Insights

Patient Support Program and Remote Cardiac Monitoring via Mobile Phone

Patient Support Systems Applied to Cardiac Monitoring

The healthcare ecosystem has been rapidly evolving over the past few decades, and it seems to be accelerating. Developing more cost-effective methods of addressing chronic diseases, such as cardiac-related illness, is a high priority.  The fairly recent evolution of Patient Support Programs (PSP) is increasingly

Do you have a Cloud Hangover?

Many organizations, eyeing their cloud adoption initiatives in the rearview mirror, are beginning to suffer some buyer’s remorse. Either the promise of the public cloud has failed to materialize, or perhaps sights were set on the wrong goals to begin with. A misapplication of the

AI is reforming the Radiational Oncology Market in Real Time

The rate of change in the field of oncology has continued to accelerate, with an information doubling expected to occur every two months – or expanding at the rate of 64x per year. The oncology field has long since crossed the line that individuals can

Golden Age of Molecular Diagnostics

Recently, the New York Times had an article on Page 1, above the fold, titled, “Suddenly, It Looks Like We’re in a Golden Age for Medicine”. As the piece describes, the explosion of the utility of new biotech technologies, from CRISPR to mRNA, is leading

Competing in the Enormously Competitive Surgical Robot Space

Intuitive Surgical shipped their first surgical Robotic Assisted Surgery (RAS) in 1998. In the twenty-five years since, the technology has become ingrained in most surgical procedures. Incredibly, the market itself is projected to grow 7-fold over the next 7 years. This growth has created a

Evolving Digital Health Impacts EP

The expanding impact of Digital Health and Digital Therapeutics is being felt by the EP sector.  Remote monitoring of implantable cardiac devices (ICDs), cardiac resynchronization therapy devices (CRT-Ds), and pacemakers have been shown to improve patient outcomes. More recent work applying convolution neural network (CNN)

Rapid Changes to the Healthcare Information Ecosystem

The pressure to extend product capabilities within the healthcare information systems industry has gone through cycles over the past few decades, but it has never been higher than it is right now. If you were to look at the HIMSS education track from ten years

Remote Cardiac Monitoring: New Challenges with the New Normal

Pressure continues to mount to reduce the use of in-hospital resources in order to improve the cost performance of healthcare. Developing more cost-effective methods of addressing cardiac-related illness, still the number one cause of death in the US, is a high priority. Remote monitoring and

Leveraging AI in Radiation Oncology: What You Need to Know

The radiation oncology (RO) market continues to change rapidly. Efforts with the goals of improving the effectiveness of treatment, while reducing costs, and preventable treatment errors is driving the new capabilities into both delivery and treatment planning systems. In a change from recent years, a

Good Contracts Lead to Good Relationships

Medical device manufacturers might consider outsourcing product development or product testing activities for a number of reasons. In general, if an outsource provider has specific experience that you lack, has more resources available, or doesn’t carry all the overhead of a large corporation, then you

Harder Than It Looks: Medical Device Startups

You saw the prototype working. The preliminary clinical data looked promising. There was a huge market need for the product. It looked like a sure thing. Then, two years later than anticipated, the product finally gets to market. Development costs millions more than expected. Worst

Good Products from Good Processes

The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem that luck has more to do with success than anything else. Why do companies with similar products sometimes take very different amounts of time to launch new

Using Design Controls to Reduce Time to Market

FDA’s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true. Understanding and following

Software Safety for Every Phase of Software Development

Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software

How to Avoid the Biggest Mistakes in Medical Device Development

How do some medical device firms manage to trip over their own feet? Trying to get away with “good enough” and consequently earning a reputation for sloppy work are not uncommon. But the biggest single mistake is putting risk management, verification and validation at the

Validation Value

Medical device manufacturers that use manufacturing or test instruments that rely on software may be required by federal law to validate that software. This may include software that is embedded as part of the instrument, or external, including off-the-shelf, software that interacts with the instrument.

Recipe for Risk Management

Manufacturers of medical devices are required by federal law to validate software that is part of the manufacturing or quality system. But there is confusion about what this means. What software does the FDA regulate? What level of validation is required? There are no checklists

Ideas for Validating Production Software

The FDA requires medical-device manufacturers to validate software that is part of production or a quality system. But what does that mean? Those charged with the job are often not software engineers nor do they have backgrounds in validation or regulatory issues. As a result,

Validating Software for Manufacturing Processes

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical device. Perhaps not as widely understood or accepted is the regulatory

Best Practices for Dealing with Offshore Software Development

Offshore outsourcing (offshoring) of software development has been an increasingly popular trend in recent years. The cost benefits are easy to understand when you consider that the average annual salary for an engineer in the USA is $70,000 in 2004, compared with a $13,580 average

