Heart surgery survival chances ‘better in the afternoon’

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Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.

And it says the difference is not down to surgeons being tired in the morning.

Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.

The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

  • 54 out of 298 morning patients had adverse events
  • 28 out of 298 afternoon patients had adverse events
  • Afternoon patients had around half the risk of complications
  • One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”

He also said it would be impossible for hospitals to conduct surgery only after lunch.

But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”

Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.

Heart health is already known to fluctuate over the course of a day.

The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

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Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.

“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.

Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

With Macy Foundation Grant, Drexel Teams with 12 Institutions to Enhance Professionalism in Medical Education

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The Josiah Macy Jr. Foundation has awarded a grant to Drexel University faculty to support the dissemination and enhancement of an online resource for teaching future health care providers about professionalism in medicine — including empathy, compassion, honesty, ethics and social justice.

Dennis Novack, MD, associate dean of medical education at the College of Medicine, was previously awarded a grant to create ProfessionalFormation.org (PFO), an online resource for professionalism learning, assessment, remediation and research in clinical education. With the support of the Macy Foundation, Novcack and Kymberlee Montgomery, DNP, chair of the Department of Advanced Practice Nursing in the College of Nursing and Health Professions, are working with a variety of institutions to disseminate and enhance this resource for over 30 health care education schools across the country.

“This generous grant will enable us to address the challenge of generating new educational resources for the entire health care education community. We will also publish educational research that contributes to a growing national understanding of the components of effective teaching and learning of professionalism and interprofessional care,” Novack said.

Teaming up with Drexel University are 12 institutions including: Alabama College of Osteopathic Medicine, Albert Einstein College of Medicine, Commonwealth Medical College, Duquesne University, Indiana University, Jefferson College, Ohio State University, Southeastern Louisiana University, Stony Brook, University of Pennsylvania, University of Texas – Rio Grande Valley and Western Michigan University School of Medicine. Each of these institutions is affiliating with colleges, such as nursing, pharmacy, physician assistants, dentistry and others for this unique collaboration.

“Leaders in health professions education have worried about the professional image of health care clinicians, and the public’s declining trust in health professionals. Managed care has grown, clinical care has become more fragmented, and there has been adverse publicity about errors in care,” Montgomery said. “A new paradigm for care demands commitments to professional values, and skills in working in teams. We are partnering with these institutions to enhance and expand their education in professionalism and interprofessional care. To practice together, it is essential to learn together.”

The American Board of Medical Specialties defines medical professionalism as a “belief system in which group members declare to each other and the public the shared competency standard and ethical values they promise to uphold in their work and what the public and individual patients can and should expect from medical professionals.” Central to those decelerations is a focus on an ethical value system, the knowledge and technical skills necessary for good medical practice and the interpersonal skills necessary for working with patients and colleagues.

Read More: http://snip.ly/4km9u#http://drexel.edu/now/archive/2017/September/Macy-Foundation-Grant-Professionalism/

Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally is more than double that of the east of England.

English health ministers said thousands of new posts were already planned.

The government in England recently announced there would be 570 extra consultant psychiatrists by 2020-21.

And the Welsh government said it was committed to improving mental health services in Wales.

But the Royal College of Psychiatrists said there were too few medical students specialising in psychiatry and not enough psychiatrists becoming consultants.

In England, in the past five years, it said there had been a 1.7% increase in psychiatry consultants compared with a 20.2% increase in other consultants across the NHS.

Areas such as London and the north-east of England have more than 11 psychiatrists per 100,000 people but the south-west has six and Yorkshire five.

‘Falling short’

Prof Wendy Burn, President of the Royal College of Psychiatrists, said: “People with a severe mental illness should expect to see a specialist consultant, just as you would for a severe physical illness.

“The huge variation in consultant psychiatrists across the country means reality is increasingly falling short of our expectations.

“As highly skilled medics, psychiatrists must be able to spot the nuance in symptoms, ask the right questions, and understand what the problem is.

 

Read More: http://snip.ly/u70ov#http://www.bbc.com/news/health-41201396

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

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Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals have always been flocking to GlobalCompliancePanel to partake of professional trainings courses that are valuable, relevant and highly interesting. They will now have more reasons for doing so and join thousands of healthcare regulatory professionals who have already benefited from GlobalCompliancePanel’s professional trainings, because it is not every day that one comes across an offer in which the professional gets to pay a mere 5% of the original price of the webinars!

These recorded webinars are on a number of topics concerning healthcare. Healthcare professionals can use these courses to augment the learning they have gained over the years and climb up in their professions with even greater ease. What’s more; healthcare professionals have such a huge number and variety of courses to choose from that they can opt for several courses of relevance to them without burning a hole in the pocket.

