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Rimsys Announces Rimsys AI to Eliminate Repetitive Tasks and Enhance Decision-Making for MedTech Regulatory Teams
Rimsys, the leading Regulatory Information Management (RIM) platform for the MedTech industry, today announced the launch of Rimsys AI, a suite of embedded artificial intelligence (AI) agents.
The ultimate guide to the medical device single audit program (MDSAP)
This article is an excerpt from The ultimate guide to the medical device single audit program (MDSAP) ebook.
Table of contents
- What is MDSAP?
- History of MDSAP
- Who is responsible for the MDSAP?
- How does an MDSAP audit work?
- Audit sequence
- You got a nonconformity – now what?
- What does an MDSAP audit cost?
- Why choose the MDSAP certification process?
- Potential disadvantages of the MDSAP
- Ready to participate? – Here’s how to get started
- Completing a successful MDSAP audit
The Medical Device Single Audit Program (MDSAP) was designed and developed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. The MDSAP provides efficient and thorough coverage of the standard requirements for medical device manufacturer quality management systems, and requirements for regulatory purposes (ISO 13485:2016). In addition, there are specific requirements of each medical device regulatory authority participating in the MDSAP that must be met:
- Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
- Brazilian Good Manufacturing Practices (RDC ANVISA 16)
- Medical Device Regulations of Health Canada (ISO 13485:2003)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No 169)
- Quality System Regulation (21 CFR Part 820), and specific requirements of medical device regulatory authorities participating in the MDSAP program.
This means that a report from a single MDSAP audit of a medical device manufacturer would be accepted as a substitute for routine inspections by all the member Regulatory Authorities (RAs) across the world. There are currently five participating Regulatory Authorities (RA) representing the following countries: Australia, Brazil, Canada, Japan and the USA.
In April, 2021, the RAs released an “Audit Approach” document (MDSAP AU P0002.006) that combines the formerly separate MDSAP Audit Model and Process Companion documents into a single guidance document. It includes guidance for assessing the conformity of each process and includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes.
In March 2012 the US FDA announced that they had approved a final pilot guidance document “Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.” This allowed the owner or operator of a medical device manufacturing facility to be removed from FDA’s routine inspection work plan for 1 year upon completing a ISO 13485:2003 audit. This guidance document went into effect in June 2012, and was intended as an interim measure while a single audit program was being developed.
This pilot program was not very successful and few companies signed up because they did not see any advantage in participating. The manufacturer had to pay for a third party to inspect their facilities, generate a report, and share the inspection results back to the FDA. Many companies were reluctant to contract “someone else” to perform their inspection when they could easily wait for the FDA to conduct an inspection for free.
During its inaugural meeting in Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) appointed a working group to develop a set of documents for a harmonized third-party auditor system. Hence, the “Medical Device Single Audit Program” (MDSAP) was formed. The concept was similar to the FDA’s original idea of creating a third-party auditor to help reduce their workload of performing regulatory audits of medical device manufacturers’ quality management systems. This new approach would consist of a single audit that would review regulatory QMS compliance, conducted by a third-party, who would later be called an Auditing Organization (AO).
From January 2014 to December 2016, five countries participated in a Medical Device Single Audit Program Pilot. In June 2017, a report was generated summarizing the outcomes of prospective “proof- of-concept” criteria established to confirm the success of the program. The outcomes are documented in the final MDSAP Pilot Report and recommended that the program become fully active and open to any manufacturer who requested this type of audit.
The governing body of the MDSAP is the Regulatory Authority Council (RAC), which is composed of two senior managers (and a few other staff members) from each participating RA. They are responsible for executive planning, strategic priorities, setting policy, and making decisions on behalf of the MDSAP International Consortium. The RAC also reviews and approves documents, procedures, work instructions, and more. The mission of the MDSAP International Consortium is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers on a global scale.
Other international partners that are involved in the MDSAP include:
MDSAP Observers:
- European Union (EU)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
- Singapore’s Health Sciences Authority (HSA)
The observers and affiliate members are not the same as the participating member RA’s. The observers simply observe and/or contribute to RAC activities. Affiliate members, on the other hand, are interested in engaging in the MDSAP program and are subject to certain rules. They are only given access to a certain level of information about the manufacturers, audit dates, and information in audit reports.
They are also invited to attend sessions that are open to members, observers, and affiliates only.
Audits can also be conducted by MDSAP participating RAs at any time and for various reasons including:
- "For Cause" due to information obtained by the regulatory authority
- as a follow up to findings from a previous audit
- to confirm the effective implementation of the MDSAP requirements
The purpose of audits conducted by the RAs is to ensure appropriate oversight of the AOs MDSAP auditing activities. The AOs are appointed by the RAs and a list of the currently approved AO’s is published on the FDA website. Most AOs offer a broad range of management system certification services, beyond just medical devices. Manufacturers should verify that prospective AOs are clearly trained and perform MDSAP audits of medical devices.