Medical Device Validation: How Vendors Can Assist their Customers

The current Good Manufacturing Practices – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485:2003 – require medical device manufacturers, contract manufacturers, and specification developers to validate any software used in their devices or in the development or manufacture of a device. Suppliers of instruments

Bringing Legacy Devices Into Compliance

There are no standard guidelines for changing legacy medical products, but there are proven approaches. The best of these include the expectations of business, customers, and regulators. Assessing the state of a device when planning product improvement must include device performance, design documentation, and the

Validating Medical Device Software Includes and Goes Beyond Testing

The Food and Drug Administration (FDA) pays special attention to software because it is now embedded in a large percentage of electromedical devices, and the amount of device functionality controlled by software is continually growing. Software also controls many of a medical device manufacturer’s design,

Using Design Controls to Reduce Time to Market

FDA’s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true. Understanding and following

Solid Strategy, Sound Management

System-level testing, also known as “black-box testing,” tests software with no knowledge of the design and implementation details of the software. On the other hand, unit-level (whitebox) testing individually tests each unit for function, subroutine, and other software standards and is based on intimate knowledge

Unit Level Software Testing

A System-level, or “black-box”, testing verifies that software correctly implements the system-level requirements and specifications. It requires no knowledge of the software design or structural implementation. In contrast, unit-level testing is based on detailed knowledge of the architectural and logical design, data structures, performance and

FDA Regulation of Software for Medical Device Manufacturers

While the dizzying array of FDA regulations and changes may seem overwhelming, there is a checklist that can help you stay sane and in compliance Medical device manufacturers are regulated in two different but related ways by the FDA. First as with drugs, device manufacturers

Communications Protocol Testing:

Testing the increasing number of microprocessors that need to communicate reliably with each other within medical devices poses not one but three different testing challenges: technical, planning (resources, schedule, budgets, etc.), and compliance. It’s a rare electronic medical device that does not make use of

Software User Interface Requirements for Medical Devices

Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software

FDA Steps Up its Cyber Security Vigilance

Full Spectrum is often engaged to assess software cybersecurity for our clients.  So, when the FDA issued its new draft guidance to the MedDevice industry (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA – April 8. 2022) we expected

What Has Covid Taught us about Medical Device Development?

Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years. In March of 2020, when Covid cases started spiking and emergency orders closed offices and manufacturing plants across

Patient Support Program and Remote Cardiac Monitoring via Mobile Phone

Patient Support Systems Applied to Cardiac Monitoring

The healthcare ecosystem has been rapidly evolving over the past few decades, and it seems to be accelerating. Developing more cost-effective methods of addressing chronic diseases, such as cardiac-related illness, is a high priority.  The fairly recent evolution of Patient Support Programs (PSP) is increasingly

Do you have a Cloud Hangover?

Many organizations, eyeing their cloud adoption initiatives in the rearview mirror, are beginning to suffer some buyer’s remorse. Either the promise of the public cloud has failed to materialize, or perhaps sights were set on the wrong goals to begin with. A misapplication of the

AI is reforming the Radiational Oncology Market in Real Time

The rate of change in the field of oncology has continued to accelerate, with an information doubling expected to occur every two months – or expanding at the rate of 64x per year. The oncology field has long since crossed the line that individuals can

Golden Age of Molecular Diagnostics

Recently, the New York Times had an article on Page 1, above the fold, titled, “Suddenly, It Looks Like We’re in a Golden Age for Medicine”. As the piece describes, the explosion of the utility of new biotech technologies, from CRISPR to mRNA, is leading

Competing in the Enormously Competitive Surgical Robot Space

Intuitive Surgical shipped their first surgical Robotic Assisted Surgery (RAS) in 1998. In the twenty-five years since, the technology has become ingrained in most surgical procedures. Incredibly, the market itself is projected to grow 7-fold over the next 7 years. This growth has created a

Evolving Digital Health Impacts EP

The expanding impact of Digital Health and Digital Therapeutics is being felt by the EP sector.  Remote monitoring of implantable cardiac devices (ICDs), cardiac resynchronization therapy devices (CRT-Ds), and pacemakers have been shown to improve patient outcomes. More recent work applying convolution neural network (CNN)

Rapid Changes to the Healthcare Information Ecosystem

The pressure to extend product capabilities within the healthcare information systems industry has gone through cycles over the past few decades, but it has never been higher than it is right now. If you were to look at the HIMSS education track from ten years

Remote Cardiac Monitoring: New Challenges with the New Normal

Pressure continues to mount to reduce the use of in-hospital resources in order to improve the cost performance of healthcare. Developing more cost-effective methods of addressing cardiac-related illness, still the number one cause of death in the US, is a high priority. Remote monitoring and

