Challenges of the Medical Device Design File History

The experts discussed what medical device manufacturers need to know about medical device design compliance. Below are some highlights.

Three Pillars of Design Compliance

There are three pillars of compliance for medical devices design:

  1. Medical Device Design Controls: The moving parts of product design and development
  2. DHF: Collection of records from design and development activities
  3. Device Master Record (DMR): The “recipe” for product manufacturing once design is complete

In order to achieve FDA compliance and effectively bring your product to market, you must successfully satisfy each of the three pillars.

What is a DHF?

The DHF is a compilation of documents that describe the design and development activities of a medical device. Its purpose is to show that the medical device was developed using the design control process, pictured below, needed to meet FDA requirements.

The FDA records explicit rules for DHF under 21 CFR 820.30 (j): 

“Every producer will set up and keep up a DHF for each kind of clinical gadget. The DHF will contain or reference the records important to show that the plan was created as per the endorsed configuration plan and the guidelines of this part.” 

The DHF likewise gives detectability to necessities, can help with change control and goes about as a device for information protection and data sharing inside your association or with your flexibly chain. 

Complexities of an Incomplete DHF 

As the second mainstay of plan consistence, the DHF associates the first and the third columns. As noted, it reports that the right plan control measure was followed. The DHF is additionally the premise of the DMR, which must be made by plan determinations. 

A deficient DHF makes it almost difficult to demonstrate you utilized the right plan control measure for meeting FDA consistence, or make an agreeable DMR. 

Moreover, if there are insufficiencies noted inside the plan control subsystem during an investigation, they are archived by the FDA. On the off chance that your organization’s reaction is deficient or not convenient – which is likely when your DHF is missing – a public admonition letter could be given. This couldn’t just damage your believability on the lookout, yet it may likewise give your opposition a few bits of knowledge that you’d preferably have stayed with inside your’s dividers. 

Five Common Pitfalls of the DHF 

As per specialists, these are some different reasons a DHF may fizzle: 

Not having a DHF 

Generally little organizations tied for assets will invest every one of their amounts of energy into planning and getting an item to showcase, with the goal of doing the DHF later on. This could be because of an absence of comprehension of what DHF yields are required. 

Disordered and sloppy DHF 

This is more normal in paper-based organizations that keep all data in fasteners, however leave off dates or incorporate unapproved records, making it difficult to arrange at the hour of a review or assessment. 

Disruption — regardless of whether paper-or email-based — likewise makes it hard to oversee changes and corrections because of data storehouses and absence of sharing data. 

Counting superfluous records 

Adding business records, for example, provider cites, budgetary data or unused ideas, can bring a whirlwind of undesirable inquiries from overseers. This can likewise be a side effect of not having a DHF instrument or format, just as a direct cycle that includes protracted audit and endorsement times. 

Unmaintained DHF 

Frequently organizations utilize either obsolete or inappropriate innovation for the work. Paper-based frameworks, email, common envelopes with read-compose access and so forth, are not generally compelling record controls. This can prompt lost duplicates of significant records, making a DHF rebellious. 

Not recognizable to yields 

Without a DHF, it’s difficult to make your DMR, and exceptionally hard to build up your discernibility lattice. On the off chance that plan control results are not very much recorded, simple to find or current, your DMR will neglect to be agreeable. 

On the off chance that it seems like making a DHF is a weighty weight, you ought to truly consider the options just as the desire to make it a reconsideration. In the event that you treat your DHF as a component of your plan and advancement measure, these necessities become consistent and help facilitate the way to consistence.

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The Development of Devices Regulations in the UK and Europe

It is normal the UK and the EU Regulations won’t consent to hold the guideline of clinical gadgets inside a typical EU administrative structure. This implies that from January first 2021 the Medicines and Healthcare items Regulatory Agency (MHRA) will turn into the independent drugs and clinical gadgets controller for the UK.

CAB, UKCA and other post-Brexit changes in the Regulations

With respect to the guideline of clinical gadgets, the UK Government is arranging another bit of enactment called the Medicines and Medical Devices Bill. The MHRA has just expressed in its latest exhortation that it means to “contemplate worldwide principles and worldwide harmonization” in the advancement of any future arrangement of clinical gadget guideline. Also, that they will “distinguish and organize components of worldwide practice that advance general wellbeing and patient security.” So two topics arise: (1) the function of global principles, and (2) the longing to line up with worldwide necessities where conceivable.

Two changes coming because of Brexit are especially applicable to convenience:

New bodies, called Conformity Assessment Bodies (CAB) will perform viably similar capacity as Notified Bodies in that they will evaluate the nature of the specialized data provided by producers, including obviously the convenience designing information.

