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MedTechStart Spring 2024

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Dear Readers,

I am thrilled to welcome you to the Spring 2024 edition! I am

excited to embark on this year’s journey with you, focusing on the

incredible world of medical device start-ups and the transformative

landscape of the new digital economy.

In the ever-evolving field of healthcare, entrepreneurs like you play a

pivotal role in driving innovation and improving patient outcomes.

With the rise of the digital economy, opportunities for medical

device start-ups have never been more promising.

In each issue of MedTechStart, we aim to provide you with valuable

insights, expert interviews, and practical advice tailored specifically

for those navigating the challenges and triumphs of launching

medical devices in the digital era.

Here’s what you can expect from our magazine:

•

Industry Trends: Stay informed about the latest trends shaping the medical device landscape in the digital economy.

•

Success Stories: Learn from the experiences of successful entrepreneurs who have turned their innovative ideas into

thriving businesses.

•

Expert Advice: Gain insights from industry experts, regulatory professionals, and investors who can guide you on your

entrepreneurial journey.

•

Technology Spotlights: Explore the cutting-edge technologies revolutionizing the medical device sector and how they can

benefit your start-up.

•

Navigating Regulations: Understand the regulatory landscape and discover best practices for compliance to ensure a

smooth path to market.

Whether you’re a seasoned entrepreneur or just starting out, MedTechStart is your go-to resource for inspiration, knowledge,

and connections within the dynamic world of medical device start-ups.

I invite you to dive into the pages of our inaugural issue and join us in shaping the future of healthcare innovation. Your ideas

and dedication are the driving force behind the advancements that will impact lives around the world.

Thank you for being a part of the MedTechStart community. Here’s to a future filled with innovation, collaboration, and

success!

LETTER FROM THE EDITOR

Bill Jacqmein

With heartfelt thanks,

Bill Jacqmein

CEO

Prime Path Medtech

bjacqmein@primepathmedtech.com

SPRING 2024��

CONTENTS

info@primepathmedtech.com

HOW DENTAL CLINICS CAN HELP YOU

MANAGE PATIENT FEAR

MDSAP: SIMPLIFYING GLOBAL

COMPLIANCE

SUPPLY CHAIN MANAGEMENT 101:

WHAT MEDICAL DEVICE COMPANIES

NEED TO KNOW

MEDICAL APPLICATIONS OF LASER

TECHNOLOGY

THE POWER OF MULTI-CHANNEL

MARKETING FOR

STARTUP GROWTH |

PRIME PATH MEDTECH

9 SIMPLE WAYS TO CUT

BUSINESS EXPENSES

ORIGINS OF ANCIENT MEDICAL

ADVANCES

HEALTHY SNACKING:

SMART CHOICES FOR SATISFYING

CRAVINGS DURING A BUSY WORK DAY

OR BUSINESS TRAVEL

BUILDING A ROBUST INTELLECTUAL-

PROPERTY (IP) STRATEGY:

SAFEGUARDING INNOVATIONS FOR

COMPETITIVE EDGE

THE POWER OF STORYTELLING

WHEN BUILDING A BRAND

COMBATTING ANXIETY THROUGH

GENTLE MOVEMENT:

CAN YOU OHM YOUR WAY TO LESS

ANXIETY?

THE ROLE OF SOCIAL RESPONSIBILITY

IN MODERN START-UPS

POST TRAUMATIC AMNESIA IN

THE NFL

STAFF PICKS FOR BEST TRAVEL

SUITCASES

BRAIN WORKOUT

SPRING 2024��

ear is a common problem in

dental patients that can impact

their care. In fact, about one in every

seven patients is so anxious that dental

practitioners must take extra care.

Dental fears can cause patients to delay

or even forgo necessary treatment.

Dentists, hygienists, and other dental

staﬀ can make a diﬀ erence. When the

dental team takes time to understand

what dental anxiety is, what causes it,

and how to help patients, then patients

can get the care they deserve.

WHAT IS DENTAL ANXIETY?

Dental anxiety is a fear of a dental

procedure that outweighs the actual

risks. Someone might be afraid of

specifi c procedures at the dentist’s

oﬃ ce or something in particular. Also

known as dental fear, this anxiety

exists on a spectrum.

Some patients with dental anxiety may

feel a racing heartbeat when in their

dentist’s chair but otherwise feel ok.

Other patients may feel unable to get

through a cleaning. Some even avoid

dental work altogether. Severe cases are

sometimes known as “dentophobia.”

