Brands I have worked with, present and past;

BEAUTY BAZAAR HARVEY NICHOLS UK, BEYOND MEDISPA UK, BEVERLY HILLS IV THERAPIES, EPIONCE US, ALUMIER MD US, TEBISKIN ITALY, TEBITECH ITALY, LYCOGEL US, DR MURAD US, VENUS CONCEPT US, SKINMED UK, AGERA US, THE BALDAN GROUP ITALY, SKINADE UK, DERMA FNS UK, JUVESA PRO OXYLIGHT LOS ANGELES, ENERPEEL ITALY, TREVOR SORBIE UK.

All my equipment is produced in ITALY, my equipment and technology is exclusive to my brand, this process takes many many years to achieve, I like to offer my own branded treatments that I am 100% confident in delivering real results and effectiveness for my patients, I know exactly what you want and how to deliver.

I AM ALSO IN THE PROCESS OF DEVELOPING MY VERY OWN BRANDS... KYDOLCE IS A REGISTERED AND PROTECTED TRADEMARK IN THE EU.

UNDER THE UMBRELLA OF KYDOLCE TRADEMARK WE HAVE KYBROWS™ WHICH IS A BESPOKE LINE OF BROW TREATMENTS AND KYDOLCE™ EARTH ORGANIC VEGAN SKINCARE WHICH WILL BE LAUNCHING IN THE UK 2025.

I HAVE ALMOST COMPLETED A 6YEAR DEGREE IN PRODUCT DESIGN, WHICH ALSO INVOLVES RE-ENGINEERING AND DESIGN ENGINEERING INCLUDING MANUFACTURING MEDICAL PRODUCTS AND MEDICAL TECHNOLOGY.

I ALSO HAVE MY 2ND DEGREE TO COMPLETE IN MEDICAL DERMATOLOGY, I AIM TO COMPLETE BY 2028.

There is a huge difference between purchasing any technology from a manufacturer and claiming you designed this, then selling this to patients and the beauty industry as accommodating the most advanced technology for treatment today, many companies worldwide claim to have designed the technology and machines when this is not the truth, they import existing technology from other countries then rebrand to sell onto beauty and aesthetic businesses, they will claim to have invested 100’s of thousands in designing the technology and entire design including the aesthetic look of the machine when in fact all these companies have invested in is white labelling existing technology, putting their brand logo on the machine or product and claiming the designed the product from scratch which is nonsense!

There is nothing wrong with this at all but making false claims and miss-leading patients/clients/customers and gas-lighting is wrong, if the company has engineered any part of the technology, actual product design and engineering of the technology, developing ingredients and manufactured everything themselves, the registered blueprint designs for every part right down to the touch screens, electronics and button design will be documented, approved and certified, even if the company may choose only to re-engineer technology and design for their brand, this process is highly complex, requires a whole team of qualified product engineers and product designers, huge investments in the hundreds and millions of investment, on the other hand, white labelling, well anyone can do this with the right amount of investment of only in the ten’s of thousands. Whichever process is used by any company, third-party distributors must by law not make false claims, it is important to be truthful about their products and where they are sourced, and developed, ensuring that they fully explain this to their buyers ie; clients/patients/customers who purchase or use the technology. Product re-engineering can involve taking original existing tech, products and changing, redesigning to improve and enhance the efficiency of a product improving it’s effectiveness or advancing the technology.

Medical device design is a complex process that requires a deep understanding of the medical industry, design principles, and regulations.

• There are five key aspects to medical device design, including user needs, design controls, risk management, prototyping, and testing.

• Understanding user needs is crucial for creating successful medical devices that address real-world problems.

• Design controls help ensure that medical devices meet regulatory requirements and quality standards.

• Prototyping and testing are important steps in the design process to identify and resolve issues before final production.

Aspect 1: User Needs and Requirements

The first and most important aspect of medical device design is to identify user needs and requirements. Understanding the needs of the end-user is critical to developing a device that is safe, effective, and user-friendly. Medical device designers should conduct extensive research to gather information about the user’s needs, preferences, and limitations.

