Care: The Multinational Association of Supportive Care in Cancer (MASCC) recommends the treatment of red light therapy for oral mucositis (OM), a common symptom of cancer treatment.
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It’s difficult to predict the success of a new product. Even the largest, most mature companies have created products that fail to gain market acceptance and profitability. And as we’ve seen in numerous industries, product success can’t be guaranteed by financial investment or process optimization.
With the need to move fast in the light therapy market and an inability to guarantee success through any means, we continue to seek ways to manage the inherent risk in product development.
There is a gap between user wants and user needs and while it is easy to assume that the difference might not be clear, taking an empathetic approach creates a finer line between the two. Although Creative Directors are problem-solvers at their core, they achieve this by building data-based frameworks for visualizing how best to serve their target audience.
It is no longer about market data assessment and sales hands-off alone; there is a need to properly distinguish between user needs and wants while choosing how best to attend to those needs and paying just enough attention to user wants. Understanding the user metrics for this analysis and insight might seem daunting, especially when the aim is to improve product experience directly, but taking a design-thinking approach helps make better sense of the process.
Popularized by IDEO, Design Thinking is a human-centered, empathy-first approach to creativity and innovation. Its underlying principle focuses on user needs, aspirations, wishes, concerns, and frustrations in attempting to solve their problems. Interestingly, Design Thinking focuses on the most important view from which problem-solving should be approached; the users. When problem-solving is approached from a user’s point of view, it allows for uncovering novel insights into the product’s user flow, thereby finding the right solution to the right problem.
The Design Thinking process is quite similar to the Agile methodology of Product Management; as a matter of fact, Design Thinking helps to materialize the otherwise abstract concept by allowing ease of iteration and faster user-testing processes. Implementing design thinking in product management makes it easy to consider expedient user experience factors. Top on the list includes:
Companies employing design thinking are allowed to release products more often, gather meaningful customer feedback, and validate a product’s use and vision in a marketplace while sustaining a high level of customer satisfaction, as one release builds on another to add features customers desire most.
Implementing design thinking into product development can be broken down into 5 steps:
Most of the companies jump straight to point #4, which is a terrible mistake.
To make things clear, structure your tasks: build up a framework, define both focus points and sticking points of your research, and remember that most questions have two answers — the one that appeals to business and speaks to a customer.
Think like a detective when starting a product development cycle, and ask these questions:
Who is going to use your product? What are their habits and preferences? It is essential to understand real user needs and how they are addressed without your product. Define the key problems and set your sights on them. What’s the context of use? What is their motivation behind using your product, and how can you inspire them to make the most out of it?
Think big. What is the place of your product in the ecosystem? Sometimes it may be just a part of greater service. Keep in mind the environment of use since it creates a general customer experience.
Whether you like it or not, time is vital for your project. “Done” is better than “perfect.” That’s why it’s important to keep the scope of your project in mind, to limit it to essential things for a quick market release.
What is the real value of the product for your customer and your business? What issues does it address, and in what way? Why did you create it, and what’s its role in the company development?
These questions are essential for creating a general perception of the main problem you are solving for your client: it’s so easy to get side-tracked with a load of on-demand, seemingly effortless tasks. Besides, it’s impossible to solve a problem that doesn’t exist, so why carry an extra burden? When details are pushing you to the limit, take an imaginary step back and see the problem from a different angle. Visualize the role of a certain detail in the general canvas of your work. It does not mean you have to bury your project under piles of documentation. We all know that red tape is more about restricting rather than making things easy, and freedom is essential at the initial stages of any project. This is how innovation is born; under conditions of free thought, bright vision, and sheer inspiration.
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.
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.
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.
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.
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.
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.
Here is the official FDA regulation for design controls pertaining to design inputs, as found in Part 820.30(c):
Each manufacturer shall establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
ISO 13485:2016 also covers this topic in section 7.3.3 Design and Development Inputs:
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management
These inputs shall be reviewed and approved.
Requirements shall be complete, unambiguous, and not in conflict with each other.
There are several terms used interchangeably when referring to design inputs:
Medical device product development should be a holistic process that builds upon itself as the project progresses.
Rushing the product to the market isn’t a recommended best practice in medical device development. Spending time in design inputs will really benefit your project. In device development, establishing design inputs can easily take up to 20% of the entire project timeline.
Writing design inputs takes practice and dedication. Also, design inputs should not just be the responsibility of one person. It’s a team effort. When a team is involved, you get the benefit of everyone’s opinions and experience.
You also should consider all sorts of other sources to help you define design inputs:
It’s important to remember that user needs should be established first in order to inform design inputs. Your goals when defining design inputs include:
You have to consider all types of sources and resources for design inputs. Your design inputs need to be comprehensive, covering all aspects of your medical device.