Why is GlobalCompliancePanel doing this? Simple: It wants more and more healthcare professionals to take up courses that are relevant and valuable to them, so that the knowledge needed for becoming successful in their careers spreads wider and goes deeper. After all, meeting regulatory compliance requirements is the number one challenge for any healthcare professional, who sees no way out of the regulatory maze without the professional trainings needed to understand them. When such a course is available at a throwaway price of $10, isn’t that a delightful thing to have?

Let us feature a couple of the topics on which GlobalCompliancePanel is offering these courses to healthcare regulatory professionals:

The HITECH Acts Impact on HIPAA

HIPAA enforcement is a matter of serious concern to many healthcare professionals. Many of them, even highly experienced ones, are clueless about some of the aspects of this enigmatic law. When HITECH combines with HIPAA; the confusion is doubled. The two laws intersect at many places, thus compounding the complexity of enforcement. This webinar from GlobalCompliancePanel offers clarity and helps them ease the confusion about this law.

Further, the nature and roles of a host of HIPAA-related items such as breach notification, business associate contracts, training of staff and security of PHI for Business Associates can be daunting to understand and implement. Webinars such as this are designed to help healthcare professionals steer clear of the stumbling blocks that they could encounter in implementing these.

Preparing a Medical Product Regulatory Requirement Plan

What happens when healthcare companies fail to meet regulatory requirements set out by the FDA and other regulatory agencies? The consequences are disastrous, and can range from penalties to having their business shut down. One of the foundations to avoiding this sort of situation is to develop a medical product regulatory requirement plan.

A medical product regulatory requirement plan charts out the regulatory requirements  that need to be met from step one, which is quite literally Day One of the start of the process of making healthcare products. A detailed and organized medical product regulatory requirement plan is indispensable to ensuring in the end that the healthcare product meets the regulatory requirements.

It is this priceless learning that this webinar from GlobalCompliancePanel imparts. And yes, at $10!

Drug Safety and Pharmacovigilance

Pharmacovigilance, a crucial area of healthcare, needs to be implemented in full according to the requirements set out in regulations from the FDA, EMA and other regulatory agencies. Drug safety being deeply tied to PV; the proper implementation of the latter is needed to ensure the former.

PV is essentially about ensuring drug safety by implementing measures throughout the process of production. A healthcare company has to comply with directions from a number of regulatory agencies in order to have its products passed by them and to gain permission to enter different markets. They cannot afford to take one wrong step in the whole process. A number of areas such as clinical trials, marketing, disease management and government are just some of the areas in which pharmacovigilance is indispensable.

This webinar from GlobalCompliancePanel is a great means to getting a complete understanding of this intricate topic. The topic is of great relevance to healthcare professionals, but what’s more; it comes at this unbelievable price tag of just $10!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

The Ultimate Guide To Design Controls For Medical Device Startups

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What’s this guide about anyway?

Back in 1998, I started my career as a medical device product development engineer.

At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general.

In those days, we all struggled to understand how and what to do with respect to Design Controls.

As my career progressed, I started to understand the purpose and intent regarding Design Controls. But it didn’t happen overnight.

Over the past 17 years, I’ve been fortunate to have played a part in getting 40+ medical devices through FDA clearance as a product development engineer, through my consultancy, and more recently as co-founder of greenlight.guru.

However, for many, Design Control is still a topic that is as confusing today as it was for me many years ago.

With this guide, I plan to share valuable insights to explain what Design Controls arehow to address them, and how they benefit your medical device product development efforts.

 

You have an idea for a new medical device. Now what?

Congratulations! You have an idea for a new medical device.

Chances are you believe your idea will have a significant impact on the quality of our lives in some way. Chances are your product will help solve some current problem and address unmet needs.

What do you do now?

Throughout the world, there are agencies that govern and regulate medical devices. For example, in the United States, medical devices are regulated by the Food & Drug Administration (FDA).

These regulatory agencies have defined rules and regulations that you and others developing and manufacturing medical devices must follow.

And these regulatory agencies have defined rules and regulations about how medical devices are classified and what is required before the products are sold into the marketplace.

Most notably, since you have an idea that you want to develop further, there are regulations established for you to follow during the product development process. These regulations are known as Design Controls.

This may sound confusing and discouraging. I get that.

And I don’t want you to be confused or discouraged.

This is what drove me to create this “Ultimate Guide to Design Controls for Medical Device Startups.”

In this guide, I will share with you the necessary background about Design Controls from a global regulatory perspective.

I will provide you with knowledge and information that will arm you with more than just the basics.


 

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Some explanation about a Quality System

Yes, I know — this guide is supposed to focus on Design Controls. And it does.

