Medical device developers should focus on these five outcomes to compete in today’s market.
Approach product lifecycle management with an eye to device security in the digital age.
Today, even the smallest hint of a security flaw is enough to send people running scared. Just ask St. Jude Medical Inc. The Minnesota-based medical device company’s stock recently took a dive when Muddy Waters Capital, a financial research group, made claims of “worrying” problems with the security of St. Jude’s connected pacemakers and other heart-rhythm devices. In their report, Muddy Waters suggested the recall and remediation of St. Jude Medical's cardiac devices that would result in roughly a 50 percent decrease in St. Jude Medical's revenue for the next two years — the estimated period for remediation.
St. Jude Medical is now suing the firm for spreading false information to hurt its stock prices. I am sure we have not heard the end of this story. But, this is the first time that the potential for a security breach has resulted in financial impact for a company (i.e. stock prices).
And it’s not just healthcare’s problem. Virtually every industry from oil and gas and automotive to manufacturing and financial are under increasing attacks from cyber criminals. In the last year, the number of records exposed in data breaches rose 97%, according to the Identity Theft Resource Center.
Given the statistics, it’s not surprising that security is the number one barrier to connected technology adoption, according to Vodafone’s annual Barometer report. We know it’s a problem, yet in the race to bring connected solutions to the market, security is often an afterthought.
A truly successful security strategy for connected devices will require security measures throughout all phases of the product lifecycle to better protect your company and your users.
You might not think there is a need to think about security this early in the product lifecycle, but the Roadmapping Phase is the perfect place to start planning. Preparing for a cyberattack sounds dire, but it’s important to consider who might attack the device or application to determine your risk. This is known as threat modeling.
In the process of threat modeling you explore what information cyber attackers might want and how they might gain access (entry points) and get out (exit points). Every avenue must be evaluated and assessed. With connected technology, your entry or exit points may even be devices or applications to which your product connects. Once you have identified the potential threats to security, you can estimate the total damage potential, how a breach would affect users to determine your overall risk.
But, threat modeling is exactly what it sounds like—a model. It is limited in its scope and while it will help you to understand the dangers, it won’t tell you to manage or mitigate them.
Integrating everything you have learned from your threat model into product design and development is not an easy task—but an important one. As the final product design is narrowed down and defined, security testing needs to occur on new features or functionality that are added to ensure they do not introduce new vulnerabilities. This is also the time to consider all of the devices and applications your product will interface with to ensure they are built with the same level of security.
Finally, before the Development Phase comes to a close, a thorough security review and penetration test should be performed to assess any new vulnerabilities or weaknesses in the product.
Because cybersecurity risks are continually evolving, it is not possible to completely mitigate all risks during the Roadmapping and Development Phases of the product lifecycle.
Updating operating systems regularly is an important part of your ongoing security strategy throughout the Fulfillment Phase. Hackers target vulnerabilities in operating systems, so regularly installing updates helps close those holes and protect your data. We recommend developing a policy of notifying users of important software and security updates and enforcing update requirements as necessary.
Security is an ongoing concern that is growing larger with every new connected application. Every additional device or connection opens up another possible point of entry for real users and for those with malicious intent. Don’t be your own biggest security risk—make sure you address security throughout the complete product lifecycle.
Join us on 20-22nd September 2017 Medtec China, sourcing the qualified supplier and material you need.
It doesn’t have a snazzy name yet. But researchers at top universities have been making strides with custom-built 3-D printers that create with multiple materials from the nanoscale to the macroscale—enabling significant medical device innovation in the process.
Here are four aspects of medical device product development you should especially watch out for, courtesy of a top research engineer at a major medtech manufacturer.
Now that the UK has voted to leave the EU, how might the fallout impact medical device companies?
Last week, citizens of the UK took the unprecedented step of voting to leave the EU. The results of the June 23 referendum shocked people and roiled financial markets around the world.
But what might Brexit mean for the country’s medtech industry?
Here are a few theories:
UK Will Lose Life Science Jobs and Investment
George Freeman, a member of the UK Parliament and minister for life sciences,wrote earlier this year that he believed a British exit from the EU could jeopardize the economic impact of the country’s life sciences sector.
“The jobs and prosperity being created in our area by the high growth businesses of tomorrow are strongly linked to our membership of the European Single Market, scientific community and to the UK's strong role in influencing the market regulatory framework of the EU,” he wrote.
Freeman predicted in February that the impact on the country’s economy could be comparable to what the UK saw during the global recession of 2008—and that’s without even taking into account trade barriers that could be imposed by the EU.
According to the Irish Times, IDA Ireland, an agency of the Irish government that aims to attract more foreign direct investment to the Emerald Isle, already has plans to lure companies from the UK to its own shores.
UK Will Have Less Influence Over EU Medical Device Regulation
This past May, the Association of British Healthcare Industries, a medtech trade association in the UK, released the results of a Brexit survey of its members. Nearly three-quarters said remaining in the EU would be beneficial to the country as a whole. Among the reasons cited for staying was the possibility of regulatory divergence with the EU if the UK were to leave.
“Companies believed that Britain’s influence in the development of the regulatory environment had been positive and an exit would mean both the loss of this influence and the duplication of approval processes for the UK and EU markets,” according to a press release from contract research organization Donawa Lifescience.
Law firm Hogan Lovells delved into some other potential specifics, suggesting that UK life science firms could face supply chain interruptions, increased quality control testing, and new export charges.
IP Will Be Put in Jeopardy
Hogan Lovells also explained that Brexit could bring uncertainty in the realm of intellectual property.
“. . . unless alternative arrangements can be secured, all pan-EU intellectual property (IP) rights would cease to apply in the UK upon the exit taking effect,” the firm worte.
EU-wide orders issued by UK courts could also be rendered null on the Continent, according to the firm.
UK Device Firms Will Face a Worker Shortage
The UK will need more than a quarter-million more engineers by 2022, according to the trade group Confederation of British Industry(CBI). If the country were to remain in the EU, British companies could draw talent from any of the 27 member states without having to worry about securing visas. Once the UK leaves the EU, those positions could be harder to fill.
Manufacturing workers, too, could be harder to come by. According to CBI, 185,000 EU nationals currently hold manufacturing jobs in the UK.
UK Exports Will Increase Outside the EU
It might all sound like doom and gloom for UK device firms, but at least one person in the industry sounded a somewhat optimistic note.
According to CBI, Jarl Severn, managing director at medical device maker Owen Mumford, posited that if the country’s currency loses value as a result of Brexit, its products could become more attractive to export markets outside of the EU.
Still, Severn admitted, it would be “a bit of a seesaw and rollercoaster ride for all concerned.”
In this chronological feature, we round up the most important medical device innovators from the early 1800s to the present.
The medical device continues to confront seismic shifts. Many medtech companies are diversifying their business after realizing that they have more to do than just make medical devices—they must support an ecosystem that helps improve healthcare outcomes while ideally cutting costs.
Inadequate instructions, component issues, and assembly errors—those are but some of the causes behind recent medical device recalls and serious warnings announced by the FDA.