One way to gather this information is by conducting user interviews, surveys, and observations. This process helps designers to create a device that meets the user’s expectations and fits into their daily routine seamlessly. For example, a company called Medtronic developed a continuous glucose monitoring system for diabetic patients. Medtronic used extensive research to develop a device that met the needs of patients by providing continuous glucose monitoring without the need for finger sticks.

Aspect 2: Design Controls

Design controls are processes that ensure the medical device is safe, effective, and reliable. Design controls help designers to manage risks and ensure that the product meets regulatory requirements. The design control process involves the use of a risk management system, design verification and validation, and design transfer.

The FDA has specific requirements for design controls, and medical device designers should be familiar with these requirements. For example, a company called Avanos Medical had to recall its product because it failed to comply with FDA design control requirements. The company had to pay a $22 million fine to settle the case.

Aspect 3: Medical Product Design

The design of a medical device should be aesthetically pleasing and should align with the brand’s identity. Medical device designers should create a product that is ergonomic, easy to use, and easy to maintain. Medical product design should also consider the device’s life cycle, including the manufacturing process, packaging, and disposal.

One example of excellent medical product design is the Philips Sonicare toothbrush. The toothbrush is ergonomically designed to fit comfortably in the user’s hand and has a sleek, modern appearance that aligns with the brand’s identity. The device’s packaging is also designed to be environmentally friendly, with a smaller carbon footprint than traditional packaging

Aspect 4: Medical Device Prototyping

Medical device prototyping is a crucial aspect of the design process. Prototyping helps designers to test the device’s functionality, identify design flaws, and make necessary adjustments before mass production. Prototyping can also help to reduce costs and improve the efficiency of the manufacturing process.

Medical device designers should use a variety of prototyping techniques, including 3D printing, machining, and injection moulding. For example, 3D printing can create intricate parts and components that are difficult to manufacture using traditional methods.

Aspect 5: Regulatory Compliance

Regulatory compliance is critical for ensuring that the medical device is safe and effective for patients to use. Medical device designers should be familiar with regulatory requirements in the countries where the device will be sold. In the United States, the FDA regulates medical devices, and companies must obtain FDA approval before marketing their products.

Medical device designers should also consider the European Union’s Medical Device Regulation (MDR), which went into effect in May 2021. The MDR has stricter requirements than the previous Medical Device Directive (MDD) and requires additional documentation and testing.

Medical Device Design Services

Medical device design is a complex and highly regulated field, but by following the proper design controls, businesses can create safe and effective medical products that benefit patients and healthcare professionals alike. UK businesses looking to develop medical devices should take advantage of the country’s robust regulatory environment, which prioritizes patient safety and provides clear guidelines for product development and approval.

Additionally, partnering with experienced designers and engineers can help businesses navigate the complexities of medical device design, from concept development to prototyping and manufacturing. By investing in high-quality design and development processes, UK businesses can create innovative medical devices that improve patient outcomes and contribute to the growth of the healthcare industry.

For further reading, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) offers a wealth of resources on medical device regulation, including guidance on design controls, risk management, and post-market surveillance. The National Institute for Health and Care Excellence (NICE) also provides guidance on the development and evaluation of medical technologies, including medical devices.

THESE ARE MY LATEST BRANDS…

All our technology is for in-patient clinical treatment only, we do not sell any of our technology, nor do we offer training, our equipment is bespoke for KYDOLCE brand only, some of our technology shown on our website are only showcase prototypes for demonstration purposes only, any medical equipment used on our patients are completed models that have been fully tested and engineered to comply with CE regulations including FDA approval, we hope to develop a small range of products in the future that can be used for patient home use and personal product home use and maybe in the future we may consider producing technology for selling on through a training academy for the medical aesthetic industry.

KYDOLCE® LIFT & PLUMP

KYDOLCE® OXYGLOW

KYDOLCE® SLIM TIGHT

KYDOLCE® SCULPT SILHOUETTE

KYDOLCE® PLASMA LIFT

KHYDRAFACIAL+1H+2Ho™

KYDOLCE® PRISM ANALYSIS 3D