Over 50% of Circuitwise’s business is PCB assembly for medical devices. We play a critical role in ensuring that the beating heart of medical devices is manufactured in accordance with the regulatory requirements. We also ensure that all electronic components are traceable, up and down the supply chain.
While our role in medical device development is critical, we are only one part of the complex process of medical device product development. To support the industry, we sponsor the NSW Active Medtech Community which recently celebrated one year of delivering educational webinars.
We thought we would summarise what we have learned in hosting over 25 hours of educational content. Following are the key takeaways:
Understand what an active medical device is: First determine if it’s a medical device at all, which usually means it is used to diagnose, treat, prevent or treat a medical condition. If it is a medical device. Active devices are typically those with electronics and software. There are several classes of device ranging from tongue depressors to implantable pacemakers. The bulk of the Australian product development market is aimed at Class IIb which are medium-high risk devices such as the emergency ventilators we helped build.
Ensure you have a business case: Many entrepreneurs have a great idea or technology and think the first step is to just show it could work, and everything else will follow. Wrong! Product development starts with being clear on the value proposition, business model and all the other elements that go into building a business case. A key part of the business case is ensuring you have "freedom to operate", from an intellectual property perspective. You will generally want to have patents in place to protect your huge investment and also ensure that no one else has patents in place to stop your product from going to market, or worse make you recall it after you have already launched!
Build your team: It's impossible for entrepreneurs to become expert in every aspect of medical device development. Key to success is developing a trusted team around you to deliver everything required. If you choose to build capability in-house you will need to find a way to be assured of the competence of your team and the quality of your outputs. Most start-ups and mid-range companies outsource some or all of their non-core functions to ISO 13485 certified service providers. The first thing you need to do is get a non-disclosure-agreement in place with everyone you talk to.
Planning: One of the first tasks, and an input to your business case, is to generate a ballpark estimate of what it will cost to take your product to market. If you outsource everything, you can use consultants to do the work for you through their quotes. You can use these quotes to also get an estimate of the timeline, typically about 2 years.
Funding: The single biggest challenge and the primary task of the MedTech entrepreneur is to raise the funds necessary to develop the product. Many start-ups naively think they can go to market for a few hundred thousand dollars. The reality is, very few devices make it to market for under A$2 million (depending on the class and complexity of course) and the more successful global plays invest many multiples of that figure. Funding sources include incubators, venture capital, angel investors, large MedTech corporates, and a large arrange of grants. Grants usually require matched funding and are mostly competitive, meaning there is no guarantee you will get them. Funding, and cash flow in particular, is the thing that mostly keeps entrepreneurs awake at night. A key point to make is that the more you have de-risked the concept and can prove its viability the less equity you have to give away to investors.
Regulatory Requirements: A defining feature of medical devices is the need to comply with regulatory requirements. If you are planning to export your product, as most MedTech companies do, then you have to understand the requirements specific to each country and region (such as Europe) you are targeting. Regulatory approvals are needed from authorities such as the TGA in Australia, the FDA in the US and gaining the CE mark in Europe. A regulatory strategy is required to determine the best path to compliance, or which country to get approvals from first to make it easier to get subsequent approvals from other countries.
Standards: To develop a medical device means becoming intimately familiar with a whole range of standards. The big one is the ISO 13485 standard on quality management systems. Any company that want to manufacture and sell medical devices is required to have this quality management system in place. For active devices, there are a whole lot of other standards such as IEC 60601-1 on safety and performance, ISO 14971 on risk management and IEC 62304 on software engineering. If you outsource the product design, your contracting consultants will do the work for you around these standards.
Quality Management: Many start-ups underestimate the work involved in setting up their quality management system. You need documentation for every single thing you do in the design, development, manufacturing and support of your product, as well as every aspect of running your business. While start-ups can outsource most things, it’s hard to avoid employing at least a few people to run your quality management system (QMS). The QMS covers everything from HR processes, to auditing of suppliers, maintaining a history, proving traceability of design history and supplies, and importantly control of your documentation.
Documentation: The main reason medical devices are so much more expensive to develop than consumer or industrial devices is the huge amount of documentation required to prove you have followed all the processes required by regulatory authorities and adhered to all the standards. There are literally thousands of documents generated, starting with User Needs, through a whole range of planning, design and risk analysis tasks, ultimately ending with the Medical Device File – a compilation of all the documents that you need to submit to the regulatory authorities.
Product design and development: The bulk of the budget is expended on this key part of the project. Key D&D functions include industrial design, mechanical engineering, electronics design, software development, specialist packaging, design for manufacture and more. Product design begins with User Needs and embraces the concept of design controls, which includes the processes of verification and validation to make sure your medical device performs as intended. The range of D&D sub-topics is too many to list in this short introduction but to give you a taste they include: human-centred design, concept development, branding, usability, system architecture, circuit schematics, electromagnetic compatibility, software partitioning, and configuration management.
Clinical Trials: Toward the end of your design and development phase, the project will produce prototypes that are essentially identical to the final manufactured product. These prototypes can be used in both usability and clinical trials to gather evidence that the device is safe and does what it intends. If there is a predicate device on the market, it may be possible to avoid full-blown clinical trials by proving equivalence, but this phase involves some work regardless. The key standard here is ISO 14144 and involves the development of an investigational plan, investigator’s brochure, case report forms, clinical investigational report, data set management, trial master file. The output is a Clinical Evaluation Report which is a key part of the Medical Device File submitted to regulatory authorities.
Manufacturing: Finally, after a very long journey. A design transfer package is developed which contains all the information required to manufacture your device. Generally, you will have subcontractors building the key sub-assemblies, which in the case of active medical devices includes the PCB assembly which Circuitwise specialises in. You need to manage your supply chain to ensure that everyone is adhering to the relevant quality and regulatory requirements. The sub-assemblies then come together in what is called the box-build, so-called because it includes the packaging for the individual product and the bulk shipping. And because it’s a medical device, there are standards for the packaging and transporting of the devices too! A key point to note is that each unit has to be tested, again with verifiable processes, before it can be shipped. The cost of testing can sometimes exceed the cost of manufacture, so it pays to optimise this process early on in the design of the product.
There is a lot in the above that would lead one to conclude that developing medical devices is not for the faint-hearted. However, when broken down into individual tasks, the challenge does not seem so insurmountable.
The concept of boot-strapping is really about taking one step at a time. Initial funds should be employed to best effect to take the start-up to a position where it is credible enough to acquire the funds required for the next phase, then repeat.
The secret is building the right team around you. Start with a good mentor and make sure you select the right partners. Circuitwise is happy to recommend the best designers and developers in NSW. Give us a call if you are at the start of your journey and we will help you out in whatever way you can.