With several healthcare products facing delays in recent years, Anthony Giles, Managing Director of Blackwood Embedded Systems, believes it is time to rethink the way software is documented and tested during product development.
Anyone who has worked on bringing a new product to market understands the importance of proving the concept early on.
Typically, this not only needs to be achieved within a limited budget; the developer is also under enormous pressure to get a working prototype ready to show to existing and potential investors.
However, realistic investment phase planning from the outset is essential.
From a software point of view it is coding the task that has visible outputs to investors and board members. Yet this typically makes up only 30% of the complete process.
For medical products, it is the documentation and evidence gathering process, rather than the technology, which is the critical path to achieving the CE mark.
As well as having significant implications on development time, not getting the paperwork in place quickly enough can result in companies having to start all over again or failing.
Moreover there is a balance that should be struck between demonstrating a working prototype to investors and ensuring the product is ultimately market ready.
As well as ensuring companies have a working version of the product quickly , I believe that by establishing a documentation baseline early, companies also have a set of notes demonstrating their understanding of the basic principles or product outline from the outset and how these have historically changed.
Additionally it shows why and how these requirements have been specified, the risks associated with each and how these will be verified and validated for accuracy and to ensure the product is compliant and safe.
To make this process as smooth as possible, it is essential to embrace industry standards – particularly IEC 62304: 2006.
IEC 62304: 2006 defines the life cycle requirements for medical device software and is used to establish a common framework for medical device software life cycle processes.
Whilst many companies have expressed concerns around the formalised structure and requirements, those that embrace the set of processes, activities, and tasks described in this standard, are actually able to bring products to market without unnecessary or unanticipated delays.
Food and Drug Administration (FDA) guidance also says this is the “least burdensome approach”; although this is a phrase that is often misunderstood with many associating the standard with extra time and costs.
It is time we clarify this.
As well as many white papers on the subject, every formally trained engineer is taught that planning and breaking your design down into simpler blocks results in easier to understand systems and correctly resourced projects.
This reduces software bugs - a major time/money waster in projects, and results in safer designs by aiding identification or risk management early on and not having to rework software due to incorrect architecture implementation.
By following 62304 it is possible to achieve both time and cost savings - hence why the FDA rightly calls this the “least burdensome approach”.
I believe it is also essential to correctly identify the Safety Class early in the project.
With 62304 defining the medical devices software classed as either A, B or C where:
Class A: No injury or damage to health is possible [FDA –Minor level of concern]
Class B: Non-Serious Injury is possible [FDA – Moderate level of concern]
Class C: Death or Serious Injury is possible [FDA – Major level of concern]
The 62304 standard does not state how to determine this. However, the FDA provides an easy to follow tick box questionnaire in its “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”.
It is important to understand the full software lifecycle and documentation required to meet the CE mark for the products and avoid any unnecessary risks of failure arising from not having them.
SOUP (Software Of Unknown Provenance) as described by 62304 and the OTS (Off The Shelf Software) as described by the FDA, can save time and be very useful for getting technology uncertainty addressed early on.
However there should be a word of caution here.
The software safety class will also dictate the potential use of SOUP. Class A software where for example there would be no restrictions as failure of the SOUP by definition cannot harm the patient or user in any way.
In Class C however you would have to seriously consider not using it as it would take more time, or in some cases be impossible to, validate the safety of the software.
In conclusion, investors should not be fooled by a fully working prototype; check the paperwork process has been followed or assume at least another 18 months to market.
With dozens of new healthcare applications (apps) and medical devices available almost daily, we spoke to Anthony Giles, Managing Director of Blackwood Embedded Solutions, about how medical companies can ensure their products get to market safely and quickly.
“The level of innovation and application of technology in healthcare is encouraging to see for any product developer. Equally impressive is the ability of these devices to communicate with a number of different systems across the internet including those found within hospitals.
“However, we are also seeing a sharp rise in the number of ‘healthcare apps’ entering the market that are then used as medical applications due to their cost.”
