Device development - here to help at every stage
Skiant helps clients across all stages of medical device development, from concept to market. We add the most value when working holistically with you across the entire journey, but we also regularly work with clients on specific parts of the new product development process. Designing and developing a medical device is complicated — we’re here to simplify it.
Medical device ideation
Coming up with ideas is easy; coming up with the right idea is the difficult part. We are experts at working with clients to extract and fine-tune life-changing ideas for medical products. But the idea itself is just the beginning. What comes next is the analysis to make sure it’s actually feasible — including high level cost analysis and product realisation. You can then proceed with your investment, knowing that your vision can — and will — become reality.
Medical device strategy
Having a great idea is one thing — divising and executing the strategy to turn it from idea to reality is another. We help you create a roadmap to success; how do we start this project? What skills do we need? What team should we be recruiting? Who do we need to partner with? Who is the target market? We answer all those questions and more, alongside insourcing and outsourcing plans, timeframes and potential sales models. The result is a strategy that answers questions before they've even been asked.
Mechanical engineering and design
Our team of expert engineers and industrial designers will ensure your medical device is structurally sound and works as intended. But we go further than that. We will ensure not only that your design works, but will proactively seek ways to improve useability, safety and cost effectiveness. As part of this process, we also assess usability and interactivity with humans, material selection, and biocompatibility assessment. Alongside the physical engineering we also offer project management and preparation of drawings, documents, and bills of materials ready for the exciting next stage — manufacturing.
Medical device manufacturing
We can oversee all elements of the manufacturing for your medical device; maximising efficiencies, reducing waste and ensuring quality control at every step. We also work with clients on tooling design and testing procedures for tooling, the creation of assembly instructions, and preparing your design for manufacturer. This includes refining and simplifying the product design for ease of manufacturing, with the ultimate objective being to make a superior product, at a lower cost.
Device commercialisation
We’ve been in this industry for 10 years and know the pitfalls, challenges and barriers to getting a medical device to market once it is designed and manufactured. When you work with Skiant you can rest easy knowing you have commercialisation experts on hand; covering everything from supply chain and product sourcing, price negotiations for components, documents, manuals, warranties and associated product paperwork. We can also assist with packaging design and sourcing. With over a decade of experience helping clients take their products to market, we make it easy.
Medical device compliance and support
The most revolutionary medical device in the world means nothing if it isn’t compliant. We are experts in regulatory and jurisdiction compliance for different countries. Compliance can be complicated — and mistakes can be costly. The first step is to establish a product compliance roadmap, including analysis of existing products on the market. From there, we work closely with you to establish the compliance representatives and collaborate with them for compliance certification. We also advise on technical file creation, rollout of Quality Management System (QMS), and product compliance labelling. The result is peace of mind that your product is fully compliant in every country and jurisdiction you need it to be.