Another imprint – the UK Conformity Assessed (UKCA) mark supplanting the CE mark – will be accessible for makers to use from January first 2021 onwards. The UKCA mark is compulsory on all gadgets from July first, 2023. So a CAB should be fulfilled that the nature of ease of use information is satisfactory to help this new imprint.

In the two cases, these progressions are huge for convenience since they give the human elements (i.e., ease of use designing) measure system by which the nature of information, for example, the aftereffects of a human variables approval test, will be assessed as supporting proof.

What occurs for clinical gadget ease of use necessities?

All in all, what are the reasonable ramifications for clinical item designers as far as convenience? Indeed, to get on the focuses about worldwide principles, and worldwide harmonization, somehow or another the progressions are procedural and not especially considerable and, accordingly, the key methodologies won’t change. Why?

Function of IEC62366-1: MHRA states that global principles will keep on being utilized. The Usability Engineering standard IEC62366 is perceived by Notified Bodies and is sure to be continued into the CABs. So this implies that producers should keep on utilizing IEC62366-1 as the “go-to” standard for applying Usability Engineering techniques. As we have composed already, there are solid connections between the exercises suggested in IEC62366-1 and the ease of use necessities characteristic in the European Medical Devices Regulation (MDR).

MHRA Human Factors direction: MHRA created their own human components direction in 2017. This direction prescribes a way to deal with human factors that adjusts intimately with the US FDA, and furthermore with the necessities in IEC62366-1. We are not expecting MHRA to refresh this direction any time soon, so for a long time to come they will be the most current direction from MHRA.

Clinical gadget guidelines: The UK Government’s impending guidelines on clinical gadget endorsements will very likely have convenience prerequisites that are indistinguishable from those natural in the EU MDR. This is on the grounds that the basics of convenience designing (or human variables) don’t perceive geology. For instance, the need to obviously characterize proposed clients and plan the clinical gadget considering clients’ abilities and requirements is remembered for the MDR just as the US Code of Federal Regulations 820 (Title 21, subpart C, Design controls). It is incomprehensible that the UK’s impending guidelines will contrast profoundly.

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When does in-house prototypes make sense?

Medical device companies have increasingly outsourced prototypes over the past two decades. It doesn’t have to be that way.

Dr. Elliot Fegelman & Benjamim Ko, Kaleidoscope Innovation

Product creators have historically constructed their own parts and prototypes, whether tinkering in the workshop or at multi-specialty design/build shops.

However as machining capabilities have accumulated complexity and capabilities, they have also become more costly and have occupied more floor space. A five-axis CNC machine, for instance, requires knowledge that a knee mill does not.

Many of the in-house “build” skills that were once the hallmark of product design have been outsourced to prototyping specialists with this increased specialisation. However an in-house rapid prototyping shop will still make sense for those with the space and access to a workforce trained in CAD and machining. This is how:

Turnaround time

While the off-site prototype shops excel in rapid turnaround and shipping, there’s a greater efficiency created when engineers just need to walk down the hall to consult with a prototyping specialist, discuss the item and know it will go into the queue that afternoon.


That visit to the specialist involves more than just handing over a CAD file. Using their skills in CAD and machining, the specialist can make suggestions to the design engineers on placing a radius, augmenting tooling efficiency and reducing touch. These prototyping recommendations can often be translated into the final manufacturing process to save valuable time in a complex schedule.


With the advent of 3D printing, designers and engineers have enjoyed rapid turnaround and true-to-form pieces, but the tolerances or robustness of those pieces can be lacking. Machined parts made of true material make the integration between pieces more predictable and the tolerance for field stressors more robust. This method of prototyping also eliminates the oft-heard excuse of blaming 3D-printed parts for technical flaws that may or may not truly be mitigated by production-equivalent devices.

Customer satisfaction

The triple constraints of time, cost and quality are still alive and well, heightened by today’s speed of innovation. In-house prototyping shortens the iteration cycle, but more importantly, reduces the need for iterations. When the pieces fit and function the first time, the critical design improvements needed to enhance the product — not the prototypes — are more easily identified, shortening the process.

Business development

For businesses that deliver value through innovative design and manufacturing processes, differentiation is critical. An in-house rapid prototype shop staffed by specialists, combined with 3D printing capabilities, offers clients an efficient and bespoke approach to meeting their needs.

Some trends are best followed; many are best to lead. Sometimes it’s most impactful to buck the trend. In-house machining capabilities with multi-axis CNC lathes and mills, precision EDM wire machines along with the specialists to wield them can add overall improvements in timelines, costs and customer satisfaction.

