5D Health Protection Group Ltd

We are a leading organisation in the field of microbiology testing services, with a focus on antimicrobial agents and biofilms. You will find us globally supporting woundcare, medical devices, healthcare, veterinary medicine, the cosmetic industry, and the water and engineering sector. Our skills, world wide connections and knowledge, along with a sound understanding of academia, commerce and investment strategies make us a superb partner to help drive your business growth. All our business support services are, naturally, customer specific and all projects we work upon are confidential in nature.

Our level of involvement also varies, from the provision of initial advice, right through to complete project management. We take pride in our flexible approach. We are always happy to discuss your needs, in confidence and with absolutely no obligation. We have a sound understanding of both business and the rigorous requirements of scientific research and marketing. 5D is working with a variety of businesses and organisations around the world. Our services are utilised by corporations for both routine testing, to support new projects or helping in the development of new company strategies.

Regulatory and Quality Support

5D provide significant support for companies that may require assistance to guide staff in the design, development and also execution of activities related to quality and regulations.

When new products are being developed it is important to fully understand the regulatory compliance requirements.

All projects we undertake are unique and customer specific. We have many years experience in the development of technical files and design dossiers for CE marks and 510k submissions. The FDA require 510(k) premarket submissions for new devices that are not subject to Post Market Approval (PMA). The submission demonstrates that a device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)).

In the USA, companies must compare their device and show equivalence to similar legally marketed devices. CE marks and 510(K) submissions are required, when the commercialisation of a new device is occurring for the first time or when there is a change/modification to an existing device. In addition, we have experience in auditing suppliers and testing laboratories. We can review standard operating procedures (SOPs), carry out audits of test methods and procedures in microbiology and testing laboratories and R&D facilities in all sizes or organisations.

Marketing and Business Development Support

Both the use of business development and marketing are significant for growing a business. In order to grow a business, both marketing and business development need to be aligned to ensure that they are focused on the same goal to ensure that customers are attracted to their services and products and that true benefits can be achieved by adopting that service. Business development is considered to be responsible for the development of partnerships in organisations, building and enhancing strategic partnerships and sourcing new contacts in chosen markets to ensure new business and customers. Marketing is considered more strategic as they have the responsibility for both understanding the needs and also the wants of the markets and targeted customers. From this data strategic plans for companies can be developed to help establish a company's value proposition, provide guidance on its capabilities and ensure that the appropriate target markets are addressed. At 5D we can offer both business development and marketing strategies to help grow a business. A few areas where we have helped customers have included strategy development, content development for training and educational support at conferences, work shops and forum meetings, campaign development and speaking engagements at industry events and conferences.We also have written and presented large numbers of abstracts, posters and journal publications which have lead to significant sales growth for organisations.

Universities

We form a bridge between academics and industry. Pure research may lead to the development of a new technology, but no one knows its potential. That’s where we come in, working with PhD students or professors to explore the possibilities. Is there a commercial use? Is it viable? What would it take to move the technology from a concept to a practical and commercial proposition? Our research, innovation, testing and business support services help to move ideas from the research paper to the finished product.

Exploiting an innovative academic idea, patent or technology needs support and promotion in order to achieve its full commercial potential. However, it is often found that the time required for an innovation to move from bench to bedside is a long process unless a strategic and risk assessment plan is put in place to mediate issues.

At 5D we have over 25 years innovating, developing and commercialising products particularly medical devices on a global scale. We have been working globally with, and along side, universities for 28 years in may different capacities. We have secured significant grant income for the development of next generation game changing technologies, research and innovations. In particular we have been supporting and developing patents for antibiofilm agents, antimicrobial surfaces, biosensor technologies, biomaterials, biocides and game changing medical devices particularly in wound care and catheters.

Spin-off, SME and Large Multinationals

In addition to routine scientific testing and support, we are frequently asked to support companies with new tests when they’re implementing new technology or equipment and marketing strategies. Recently we have been collaborating with a client, undertaking research with their products to help achieve improved marketing claims. It is often a two-way process – a partnership that drives discovery and innovation, using our knowhow and our partnering company’s corporate muscle.

Many businesses have a great product that works, but they do not know why. Our job, then, is to explain and help market the science that underpins the product’s efficacy.

Solutions to Problems

5D provide cutting-edge science and technology solutions to companies of all sizes. We have a proven track record across a diverse spectrum of industries that include as examples healthcare, medical, life sciences, water and engineering. We provide a comprehensive, integrated approach to problem solving.

Our team is unique in their ability to evaluate technologies and provide expert advice on avoiding and mitigating problems early in the product innovation and development life cycle.

Investors

Before investing in the development of a new product – or a start-up aiming to bring one to market – investors often turn to 5D for assistance, particularly in the fields of life science and medical device development in particular skin and woundcare. Using our testing and scientific skills at an early stage becomes a key part of an investor’s due diligence process and assists in the move towards fully licensed technologies. Some testing providers only perform a limited range of services or are restricted in the facilities or microorganisms they can use. For a specialist job, you need a specialist supplier – one that delivers cutting-edge scientific testing, efficiently and without any compromise. That supplier is 5D.

Due Diligence

5D have substantial expertise in conducting medical device and life science due diligence. This expertise is regularly employed to support mergers and acquisitions, financial investment and licensing technologies on behalf of our clients. We also offer companies a reality check service. This is a useful checkpoint for a company before it formally enters into a due diligence program. Our teams of experts have gained extensive skills and knowledge in Medical Device Innovation, Product Development, R&D, Marketing, Business Development, Quality and Regulations, Clinical Trials and Education. The team's capabilities and experiences have been developed from working in a range of companies including start-ups, SMEs, global multinationals, academic institutions, and international public health bodies.