Knowledge Center

Challenge: An international clinical trial company developing a custom Clinical Trial Management System (CTMS) required a software design that significantly reduced the cost of deploying CTMS for each new trial.

Solution
Designed and developed a sophisticated randomization scheme generator which once validated created new protocols that were validated at the time of creation while simultaneously complying with GxPs and 21 CRF Part 11.

Return
Significantly reduced overhead costs and increased customer satisfaction with each new trial because new trial protocols did not require validation.

An early stage medical device company intended to enter the Australian Market in one year’s time and needed a strategic compliance roadmap to meet the requirements of FDA 510K clearance, CE marking, UL marking, Canadian CMDCAS requirements, and the Australian AS/NZS 3200 Suite of Standards for Medical devices

Solution
Designed and developed a sophisticated randomization scheme generator which once validated created new protocols that were validated at the time of creation while simultaneously complying with GxPs and 21 CRF Part 11.

Return
Significantly reduced overhead costs and increased customer satisfaction with each new trial because new trial protocols did not require validation.

A global research organization found their projects jeopardized because the research staff consistently avoided project validation requirements due to their misunderstanding of their importance for their business, operational and scientific needs.

Solution
Customized validation training program that demonstrated the value of the organization’s SOPs by applying them to commonly used objects in a way that produced immediate appreciation of their benefit.

Return
Willing compliance with internal standards, improved quality and increased client satisfaction.

FDA found web-based software tracking cGMP applications at a large pharmaceutical company out of compliance.

Solution
Redesigned web based inventory application and implemented new design to meet 21 CFR Part 11 requirements.

Return
Company successfully demonstrated regulatory compliance which ensured continuity of manufacturing operations.

Large biotherapeutics company in reorganization sought out-sourced hosting company for over 100 critical business systems with the need that the new vendor could from day one successfully withstand a FDA inspection.

Solution
Quality Management System and compliance audit of several third party specialized IT services providers vertically focused on Pharmaceutical, Healthcare and Financial Services companies. The audit focused on compliance, detected risks and risk remediation recommendations.

Return
The biotherapeutics company confidently chose a new IT vendor and successfully migrated business solutions to a cost saving environment.

An emerging software company developing a life science application had little experience with FDA regulations, which caused significant delays in their commercialization strategies.

Solution
Developed for the company a framework that included intensive regulatory training, the backbone of a Quality Management System and a software validation strategy.

Return
A successful and more cost effective commercialization effort that delivered to the market an FDA compliant system.

A medium sized pharmaceutical company recognized the economic value of adopting Software-as-a-Service (SaaS) solutions for managing critical data but did not have in place the SOPs and validation processes appropriate for SaaS solutions.

Solution
Evaluated the completeness and accuracy of SOPs in describing validation process steps required by industry standards,
created a gap analysis of process steps required to ensure compliance and filled gaps by authoring SOPs.

Return
Regulatory compliance for managing critical data in preparation of an electronic submission to the FDA.

A small Medical Device company was behind in its submission timeline. For company investors to release much needed operating capital, the company was given a very short deadline to submit a traditional 510(k) for their Software as a Medical Device (SaMD). But the company lacked the resources to build their 510(k), and they didn’t know the FDA’s current thinking about SaMDs in order to meet the required timeline.

Problem Assessment:
MethodSense assessed the condition of the company’s SaMD documentation and identified documentation deficiencies and gaps. An action plan was then developed that marshalled a team comprised of personnel from the company and MethodSense to meet the timeline set by investors.

Solution:
MethodSense and the company followed the action plan and, with merely two months’ effort, completed and submitted the 510(k) to the FDA on time, satisfying the investors who then continued company funding.

An early-stage oncology medical device developer received a show-stopping FDA designation – they were misunderstood by FDA to be a drug rather than a device.

The oncology device developer approached FDA through multiple Q-Submission meetings to correct their understanding of the product – but each communication backfired, furthering FDA’s finding of the drug designation.

Problem Assessment:

The client asked MethodSense to review and revise the product’s designation justification and regulatory pathway. MethodSense quickly developed a technical understanding of the device and reviewed all FDA correspondence to understand FDA’s position and concerns.

MethodSense found that communications with FDA had started down the wrong path. The client’s original partner, a pharmaceutical-based technology partner, had formally approached FDA about the product using pharmaceutical terminology – and unintentionally misrepresented the product entirely – resulting in FDA concluding the product was a drug, rather than a device.