Some patients with dental anxiety

are afraid of specifi c parts of the

experience, including:

•

Anesthesia

•

Needles

•

Pain or discomfort

•

Th e dentist or hygienist

Unpleasant sensations can worsen

these fears, such as loud noises, bright

lights, and unique smells. But what

makes people so afraid of dentists?

What Causes Dental Anxiety?

Th ere’s no singular cause for dental

fear and anxiety. However, some

experiences and factors can cause

someone to be more likely to

experience dental anxiety.

First and foremost, having a negative

experience with dentistry can cause

someone to fear all dentists. Patients

might have had a failed treatment,

extreme pain, or other traumatizing

experience. Even if your practice wasn’t

responsible for that, the patient could

be anxious that you’ll cause the same

stress.

Some patients are afraid to experience

shame or judgment at a dental oﬃ ce.

People have dental problems for all

kinds of reasons. Th ey may have

missed years of cleanings due to

anxiety, cost, or other issues. Some

may have a genetic predisposition

to dental problems, or they may be

getting sober from an addiction that

damaged their teeth.

All of these issues may cause the

patient to feel ashamed of their smile.

Th ey worry that a dentist or hygienist

will make them feel worse about

themselves.

Finally, popular media and societal

expectations can infl uence people’s

feelings about going to the dentist.

Often, movies, shows, and more

portray dental treatments as extremely

painful.

Strategies for Reducing Dental

Anxiety

Dentists, hygienists, and other staﬀ

can help patients cope with their

dental anxiety. You can implement

some of these strategies for every

patient. You might use diﬀ erent coping

mechanisms only for patients who

show signs of anxiety, such as:

•

Shallow, quick breathing

•

Shaking

•

Excessive sweating

•

Wincing when touched

•

A worried expression

Th ese strategies can put your patients

at ease and lead to better care.

Show Empathy and Compassion

Perhaps the best thing that dental

professionals can do for anxious

patients is to show empathy. When

you show your patients that you

understand their fears, they may trust

you to care for them. You can try

phrases like:

•

“I know this might feel scary. I’m

going to take good care of you.”

•

“Th ere’s no need to feel

embarrassed. I’m here to help, not

judge.”

•

“Please let me know if anything

feels overwhelming. I’m here to

help.”

Empathetic communication can be

essential for patients who feel ashamed

or embarrassed about their oral health.

Communicate Everything

Many patients feel better when they

know what to expect. You can ease

their fear by telling your patient what

you will do before you do it. Some

practitioners use the “tell, show, do”

method:

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By Staﬀ

SPRING 2024��

1. Tell the patient what you will do.

You might also include what they

might feel and why you are doing

it.

2. Show the patient what instruments

you’ll use or anything else that

might help them understand what

to expect.

3. Do what you told the patient you

would do. If you have to change

the plan, let them know.

Depending on the patient, you can use

this technique for every small detail or

to go over the entire plan all at once.

Give T em Control

When possible, give your worried

patient choices. Th is can help the

patient gain some feelings of control

over the situation, which can reduce

anxiety. Some ways you can provide

control include:

•

Giving the patient a way to tell

you that they are in pain

•

Letting the patient tell you when

they are ready to begin

•

Giving them hand signals for

“stop” and “go ahead.”

Even these small adjustments can go a

long way toward calming the person in

your care.

Breathing Techniques

Lead the patient through calming

breathing exercises. You can even

participate as well. Th ere are many

breathing techniques that can

work. For example, you can try box

breathing. Have the patient breathe in

for four seconds, hold for four, exhale

for four, and then hold again for four.

Try a few rounds of this and see how

you both feel.

Create a Calming Environment

Your oﬃ ce environment and

procedures can change the patient

experience. Th ink through the patient’s

full experience from the moment they

schedule through check-out. You can

likely fi nd ways to create a peaceful

environment at every step.

Here are just a few ways to create a

calming dental oﬃ ce:

•

Ensure oﬃ ce staﬀ are kind and

empathetic

•

Play calming music in the lobby

•

Consider ways to make the

practice smell good

•

Install televisions that can distract

patients from their fears

•

Have comfortable seating in the

waiting room

•

Use natural lighting where possible

Each of these adjustments can help

your patients feel better about visiting

your oﬃ ce. Th en, they can be more

likely to attend their cleanings and get

additional care. Th ey may even tell

their friends and family how much

better your practice is than previous

experiences. How will you help your

patients feel calm in your practice?

You can take steps today to improve

dentistry for everyone.