AOs have the final word as to whether a manufacturer has met the requirements for the MDSAP during the execution of the audit and generation of the associated reports summarizing the results. MSDAP RAC participating RAs have the final decision regarding all development, implementation, maintenance, and expansion activities associated with the program.
Although an unannounced visit by an AO is rare, it can happen in circumstances where high-grade nonconformities have been detected.
To continue reading this eBook including a detailed look at the MDSAP audit process and grading, pros and cons of the approach, and how to get started please register to download the full version.
The beginner's guide to the FDA 510(k)
This article is an excerpt from The beginner's guide to the 510(k) ebook.
Table of Contents
- Introduction
- 510(k) basics
- Contents of a Traditional 510(k)
- 510(k) submission and timelines
- Other 510(k) forms
Congratulations! You have successfully developed a new medical device. Now you need to take it to market. In the United States, this often means submitting a 510(k). A 510(k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration (FDA) for “clearance” before you can sell your device in the U.S. In order to receive clearance from the FDA, your 510(k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device). The substantial equivalence approval process is a simple equation that looks something like this:
The 510(k) is generally the most efficient route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, instead of needing to present more extensive clinical trial data.
There are three types of 510(k): Traditional, Abbreviated, and Special. This eBook will begin with a general overview of the 510(k) process, including its purpose and benefits. Next, we will explore the Traditional 510(k) and the sections and components required in depth. Finally, we will look at the Special and Abbreviated 510(k).
FDA: background and device oversight
Before we explain what a 510(k) is let’s first talk generally about the FDA and device oversight. The FDA is the U.S. governmental agency responsible for overseeing medical devices, drugs, food, and tobacco products. When it comes to medical devices, the FDA’s mission is to “protect the public health by ensuring the safety, efficacy, and security of…medical devices.” At the same time, the FDA also has an interest in “advancing public health by helping to speed innovations.” In other words, the FDA’s goal is to make sure devices are safe and effective for public use, while also ensuring that devices have a quick and efficient path to market.
In order to achieve this balance of safety and efficiency, the FDA has three different levels of oversight depending on the risk level of the device: (1) exempt from premarket submission, (2) Premarket Notification, also known as 510(k), and (3) Premarket Approval (PMA).
When is a 510(k) required?
A 510(k) is required for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is required for high-risk or novel devices which require a higher level of scrutiny to be confirmed safe and effective.
A 510(k) is not only required for new devices, but also for devices that have been modified in a way that could impact safety or effectiveness. This could include changes to the:
- Design
- Components
- Materials
- Chemical composition
- Energy source
- Manufacturing process
- Intended use
You must submit your 510(k) at least 90 days before marketing the device.
What Exactly is Substantial Equivalence?
Now that we know what a 510(k) is, let’s talk about the substantial equivalence standard. You’ll recall from the introduction that your 510(k) must show that the new (or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.
More specifically, you must show:
- that the new device has the same intended use as the predicate, and
- the differences between the two devices do not raise questions about the safety and effectiveness of the new device.
Now let’s take a closer look at intended use and technological characteristics.
Intended use
Intended use means the general purpose or function of the device. The FDA will look at your proposed labelling and your Indications of Use section of the 510(k) to determine the intended use of your device (this is covered in Chapter 2). Intended use includes:
Technological characteristics
Once the FDA has determined that a predicate device exists and that the new device and the predicate device have the same intended use, it will move on to compare the technological characteristics. Technological characteristics include:
- Materials
- Design
- Energy source
- Other device features
The two devices do not have to be identical, and in fact they almost never are. The key here is to demonstrate that any differences do not have a significant impact on safety or effectiveness. Here’s what to cover when you compare your device’s technological characteristics with that of the predicate device:
Overall description of the device design
- Engineering drawings or diagrams to explain the device and component parts.
- List of component parts and explanation of how each component contributes to the overall use and function of the device.
- Physical specifications: dimensions, weight, temperature, tolerances, etc.
Materials
- Detailed chemical formulation used in all materials of constructions (especially those that come into contact with a patient).
- Any additives, coatings, paint, or surface modifications.
- How materials have been processed and what state they’re in.
Energy Sources
- Use of batteries, electricity, etc.
Other technological features
- Software/hardware
- Features
- Density
- Porosity
- Degradation characteristics
- Nature of reagents
- Principle of the assay method
In deciding whether the differences in technological characteristics impact safety or effectiveness, the FDA will typically rely on descriptive information about the technological characteristics as well as non-clinical and clinical performance data.
Let’s look at an example: A manufacturer submits a 510(k) for a new type of contact lens. Both the new device and the predicate device are indicated for daily wear for the treatment of astigmatism. The predicate device is only available in a clear lens, but the new device comes in a line of colors, including purple tinted lenses.
