Software as a Medical Device (SaMD)

Doctor examining images of a human body

Almost every business now uses software, which has increased the manufacturing and delivery of millions of great products while also bringing new conveniences and complexity levels to the market.

The market for medical devices is no exception. Initially, physical devices were operated by software. However, it didn’t take long for people to start developing software only solutions that were independent of medical device hardware.

Our team members are enthusiastic patient advocates with the expertise and credentials to understand the requirements for regulatory approval and effectively collaborate with industry internal stakeholders, HCPs, advocacy, caregivers and patient groups to collect user input and feedback. We demystify SaMD development and help you develop regulated medical software that addresses a clinical problem to solve (unmet need) and that has the potential to impact patient outcomes.

Our SaMD development consulting services include the following:

We Drive Smart Development Through Expert Project Management in Key Work Streams

1

Project Initiation

  • Concept Creation
  • Market Research
  • Business Case
  • Project Execution Plan
  • Management Oversight
  • Communication Strategy
  • Budget
2

Project Execution

  • Quality Management Plan
  • Regulatory Strategy
  • Writers of Reg Submission Documents
  • Drive Software Development Lifecycle
  • Risk Management Plan
  • Formative Study Execution
  • Statistical Support
  • Privacy and Security
3

Validation

  • Software Validation
  • Human Factors Validation
  • Test Subject Recruitment
  • Testing Facility
  • Clinical Validation
  • Data Hosting Plan
  • Governance Planning
4

Regulatory Filing

  • Complete Technical File
  • ISO Certification
  • Design History File
  • Registration Support
  • Clinical Validation
  • Data Hosting Plan
  • Governance Planning
  • Guide and Coordinate our clients through conversations with the FDA and other Regulators
5

Post Launch

  • Management of governance following launch across vendors
  • Onboarding Users
  • Maintenance
  • Complaints
  • Safety
  • Data exchange

We support holistic service offerings for SaMD Development

Doctor using laptop overlaid with anatomical displays of human body as well as shield with checkmark

10+ Years of Successful SaMD Development

We Have the Expertise and Experience!

Digital Tx, Digital Dx, CDS and AI/ML driven health innovation

Clock Clock

Clinical Evaluation

  • Clinical Evaluation for SaMD
  • Technical Knowledge for study planning
  • Leverage SMEs for unique product types (we have the network)
  • End to end offering (Not just validation)
  • Validation of DHTs
Clock Clock

Patient Centricity

  • Patient-Centered Development Design Thinking
  • Stakeholder Engagement
  • Journey Mapping
  • Design for Life Integration
  • Market access strategy
  • Personalized healthcare strategy
Clock Clock

Cybersecurity

  • Cybersecurity for SaMD
  • FDA 2022 Guidance (Oct. enforced)
  • Skilled team in cyber risk management process and labeling

Our Software as a Medical Device (SaMD) development services include the following:

What is SaMD?

SaMD is described by the International Medical Device Regulators Forum (IMDRF) as “software intended for one or more medical purposes that accomplishes those objectives without being part of a hardware medical device.”

According to the FDA, SaMD is software that fulfills the definition of a device in Section 201(h) of the FD&C Act and which on its own is a medical device, and is not integral to a hardware medical device (Software in a medical device).

SaMD can be referred to as Clinical Decision Support Software (CDSS) if the technology is designed to assist a Health Care Provider in clinical care decision making. It can also be referred to as a Digital Therapeutic (DTx) which delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.

SaMD vs. SiMD: an Important Distinction

There are two distinct software types when it comes to medical devices: software in a medical device (SiMD) and software as a medical device (SaMD). Only SaMD can run independently.

  1. SaMD: forms a stand-alone medical device that can fulfill one or more medical functions without being a component of a hardware medical device.
  2. SiMD is software that is necessary for a medical device to function properly; it serves no independent medical function. Instead, it works in conjunction with a hardware-based medical device. Despite frequently being assumed to only refer to software that is embedded within medical equipment, this term also refers to mobile, cloud, and desktop, which are either components or accessory of a medical device.
Real-world SaMD and SiMD examples highlighting the differences include:
  • Example 1: SaMD is software that uses a patient’s food log and data from a blood glucose meter to generate recommendations for insulin dosage for diabetes. The software is a SiMD if it serves as the main display for a specified glucose meter.
  • Example 2: SaMD is specialized software that tracks a mole for a predetermined amount of time in order to gauge its melanoma risk. Software that runs a handheld spectroscopy-based tool that assesses suspicious skin lesions for skin cancer is SiMD.
  • Example 3: SaMD is software that uses MRI analysis to help radiologists and physicians locate and identify cardiovascular conditions. SiMD, on the other hand, is the piece of software that activates and manages the X-ray machine.
  • Example 4: SaMD is software that evaluates a patient’s diagnostic data and medical history to establish the proper medication dosage. SaMD or SiMD are not, however, the programs that collect, arrange, or retrieve the actual medical data. An electronic health record (EHR) system, for instance, is not a SaMD or SiMD.

