Healthcare sector stakeholders are unlikely to change the way they operate to accommodate your new medical product unless it benefits patients and professionals alike. Similarly, your product must be future proof.
So, what steps can you take to make sure your medical product design provides value to stakeholders, both in the present day and the future?
Medical product design and innovation
Technology is evolving at an ever-increasing pace—just look at the recent rise of 3D printing and cloud computing, and their implications for medical device development. This means that, in order to create successful, future-proof medical product designs, you’ll need up-to-date resources and facilities.
Attempting to acquire new resources or update existing ones to be in line with these technological advances can quickly outweighs any financial return when taking your medical product to market.
Innovation as a service
A more sensible alternative is to approach innovation as a service rather than an investment. The right outsourcing partner can streamline your product development cycle with the latest technology. With the right third party, you can develop real-life applications for your medical device, define the production and distribution processes, and adequately prototype your devices for testing and medical trials. Since you won’t need to invest in new infrastructure, personnel or training up-front when working with a subcontractor, the turn-around time for developing Minimum Viable Products (MVPs) and working prototypes is much shorter.
It’s important to define the key attributes of your products, as well as how collaboration between you and your outsourcing partner will work. This will help avoid problems such as miscommunication and unclear mandates, which can cause delays and nullify the advantages of working with a third party.
With a clear plan in place and all parties briefed adequately, outsourcing to the right partner does more than just ensure you’re developing a product in line with the latest material, manufacturing, producing, and distribution innovations: it enables you to benefit from a specialized company’s expertise in medical product design.
Innovation and compliance
Regulatory compliance requirements can make or break a new medical device. Different parts of the world are governed by their own regulatory bodies, like the FDA in the US. These bodies regulate the health and safety conditions any medical device must abide by to ensure the wellbeing of patients and healthcare professionals.
The FDA, for example, follows a three-tiered classification system, with more stringent rules and regulations at each level. The more high-end and innovative your product is, the more likely it will end up being classified as a Class III device. If your innovation builds upon an established process, however, you can fast-track approval as a class I or II device through the 510(k) submission process.
Rules and regulations prescribed by different regulatory bodies evolve with technology, knowledge, and changing laws. Keeping up with these changes is non-negotiable, as following outdated processes or using outdated technology will only make it harder to achieve market clearance. Third-party prototyping and product development providers, with their knowledge and expertise, can help you streamline your product design ideas to be in line with all regulatory compliance requirements.
Technosoft specializes in in-house prototyping, preproduction, clinical trials, and device testing. We’re constantly evolving to embrace the latest product development technology and ensure a cutting edge and future-proof production process while reducing costs from end to end. Our innovative approach will help you create the best medical product design possible and greatly increase your chances of finding the right investor to take your product to market. We are also fully equipped to help you prepare for your regulatory compliance submissions, like the 510(k).
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