Who is responsible for submitting a 510(k)?
The following four types of organizations may be responsible for submitting a 510(k):
Manufacturers
- End-of-line device manufacturers who will be placing a device on the U.S. market.
- Note: Does not apply to component part manufacturers unless components will be marketed independently.
Specification developers
- Companies that develop the specifications for a finished device which has been manufactured elsewhere
Repackers or relabelers
- Required to submit a 510(k) if they significantly alter the labeling or condition of the device, including modification of manuals, changing the intended use, deleting or adding warnings, contraindications, sterilization status.
- Note: This is rare. The manufacturer, not the repackager or labeler, is typically responsible for the 510(k) submission.
Importers
- Importers that introduce a new device to the U.S. market may need to submit a 510(k), if it hasn’t already been submitted by the manufacturer.
Now that we’ve covered the basics, let’s explore what actually goes into your 510(k).
A Traditional 510(k) should contain all the following components in the list below. In some cases, a particular section may not apply to your device. When that happens, it’s a good idea to include the section anyway and just state “This section does not apply” or “N/A” under that heading.
To continue reading this eBook including a detailed walk-through of all the Traditional 510(k) components, submission requirements and timelines, and an overview of the other 510(k) forms including the Abbreviated 510(k) and the Special 510(k), please register to download the full version
The ultimate guide to the China UDI system and database
This article is an excerpt from The ultimate guide to the China NMPA UDI system and database ebook.
Table of Contents
- Overview
- UDI basics and benefits
- UDI format requirements and issuing entities
- UDI database and submission requirements
- Implementation of UDI and the UDI database in China
The current Chinese medical device regulatory regime kicked-off in 2014 with the Regulation on Supervision and Administration of Medical Devices. This core set of registration requirements, modeled after the United States and European Union systems, established a set of device classifications (class I, II, and III) based on risk and procedures for obtaining market clearance for each type of device.
Medical devices in China are regulated by the National Medical Products Administration (NMPA). Class I devices, such as clinical laboratory equipment or non-invasive skin dressings, require only notification to the NMPA for marketing authorization, and that authorization does not expire. Class II and III devices such as implantable devices or devices with a measuring function require full registration and a formal review before market clearance can be obtained.
These initial regulations have been expanded since their introduction, adding accelerated pathways to market for certain products in certain regions, easing acceptance of clinical data from overseas, and more specific roles and responsibilities for local agents of international manufacturers. In addition, in 2019, the regulations added a provision that medical devices carry a unique device identification (UDI). China’s UDI requirements are similar to those in the US and European Union. They establish specific device ID and labeling requirements, as well as a central, state-administered database of devices.
This eBook walks through the basics of medical device UDIs, the specifics of China’s implementation, and how MedTech companies who market their devices in China can prepare for the full rollout of these regulations in the coming years.
A UDI is a unique alphanumeric code that is designed to identify medical devices sold in a particular country/region from manufacturing, through distribution, to use by a patient. Like other aspects of the medical device regulatory regime, the UDI system in China follows the approach taken by the United States FDA and European Commission, and is based on the guidance from the International Medical Device Regulators Forum (IMDRF). Generally, UDI systems are designed to improve patient safety and optimize care by:
- Increasing the traceability of medical devices, including field safety corrective actions
- Providing an unambiguous identification method for medical devices throughout distribution and use
- Making adverse event reports more accessible
- Reducing medical errors by providing detailed information related to the device
- Simplifying medical device documentation and making it more consistent
There are three components to the UDI system in China:
- UDI code: The actual UDI code can be assigned by one of three (3) issuing agencies and contains information about the product, it’s expiration date, and the manufacturing batch/lot it’s associated with.
- UDI labeling: Put simply, medical devices must carry the UDI code on them. The regulations stipulate how devices and their packaging must be labeled for compliance.
- UDI database: In addition to labeling, all device UDIs must be submitted to a central database that is administered by the NMPA.
The following sections explore each of these components in more detail.
The UDI code
The first element of the UDI system is the code itself. The UDI code is the alphanumeric identifier that is associated with a specific medical device. UDI codes have two (2) elements to them, the UDI device identifier (UDI-DI) or static portion, and the UDI production identifier (UDI-PI) or dynamic portion. You can see the two components in the UDI diagram below:
The UDI-DI contains information about the issuing entity—the organization that is authorized to assign UDI codes. In China, this can be one of three entities: GS1, an international barcode and electronic data interchange standards organization, and two domestic organizations: the Zhongguancun Industry & Information Research Institute (ZIIOT), and AliHealth. Additional details about the issuing agencies are covered in Chapter 2. In addition, the UDI-DI contains information about the manufacturer and the specific model or version of the device.