I just need to spend a few minutes explaining what a quality system is and how this relates to your medical device product development efforts.

 

What is a Quality System?

A medical device company has to establish a quality system.

A quality system is a set of processes and procedures you define and implement to describe how your company addresses medical device regulations, including Design Controls.

FDA defines the rules in 21 CFR Part 820. And if you plan to go to market in the U.S., these regulations are required.

Outside the U.S., Europe requires a quality system be established to meet the medical device directives. Many medical device companies choose to implement a quality system and have it certified to ISO 13485 to satisfy EU needs.

Canada — same thing. The expectation is that a quality system be established. Canada is a little different, requiring you to establish ISO 13485 certification and the Canadian Medical Devices Conformity Assessment System (CMDCAS).

The good news is this… FDA 21 CFR Part 820 and ISO 13485 are very similar. Meaning you can establish a “one size fits all” quality system, encompassing Design Controls too.

 

Build your Quality System as you go

The quality system expectations is that you have all parts and pieces defined and implemented by the time you go to market.

Yes, there are parts of the FDA regulations and ISO requirements that do apply to you, even if you are pre-market.

If you are going through medical device product development, there are at least 4 parts of a quality system that you need to put in place:

  1. Design Controls
  2. Risk Management
  3. Document Control & Records Management
  4. Supplier Management

The term I use is “bootstrapping a QMS”. I encourage this approach. Early on, you don’t need to spend too much time implementing a robust quality system. You need to be focused on product development.

And as you get closer and closer to going to market, there are software tools, like greenlight.guru and others, you can use to gradually implement more and more of a QMS.

Just make sure you always keep your quality system in mind from the beginning, so you don’t have to learn how to free yourself from a quality system nightmare down the road.


 

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What are Design Controls?

So far in this ultimate guide, I have spent very little time discussing Design Controls. Yes, this is deliberate.

The stuff I covered so far about understanding medical device product classification and quality systems is very important for you to have some grasp on as you pursue your new medical device idea.

If that information did not discourage you and you are still reading, rest assured.

The rest of this guide is devoted to Design Controls. Really more than just Design Controls.

I will share with you why Design Controls even matter and how they will help you during your medical device product development.

 

Design Controls – Comparing FDA and ISO

It is important that you design and develop a medical device that is safe. FDA, European Commission, Health Canada, and all other regulatory bodies throughout the world will want some assurances that your medical device is safe before you bring the product to market.

And this is really the essence of Design Controls. Proof that you have designed a safe product that meets user needs and requirements.

Technically speaking “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30 (the 21 CFR stuff is FDA terminology to describe where in the code of federal regulations the topic is addressed).

In ISO 13485 speak, the terminology and intent is similar and covered in section 7.3 Design and Development.

The table below compares the FDA clauses for Design Controls to ISO 13485 clauses regarding Design & Development.

FDA 820.30 vs. ISO 13485 - greenlight.guru

Both FDA Design Controls regulations and ISO 13485 Design & Development requirements expect you to keep documentation and records throughout the product development process.

The Design History File (DHF) is a great place to keep all of your Design Controls “evidence”.

As you can see, there is consistency regarding Design Controls. Although ISO 13485 does not explicitly call for a DHF, it is expected that you maintain records of design and development.

An industry best-practice is to construct a traceability matrix to show the linkages and relationship between User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.

Building and maintaining your traceability matrix using tools like Excel or Google Docs a is fairly straightforward task during the early months of product development.

But as your project progresses, you’ll soon find using these general purpose tools often take days, and in some cases weeks, to keep your traceability matrix properly updated and maintained.

This marks a time in your project where switching to a software solution built specifically to meet the unique regulatory needs of a medical device company, like greenlight.guru, can result in significant gains in time to market while reducing risk.

 

Product Development versus Design Controls

I’d like to spend a few minutes discussing product development versus Design Controls. Is there a difference? Or are these terms synonymous?

The short answers to these questions depends on who you ask.

And I’m telling you the answers really don’t matter all that much.

When you have an idea for a medical device that you want to turn into an actual product, you will follow some sort of product development process. And I highly encourage you to map your product development process and WRITE IT DOWN.

As an example, I like to define the product development process in major phases:

medical device product development process - greenlight.guru

 

 

During product development, you will construct some prototypes, do some testing, get some feedback, etc. Always trying to get to the next step towards launching your medical device.

As noted above, Design Controls are all about ensuring the medical device you are developing is safe.

All about making sure you have proven your medical device meets the requirements you define.

All about making sure you have proven your medical device meets the user needs and product’s intended use.

All about making sure you will be able to manufacture your medical device that you designed and developed.

