Expert Medical Device Consulting Services

Contributing Expert: Lois Oler

Medical device consultants play a critical role in the healthcare industry, as they provide vast knowledge and expertise in the industry standards and the optimal pathway to adhere to the regulations. Medical device consultants have a growing importance within the healthcare industry by mentoring and training internal resources to grow their knowledge as well. This growth and development provides real on-the-job training and critical problem-solving techniques.

Mentoring clients is the largest reward of a medical device consultant, although not why a client hires them. Medical device consultants are hired in the healthcare industry to provide top-of-the-line skills and critical thinking techniques, that make the growth and development of a healthcare industry successful, with a lower risk of regulation misinterpretations. As medical device development continues to grow, it is crucial that there are people who act as contacts between a medical device company and those interested in purchasing these devices.

The Role of Medical Device Consulting in Healthcare Innovation

Medical device consultants have a very unique advantage that many internal employees do not necessarily get to have, they get the opportunity to benchmark and apply industry best practices from other companies. This includes what works, what does not work, what is the best direction executive management is heading, and how to achieve those objectives with fewer trial-and-error obstacles. Medical device consultants also regularly conduct trainings as a continual improvement and development practice. This allows the medical device consultant to remain ahead of the trends and industry regulation changes and to remain attractive to clients who are looking for experts in the required fields or on a specific medical device.

Many Executive Leaderships are looking for strategies to obtain their goals and objectives, the medical device consultant’s job is to get them there with the best-in-breed expertise and knowledge.

AI (Artificial Intelligence) is creeping into our everyday life. From our smart phones and smart homes to the devices that save lives. I have been seeing more in the past two years, the importance of IT (Information Technology) in my everyday life and how to conduct those activities IT cannot prioritize completing for everyday life work experiences.

Conducting AI into Everyday Life

Organizations are looking for intuitive methods for obtaining clean data and how to present data in more useful manner. Managing data is an FTE job in itself. Integrating Power Apps and Custom Automated Flows makes mundane tasks seconds, as opposed to hours, and no human errors. Presenting that data in a clean and useful manner is where software applications such as Tableau and Power BI come into play. These softwares connect directly to datasets and provide a dashboard-view of the data in an interactive method, where drilling down into the data and playing with it is a playground to bring the audience with you. Looking into the data and seeing the story it tells can save countless hours of assumptions and yielding misguided decisions.

Innovations of Projects with System Updates

Since 2019, I have been on more projects that have software integrations, than ever before, with MedTech on the rise. From site transfers to vaccine generations, automated manufacturing processes and data are linked directly to SAP and PLM. Having insight and a deep understanding of software integrations can provide the critical linkages in strategizing on how to make a project work best, with the pathway of least resistance already understood by a medical device consultant.

Navigating Regulatory Compliance and Product Development

CFR 820, ISO9001, ISO 13485, and EUMDR 2017/745 are medical device consultants equivalence of the Bible. Those regulatory and compliance guidelines provide many rules and regulations to get a product to market and keep it there, all the while reducing the patient risk and increasing its market safety. These regulatory and compliance guidelines are unique in what they cover; however, they are intended to be used together and read together to create one guideline – one message: Patient Safety. Saving lives and providing honest life-saving products to the market, which one day may save our very lives or a loved one – that is the entire purpose of this field.

The lifecycle of a product begins with the innovation or concept of the idea. The idea undergoes analysis and is pressure tested against the market, confirming it meets the demand. The product is then designed and developed before it is launched. Once the product is launched, it will begin its first iteration of its lifecycle and likely many improvements to enhance its market use until the discontinuation or end of the product's life cycle management.

The Journey from Conceptualization to Execution

Product Development Process:

1. Concept: Strategize on the project concept and if it should a project be established with a business commitment
2. Feasibility: Feasibility plan that the project is worth pursuing and obtain the product commitment.
3. Development: Provide a direction of confirmation the product can be produced, with design commitment.
4. Qualification: Confirmation that the product can be shipped and meets conformities, with release commitment.
5. Commercialization: Approval that the product meets conformity and the objectives of the project.

Operations & Market Process:

1. Demand: Project is requested via approval product meets conformity.
2. Initiate: A project is established and the team is assigned.
3. Planning: A pathway to market is strategized, documenting all risks, assumptions and the roadmap to success designed.
4. Execute: The plan is put into action.
5. Validation: The plan is pressure tested to confirm it meets design requirements and regulations.
6. Closure: The plan is pushed to the business for commercialization and closure of project.

The Diverse Responsibilities of Medical Device Consultants

Medical device consultants are the best-in-class experts within the medical device industry. Many times, a medical device consultant is hired because an organization has a need that cannot be fulfilled internally. From my experience, this is when organizations are under immense pressure such as Warning Letters, Consent Decrees and DoJ Guilty Pleas. When an organization undergoes hard and stressful events, there is so much knowledge learned and obtained. Coming from the other side of these events, there are lessons learned and knowledge that would have served beneficial had known during the event.