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Nanotechnology & Medical Device Development

The production of medical devices using systems and methods of nanotechnology is just getting underway. A National Science Foundation Nanosystems Engineering Research Center to investigate and do basic research on self-powered health monitoring will be led by North Carolina State University. The software is called ASSIST, for Integrated Sensors and Technology Advanced Self-Powered Systems.

In daily life, medical devices have become indispensable and serve growing demand. Medical device applications range from big devices (e.g. heart-lung machines) to diagnostic instruments such as software and implants, injection needles and to name a few, mechanical contraceptives. The compatibility of the materials utilized to create medical devices with the biological surfaces they encounter is of high importance, especially for the use of such devices at and within the human body.

An indispensable aspect of the field of medical devices is nanotechnology. With nanotechnology, the extremely small size of batteries (e.g. pacemakers) or electronic circuits and sensors used in medical devices today has been made possible. New teeth-filling ceramics or dental implant screws are increasingly made up of materials derived from sintered nanopowders (comparable to 3D printing) or have a specially built surface made of so-called nanostructures.

Supported over five years by an NSF grant of $18.5 million, the goal is to build nanoscale sensors powered by the body’s own energy, thus removing the need for battery power. The sensors would be built into wearable devices, such as patches or wristbands, which would provide continuous monitoring of heart rate, respiration rate, and other measures of health, as well as environmental pollutant exposure monitoring.

This news is representative of where the design and production of medical devices are going. While the program is just getting underway and the technology is in the very early phase of testing, Forma hopes to actively contribute by helping to conceptualize what these devices might become and how the nanotechnology might be packaged in future medical devices.

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Medical Device Manufacturing Constraints – The Good and the Bad

In the medical device industry, injection molders are specialized in achieving thin walls, close tolerances, and very small component characteristics. In these respects, the design of medical devices has fewer restrictions than other industries in which walls are usually thicker and structural integrity features wider. Generally, in our projects, we do everything possible to minimize undercuts and other troublesome geometry. But for certain medical goods, relatively lower price pressures build economies for the medical devices industry that allow design features that might be cost-prohibitive to achieve in other industries. In order to produce undercut features, collapsible cores can be used, tighter tolerances can be preserved and draught angles can be lower. In this article, we will talk about the challenges of medical device manufacturing.



The main driver behind the high cost of the development of new products is the amount of time needed to take an idea from conception to realisation. These costs can be reduced by establishing a solid basis for a design project with clear and concise requirement specifications, and organisations will realise faster “to-market” times and enhanced ROI.


The significance of understanding who the stakeholders in the design specifications process are and involving them early in the process was addressed. When it comes to coping with the issues posed by the new regulatory landscape for medical devices, your regulatory and quality team are key contributors.It is crucial, however for all team members, especially engineers and project leaders, to have at least a high-level understanding of the requirements, as you are likely to experience problems.


As the Internet of Things (IoT) becomes rapidly incorporated into society and more devices hold essential personal data from users, privacy and trust are a growing security issue for companies in the field of medical devices.

Technology and data integrity criteria were also noted in section 1., above, as an example of a significant consideration from a cost-savings perspective for the early stages of the product design/requirements process.

Organizations need to approach this issue with a ‘security by design’ mentality to ensure regulatory enforcement and consumer confidence and trust, i.e. designing technology and security considerations from the outset, instead of as a post-design necessity. This is why it is important to include IT in the stakeholder team of design specifications from the beginning.

The first step in ensuring user privacy is secured at the heart of the product is the integration of privacy and protection measures into the embedded software systems in the earliest stages (authoring requirements). It mitigates a variety of privacy concerns that may arise further down the development path by integrating protection as functionality. Requirements also allow writers to provide contingency plans on what to do if/when a violation occurs.


Brand recalls are another manner in which the reputation and bottom-line of a business can be easily and devastatingly affected, along with regulatory agency compliance measures and data breaches. More importantly, poor product quality can lead to severe injury to end-users or even death. Although these problems are faced by even the most common medical devices, newer, more technologically advanced products are at even higher risk.


In today’s highly competitive medical device industry, providing a clearly defined, efficient process for requirement preparation is much more important. Companies need to be more efficient and effective than their competition in responding to consumer needs. The key to this is to ensure that all those who have a stake in the process are included, along with streamlining the process of requirements and using resources to ensure that clearly specified requirements are established from the beginning.

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Reduce Pain through Medical Device

Because of the opioid addiction epidemic in the US, there has been a push this year to encourage the development of non-addictive methods to Reduce chronic and Acute pain.

