Development cycles and medical devices: the long and winding road

So you have an idea for a product that will improve something, change something, or make a difference in the healthcare industry. Now what?

Product development for the healthcare industry, specifically for medical devices, is a complex process that can be hard to navigate and difficult to fully appreciate. Below, Clare Cornes, Innovation Development Manager at Greater Manchester’s GC Business Growth Hub, looks at the key development points, the challenges they may include, and how to overcome them. 

Medical device development cycles

In advance of starting any product development, there are several questions that should be asked, including:

• What problem am I trying to solve with this new product? Is it a major issue or a niche concern, and does the problem exist in one area or across multiple locations?
• Does this already exist elsewhere or is it in development already elsewhere? 
• Can this be delivered without the input of a strategic partner, and if not, who could play the role of strategic partner?

Undertaking a structured review of the idea, challenges and commercial opportunities can often be a way to shape the path in which development takes. Tools are available to help, including the  KTN Innovation Canvas, which is used by GC Business Growth Hub to help business extract maximum value from a new product or project. 

Using structured tools like this can help measure time taken throughout development and commercialisation – supporting future development and resource planning – as well as identify key risks, including those that might impact development and future commercialisation.

The cycle of product development

The seven steps of product development are still true in the case of medical device development, and should be reviewed in advance of commencing development of any product: 

1. Ideation of a solution to a problem
2. Idea editing, to ensure the final product will solve the challenge with the highest chance of success
3. Developing a market strategy by conducting a thorough review of the existing market, future growth and potential competitors
4. Minimum Viable Product (MVP) development and testing
5. Product development iterations for improvements after testing
6. Market testing with potential consumers 
7. Market commercialisation

Alongside these steps, being mindful of best practice and guidance available including things like ISO standards (such as ISO 14971:2007 “Medical Devices – Application of Risk Management to Medical Devices), can ensure the development process does not meet any avoidable barriers. 

However, at any point in the above steps, failure can occur. Using tools and best practice to develop ideas and structured approaches can help reduce the likelihood of failure – but remembering that failure is a normal part of innovation will be key to ensuring you know when to push ahead and when to cut your losses and move on. 

Whilst these steps assist with ensuring development happens in the correct order, additional considerations are required for medical devices. The regulatory requirements for the area in which the device will be sold will govern how it will be assessed and registered. In the UK, all devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) in advance of sales in the UK. Currently, devices are regulated under:

• Directive 90/385/EEC on active implantable medical devices (EU IAMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

These directives are in effect in UK (including post-Brexit) and, as such, device development will need to meet them where relevant. Approved UK bodies will assess devices in advance of registration with the MHRA and entry in the UK market for sales. Conformity assessments are used to demonstrate that medical devices meet regulatory requirements in advance of being sold in the UK, and the route the conformity assessment will take (if one is required) will depend on the classification the device falls under, which relates to the level of risk associated with the device. 

If the UK is the not the initial market you’ll be targeting, familiarising yourself with the regulatory landscape in the country of choice in advance of beginning will save time later.

Development challenges and how to overcome them

There are several key challenges that may impact how development takes place, how long it takes and whether it will be successful in the end. These include:

• The cost of product development, particularly where iterative testing approaches are taken
• Understanding changes in regulatory requirements, particularly in light of Brexit and any new agreements between the UK and other nations

• Understanding that even when there may appear to be a need, creating a profitable product is not guaranteed

• Navigating intellectual property considerations, both nationally and internationally, can be time consuming and confusing, along with potentially expensive. 

Such challenges can delay or even end a development and commercialisation journey. However, support is available for business locally, regionally, and nationally. Taking advantage of resources that are freely available, including those provided by GC Business Growth Hub, may help identify potential major problems in advance of them happening. 

These resources can also offer information on alternative routes for development or ways in which new technologies or innovations could improve the product itself, including new developments in med-tech.

Medical devices and med-tech

Med-tech is a term recently applied to medical devices which utilise a higher level of digital capability. With the development of more Internet of Things-related devices, med-tech is noted as a key growth area in the healthcare industry. However, the recent increases in the use of sophisticated software and connectivity integration with medical devices is presenting a separate set of challenges to the industry. 

Integrating the use of digital technologies in devices increases their overall complexity, which then increases both the development work and the potential number of future risks. Key risks for connected medical devices include (but are not limited to):

• Considering cybersecurity and the impacts of not maintaining effective digital security for those using the device 

• Interoperability with other devices, particularly those with less or more sophistication and how this interoperability could impact user needs 

• Patient understanding of the device, the data being collected and the limitations of what the data may tell medical professionals.

Any new device that incorporates an element of digitisation or connectivity should consider regulatory requirements and best practice to support the integrity and of data and data security. Maintaining a security by design approach will help ensure the end result meets regulatory and user expectations.

So you have a new idea. Now what?

If you have an idea for a new product, we can offer support across the full product development journey. Business advisors can assist with concept editing, accessing grant funding and creating relationships with local knowledge bases such as universities, along with future customers. Though the journey through development to commercialisation may be challenging, the support available can help ensure you’re able to work through these challenges and reach your end goal. 

To access specialist medical devices innovation support, funding and tailored resources, go to www.businessgrowthhub.com/innovation or email [email protected].

Businesses looking to access specialist support can visit www.businessgrowthhub.com for more information about the organisation’s extensive range of services. This and other GC Business Growth Hub projects are part-financed by the European Regional Development Fund (ERDF) as part of the GM Business Growth Hub project, designed to help ambitious SME businesses achieve growth and increase employment in Greater Manchester. The Hub is also supported by the Greater Manchester Combined Authority and Greater Manchester local authorities.