Solution:

Together, MethodSense and the client took a new critical look at the product. The product had no biochemical reaction, no pharmaceutical aspects, chemical agents, or distinct attributes, the testing pathway was similar to that of other devices, and the preliminary testing had fantastic results.

MethodSense authored a justified regulatory pathway and reviewed similar predicate medical devices. They used FDA Medical Device Guidances to clarify the device’s mechanism of action. Following a methodical approach, MethodSense used Medical Device terminology to describe how the product works and re-authored the product’s technical documentation.

MethodSense created a pre-submission package that addressed the FDA’s concerns about the product and supported the client during the FDA meeting. Together, they were able to successfully clarify the true use and mechanisms of the product and obtain FDA’s agreement for a device designation. Most importantly, the client and Agency established a positive and productive working relationship moving forward.

A Class II medical device manufacturer was notified that FDA would perform an audit in the next seven days. Their sales were growing rapidly – having devoted much of their resources to manufacturing and selling the product – but keeping up with documentation and recordkeeping was challenging.  The company was concerned about the FDA Audit, and the impact FDA publicized findings (Warning Letters) would have on their industry reputation and sales.

Problem Assessment:
The manufacturer asked MethodSense for audit support. With an understanding of FDA’s audit approach and expectations, MethodSense assessed the client’s audit readiness. MethodSense found significant problems that, if observed by the FDA during the inspection, could significantly deter the company’s growth.

Solution:
MethodSense worked with the client to establish a formal plan to address all the identified deficiencies with confidence. MethodSense and the manufacturer worked together to resolve the highest-priority deficiencies. During the audit, MethodSense was able to use this plan to demonstrate to the FDA how the client maintained the product quality and was working to address unresolved deficiencies.

MethodSense was able to use this approach to manage and defend the three-day inspection, resulting in zero deficiencies; more importantly, the company had the tools to implement lasting solutions for long-term compliance.

An emerging company developed a pediatric implant with the potential to increase patient compliance and make existing therapies more effective. Based on positive clinical results, the company identified a wide array of intended uses for their device.

The company had the resources to get to market via the 510(k) pathway, but multiple evaluations from various regulatory professionals identified the product as a Class III Medical Device. A Class III device required a Premarket Approval (PMA) rather than a 510(k).

The company did not have the resources to pursue a PMA, and turned to MethodSense to understand if there was any way to bring the device to market safely with the resources at hand.

Problem Assessment:
MethodSense assessed the product’s pathway through the FDA and evaluated the company’s goals and resources. MethodSense analyzed the product’s capabilities and clinical results, proposed intended use, and products already cleared by FDA to understand alternative regulations and pathways to market.

Solution:
MethodSense shifted the regulatory strategy focus on avenues that could provide immediate market entry, and sustainable growth. This included a multi-step regulatory pathway strategy for the product that could include multiple submissions; with each, the company could expand its market, and gain additional capital and corporate resources.

The strategy shift enabled the company to acquire initial capital, obtain 510(k) clearance as a Class II product, and support a later PMA. MethodSense’s strategy allowed this company to take confident strides along their regulatory pathway and positioned the company for long-term market success.

An established  medical product company, manufacturing a combination product, enjoyed strong sales and an excellent reputation in the EU. The company was presented with an excellent US business opportunity in partnership with a global  Pharmaceutical company – all they needed was to obtain clearance on their EU combination product in the US.

The company tried multiple times to get FDA clearance for their innovative product – and could not. Despite demonstrating success, safety, and effectiveness in the EU and other global markets, they were challenged by the differences in the regulations and the differences in the evaluation and expectations of safety concerns by US regulators. After two years’ effort, and multiple withdrawn FDA Submissions, the company was in need for a regulatory strategy that would deliver success for the medical device company and their Pharmaceutical partner.

Problem Assessment:
The company asked MethodSense to help navigate their US FDA Regulatory challenges. MethodSense reviewed the product design and regulatory history with FDA and paid particular attention in understanding FDA’s concerns.  MethodSense evaluated the strengths that the partnership could provide to help resolve the regulatory challenges with an agreed-upon strategy.

Solution:

MethodSense worked with their client and their partner to clearly define the problem, and develop an actionable strategy that addressed FDA’s concerns. Through a methodical execution of the strategic action plan that included multiple FDA meetings and communications, the company and their partner were able to implement a regulatory strategy  that created US success, and strengthened the company partnership.

After MethodSense and its medical product client implemented the actionable strategy, the medical product company and its partner celebrated a successful 510(k) submission, and continue to enjoy a rapidly-growing market share.