The UDI-PI contains information about the manufacturing and production of the device. This typically includes information about the lot or batch number in which the device was manufactured, the manufacturing date and expiration date for the device (if applicable), and the specific serial number for the device. Here you can see all of the components marked up using the same UDI example:
Note that each packaging permutation and level for a given device will need to be assigned its own UDI. So for example, let’s say that a company manufactures 5ml enteral (oral) syringes in two packaging options: 1 – packaged individually and 2 – packaged in a box of 5. Each packaging option would need its own UDI, despite the fact that the underlying product is the same.
Now looking at packaging levels, let’s assume that the manufacturer packages the single syringe offering into boxes of 6, and again into larger containers of 24. Each of those packaging options needs its own UDI as well.
Labeling
In addition to obtaining UDI code for each device as outlined in the previous section, medical device manufacturers are required to ensure that devices are appropriately labeled with the assigned UDI. This label is called the UDI Carrier. The UDI is represented in two forms on the UDI Carrier: a machine-readable form and a human-readable form.
The machine-readable form or automatic identification data capture (AIDC) is a barcode or some other technology that can be used to automatically capture UDI information. The NMPA regulations support 3 types of machine-readable formats: 1-dimensional barcode, 2-dimensional barcode, and radio-frequency identification (RFID).
The regulations note that “use of advanced automatic identification and data collection technologies is encouraged”—prompting manufacturers to use more modern 2D and RFID machine-readable carriers where possible. Note, however, that if a device uses RFID, the UDI Carrier must also include the UDI in barcode format.
The human-readable form or human-readable interpretation (HRI) is the numeric or alphanumeric code for the UDI that can be read and manually entered into systems.
The UDI Carrier should be included on the device and on all levels of packaging. The UDI Carrier must be clear and readable during the operation and use of devices. If there isn’t room on the device for both the human and machine-readable forms of the UDI, then manufacturers should prioritize the machine-readable form.
UDI database
The third component of the NMPA UDI system is the UDI database. This is a centralized database of UDI and product information, administered by the NMPA. Manufacturers are required to submit UDI information into the database within 60 days after a product is approved (for sale in China) and before it is commercialized. The database contains a more detailed product record than what is included in the UDI itself, and it is the responsibility of the manufacturer (and/or their in-country representative) to submit the information correctly, and ensure that it’s kept up to date.
Chapter 3 of this eBook goes into detail about the specific fields and data requirements for UDI database submissions.
To continue reading this eBook including information about UDI format requirements and issuing entities, implementation timelines, and affected device types, please register to download the full version.
Dispatches from RAPS Convergence: The state of regulatory tools
A few weeks ago we attended (virtually) the RAPS Euro Convergence conference. The event, despite the virtual format, still brought together regulatory professionals from across the European region for several days of immersive learning. At Rimsys, we took advantage of the opportunity to explore the state of regulatory tools and processes in the region, and see how they compare to those of North American teams.
Visitors to the Rimsys booth, both at RAPS Euro Convergence and at last year’s North American RAPS Convergence event were invited to fill out a short survey in exchange for the opportunity to win an Amazon gift card. While the respondents were self-selected, and the results aren’t statistically significant, they still showcase some interesting differences in the tools and mindset of regulatory affairs professionals in each region.
Regulatory tools used
Across both regions, Excel is the most commonly used tool by regulatory teams. Over half of respondents across both regions reported using Excel to manage regulatory information and processes. European regulatory affairs professionals were much more likely to use an electronic quality management system (eQMS) to manage their work, and about one-third of respondents to both surveys indicated that they used physical paper-based documents.
We also asked respondents how well their tools were working. European respondents were generally more content with their toolset with 66% saying their tools were “good”. By comparison only 22% of North American respondents felt the same. One thing that was clear was the impact of paper-based processes on satisfaction. Respondents who reported struggling with their current tools were nearly twice as likely to use paper-based processes as part of their regulatory activities.
Work efficiency and satisfaction
Just over 50% of all respondents indicated that the tools they use “could be better”. This may have something to do with the amount of manual work that RA teams find themselves doing. As part of the survey we asked respondents how many hours it takes on average for them to update one of their Essential Principles / General Safety and Performance Requirements (GSPR) tables. The most common response from the EU event was 3-7 days, while those at the North American event were most likely to report greater than 7 days for the same task.
Given their slightly better estimated performance when it comes to regulatory processes, respondents from the EU were less likely to express frustration with their roles and dissatisfaction with their productivity. We asked attendees at both conferences to rate their “regulatory frustration” and satisfaction with their productivity on a scale from 1 to 5 with 1 being very frustrated/unsatisfied, and 5 being very satisfied/not frustrated at all.
EU respondents were noticeably more positive in their assessments than our North American respondents, although everyone generally had a favorable view of their productivity.