These non-traditional uses of applications and devices are resulting in more challenges for manufacturers and the recently raised class-action suit against popular activity-tracker, Fitbit, should serve as a warning call to get things right from the beginning says Mr Giles.
“The Medicines and Healthcare products Regulatory Agency (MHRA) says that if an app is used for a medical purpose, it should be CE marked. Sadly we are regularly seeing apps purposefully called health apps to get around medical device regulations. The problem with this approach is that this results in the release of applications and products before they are rigorously and properly tested as would be required with medical products with a CE mark.
”Add to that the increased frequency and risk from cyber-attacks globally and Mr Giles strongly suggests that medical product designers and developers ask themselves as a matter of urgency whether it is realistic to expect a product to be ready within six months.
“Within six months, the maximum you should reasonably expect is a good prototype, most probably without any paperwork or verification and validation completed.
“Moreover the principles behind the IEC62304 software design process, addresses many of the patient safety and cybersecurity issues, by implementing good design practice.
”In considering the impact on your new product design, Mr Giles suggests companies start by looking carefully at the following guidance documents:
MHRA guidance on medical device stand-alone software including apps for deciding whether your app is a medical device or consumer health app
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – this provides an easy to follow tick box questionnaire to correctly identify the software Safety Class required for the device early on in the project
FDA General principles of software validation – overview of the software design life cycle for medical devices
FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
FDA guidance on Off the shelf Software use in Medical Devices
Blackwood Embedded Solutions was established by Anthony Giles in 2008. As its name suggests, the company was originally based in Blackwood and moved to Welsh ICE in March this year.
The company designs electronic systems and software for a range of devices – most notably for the medical industry. Anthony explained: “An embedded system is a hidden system – a computer based on a chip rather than a standalone computer. “My background is medical electronics, which I’ve been working in since I was 18. I’ve done everything from production line to design. “I worked for a number of companies over the years and then I was put in touch with a company that were looking for a contractor and that’s how the company was started.
“That was 2008 and then the recession kicked-in. Three months after that first contract ended there was no work at all, but since then we have gone from strength-to-strength. “Things have really taken off though in the last two years.” The company has since grown to nine staff members and was a finalist in last year’s Caerphilly Business Forum Awards.
Products the company has helped develop include a device to clear smoke in laparoscopic surgery and it is currently working on drug delivery system for a client.In the space of just three years, the firm has worked with clients to get seven products to market.It is now looking to further its growth by developing its own products.
Anthony said: “It’s going really well here at ICE. There is lots of mentoring and advice available to help us grow.”
Keen to support its home community, the company sponsors Blackwood RFC and the Blackwood Stars rugby team.
It’s November in central Düsseldorf, and a group of Welsh executives are preparing to bed down on a fleet of boats bobbing on the Rhine. No, it’s not a stag trip, or an attempt to get to Euro 2016. The medical business types are here for the Medica show as part of a Welsh trade mission, and the boats provide their accommodation.
Winning international orders needs a bit of flexibility, whether it’s sleeping on the Rhine, using an agent or distributor, or getting your head around different cultures. For shows like Medica, you’ll also need to get your head around 17 vast halls at a convention venue so big it has its own internal bus service. The experience is “knackering,” says Dominic Griffiths, managing director of Cardiff based Alesi Surgical (link is external), exhibiting at Medica at the Welsh Government stand. But the effort is worth it: “We’re here to talk to people we know, meet people, sniff out what’s going on, look at new technology and see manufacturers. You can have 20 to 30 meetings with existing and future business partners. To do that another way would take six months.”