SPRING 2024��

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By Jennifer Day

MDSAP, or the Medical Device Single Audit Program, stands as an acronym that resonates across the medical device

industry. But what exactly is MDSAP? It represents the Medical Device Single Audit Program, a pioneering international

endeavor. Th is program empowers medical device manufacturers to undergo a unifi ed regulatory audit that fulfi lls the

requirements of multiple regulatory authorities.

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MDSAP condenses the regulatory process by enabling manufacturers to satisfy the criteria of

multiple countries with just one audit, eliminating the need for individual audits in each nation.

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Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP unites regulatory authorities from

Australia, Brazil, Canada, Japan, and the United States. Its overarching objective is to harmonize and standardize the

regulatory landscape for medical devices across participating countries. Th is initiative signifi cantly diminishes the need for

redundant audits and assessments.

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Manufacturers can save time, resources, and costs associated with undergoing separate audits

and assessments from diverse regulatory authorities.

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Facilitating entry into major markets including Australia, Brazil, Canada, Japan, and the United

States, collectively representing a substantial segment of the global medical device market.

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MDSAP aligns regulatory requirements and audit protocols among participating countries, endorsing

a more uniform approach to compliance and quality management.

SPRING 2024��

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Manufacturers are encouraged to implement robust quality management systems (QMS) adhering

to international standards like ISO 13485. Th is fosters elevated product quality and patient safety.

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MDSAP emphasizes a risk-centric approach to auditing, allowing regulatory authorities to concentrate

on higher-risk areas within a manufacturer’s QMS.

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Th e program cultivates communication and collaboration between regulatory authorities

and manufacturers, fostering a more profound understanding of regulatory expectations

and requisites.

��

MDSAP contributes to the harmonization of regulatory requirements across participating

countries, diminishing disparities and simplifying manufacturers’ navigation of international

markets.

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Th rough the audit process, manufacturers receive constructive feedback on their quality

management systems, providing an opportunity for refi nement and ultimately yielding higher

quality products.

��

Manufacturers aligning with MDSAP requirements may gain a competitive edge by exemplifying a

dedication to quality and compliance on a global scale.

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MDSAP oﬀ ers a meticulously standardized system that defi nes clear expectations between manufacturers and regulatory

authorities regarding audit procedures, duration, nonconformance grading, and ensuing actions.

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Th e MDSAP Audit Approach Document stands as a comprehensive guide for auditors and participating manufacturers. It

ensures audits are conducted uniformly, adhering to established standards and procedures. It categorizes processes within the

QMS and delineates specifi c tasks for assessing conformity.

For further transparency, this document is publicly accessible through the FDA website’s MDSAP Audit Procedures and

Forms page. Th is empowers manufacturers and auditors alike with precise insights into what should be reviewed and assessed

during an MDSAP audit.

SPRING 2024��

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MDSAP exercises meticulous control over the duration of audits, taking into account various factors. Th ese include the

complexity of the manufacturer’s operations, the scope of the audit, and the size of the organization. Th e key considerations in

duration determination include:

•

Size and Complexity of the Manufacturer:

Larger or intricately structured organizations may require extended audit durations to thoroughly assess all pertinent areas

of their quality management system (QMS) and regulatory compliance.

•

Scope of the Audit:

Th e audit’s scope defi nes the extent of the manufacturer’s operations under evaluation. A broader scope encompassing

multiple sites or an extensive range of products may necessitate a more prolonged audit duration.

•

Number of Sites and Locations:

Manufacturers with multiple sites or facilities may require additional time for on-site inspections and the assessment of

quality management systems at each location.

•

Range of Products and Processes:

Manufacturers producing a diverse array of medical devices or involved in complex manufacturing processes may necessitate

more time for a comprehensive evaluation.

•

Regulatory Requirements of Participating Countries:

Specifi c regulatory requirements of participating countries may infl uence the depth and breadth of the audit, potentially

aﬀ ecting its duration.

•

Risk-Based Approach:

Th e risk assessment performed by the audit team may guide the allocation of time to higher-risk areas, potentially aﬀ ecting

the overall audit duration.

•

Cooperation and Accessibility of the Manufacturer:

Th e readiness and cooperation of the manufacturer during the audit process can signifi cantly contribute to the eﬃ ciency of

the assessment.

Ultimately, the audit team determines the audit duration based on a judicious consideration of these factors. Eﬀ ective

communication and collaborative eﬀ orts between auditors and manufacturers are crucial to ensure the audit is comprehensive

and conducted eﬃ ciently.