Implications
Looking at the survey results, there are some interesting discrepancies. Teams in both regions heavily use poorly-suited tools and manual approaches to regulatory processes, yet have generally favorable views of their productivity. This points to two likely conclusions. One, that regulatory affairs professionals are particularly comfortable with a lot of manual administrative work, and two, that they’re largely unaware of the new class of regulatory information management (RIM) solutions that are specifically designed to automate and streamline regulatory workflows.
RIM platforms (like Rimsys) provide a digitized central repository for regulatory information and content, allowing RA professionals to streamline product submission, authorization, and maintenance processes (such as updating GSPR tables that we discussed earlier). RIM platforms can reduce the time and resources required to complete regulatory activities by more than 50%.
Building a business case for a RIM system
While the space is growing quickly, regulatory information management (RIM) systems are still relatively new to a lot of medtech companies. RIM systems help companies digitize and automate regulatory activities associated with their products. They provide a central information repository for all regulatory content and streamline activities like market registrations, data capture and transmission of unique device identification (UDI), and building essential principles tables while tracking associated standards.
Given that many regulatory affairs teams still manually manage these processes through complex spreadsheets and disjointed documents, the value of an automated solution is pretty obvious, but quantifying that value—especially for teams that aren’t seasoned software acquirers—can be a bit harder. This guide provides a framework for regulatory affairs teams to quantify the potential benefits of a RIM system, and build an internal business case for investment.
Challenges with the traditional approach to regulatory affairs
While functional, there are a number of painful inefficiencies that come along with traditional approaches to regulatory processes. Without an automated way to keep track of all the information and supporting documents associated with these processes, companies struggle with:
- Lack of visibility into regulatory data, clearance/approval status for different markets, and time-to-market metrics
- Compliance gaps driven by disconnects between go-to-market, distribution, and regulatory affairs teams
- Difficulty assessing the impact of, and responding to changes in standards or regulations
- Accumulation of “tribal” knowledge among individuals that limits continuity and visibility across the organization
These pains represent specific costs to MedTech companies in the form of:
- Staffing: Companies must over-staff regulatory affairs teams to support highly-manual processes. Expensive consultants are often brought in to help address in-house resource shortages.
- Productivity: Regulatory affairs teams lose huge amounts of time repeatedly hunting for information (up to 50% of their time spent).
- Lost revenue: Long application times and lack of process visibility delay market entry for new products. Non-compliance can lead to fines, or the need to pull products out of specific markets.
The automation and data consolidation/integration provided by a RIM system can significantly reduce these costs, and provide a clear, measurable return on investment.
Additional benefits of a RIM system
In addition to the addressing the pains outlined above, RIM systems can provide valuable benefits across MedTech companies:
- IT teams: Without a bespoke platform to manage regulatory processes, regulatory affairs teams rely on a broad collection of tools to support their day-to-day work. This can include specific software to create and manage UDIs and access regulatory intelligence, as well as use of software designed for other functions: enterprise resource planning (ERP), product lifecycle management (PLM), or quality management systems (QMS)—highly-configured to try and support regulatory activities. A comprehensive RIM system (like Rimsys) provides support for multiple regulatory functions, saving IT teams the cost of acquiring and maintaining separate systems. With functionality specifically designed for regulatory processes, a RIM system is easier to support than customizations to tools designed for other functions.
- Go-to-market teams: Sales and marketing organizations can also benefit from the adoption of a RIM system. In addition to bringing new solutions to market more quickly, RIM systems can also help with planning and forecasting. Visibility into the time and cost required to enter different markets, and the specific regulations associated with each market, can help go-to-market teams better prioritize target markets, and set revenue projections for their product lines. RIM systems can also provide workflows for project requests, allowing go-to-market teams to better coordinate registrations to support planned product launches.
- Distributors, in-country sponsors, and notified bodies: One-off email communications with external parties is not only time consuming for regulatory affairs teams, but inefficient for partners. RIM systems can provide controlled access for external parties, allowing them to login and directly access needed information without sending an email, and waiting (sometimes days) for a response. Streamlining these communications allows partner organizations to move more quickly, and ultimately accelerate the delivery of products into new markets. This helps to grow revenue while also improving the productivity of regulatory affairs teams who no longer have to interrupt their work for every internal or external information request.
Building your business case
Putting together the challenges and benefits outlined in the previous section (as applicable to your team), will feed the primary content of your business case. Next we’ll take a look at how to structure the content.
Part 1 – Your current situation and challenges
One of the best places to start when putting together a business case for a RIM system is to look at your current situation. What are the challenges that your organization faces? How much time is spent looking for information, submitting marketing applications, completing regulatory impact assessments, creating and maintaining the new MDR / IVDR GSPRs? How long does it take your team to complete new registrations? How well do internal teams communicate and coordinate go-to-market activities for new products and markets? How many products and countries does your team support today? What would happen if that number increased significantly?