But since I posed the question about product development versus Design Controls, I’ll give you my opinion.

product development vs design controls - greenlight.guru

It’s my opinion that Design Controls fits within the broader medical device product development process.

Product development includes much, much more than just Design Controls. Things like budget, timeline, business development, marketing, sales, and so on.


 

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Maintaining a Design History File

What is a Design History File (DHF)? When you read FDA Design Controls regulations, the part about DHF is mentioned towards the end. And ISO 13485 doesn’t officially talk about a DHF.

I want to cover DHF now so that you understand what it is and why it matters.

A Design History File is, simply put, the place where you keep all your Design Controls.

A DHF should be organized and accessible to the entire project team.

A DHF is the place where you will show the linkages and relationships between all the Design Controls.

Demonstrating traceability of all your Design Controls throughout the product development process is expected and required.

Whether you use a paper-based approach, general purpose tools, or a software solution designed specifically with Design Controls traceability in mind like I mentioned before, know that the responsibility to prove this is yours.

 

Keep the DHF separate from project file

My comments about product development versus Design Controls may seem somewhat trivial.

Except that it isn’t.

And the DHF is my main reason for saying so.

Yes, Design Controls and the DHF where these documents and records are maintained are important.

The DHF is the central hub for all the things medical device regulators care about.

Which is why it is so important to keep your Design History File as a stand-alone thing.

Going through medical device product development, you seldom consider how to maintain documentation and why it even matters.

And after you launch your medical device, the DHF is important in the event the project is ever audited by the FDAor others.

The last thing you want to do when finishing up a project is to spend weeks going back organizing documentation and records, including the Design History File.

I’m telling you that if you do not keep things shipshape as you go, you will not go back to clean it up.

This is why I recommend building your Design Controls traceability matrix early and keeping it up to date as you go. With this approach, you won’t stress about the possibility of being audited because your DHF will always be up to date and audit ready.

 

 

Design Controls Traceability Matrix - greenlight.guru
A Traceability Matrix Using greenlight.guru (Click here to get a free demo)

Ensure the DHF is organized and accessible

Ensuring Design Controls documentation and records are stored in a DHF is very important.

Keeping the DHF in a place where your entire product development project team can access it is also important. Why? Throughout product development, your team will be contributing valuable content to include in the DHF, and accessing this same content to conduct product development.

Be sure you are deliberate in how you plan to keep the DHF organized and accessible.

Do you plan to use a paper-based approach? If so, be sure you are aware of the challenges paper systems pose.

Do you plan to store electronic records on a company server or some type of electronic document management system? There are also challenges with this approach as well.

Do your homework. Choose your solution wisely.


 

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Why capturing User Needs sets the stage

Remember when you had the idea for your new medical device, you came up with this wonderful product because you want to address unmet clinical needs. There are two terms that you should understand: intended use and indications for use.

Intended Use is the general purpose of the medical device or its function (what you “claim” the medical device does)

Indications for Use describe the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population

All of this relates to the User Needs for your medical device and are part of Design Controls.

Now you can do a lot of digging to try to get a better understanding of what User Needs really are. FDA doesn’t really define User Needs in the 820.30 regulations per se. User Needs are shown kicking off the Design Controls process in the classic “waterfall diagram.”

 

design controls waterfall diagram - greenlight.guru
Classic Design Controls waterfall diagram originally published by Health Canada & published in FDA Design Controls Guidance

 

The best place, aside from this guide, for you to get some insights about what User Needs are is the FDA Design Controls Guidance.

And when you read the FDA guidance, just about every reference involving User Needs is tied directly to Design Validation. Validation proves your medical device meets User Needs and intended uses.

 

Documenting User Needs

Okay, so let me get into documenting User Needs. When documenting User Needs, think about your medical device product idea.

User needs describe how your medical device is going to be used. User needs help establish the framework for your medical device product design. Intended use describes the clinical issue your product addresses. Indications for Use pertain to clinical applications use, environment, and end user.

Here are some questions to help you better understand User Needs.

  • What do you want it to do?
  • Who is going to use it?
  • When will it be used?
  • What important features and attributes should be considered?
  • How will the user and patient interact with the device?
  • What type of procedures will the device be used?
  • What type of environment will the device be used?
  • When will the device be used?
  • Is the device used one time or over and over?
  • What other products will the device interact and interface with?

There likely are dozens and dozens more questions you need to ask.

And answer! Document your responses to all the questions.

Your responses become the information you should consider as the User Needs for your medical device idea, and included as part of your Design Controls.

Looking again at the waterfall diagram, you see that the proposed next major step after User Needs is Design Inputs. Logically, User Needs are the lead into Design Inputs.

And many medical device product development professionals will share with you how important Design Inputs are to the success of a new device.