Apply this knowledge opportunity to the everyday life of a medical device consultant. They live and breathe the stress, fast-paced, strategies, and getting the goals and objectives handed over to the organization. Their experience is conceptualized by real industry knowledge, which having onboarded to an organization could ensure that the right resources are assigned to the objective, at the right time, all the while saving hundreds of thousands of dollars, if not millions of dollars, reducing operational risks and increasing opportunities.

As a Medical Device Consultant, when I enter into an organization, it is not only to complete the required objectives, but to make the organization a better place when I leave, as well as a greater appreciation for my line of work. I have conducted Six Sigma Yellow Belt Trainings, countless Project Management Trainings, data system trainings and leadership development trainings. All of this is to elevate the organization and its internal talent via mentorship. Mentoring an organization as a medical device consultant is always a perk of the job. I get to see someone succeed and grow professionally – praising their growth and development is the hidden honor that makes it easier when I need to step away and into my next assignment.

Medical device consultants can assist in clinical study protocols, preparing regulatory submissions, and conducting product development research, as they have been able to benchmark the industry and have the skillsets to obtain this detail at a more accurate and faster rate. The level of skills is generally more challenging to locate internally, and when they are located, from my experience, they are senior managers who have an assigned team that is not equipped to take on the demands.

In having personal experience with preparing regulatory submissions, I was able to take on the role of an equivalent 3 FTEs. That is not a skill set that is generally available to an organization internally. Medical device consultants are highly skilled professionals who can effectively and efficiently complete a task.

As a Program Manager, I always want to know what needs to happen and when. Generating a project plan for my clinical evaluation reports and submission deadlines provides me with a roadmap to the timeline. I am able to deliver on time and at or above expectations.

To prepare for Regulatory Approvals, I enhance the project plans with a sophisticated and dynamic project team to align to our Communications Plan of a cadence with the regulatory body or notified body. Having the opportunity to go from one highly demanding role to another, I get to have insight into these notified body expectations and requirements. This knowledge is what benefits the organizations I get assigned to and the colleagues I am honored to work alongside.

Building Effective Communication and Relationships in Healthcare

Communication is everything. Many times, I find that there is more to how something is said. Having direct interactions with the Sales Reps, end users HCPs (Health Care Professionals), and patients is what provides insight to product and process improvements. I truly enjoy the MedTech industry, but I refuse to ever be 100% satisfied with it, leaving a large space for growth and development. I see organizations equally acting in the same manner – always looking for ways to make products less invasive, faster healing, more robust and dynamic and readily available to improve the quality of life.

Building relationships requires a form of trust and leadership. I commit to taking heed to the information shared, and listening intently, and respecting every minute of time that is shared. As a project manager, I am 100% assigned to a project – it is my daily life. However, others I come into contact with are subjected to my project as an assigned resource, many times having to hold their daily jobs while being an assigned resource. Respecting time allocated and using at or below expected allocation builds that trust.

Relationship management has nearly everything to do with communication. Properly conveying what was spoken, speaking clearly and confidently, and being able to read the room – meaning hearing the tone and reading between the lines, if you will.

The Future of Medical Device Consulting

From my experience, I have witnessed many medical device companies bring on several consultants to throw at a problem, then once the problem is nearly addressed, they remove them quickly. This abrupt removal hinders the opportunity for mentorship and thorough assessments in other troubled areas within the organization. These areas could greatly benefit from ongoing guidance and expertise of a Medical Device Consultant, ultimately preventing potential long-term issues and impacts. I have seen the field for medical device consultants rise within the past 10-years, as the Medical Device rules and regulations have changed to better align to one common goal: Patient-Safety.

Adapting to Market Growth and Regulations

With the ever-evolving landscape of medical device consulting, professionals in this field have a plethora of career opportunities awaiting them. As market trends shift and regulations continue to evolve, the demand for skilled individuals in medical device consulting is on the rise. By staying ahead of the curve and adapting to these changes, experts in this field have the potential to truly make a difference in ensuring patient safety and driving innovation in healthcare.

The field of medical device consulting offers a unique blend of challenges and rewards for those who are passionate about making a positive impact. From navigating complex regulatory requirements to spearheading groundbreaking advancements in medical technology, professionals in this field have the opportunity to shape the future of healthcare.

By embracing the growth of the market and staying abreast of regulatory shifts, medical device consultants can play a vital role in driving progress and improving patient outcomes. With a focus on innovation, safety, and efficiency, these professionals are at the forefront of revolutionizing the way healthcare is delivered.

How ALKU Can Help

Medical device consulting services play a crucial role in driving healthcare innovation and improving patient care. By providing expertise in areas such as feasibility, development, qualification, and commercialization, medical device consultants ensure that all products made by medical device manufacturers meet regulatory standards and are safe and effective for patients.

ALKU's network of Medical Device Experts bring a wealth of industry knowledge and experience to any medical device company, helping them navigate challenges such as regulatory submissions, product development research, and clinical study protocols. By leveraging their skills, our Medical Device Consultants can streamline processes, improve risk management, and ultimately enhance the quality of healthcare delivery.

As the field of medical device consulting continues to grow, professionals in this sector have the opportunity to shape the future of healthcare. By staying ahead of market trends and regulatory changes, they can drive progress, improve patient outcomes, and ultimately contribute to a safer and more efficient healthcare system.