Next, look at the business implications of the current situation. Does your team have a backlog of requests from go-to-market or other management teams? How often do you bring in external consultants to help with workload? Note the associated costs of your project backlog (delays in receiving market clearance), and the amount spent each year on consultants. Are there any other business risks such as continuity or non-compliance that are associated with your current approach? Does your team have the ability to identify regulatory roadblocks associated with markets you’re planning to enter?
Part 2 – Recommended solution
Here’s where you make the primary case for a RIM system. Highlight the specific capabilities and benefits of your solution of choice, and how it will address the challenges of your current situation. Highlight areas where other teams will benefit from the solution, and opportunities to drive greater organizational alignment.
Part 3 – Costs and expected ROI
Estimating costs and returns can be difficult, but it’s one of the key ways to improve the credibility of your business case. If you’re unsure about costs you can generally assume that a full-featured RIM system will cost the equivalent of 1 to 3 full-time regulatory affairs professionals, and use that as a starting point.
When calculating returns start with time-savings. If regulatory activities could be completed 50% more efficiently, how would that impact the number of consulting hours you use or hiring plans? If you could reduce pre-market clearance time by 6 weeks, how much additional revenue could be generated? Have you had instances where you incurred fines or had to remove products from a market due to compliance issues (i.e. shipping to markets where the product hasn’t been approved)? What were the associated costs?
Next, look at what your RIM system is replacing. Do you have individual tools for UDI or other functions that could be replaced? What about other tools? Does your team have seats in ERP or QMS tools that won’t be needed any more? All of these are relevant cost savings. In most cases, a RIM system will show strong ROI once you’ve estimated all of these savings.
Part 4 – Alternatives
Here’s where you want to demonstrate that you’ve done your due diligence in support of your recommendations. Have you evaluated multiple software solutions? Enumerate the specific capabilities or approach that led you to recommend your preferred vendor. Are there other ways to address your current challenges: expanding the regulatory affairs team, or implementing other types of software (rather than a RIM system)? Explain why you think these solutions will be less effective.
Putting it together
RIM systems can provide significant benefits specifically to regulatory affairs teams and broadly across MedTech companies. With a bit of legwork, it’s easy to put together a compelling case for investment in a solution. What can sometimes lead to difficulty in quantifying potential benefits—the fact that many MedTech companies don’t have a robust measurement framework for Regulatory affairs processes—means that you’ll be in a much better position to assess the performance of your team and impact of your investment once the analysis is complete.
Ready to get started? Download our RIM business case template. Questions? Our team is happy to work through the process with you and validate your estimates based on the experiences of our clients.
5 ways a RIM system can accelerate time-to-market for MedTech companies
Like all products, time-to-market is a critical success factor for medical technology (medtech). Product research and development ties up capital investment that can only be recouped when products start selling. For start-up and early stage companies, time-to-market can be the difference between success and failure. With a limited capital runway, they must demonstrate market success to access additional funding and growth opportunities. Unlike other products, however, medical devices have an added hurdle of regulatory clearance that must be obtained before products can be marketed and sold.
Underestimating the regulatory burden
It’s easy to underestimate the amount of time and effort required for regulatory activities related to New Product Introductions (NPI), especially during the development process. Policies, procedures, and submission processes can vary significantly between countries and regions, and almost all of them require government clearance before devices can be marketed. For larger companies it’s not unusual to operate in 100+ countries, creating an enormous array of standards and applications that must be manually managed.
These challenges are exacerbated by unclear lines of communication and siloed information across systems. Product development and testing information is stored within Product Lifecycle Management (PLM) and Quality Management System (QMS) solutions. Sales forecasting, marketing, and production information is stored within Enterprise Resource Planning (ERP) and Customer Relationship Management (CRM) systems. And regulatory, standards information, and compliance documents are stored across various file systems.
Regulatory submissions must synthesize information from R&D, QA, and go-to-market teams, and data from across all of these systems. Any mis-steps, or missing information can result in significant go-to-market delays, and even rejections from regulatory bodies. Coordinating regulatory status between go-to-market regulatory affairs teams can be a particularly vexing challenge. Without clarity about what markets have been cleared/approved, companies run the risk of moving too quickly ahead of the regulatory process, or unnecessarily delaying market entry.
What is a RIM system?
Despite all of the complexity associated with regulatory submissions, many teams rely on rudimentary approaches to coordinate and manage them. Submissions and associated data are managed via individual documents or complex color-coded spreadsheets, with no central repository of submission records or status.
Regulatory Information Management (RIM) systems are software solutions designed specifically to help companies streamline the submission, authorization, and maintenance process. They provide a digitized central repository for all regulatory information and content, allowing companies to automate and maintain compliance in the global market.