Do not be too worried about whether or not your User Needs are exactly correct. Do not get too hung up on the format and wording.

Do realize that one day in the future, you will need to demonstrate that the product you develop addresses the User Needs you define.

The traceability matrix described earlier in this guide starts with the User Needs. User Needs feed into Design Inputs. Design Validation proves User Needs are met.


 

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The purpose behind Design & Development Planning

In my experience, the topic of Design & Development Planning is very misunderstood. When most medical device product developers think about Design & Development Planning, the first thing that comes to mind is this:

Project schedule.

Since there is confusion about this, let me share what FDA and ISO state about Design & Development Planning.

FDA 21 CFR 820.30(b) Design & Development Planning: Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

ISO 13485:2003 7.3.1 Design and development planning: The organization shall establish documented procedures for design and development.

The organization shall plan and control the design and development of product.

During the design and development planning, the organization shall determine

a) the design and development stages,

b) the review, verification, validation, and design transfer activities (see NOTE) that are appropriate at each design and development stage, and

c) the responsibilities and authorities for design and development.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be documented, and updated as appropriate, as the design and development progresses.

NOTE – Design transfer activities during the the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.

Did you come across anything that suggests project schedule? Or timeline?

Your product development schedule is definitely important. Don’t mishear me.

Remember where I shared some thoughts about product development versus Design Controls earlier in this guide?

Project schedule versus Design & Development Planning is in the same vein. Project schedule is a product development thing. Yet there is also a definite relationship with Design & Development Planning.

 

What goes into a Design & Development Plan?

Let me pick out the important aspects about Design & Development Planning from what FDA and ISO state about the topic:

  • Identify Design & Development stages and activities
  • Define responsibility for Design & Development activities
  • Define the resources required; this includes project team members, as well as vendors
  • Plans should evolve throughout Design & Development

Design & Development Plan describes all the Design Controls, including when Design Reviews are expected. The plan describes who the team members are, including roles and responsibilities. The plan is not a “one and done” and needs to be revisited and updated throughout the project.

 

 


 

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Understanding the role and importance of Design Reviews

Design Reviews are moments in time for you to evaluate the progress of your medical device project as it progresses through development.

During Design Reviews, you and the project team are formally reviewing — and agreeing to — Design Controls.

Design Reviews are also a time in a project to bring the team together in order to scrutinize and evaluate the state of the medical device and ensure that what needs to be done has been addressed.

 

How many? Who is involved?

How many Design Reviews does your medical device product development project need? This is a good question to ask. I do not have the answer for your project.

Here’s what I can tell you about Design Reviews.

How many Design Reviews to have depends on numerous factors. Factors like what the product is and who the players are need to be considered when determining timing of Design Reviews.

The expectation is that your Design Review include the right functions (engineering, marketing, manufacturing, etc.). Also, you need to include a resource who is independent.

When should Design Reviews happen?

All Design Controls must be included as part of a Design Review. As noted, I cannot for certain tell you exactly when to have Design Reviews. If you press me to provide a definitive response on this question, I will defer to the what is suggested by the Design Controls waterfall diagram.

I will advise you to have a Design Review when User Needs are drafted.

I will advise you to have a Design Review after Design Inputs are established.

And after Design OutputsAfter Design VerificationAfter Design Validation…and before going to full production.

 

Design Reviews – the absolutes

Okay, let me be more helpful regarding Design Reviews.

First, you must have a record to prove that all Design Controls have been included as part of a Design Review.

Let me provide you a few “rules” when it comes to Design Review:

  1. Design Verification can not happen until Design Outputs and Design Inputs are done.
  2. Design Validation can not happen until User Needs are done.
  3. Design Transfer can not happen until Design Outputs are done.

 

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Becoming a Design Input artist

 

Ah, Design Inputs. It is important for you to understand Design Inputs and how critical these are to the entire success of your medical device project.

Design Inputs, in my opinion, are the most important Design Controls.

Keep in mind that throughout medical device product development, the terminology used is grossly inconsistent and highly dependent on who is talking.

What I mean by this is that very few use the terminology as described by FDA and ISO. Most have adapted their own lexicon when it comes to medical device product development.

No where is this more true than on the topic of Design Inputs.

Keep this in mind as you define Design Inputs and work with others who will contribute.

Here is a non-inclusive list of terms that is often used to mean “Design Inputs”:

  • Design Inputs
  • Design & Development Inputs
  • Design Input Requirements
  • Requirements
  • Design Requirements
  • Product Requirements
  • Requirements Specifications

It can be very confusing. And because of this, I highly encourage you to make sure that you and your team members speak the same language when it comes to Design Controls — especially Design Inputs.