The Value of SaMD

SaMD on mobile devices, for instance, can increase accessibility to patients, gather user feedback, and swiftly collect large volumes of data. This fast-moving feedback loop can speed up product revisions, reduce time to market, and promote innovation for businesses utilizing or developing SaMD.

SaMD can provide more precise treatment options due to its ability to leverage data for insights driven care, especially when paired with cutting-edge techniques like AI and robust big data tools to uncover novel clinical insights.

Modern SaMD platforms can enhance care administration and delivery, lower costs, and improve patient outcomes.

Software systems can also be trained to accurately predict the potential disease progression for either rare or chronic disease and help with clinical treatment decision support by utilizing sophisticated machine learning or Artificial Intelligence algorithms/applications.

For patients with complex disorders, SaMD can shorten the time between diagnosis and treatment as well as help provide individualized/personalized treatment strategies.

SaMD Regulation

Regulators collectively realized that for stakeholders to promote responsible innovation and safeguard patient safety, best practice guidelines were needed for the SaMD industry.

To harmonize medical device regulation, regulators from all over the world formed the International Medical Device Regulators Forum (IMDRF). IMDRF establishes standards and best practices that are widely accepted on a range of regulatory topics pertaining to medical devices.

The IMDRF formed the SaMD Working Group (WG) in 2013 to promote innovation and speedy access to secure and reliable SaMD worldwide. The group, led by the FDA, came to an agreement on the essential specifications for SaMD, as well as the framework for risk classification, quality control, and clinical examination.

Developing SaMD

To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions. With more than 125 years of combined expertise, we provide a potent mix of abilities and skills to design, develop, validate, and secure regulatory approvals for innovations that enhance patient health.

Innovenn maintains its position as a leader in its industry because of its collaborative culture. We open doors to interdisciplinary partnerships by facilitating the creation and development of innovations that support new drugs, medical equipment, and SaMD, all of which are targeted to serve an unmet need and satisfy the particular requirements of the patient.

FAQs

The FDA defines SaMD as software that fulfills the definition of a device in Section 201(h) of the FD&C Act and which on its own is a medical device and is not integral to a hardware medical device (Software in a medical device). This comprises computer programs or mobile applications created with the goal of managing, preventing, or curing sickness or other disorders.

Even if technology won’t replace doctors any time soon, SaMD is still a vital tool for providing patients with improved care. SaMD can speed up the identification, administration, and treatment of numerous medical problems by assisting with areas of care that can be automated utilizing cutting-edge technology.

To qualify as a SaMD, a product’s software must operate independently of any hardware while carrying out the tasks that define it as a medical device. The requirements for SaMD are not met by software that powers hardware or operates a hardware device.

Innovenn is uniquely positioned to support our clients in the design, development, regulatory approval and adoption of complex, leading-edge SaMD (digital Tx, Digital Diagnostics, & imaging CDS), and AI-driven devices. By combining deep regulatory knowledge, risk management with advanced human factors expertise, Innovenn serves as a trusted partner for developing and launching health and wellness software.

Why Choose Innovenn for your SaMD Development Services?

SaMD products are becoming a critical part of the healthcare field, especially as technology continues to push forward all elements of the industry.

Innovenn’s team of experts can help your team to navigate SaMD development and its regulatory landscape. Working together, we can bring your SaMD’s benefits to patients by generating better, and safer, products.

To learn more about Innovenn’s Global SaMD development services and how we can help you bring your medical device to market, contact us to discuss your specific needs.

Contact an Expert
Innovenn logo
Where healthcare innovation intersects with improved patient outcomes
Contact Us
Contact Innovenn

Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada

6410  Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com

Stay Informed

Sign up to get the latest industry news, insights and tips.

Sign Me Up