Using a RIM system to manage regulatory submissions and compliance can improve efficiency and productivity, reduce the risk of rejected submissions and noncompliance, and provide greater visibility into ongoing registration processes and status across the organization. While RIM systems provide specific benefits to regulatory affairs teams, they also provide company-wide benefits—specifically when it comes to accelerating time-to-market for new products.
5 ways a RIM system can accelerate time-to-market for new products
Full-featured RIM systems (like Rimsys) provide a number of capabilities that MedTech companies can take advantage of to get new products to market more quickly—and keep them there.
- Regulatory intelligence. Medical device registration requirements and standards vary across regions and countries. Understanding market entry requirements and timelines for regulatory submissions are necessary for any go-to-market planning, but finding and keeping track of this information can be challenging—especially for early-stage companies. RIM systems can provide up-to-date information about regulatory requirements without a lot of manual research and document management. Go-to-market teams can leverage the breadth of regulatory information in the system to develop rollout strategies for different markets, and identify the most attractive markets based on size and regulatory complexity.
- Digital forms and templates. Each regulatory submission requires multiple templates and forms, many of which aren’t available digitally. Finding the correct, current form, and manually filling it for each country/region can add significant time to the regulatory submission process. RIM systems can take the guesswork out of finding forms, by providing a library of digital templates for different markets that companies can easily access and fill. Even offline forms can be loaded into the system for digital filing and storage. With a modern RIM system, regulatory teams can easily access, fill, and track progress for submission forms in all the markets they’re looking to enter.
- Centralized visibility and information storage. RIM systems can function as a “digital hub” and single source of truth for all of the information associated with the regulatory process. Submissions require detailed product information, testing results, labeling, and other information that is often stored in other systems. Rather than sourcing this information over and over again, RIM systems provide regulatory teams with an organized repository that they can reuse across global applications. RIM access can be extended to other teams, and even external partners (like in-country distributors) to provide visibility into regulatory information and the status of submissions, making it easier to drive alignment around the process and coordinate go-to-market plans.
- Process integration across systems. Market authorization is one of the most critical pieces of information that go-to-market teams need. Maintaining that information across multiple products and multiple markets, and keeping it visible to go-to-market teams is a consistent challenge. RIM systems can integrate directly with ERP or CRM systems to feed authorization information directly into sales and distribution processes. Automating the in-country authorizations across systems can prevent noncompliance, and ensure that go-to-market teams are able to launch as soon as authorization is obtained. The same integration capabilities can be used to automatically retrieve product information from PLM and QMS systems, further speeding the application process.
- Automated regulation and standards tracking. This doesn’t necessarily directly impact time-to-market for new products, but it can definitely impact time in the market. Regulations and standards aren’t static, and regulatory affairs teams must keep on top of pending changes to ensure that products remain compliant and retain selling authorization. RIM systems can help to track changes, and flag products for potential compliance issues or that are at risk of losing authorization.In addition to regulatory changes, RIM systems can track authorization expirations, and other important events, helping companies maximize the revenue potential of their products by avoiding regulatory disruptions.
Accelerating regulatory approval and product go-to-market
MedTech companies are keenly aware of the role regulation plays in getting new products to market, but they aren’t always aware of the time and effort required to reach all of their target markets. Manual processes, disjointed information, and lack of coordination and visibility across teams can make it hard to obtain marketing authorization in a timely manner. This can significantly impact time-to-market—delaying return on investment, and even putting companies, themselves at risk.
RIM systems can eliminate a lot of the inefficiencies that slow down regulatory processes. By providing insight into regulatory requirements, access to digital templates, and integration across tools, they make it easier for companies to complete timely, successful regulatory submissions, and accelerate time-to-market.
RIM software from Rimsys
Rimsys is the only holistic RIM software designed specifically for medical technology companies. It helps companies digitize regulatory management by bringing together global UDI requirements, Essential Principles/GSPR, and regulatory registrations while monitoring products at the SKU level.
To learn more about RIM software from Rimsys, read our benefits datasheet.
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Foster City, Calif., January 12, 2021 – Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc., a world-leading provider of a holistic Regulatory Information Management (RIM) software platform designed specifically for medical technology (medtech) companies.
The Arena and Rimsys partnership offers a secure cloud-based, product-centric regulatory solution for the medtech industry. Rimsys seamlessly integrates with Arena’s QMS and PLM solutions by pulling product and documentation information directly into Rimsys to create, manage, and maintain marketing applications such as 510(k), Summary Technical Documentation (STED), and Table of Contents (ToCs).
The Arena product development platform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsys integrates with Arena’s platform by syncing product information so companies can better manage global registrations and selling status at the SKU level. Rimsys has the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitors for documentation changes and alerts users when updates occur with additional reporting based on document location ensuring a single and accurate source of truth.