 

What are Design Inputs?

Design Inputs define all the performance criteria, requirements, and features of your medical device product.

There are numerous resources that feed into Design Inputs. From a Design Controls perspective, the primary resource that feeds Design Inputs are the User Needs.

Often times User Needs are broad statements that may be difficult to measure. User Needs include words like “easy”, “better”, “simple” — subjective, abstract concepts. And this is okay. I encourage having User Needs defined in this way.

  1. Design Inputs, though, should not be subjective, abstract concepts.
  2. Design Inputs should be objective. Measurable.
  3. Think of User Needs as the precursor to Design Inputs. (And show how these are linked in a traceability matrix.)
  4. Do not rely solely on User Needs as the only resource for Design Inputs.

There are things like industry standards, regulations, and competitive products that you should also consider when it comes to defining Design Inputs.

Plus, unless you are tackling medical device product development solo, you have other people working with you who should help define Design Inputs.

 

Think about Design Verification

I know I have not shared what Design Verification is just yet in this guide. Let me give you a preview: Design Verification proves you designed the medical device correctly.

Because of this, you should definitely consider how you plan to verify your product design at the time when you are documenting Design Inputs.

Considering how you will verify will have a profound impact on the content of Design Inputs. You should definitely put thought into how you will prove your medical device will be verified when you define Design Inputs.

Taking Design Verification into consideration when defining Design Inputs will also help your product development efforts. This approach will also help you plan and understand potential Design Verification activities. This is meaningful because Design Verification tasks can be very expensive and take significant amounts of time to complete.

 

Design Inputs become a roadmap for the product developer

Design Inputs describe everything that is important and required about your medical device.

Design Inputs become a roadmap, or set of “directions”, that a medical device product developer uses to design and develop a product.

Design Inputs provide the important criteria that must be included in the design of the actual medical device.


 

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Defining how to make your medical device through Design Outputs

Let’s check in a bit on what Design Controls I’ve covered with you so far.

I shared what a DHF is and why is matters. I explained Design & Development Planning. And importance of Design Reviews.

I talked about User Needs. About how User Needs are the precursor to Design Inputs.

Remember Design Inputs are the roadmap used to design and develop your medical device.

Let me spend a few minutes talking to you about Design Outputs being a recipe and how these contribute to figuring out how to actually design and develop your medical device.

 

Design Outputs are the recipe

As you get into the hands-on, nitty gritty design and development, you start to identify all the parts and pieces that are required for your medical device.

What components go into your medical device? How are these components put together?

What I’m trying to say is this: Your medical device is comprised of a number of materials, components, sub-assemblies, and so on. And each of these parts need to be defined and documented.

Things like drawings, specifications, instructions.

Think of Design Outputs as the recipe for making your medical device. Design Outputs are the documents you would give to someone to assemble your product.

As you establish the Design Outputs, you need to show how these relate and link to the Design Inputs.

Once again, this can be done in Excel quite easily early on in product development but as the project nears market release, these relationships will become increasingly complex.

 

Design Outputs are the preliminary Device Master Record

Yes, this guide is about Design Controls. At the same time, it is important how various Design Controls have an influence and impact after you launch your medical device.

Design Outputs have a huge impact on the future state of your medical device. Fast forward with me for a moment.

When you have transferred from product development into manufacturing, you need to establish a Device Master Record for each product.

Device Master Record (DMR) is defined by FDA as:

a compilation of records containing the procedures and specifications for a finished device

A DMR is the recipe.

Just like Design Outputs.


 

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Proving you designed correctly via Design Verification

Let me take you back a couple of topics. Think (or look) back at Design Inputs. I expressed that there is a strong relationship with Design Inputs and Design Verification. I encouraged you to think about how you are going to conduct Design Verification when you define Design Inputs.

When you get to Design Verification, your goal is to prove your Design Outputs meet the Design Inputs. Design Verification is all about demonstrating you correctly designed your medical device.

If you have been keeping your Design Controls traceability matrix up to date, you have a clear picture of the relationship between your Design Inputs and Design Outputs. Having this clear picture is very helpful when it comes to conducting Design Verification.

So how do you conduct Design Verification?

 

Testing, Inspection, Analysis

When you ask an experienced medical device product developer to describe Design Verification, it’s likely you will hear this described as testing.

“Yes, testing is a very common method used to conduct Design Verification.”

Remember, Design Verification is about proving Design Outputs meet Design Inputs.

Yes, testing is a completely valid way to prove this.

Although testing is not the only way to conduct Design Verification. You might also be able to employ inspection and analysis as acceptable methods for Design Verification.