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Distinct from other audits, MDSAP rigorously controls the grading of nonconformities. All fi ndings are assessed on a scale

of 1 to 5. Nonconformities graded as 4 or 5 are deemed critical fi ndings and are promptly reported to the relevant regulatory

authorities. Four factors infl uence the grading of nonconformities.

•

Impact on Quality Management System (QMS):

Nonconformities are stratifi ed based on their impact, categorized as either indirect or direct QMS impact.

a. Indirect QMS Impact:

Pertains to clauses considered “enablers” for the QMS, indirectly infl uencing medical device safety and performance. (ISO

13485:2016 clauses 4.1 through 6.3 (except 4.2.3))

b. Direct QMS Impact:

Relates to clauses with a direct infl uence on design and manufacturing controls, directly aﬀ ecting medical device safety and

performance. (ISO 13485:2016 clauses 6.4 through 8.5 (except 8.2.4))

SPRING 2024��

•

Repeat Nonconformity:

Nonconformities previously identifi ed within the last 3 years are escalated due to the increased risk they pose, indicating

insuﬃ cient corrective action.

•

Absence of a Procedure:

Th e absence of a documented process or procedure signifi cantly impacts consistency and eﬀ ective implementation,

warranting escalated grading.

•

Release of a Nonconforming Medical Device:

Nonconformities leading to the release of a nonconforming medical device into the market directly signify a QMS failure,

resulting in higher-risk grading.

Th ese factors collectively contribute to the grading of nonconformities. Starting with the impact, indirect impact initiates

at a grade of 1, while direct impact begins at 3. Subsequently, any true escalation factors (repeat nonconformity, absence of

a procedure, or release of a nonconforming medical device) increase the fi nding grade. While a grade of 6 is theoretically

attainable, the highest grade assigned remains a critical 5. Th is stringent grading system ensures thorough assessment and

prompt reporting of critical fi ndings to uphold the integrity and safety of medical devices.

In conclusion, the Medical Device Single Audit Program (MDSAP) stands as a transformative initiative, streamlining

regulatory processes for medical device manufacturers worldwide. By enabling a unifi ed approach to audits and assessments,

MDSAP not only empowers manufacturers to meet the diverse requirements of participating countries but also fosters a

culture of continuous improvement and excellence. Th rough standardized procedures, transparent expectations, and stringent

grading, MDSAP ensures the highest standards of quality and safety in the production of medical devices. Th is collaborative

eﬀ ort between manufacturers and regulatory authorities marks a signifi cant milestone in the global healthcare industry,

ultimately benefi ting patients and providers alike. As MDSAP continues to evolve, its impact on the industry is poised to be

both profound and enduring.

SPRING 2024��

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By Nicole Fallon-Peek

n today’s fast-paced and highly

regulated medical device industry,

eﬃ cient supply chain management

(SCM) is more critical than ever.

Th e unique challenges of this sector,

including strict regulatory requirements,

specialized product demands, and the

need for timely delivery, make SCM a

vital component of success.

As you work toward launching and

growing your medical device business,

consider the following best practices

for optimizing your supply chain

management. Here, we’ll look at three

critical aspects of SCM—inventory

management, supplier relationships, and

regulatory compliance—and how your

business can best address them.

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Supply chain management is the

coordinated management of a network

of interconnected businesses involved in

delivering products to end customers. At

its core, SCM involves the oversight of

materials, information, and fi nances as

they move from supplier to manufacturer

to wholesaler to retailer and fi nally

to the consumer. It also includes the

crucial elements of coordination and

collaboration with channel partners,

which can be suppliers, intermediaries,

third-party service providers, and

customers.

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In this stage of supply chain management, vendors and partners supply

the raw materials and components essential for the production of medical

devices. For example, a vendor might provide high-grade medical steel for

surgical instruments.

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At this stage, partners are responsible for converting raw materials into

fi nished medical devices. An example includes a manufacturing partner

assembling and packaging sterile syringes.

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Logistics partners ensure that fi nished medical devices are delivered

accurately and promptly to the intended locations. For instance, a logistics

partner might coordinate the delivery of heart monitors to various hospitals

globally.

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Th is stage involves managing and optimizing the processes of returns,

recycling, and waste. A partner in this stage might handle the safe disposal or

recycling of outdated or defective medical equipment.

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Th e integration and sharing of information across the supply chain is vital for

seamless operations. Here, a technology partner might provide a cloud-based

platform for tracking product movement and inventory levels throughout the

supply chain.

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