Anthony Giles, managing director of Blackwood Embedded Solutions, is on his second visit to Medica. He set a target of gaining 20 sales leads; when Insider calls round he’s already beaten that. “It provides huge access to potential clients. It’s a fantastic way to network, even with UK and Welsh companies.” Planning is essential if you’re to get the most out of shows like Medica, says Jarred Evans, commercial director of Cardiff Metropolitan University’s PDR product design and research centre. “It’s so big that you have to do all your work before you get here. You have to have an objective in mind.” Düsseldorf, at the heart of the economically powerful Ruhr-Rhine region, is among the easier destinations to get to from Wales. Many of the Welsh contingent at Medica flew there direct from Cardiff. Others are aiming to win business further afield.
JoJo Maman Bébé, the maternity and children’s clothing retailer, sells products in Germany, supplied from its distribution centre in Newport. It shipped products to the US for three years before opening a distribution centre in New Jersey. Understanding the market is important to managing director Laura Tenison. She says: “I wouldn’t like to trust another to build the business entirely, although a local distributor or agents can work well. We prefer to work directly with Germany, but due to the US being so big, we have a team of local agents. However, direct sales have grown at a far faster rate.” Her company uses trade fairs to work with businesses, and online marketing to sell to consumers.
Exporters should see distributors “almost as employees of your business”, says Steve Young, director of coaching business Winning Pitch. “Make clear what’s expected of them. Some of them may have competing products to sell, other things to do.” Markes International, based in Llantrisant, makes equipment that detects compounds, which it sells to more than 60 countries. The US has growth potential, and China accounts for 20 percent of sales. “China contains a lot of specific challenges,” says finance and operations director Tim Hawkins. “Notwithstanding the language differences, the political and regulatory environment is developing rapidly.” Markes uses a mix of local presence, distributors, agents, manufacturers’ reps and selling from Wales, depending on the market. It started by selling smaller items directly, and building a trusted distribution network, before winning a big contract. Now it operates from hubs in Germany, the UK, east and west US. Investment in Asia is “a hot topic”. “With products like ours, that require high levels of expertise, the direct model, if implemented successfully, really pays off,” says Hawkins. “But for a smaller business, it is not practical to chase a direct model in every location with growth opportunities.”
Selling comes down to relationships with the customers and end users, understanding their objectives and seeking to fulfil them. “It helps to understand cultural differences or at least respect them, and be nice too,” he says. When dealing with new customers, Markes uses letters of credit, or customers pay in advance to remove the risk of non-payment. “Once we develop a deeper relationship and a trading history we extend credit terms,” says Hawkins. “We have a monitoring service through our credit checking agency so, in theory, we try to get a heads up if a customer starts to decline in rating and we can amend payment or credit terms accordingly.” Hawkins reckons letters of credit are very important, especially when dealing with far away customers and “risky” areas, and suggests using trusted banks, rather than local banks, “which might be a risk in themselves.” The company also does business with government agencies, for which credit risk is less of a problem. Hawkins sees clear rules in distribution agreements as essential. “Make sure intellectual property is protected, warranty issues are covered, prices, commissions and payment terms are clear.”
JoJo Maman Bébé usually ensures its business customer debts. Tenison says: “Sometimes we will trade without getting insurance, but will limit our liability. For smaller clients, we tend to sell via our agents, who have an added incentive to get paid on time since their commission in only paid once funds have been received.” The biggest task an exporter faces is integrating its export plans with its growth strategy, says Young at Winning Pitch, which advises businesses on exports through the Welsh Government’s Accelerated Growth Programme: “The export strategy has to be fully committed to, fully budgeted and fully resourced. A small business might choose to target a large market such as India or China. But look at the time that takes. Some countries are easier than others – it may be best to look first at Ireland or the Netherlands.”
He advocates cutting out wasteful or speculative activities. He gives an example of a company that racked up huge bills by transporting machinery to overseas trade shows and taking people to dinner. “The idea is that the business doesn’t just export, but exports profitably.” But he’s not advocating cutting out trips altogether: “Ultimately, you have to go out there and build the relationship. You can’t do it by email or by phone.” Two mistakes made by companies on trade missions are not preparing meetings in advance, and failing to build on the contacts they made, says Young: “The six weeks before and after a trade mission are as important as the mission itself.”