The SprintPNS (peripheral nerve stimulation) device consists of an electrical lead that is guided to its placement position via ultrasound imaging. The lead is positioned up to 2 centimeters from the target nerve, where its function is most efficient. It can be positioned in various ways to stimulate different nerve fibers. The other end of the lead is connected to a pulse generator, which is a patch-like device that receives its signal wirelessly from a small, hand-held controller. The device can be worn for up to 60 days. The lead is coiled, which allows ingrowth of fibrotic tissue at the lead exit site, anchoring the lead and also reduce pain and chance that infection could develop.

Quell by NeuroMetrix

Quell supports patients with chronic back, arthritic, nerve, leg, and foot pain by using neurostimulation technology to tap into the body’s normal pain response and block pain signals. For daytime and overnight use the wearable interface is FDA-cleared. It is inserted into a cuff that can be placed on the body and has an accompanying software that helps individuals control pain management and chronic pain-affected sleep habits.

A clinical study of 713 Quell users published in April 2018 by the Journal of Pain Research found that 80% reported changes in their chronic pain and about 66% reported reductions in their usage of pain medication due to the use of Quell. On average, for 35 hours per week, study participants used Quell.

Since pain is highly personal and all persons handle it differently, people with chronic pain frequently require a range of medications to find relief-what we call a “toolbox approach” to chronic pain. 

StimRouter by Bioness Via peripheral nerve stimulation, this long-term pain solution treats chronic nerve pain. Since releasing in 2016, it has been used on 24 separate peripheral nerves. “Mark Geiger, global director of marketing implantables at Bioness, the company that produces StimRouter, says the device is 15 centimetres and “feels like a limp piece of spaghetti.

“The nerve does not transmit a pain signal by stimulating the target peripheral nerve with a tiny amount of energy that feels like a mild tingling sensation. This stimulus will cause the nerve to function more normally over time,” Geiger says. “So, compared to global pain reduction with oral or IV pain medication with all the typical, sometimes deleterious side effects, the difference is targeted pain management at the source of the pain.”

The StimRouter, when the patient is under local anaesthesia, is inserted through the skin. Patients will provide input to the doctor who is implanting the system right away.A permanent solution intended to last a lifetime is the StimRouter. In many cases patients use the StimRouter for shorter durations over time with increasing carry-over pain relief dependent on many hundreds of implants, ensuring pain relief lasts for hours/days after the patient shuts off the StimRouter,

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Types of Orthopedic Implants

While orthopedic doctors don’t create life, they do attempt to do all that they can to improve our quality of life , which not exclusively can add significance to our lives, yet permits us to live without the agony and enduring that ongoing torment or injury can bring. Furthermore, that is the place where orthopedic implants come in. Implants are utilized as substitutions of body parts, and as a general rule, the outcomes are life changing. 

The three most regular sorts of orthopedic implants are screws, plates, and prostheses, and you can be certain that once your equipment is set up, you will feel like your orthopedist has resurrected you! 


Looking almost indistinguishable from the screws you may discover at a tool shop, muscular screws can have either a level or Phillips head, and are utilized to straighten out harmed territories, for example, a torn labrum or rotator sleeve. Anticipate that your orthopedist should utilize screws to fix broke bone or reestablish soundness in a frail zone, and don’t anticipate having them taken out. Normally, your screws are there to remain. 


Muscular plates were first used to fix long bone cracks in 1886 – over 50 years after Mary Shelley composed Frankenstein. Maybe these specialists were motivated by this repulsiveness magnum opus? It is suspicious, in light of the fact that plates were at that point and stay a best treatment for cracks, recreation and steadiness. There are five essential sorts of plates: 

Support plates are utilized to hold together breaks toward the finish of long bones, specifically, at the knee and lower leg, where the crack site encounters huge compressive and other mutilating powers. These plates are molded so they can move with the body, be that as it may, some might be L-or T-formed. 

Balance plates are not a particular plate, but instead, a classification of plates that work to traverse the cracked region, adjusting the heap so that screws or different devices can make sure about and balance out the territory. 

Spanning plates are utilized to balance out the territory while giving length and arrangement. Moreover, connecting plates advance optional bone recuperating on the grounds that they safeguard the blood flexibly to the crack parts by not upsetting the harmed zone. 

Strain plates generally are wires used to make sure about a region as it recuperates. 

Pressure plates are metallic plates used to fix a bone by utilizing dynamic weight between bone pieces to advance mending. 


Orthopedists utilize an assortment of muscular prosthetic inserts to supplant missing joints or bones, or to offer help to a harmed bone. Most ordinarily, orthopedists use prostheses for knees and hips, permitting the patients to recover full scope of movement, torment free, in a moderately short measure of time. Sometimes, the prosthetic material can be joined with solid unresolved issue infected or harmed bone, or prostheses can supplant certain pieces of a joint bone completely. 

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