Dr Euan McBrearty, head of commerical & innovation, Wideblue shares five steps to successful medical device development.
Wideblue
As a company Wideblue have been involved in helping medical device companies bring their ideas to market for the past 15 years. During this time, we have identified several key elements needed for success.
Market research
Great you have a brilliant idea for a new medical device. However, is there a market for it and how scaleable is that market? Market research is essential to establish if there is a need for your device and what the competitive landscape like. Internet research and speaking to contacts in the industry can be very useful in this respect. If your product is addressing a very rare illness or disease the market might be too small to build a business around. Some of our most successful clients have come up with devices which help with COPD, asthma and sepsis, conditions which impact a huge number of people globally. Search current patents and see if there are any similar products out there. Your device might not be unique, but it may improve upon what already exists.
Compliance
The medical device sector is highly regulated and understanding the rules is vital. Too many companies rush into developing prototyping before considering the regulatory framework. The International Organisation for Standardisation (ISO) sets global standards for a broad range of products and businesses, including medical devices, and the International Electrotechnical Commission (IEC) sets standards for a variety of business types including medical devices and the electronics/software contained in them. Although these bodies do not have the force of law, they are used by the regulatory authorities such as the Federal Food & Drug Administration (FDA) as a benchmark and gold standard for compliance. However, it is important to note that full compliance is not required for approval for manufacturers but any deviation needs to be fully justified.
It is essential to find out how your device will be classified. This will depend on the risk level of the device and which medical conditions it is intended to treat. If the device is to be used in the US market you will need FDA approval. Although the UK has left the EU, European regulations still apply during the transition period. Working with a professional medical device consultancy and IP attorney can help you navigate the legal labyrinthe.
Manufacturing
Going from the idea stage to producing an actual product which people will pay money for is a long journey and can be littered with pitfalls if not planned properly. This makes the prototyping stage very important as this allows any design, operational or functional issues to be identified at an early stage and ironed out before going to the full production stage. Prototyping is the process of making either a scale or full-size replica of something that is intended for commercial production. The process if done properly can shorten pre-production timescales considerably and help avoid costly mistakes. Fortunately, advances in CAD design, 3D printing, and rapid prototyping technologies make it much easier to create a model which can accurately replicate the physical, visual and tactile quantities of the intended device. This means advanced testing can be carried out and the device can be put in the hands of potential users in focus groups for valuable feedback.
Depending on the medical application, the device may also need clinical trials in either a laboratory or hospital setting or both. This can be a long process and may involve several iterations of the product before the final design is agreed upon.
Supply chain
Great you have gone through all the regulatory and prototyping stages and you are ready to look at going for commercial production. Close collaboration between the design team and the rest of the supply chain is vital for success. Things are currently tough for the manufacture of new products with many supply chain shortages, delays, component issues and raw material price increases. Here are some of the key things to consider:
- Pick a manufacturer who has specialist expertise in medical device production. They might be more expensive initially, but their in-depth knowledge can save costly mistakes further down the line.
- Choose a manufacture location much earlier in the design process. Once selected, the design team can work with the intended manufacturer to identify the long-lead time items, test equipment and tooling.
- Key components can be “locked” into the design and commitments made for sourcing to avoid delays later in the project.
- Key electronic components can be ordered well in advance of completing a PCBA design. This avoids delays in prototyping particularly in the medium volume scenarios between the early low volume prototypes and the larger Beta trial or clinical trial quantities.
- Give early consideration to your tooling strategy for injection moulded parts or die cast parts. If necessary, follow a parallel path.
- Keep a detailed audit trail of all components, circuitry and software being used in the device especially if you are outsourcing manufacture. Should an issue or product failure occur in future it is imperative to have each item used in the device catalogued and recorded for traceability purposes.
- ISO standards are reviewed every five years so ensure that your quality control and risk management processes are aligned with the latest standards.
Going to market
Once all the prototyping, testing, audit checks and approvals have been gained it is time to launch your device into the market. Marketing is a complex subject and beyond the scope of this article, but here are some points to consider:
- What is your route to market. Will it be direct to consumers, the health authorities or through some other intermediary. What are the procurement rules and what hurdles might you face in driving sales?
- Packaging – design and what information is required for the device to be used safely and effectively.
- Promotion – is your advertising and PR within the relevant rules and regulations. Have you made any claims which cannot be scientifically or clinically proven.
- Pricing – this can be a difficult issue, price too low and you will not make a profit, too high and you could price yourself out of the market.
In conclusion, designing and bringing a medical device to market can be a long and costly journey but with professional partners to support you, the route can be made less arduous.