  1. Plan your Design Verification before you conduct tests, inspection, analyses.
  2. Identify what you are going to do before you do it. Determine the best ways to prove Design Outputs meet Design Inputs.
  3. And then do it! Complete your Design Verification activities, document results.
  4. Update your traceability matrix to show how Design Verification proves your Design Outputs meet Design Inputs.

Preparing regulatory submissions

I want to spend a few moments now talking a bit about regulatory submissions and the relationship with Design Controls.

Generally speaking, as you successfully finish Design Verification, this means you are approaching a time when you can prepare a regulatory submission.

Specifically, this is the time in your medical device project when you should put together your FDA 510(k) submission (provided this is your path to market clearance).

If you plan to conduct a human clinical investigation in the U.S., this also marks the time when you should put together a FDA investigational device exemption (IDE) submission. (An IDE is likely for FDA PMA devices or could be of interest for clinical investigation before receiving 510(k) clearance.)

Outside the U.S. regulatory submissions and files are provided to regulatory bodies during Design Transfer.

Let me share a few links that are step-by-step examples for how to handle preparing different types of regulatory submissions.

CE Marking Process for Medical Devices – A Step by Step Example

Canadian Licence Process for Medical Devices – A Step by Step Example

FDA 510(k) or CE Marking?

 


 

 

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Proving you have the correct device via Design Validation

Design Verification is about proving you designed your medical device correctly(e.g.: the Design Output meets the Design Input requirements).

Design Validation is about proving you designed the correct medical device.

Please understand the distinction. To do so, it helps to know that Design Validation demonstrates that your medical device meets User Needs and its intended uses.

Design Validation is the time when you revisit these User Needs. Validation is when you demonstrate that the User Needs are met.

Okay, not you per se. But actually end-users. Yes, that’s right — end users should be involved with Design Validation.

This is the whole intent and purpose: prove your medical device meets the needs of the end user.

 

Design Transfer begins

Design Validation most definitely involves evaluation of products. And because of this, the process of transferring a medical device from product development to production (often referred to as “Design Transfer”) begins during Design Validation.

In order to validate the design of your medical device, you need to build products. These products are to be built using production equivalent documentation and processes.

So all those Design Outputs (the preliminary DMR) need to be converted to the production environment and used by production personnel to assemble devices.

These production units (maybe the first) are then put in the hands of end users.

 

Have a plan of attack

If you remember the discussion about User Needs, I shared that sometimes User Needs have a tendency to be a little ambiguous, using words like “easy” and “better”. With Design Validation, you need to figure out how to prove that your product accomplishes this.

You need to establish a Design Validation plan. This plan needs to identify how many end users, what type of testing is required, and so on.

The end goal of Design Validation is to have objective, documented evidence.

Completing Design Validation is an important step in closing the loop on your traceability matrix too. The traceability matrix started with User Needs and ends with Design Validation.


 

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Completing Design Transfer

As I noted, the Design Transfer process actually starts earlier in your project. It begins when you build products for Design Validation.

I also shared how Design Outputs are the preliminary Device Master Record. And the DMR is used by production to make medical devices.

Once you complete Design Validation, you are anxious to officially wrap up product development.

It’s time for you to have a final Design Review. This one may be a doozy (and may be a good idea to break it up in chunks).

The goal of this Design Transfer Design Review is to make sure everything that is needed for production is ready and done.

Completing Design Transfer signifies your medical device is ready to exit product development and officially enter into production.

This is significant because up until this point the “control” of the medical device has been the responsibility of the project team. Once Design Transfer occurs, the control shifts to production resources.

 

Button up the DHF

I hope you are keeping your Design History File up to date and current as you go through the medical device product development process. This is the best option by far!

Nothing is worse than getting to the Design Transfer stage and discovering that the DHF needs work. It happens. And if your DHF needs work, take the time and do it.

Don’t fall into the trap of saying that you will get to it later.

You won’t.

I’ve shared throughout this guide tips and pointers regarding the need to create and maintain a Design Controls traceability matrix. Keeping your traceability matrix current and up to date makes Design Transfer a much simpler process.

After you complete Design Transfer, the DHF is the ultimate record proving you have satisfied Design Controls.

And your DHF might be reviewed, audited, and/or inspected one day. Keep that in mind.


 

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Launch!

After you complete your Design Transfer Design Review, you are almost ready for market launch. You also need to ensure that you have all the necessary regulatory clearances.

Then, at least from a Design Controls perspective, it’s time to sell your medical device.

 

The Ultimate Guide To Design Controls For Medical Device Startups


 

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Summary of the Ultimate Guide to Design Controls for Medical Device Startups

Design Controls should be a systematic way to demonstrate the progress of your medical device product development efforts.