"The seamless and deep integration between Rimsys and Arena solutions reduces the day-to-day regulatory management," said James Gianoutsos, Founder and President of Rimsys. "The administrative burden of compiling marketing applications and the maintenance of product data is completely eliminated, allowing for increased compliance, efficiency, and visibility throughout the organization."
"Our partnership with Rimsys makes it easier for MedTech companies to address regulatory affairs, product registration, and standards management more effectively," said George Lewis, VP of Business Development and Strategy for Arena Solutions. "This new integration streamlines regulatory compliance processes by accelerating the notification of updates to critical quality records and documents."
About Arena Solutions
Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
About Rimsys
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. Built by and for regulatory affairs professionals, Rimsys digitizes, automates, and creates regulatory order to ensure products adhere to changing global regulations. It is the only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software that makes it easy to manage global UDI requirements and navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence. rimsys.io
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated solution to address the global Unique Device Identification (UDI) requirements. This enhancement to the Rimsys ecosystem is immediately available to new and existing customers, providing a compliant method for tracking and traceability of UDI data that is fully compatible with global health authority databases.
UDI is a global harmonization effort to provide more consistent data that benefits overall product traceability throughout the medical device supply chain. It aims to adequately identify medical devices from manufacturing through distribution to patient use. Because global markets have different UDI requirements, product data can become a maintenance nightmare, even for the most mature medical technology companies. Data management is further complicated as UDI data is not static and must be updated based on changing regulatory requirements, such as market dates and registration status.
"Rimsys is the first automated UDI solution to fully integrate into a product’s registration lifecycle, ensuring that changing regulatory information is properly captured, registered, and maintained with the product and within government UDI databases like the GUDID (USA) and EUDAMED (EU)," said James Gianoutsos, Founder & President at Rimsys, "The current solutions landscape revolves around creating in-house, custom, and expensive projects with custom-built software or existing ERP software that were not designed to keep up with the fast-paced and ever-changing regulatory landscape."
In order to stay compliant and competitive, medical technology companies need to adapt quickly and flawlessly to the regulatory environment. As UDI requirements are rolled out across the globe, Rimsys’ UDI module seamlessly integrates with product registration data that is already actively managed within Rimsys, resulting in less maintenance, reduced costs, better compliance, and ultimately decreased time-to-market.
"We have already seen how our system has helped world-leading medical technology companies, such as Johnson & Johnson, Omron, and Terumo, digitize, automate, and navigate the global regulatory landscape,” said Brad Ryba, Chief Technology Officer at Rimsys, "As these requirements and demands continue to evolve, we are committed to ensuring that regulatory professionals can leverage the data integrations within Rimsys to more proactively manage their regulatory information."
Interested customers can schedule a preview of the new UDI module.
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys has been named a Finalist in Tech 50’s 2020 awards program hosted by the Pittsburgh Technology Council. The awards program, which was held November 12, 2020 at a virtual gala event, announced the winners and finalists. Rimsys was nominated as Innovator of the Year in the MedTech category, along with Sentact, Philips, and TeleTracking Technologies. In addition to the Company’s nomination, Rimsys’ Founder and CEO, James Gianoutsos, was nominated for CEO of the Year.
The awards program honors technology innovation in the region. Rimsys Inc., provider of the only holistic Regulatory Information Management (RIM) software for medtech is headquartered in Pittsburgh, Pennsylvania and was proud to be among the 2020 nominees. Rimsys was named a finalist this year, as Sentact, a provider of healthcare technology solutions for the patient care journey, walked away as the winner. Barbara VanKirk, CEO of IQ Inc., won this year’s CEO of the Year award.
"Rimsys is honored to be a finalist in both categories. Thank you to the Pittsburgh Technology Council for highlighting all of these innovative companies, and congratulations to this year’s winners," said Gianoutsos, "Rimsys is already used and trusted by leading companies, including Johnson & Johnson and Terumo, and we look forward to the near future where Rimsys’ automation of the global regulatory landscape is commonplace for medical technology companies and regulatory affairs professionals."
James Gianoutsos founded Rimsys in 2017, recognizing that while regulatory management platforms existed for pharmaceutical companies, medical technology companies face an entirely different set of challenges and requirements. Equipped with the expertise and drive to give regulatory affairs professionals a better way, he developed Rimsys: a RIM software built 100% for medtech companies.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. Its newest integrated module manages global UDI requirements.
"It’s been an unparalleled year with unthinkable challenges," said Audrey Russo, President & CEO of the Pittsburgh Technology Council, "The COVID-19 Pandemic has tested everyone’s mettle in ways never imagined. This year’s Tech 50 is a testament to the fortitude, creativity, and innovation that exists across our industry, membership, and in every Tech 50 winner and finalist."
For a full list of finalists and winners, visit the Pittsburgh Technology Council’s website.