Leveraging AI in Radiation Oncology: What You Need to Know

The radiation oncology (RO) market continues to change rapidly. Efforts with the goals of improving the effectiveness of treatment, while reducing costs, and preventable treatment errors is driving the new capabilities into both delivery and treatment planning systems. In a change from recent years, a

Good Contracts Lead to Good Relationships

Medical device manufacturers might consider outsourcing product development or product testing activities for a number of reasons. In general, if an outsource provider has specific experience that you lack, has more resources available, or doesn’t carry all the overhead of a large corporation, then you

Harder Than It Looks: Medical Device Startups

You saw the prototype working. The preliminary clinical data looked promising. There was a huge market need for the product. It looked like a sure thing. Then, two years later than anticipated, the product finally gets to market. Development costs millions more than expected. Worst

Good Products from Good Processes

The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem that luck has more to do with success than anything else. Why do companies with similar products sometimes take very different amounts of time to launch new

Using Design Controls to Reduce Time to Market

FDA’s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true. Understanding and following

Software Safety for Every Phase of Software Development

Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software

How to Avoid the Biggest Mistakes in Medical Device Development

How do some medical device firms manage to trip over their own feet? Trying to get away with “good enough” and consequently earning a reputation for sloppy work are not uncommon. But the biggest single mistake is putting risk management, verification and validation at the

Validation Value

Medical device manufacturers that use manufacturing or test instruments that rely on software may be required by federal law to validate that software. This may include software that is embedded as part of the instrument, or external, including off-the-shelf, software that interacts with the instrument.

Recipe for Risk Management

Manufacturers of medical devices are required by federal law to validate software that is part of the manufacturing or quality system. But there is confusion about what this means. What software does the FDA regulate? What level of validation is required? There are no checklists

Ideas for Validating Production Software

The FDA requires medical-device manufacturers to validate software that is part of production or a quality system. But what does that mean? Those charged with the job are often not software engineers nor do they have backgrounds in validation or regulatory issues. As a result,

Validating Software for Manufacturing Processes

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical device. Perhaps not as widely understood or accepted is the regulatory

Best Practices for Dealing with Offshore Software Development

Offshore outsourcing (offshoring) of software development has been an increasingly popular trend in recent years. The cost benefits are easy to understand when you consider that the average annual salary for an engineer in the USA is $70,000 in 2004, compared with a $13,580 average

Medical Device Validation: How Vendors Can Assist their Customers

The current Good Manufacturing Practices – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485:2003 – require medical device manufacturers, contract manufacturers, and specification developers to validate any software used in their devices or in the development or manufacture of a device. Suppliers of instruments

Bringing Legacy Devices Into Compliance

There are no standard guidelines for changing legacy medical products, but there are proven approaches. The best of these include the expectations of business, customers, and regulators. Assessing the state of a device when planning product improvement must include device performance, design documentation, and the

Validating Medical Device Software Includes and Goes Beyond Testing

The Food and Drug Administration (FDA) pays special attention to software because it is now embedded in a large percentage of electromedical devices, and the amount of device functionality controlled by software is continually growing. Software also controls many of a medical device manufacturer’s design,

Using Design Controls to Reduce Time to Market

FDA’s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true. Understanding and following

Solid Strategy, Sound Management

System-level testing, also known as “black-box testing,” tests software with no knowledge of the design and implementation details of the software. On the other hand, unit-level (whitebox) testing individually tests each unit for function, subroutine, and other software standards and is based on intimate knowledge

Unit Level Software Testing

A System-level, or “black-box”, testing verifies that software correctly implements the system-level requirements and specifications. It requires no knowledge of the software design or structural implementation. In contrast, unit-level testing is based on detailed knowledge of the architectural and logical design, data structures, performance and

FDA Regulation of Software for Medical Device Manufacturers

While the dizzying array of FDA regulations and changes may seem overwhelming, there is a checklist that can help you stay sane and in compliance Medical device manufacturers are regulated in two different but related ways by the FDA. First as with drugs, device manufacturers

Communications Protocol Testing:

Testing the increasing number of microprocessors that need to communicate reliably with each other within medical devices poses not one but three different testing challenges: technical, planning (resources, schedule, budgets, etc.), and compliance. It’s a rare electronic medical device that does not make use of

Software User Interface Requirements for Medical Devices

Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software

FDA Steps Up its Cyber Security Vigilance

Full Spectrum is often engaged to assess software cybersecurity for our clients.  So, when the FDA issued its new draft guidance to the MedDevice industry (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA – April 8. 2022) we expected

What Has Covid Taught us about Medical Device Development?

Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years. In March of 2020, when Covid cases started spiking and emergency orders closed offices and manufacturing plants across