In this guide, I have shared with you what is expected for Design History File, User Needs, Design & Development Planning, Design Reviews, Design Inputs, Design Outputs, Design Verification, Design Validation, and Design Transfer.

I hope this guide helps answer all your questions about Design Controls (let me know in the comments!) — even the questions you didn’t know you had.

Medical device product development should follow a structured, methodical approach with traceability throughout. But we all know nothing always goes according to plan.

That’s why in addition to this guide, we’ve also created greenlight.guru, an easy to use, cloud-based software platform designed specifically to help medical device startups better managing their Design Controls & Quality System.

Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of all medical device recalls are due to design problems. This is despite the fact that intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase.

When Design Controls are not built strongly enough into the medical devices, these are some of the implications:

o  Design Control flaws are a reason for a significant number of recalls

Design Control issues lead to complaints and medical device reports

o  When Design Control is not properly put in place, the manufacturer can face issues related to manufacturability, like low yields and excessive scrap and rework.

The solution is getting trained on Design Control issues and understanding the ways of implementing them

Given the severity of Design Control issues, medical devices manufacturers need to address the problem with one solid solution: Understand how to locate and fix issues early on in the design process. If this is not done, the consequences can be expensive. Finding and fixing problems for medical devices that are already in production is must more expensive than doing so at an earlier stage. What is more; such a process can also make the Design Control less effective.

How do medical device companies ensure a Design Control process that is free of hassles and will serve the primary intention for which it is to be implemented? This is the teaching a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas, will impart.

At this seminar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the Director.  In order to gain insights into how to imbibe Design Controls into the earliest possible stages of medical device manufacture, please visit Medical device companies need to get their design controls right to register for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An important session on Design Controls

The main intention of this seminar is to provide a clear and deep understanding of the nature and importance of Design Controls in medical devices, and the ways of developing Design Controls processes and tools that are compliant with the regulatory requirements. Susanne will offer these to ensure that they become a competitive strength for their organizations. With this learning, participants can learn from past issues and mend their next generations of product.

An explanation of the requirements for design controls and an understanding of how to translate them into an efficient and effective process for their organizations will be given. Susanne will begin with the history and requirements for Design Controls. The next topic she will take up in detail is the requirements and tools needed to ensure product quality, while also meeting business needs for speed to market.

Also included are exercises to help participants practice what they have learnt here theoretically. At the end of this two-day session, participants will have gained the knowledge needed to improve their design control process.

Susanne will cover the following areas at this seminar:

o  Expectations

o  Regulations and History

o  Design Control process, procedures, forms, records, files

o  Linkages to the rest of your Quality Management System

o  Lessons Learned

o  Myths

o  Challenges

o  Best Practices

o  Inspection Readiness.

Statistics for Medical Professionals

Medical statistics, also called biostatistics, is an important area for medical professionals. Statistics and the medical professionals may not seem very easily associable with each other at first glance, but a deeper look suggests the connection between statistics and the medical profession.

Statistics is a set of data and tables. These figures are meant to offer understanding and perspectives on a number of issues. When it comes to the medical profession; statistics for medical professionals becomes very important to those in the field of public health. Every time a government or an international agency of a world body such as the UN undertakes a program on public health; statistics are of immense importance for medical professionals.

Many uses of statistics for medical professionalsStatistics for medical professionals is useful in helping them analyze public health issues. Detailed figures of the incidence of malaria for instance, are a very useful piece of statistics for medical professionals. This kind of statistics helps them determine the causes of the disease and helps them decide on the plan of action.

Statistics for medical professionals is also useful at the local level. A medical professional working in a town or village could benefit immensely when she has statistics meant for medical professionals. It helps the professional understand what local causes are giving rise to health issues. Statistics for medical professionals thus helps them tackle issues at the local as well as the global levels

A specialized fieldIn developed countries, statistics for medical professionals has become a full-fledged profession. It is finessed at graduate and postgraduate programs at which they study the essentials of statistics for medical professionals. They then carry out programs that are suited for their profession.

Statistics for medical professionals is used in a wide variety of disciplines. Usually, courses on statistics for medical professionals cover the following areas:

  • Data Analysis of statistics for medical professionals
  • Dealing with Missing Data
  • Higher Issues in Trials
  • Linear Regression and Correlation
  • Logistic Regression
  • Correlated Data analysis
  • Continuous Data comparison between groups
  • Survival Data analysis
  • Risk, Rates and Odds of statistics for medical professionals
  • Randomized Trials
  • Observational Studies of statistics for medical professionals
  • Categorical Data comparison between groups
  • Calculations of Sample Size
  • Testing of Estimation and Hypothesis

More information go through this link: https://www.globalcompliancepanel.com/seminar?Linkedin_SEO